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NJ Office of the Attorney General
Division of Consumer Affairs

New Jersey Register
Volume 37, Number 14
Monday, July 19, 2004
Rule Proposal

Law and Public Safety
Division of Consumer Affairs
BOARD OF PHARMACY
Board of Pharmacy Rules

Proposed Readoption with Recodifications and Amendments: N.J.A.C. 13:39

Proposed Repeals: N.J.A.C. 13:39-3.8, 3.9, 3.10, 3.12, 3.13, 3.15, 3.16, 3.17, 4.13, 5.1, 6.4, 6.6, 8.6, 8.7, 9.8, 9.13, 9.22 and 11.4

Proposed New Rules: N.J.A.C. 13:39-2.6, 2.16 through 2.20, 3.2 through 3.6, 5.1, 6.1, 6.4, 7.1, 7.4, 7.8, 7.9, 9.1 and 9.26

Authorized By: Board of Pharmacy, Joanne Boyer, Executive Director.

Authority: N.J.S.A. 45:14-1 et seq. and 45:1-15.1.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2004-272.

Submit comments by September 17, 2004 to:
Joanne Boyer, Executive Director
Board of Pharmacy

PO Box 45013
Newark, N.J. 07101

The agency proposal follows:

Summary

The Board of Pharmacy (the Board) is proposing to readopt N.J.A.C. 13:39 with amendments. These rules are scheduled to expire on June 16, 2004, pursuant to Executive Order No. 66(1978). Because this notice of readoption has been filed prior to June 16, 2004, the expiration date of the rules in Chapter 39 is extended by 180 days, to December 13, 2004 pursuant to N.J.S.A. 52:14B-5.1c.

In compliance with the Executive Order, the Board undertook a thorough review of the existing provisions of N.J.A.C. 13:39 in order to delete unnecessary or unreasonable rules and to clarify existing provisions. The Board believes that the rules proposed for readoption, as amended, are necessary, reasonable, understandable and responsive to the purpose for which they were promulgated.

Initially, the Board notes that it is proposing to recodify many of the existing rules in Chapter 39 in order to better organize the rules and to eliminate any confusion that may exist as a result of the existing codification. The Board believes that the new codification scheme will make the rules easier to follow and understand. Subchapter 1 continues to contain provisions of general applicability. Subchapter 2 contains rules regarding pharmacist licensure. Subchapter 3 sets forth rules applicable to licensure by reciprocity. Subchapter 4 contains requirements for pharmacy permits. The rules in Subchapter 5 set forth retail pharmacy facility requirements. The rules in Subchapter 6 concern the duties of the registered pharmacist-in-charge and other pharmacy personnel. Subchapter 7 sets forth requirements for drug dispensing and for maintaining patient prescription records. Subchapters 8, 9 and 10 continue to contain rules applicable to pharmacy training sites, pharmaceutical services for health care facilities, and automated medication systems, respectively. The rules in Subchapter 11 set forth requirements for compounding sterile and non-sterile products in retail and institutional pharmacies. Subchapter 12 continues to contain rules applicable to nuclear pharmacies. In addition to the reorganization of the subchapters, the Board notes that it has made minor, grammatical changes to many rules throughout the subchapters of N.J.A.C. 13:39. The Board believes that these technical amendments are necessary in order to clarify the existing language in the rules. The proposed amendments, however, do not alter the substantive meaning of the rules so amended.

The Board notes that the new Pharmacy Practice Act, P.L. 2003, c.280, N.J.S.A. 45:14-40 et seq., recently signed into law, will become effective on July 12, 2004. Several of the amendments that are being proposed at this time are being proposed in order to make the Board's current rules consistent with the new statutory provisions. The Board also notes, however, that many provisions from the new Practice Act have not been incorporated into the rules proposed for readoption with amendments because of time constraints and because the Board is still in the process of reviewing the regulatory issues raised by the new Act. The Board anticipates that it will be undertaking rulemaking activity in the near future to address any outstanding issues raised by the new Pharmacy Practice Act.

The following is a summary of the existing rules of Chapter 39 which the Board proposes to readopt, as well as a summary of the amendments and new rules which the Board is proposing to adopt at this time.

Subchapter 1 sets forth rules of general applicability. The Board is proposing that N.J.A.C. 13:39-1.1, which sets forth the purpose and scope of the subchapter, be amended to delete the existing reference to "supportive personnel." This term is proposed to be replaced with the term "pharmacy technicians." Currently, in practice, the term "supportive personnel" is often used to describe not only those persons who perform pharmaceutical functions, but also cashiers and/or clerks employed by the pharmacy to perform non- pharmaceutical related tasks. The term "pharmacy technician" is the phrase currently used to describe individuals who perform pharmaceutical related tasks throughout the regulated community in New Jersey and in a majority of other states. The Board is proposing that all references to "supportive personnel" throughout the rules be amended to refer to "pharmacy technicians" since it is this group that the Board's rules intend to reach and whose practice the Board has an interest in assuring is adequately supervised. In addition, the Board notes that the term "pharmacy technician" is used in the new Pharmacy Practice Act which, as noted above, will become effective on July 12, 2004, and the Board believes that this change in terminology is, therefore, statutorily mandated.

N.J.A.C. 13:39-1.2 provides definitions for relevant terms as the terms are used throughout the subchapter. The Board is amending the current definition of "address of record," which currently provides that a licensee's address of record may not be a post office box, to provide that a post office box may be used, provided the licensee also provides another address which includes a street, city, state and zip code. The Board has deleted the portion of the existing definition which provides that the address of record is part of the public record and may be disclosed upon request. The Board believes that this provision is unnecessary in light of the recently enacted provisions of the Open Public Records Act, P.L. 2001, c.404, N.J.S.A. 47:1A-1 et seq. In addition, the Board is proposing that the current definition of "direct supervision" be deleted and replaced with a definition of "immediate personal supervision" as the proposed definition more accurately reflects the level of supervision a registered pharmacist must provide to persons performing pharmaceutical-related functions. The definition of "supportive personnel" in N.J.A.C. 13:39-1.2 is also being deleted and replaced with a definition for the "pharmacy technician."

N.J.A.C. 13:39-1.3 sets forth the Board's fee schedule. The fees included in the current fee schedule for the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Jurisprudence Pharmacy Examination (MJPE) are proposed to be deleted because the Board does not establish nor collect the fees for these examinations. Applicants must remit payment of the fees directly to the testing entity. Similarly, the Board is proposing the deletion of the fee currently provided for the transfer of grades because this fee is also established and collected by the testing entity. The Board is also amending the fee schedule to include a $25.00 fee for the formal verification of a pharmacy license or permit. The Board notes that informal information regarding the status of pharmacy licenses is available without charge. In addition, the Board is amending the fee schedule to include place holders for the fees to be charged by the Board for reinstatement from administrative suspensions, as well as inactive license renewals. The fees will be established as part of a separate Division-wide rulemaking in the future. The fee schedule is also being amended to delete the $25.00 fee currently listed for replacement of wall permits because this fee is duplicative of the fee currently in place for the replacement of permits. The wall permits referenced in the rule are, in fact, annual renewal permits, the fee for the replacement of which is already provided for in N.J.A.C. 13:39-1.3.

N.J.A.C. 13:39-1.4 concerns the payment of penalties and currently provides that any fines imposed by the Board must be paid within 30 days of receipt of a penalty letter or final order of the Board. The Board is proposing to amend N.J.A.C. 13:39-1.4 to provide that all fines must be remitted within 10 days of the finalization of any penalty letter or order issued by the Board. N.J.A.C. 13:39-1.5, concerning hearings before the Board, is also proposed to be amended, to clarify that a hearing conducted pursuant to the Administrative Procedures Act, set forth at N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative Procedure Rules, set forth at N.J.A.C. 1:1, shall only be required in actions before the Board when there are demonstrated facts in dispute.

Subchapter 2 sets forth the licensure requirements for pharmacists. N.J.A.C. 13:39-2.1, concerning licensure examinations, N.J.A.C. 13:39- 2.2, concerning educational requirements, and N.J.A.C. 13:39-2.3, concerning applications for examination, are proposed to be readopted with technical changes. N.J.A.C. 13:39-2.4, 2.5 and 2.6, which are currently reserved, are proposed to be deleted. Existing rule N.J.A.C. 13:39-2.7, concerning the minimum age required for licensure, is proposed to be recodified as N.J.A.C. 13:39-2.4, without change. Existing rule N.J.A.C. 13:39-2.8, which requires applicants to submit proof of character, is proposed to be recodified as N.J.A.C. 13:39-2.5, with amendments. The Board is deleting existing paragraphs (a)1 and 2 of N.J.A.C. 13:39-2.5, which require an applicant to submit evidence that he or she is not an inebriate and is not addicted to the use of controlled dangerous substances. Proposed new paragraph (a)1 of the rule provides that an applicant must present proof that he or she is not presently engaged in drug or alcohol use that is likely to impair his or her ability to practice pharmacy with reasonable skill and safety. This language more accurately reflects the requirements imposed upon applicants pursuant to N.J.S.A. 45:1-21. The Board is proposing a new rule at N.J.A.C. 13:39-2.6, which will require an applicant for a pharmacy license to undergo a criminal history background check. This criminal history background check is required of all initial pharmacy applicants pursuant to N.J.S.A. 45:1-28 et seq. Existing rule N.J.A.C. 13:39-2.9, requiring applicants for the licensure examinations to submit proof of their identity, is proposed to be recodified as N.J.A.C. 13:39-2.7, with technical changes. Existing rule N.J.A.C. 13:39-2.10, which concerns violations of the Pharmacy Act, is proposed to be recodified at N.J.A.C. 13:39-2.8, without change.

The Board notes that several of the rules in existing Subchapter 3 are proposed to be recodified in Subchapter 2 because they concern requirements for licensure as a pharmacist. As noted above, the Board believes that codifying all licensure requirements into one subchapter will make the rules easier to follow and understand. Existing rule N.J.A.C. 13:39-3.11, which sets forth requirements for applicants for licensure who are educated in a foreign country, is proposed to be recodified at N.J.A.C. 13:39-2.9. The Board is proposing an amendment to N.J.A.C. 13:39-2.9, which would clarify that the provisions of the section will not apply to any foreign educated applicant who has graduated from a pharmacy school which has been accredited by the American Council of Pharmaceutical Education (ACPE) or which has been accredited by a program that ACPE itself has deemed ACPE-equivalent. Existing rule N.J.A.C. 13:39-3.1, which concerns the issuance of licenses, is proposed to be recodified at N.J.A.C. 13:39-2.10, with a new heading "Authorization to practice; display of license." The rule currently provides that an applicant who has successfully satisfied all requirements for licensure shall be issued an authorization to practice until his or her license is issued. The rule is being amended to provide that a licensee shall maintain such authorization on his or her person at all times while engaging in the practice of pharmacy until the initial license is issued. In addition, the Board is amending N.J.A.C. 13:39-2.10 to provide that upon issuance of a license, the initial wall license and current biennial renewal license must be conspicuously displayed in the pharmacist's principal place of employment. When a pharmacist is employed at more than one pharmacy, he or she must maintain the wallet-sized license issued by the Board on his or her person when he or she is working at a location where the wall license and current biennial license are not displayed. The Board believes that these amendments are necessary in order to ensure that pharmacists are always easily identifiable while in their places of employment.

Existing rule N.J.A.C. 13:39-3.2, concerning issuance of a replacement license, is proposed to be recodified at N.J.A.C. 13:39-2.11, with technical changes. Existing rule N.J.A.C. 13:39-3.3, concerning change of name, is proposed to be recodified at N.J.A.C. 13:39-2.12, with amendments. The Board is proposing that the rule, which currently does not provide a time frame in which licensees must notify the Board of a name change, be amended to require such notification to be provided within 30 days. The Board believes that this change is necessary in order to ensure that notification of such changes is made by licensees in a timely manner. N.J.A.C. 13:39-3.4, which establishes notification requirements for a change of address, is proposed to be recodified at N.J.A.C. 13:39-2.13. The Board is proposing that N.J.A.C. 13:39-2.13 be amended to provide that the failure to notify the Board of a change in address may result in disciplinary action. In addition, the rule is being amended to provide licensees with notice that the service of an administrative complaint or other Board-initiated process at a pharmacist's address of record shall be deemed adequate notice for the commencement of disciplinary proceedings. Existing rule N.J.A.C. 13:39-3.5, concerning certification of records, is proposed to be recodified as N.J.A.C. 13:39-2.14, with amendments. The Board is proposing to amend the rule to refer to verification of licensure, which more accurately reflects the process associated with ensuring that a pharmacist's license in New Jersey is in good standing. In order to obtain a license verification, the proposed amendments provide that a written request must be submitted to the Board, and the request must be accompanied by the fee specified in N.J.A.C. 13:39-1.3. Existing rule N.J.A.C. 13:39-3.6, concerning the reproduction of licenses, is proposed to be recodified as N.J.A.C. 13:39-2.15, with technical changes.

The Board is proposing new rules concerning license renewal, reinstatement from suspensions, and inactive license status as part of Subchapter 2. New rules N.J.A.C. 13:39-2.16, 2.17 and 2.18 are being proposed in light of recent amendments to the Uniform Enforcement Act, N.J.S.A. 45:1-7.1, P.L. 1999, c.403, which mandate certain license renewal, reinstatement and inactive licensure requirements. Proposed new rule N.J.A.C. 13:39-2.16, concerning biennial license renewal, provides that a pharmacist who submits a renewal application within 30 days following the date of license expiration shall submit the renewal fee, and a late fee. A pharmacist who fails to submit a renewal application within 30 days of license expiration shall have his or her license suspended without a hearing. Such a suspension is deemed an administrative suspension. A pharmacist who continues to engage in the practice of pharmacy with a suspended license shall be deemed to be engaging in the unauthorized practice of pharmacy. The proposed new rule also requires the Board to send a renewal notice to each pharmacist at least 60 days prior to the expiration of the license. If the notice to renew is not sent at least 60 days prior to the expiration date, no monetary penalties or fines may be imposed upon the pharmacist for the failure to renew.

Proposed new rule N.J.A.C. 13:39-2.17 establishes requirements for reinstatement from both administrative and disciplinary suspensions. A pharmacist who is serving an administrative suspension as a result of failing to renew his or her license may have his or her license reinstated within five years, provided the pharmacist submits a renewal application, and remits payment of all past due renewal fees, the reinstatement fee and any outstanding penalties imposed by the Board. The applicant for reinstatement must also submit evidence of having completed all delinquent continuing education credits, to a maximum of five years or 75 credits. If a licensee has had his or her license administratively suspended for more than five years, the pharmacist must also pass the MJPE and NAPLEX examinations. A pharmacist seeking reinstatement following a disciplinary suspension must submit an application, at the conclusion of the suspension, and must remit payment of the reinstatement fee and the applicable renewal fee. In addition, the pharmacist must furnish evidence of having satisfied all conditions imposed by the Board pursuant to any applicable disciplinary or reinstatement orders.

Proposed new rule N.J.A.C. 13:39-2.18 allows pharmacists to choose inactive status upon license renewal. A pharmacist electing inactive status may not engage in the practice of pharmacy in New Jersey for the entire biennial registration period. Only upon Board action in response to an application may a pharmacist resume the active practice of pharmacy in this State. The new rule provides that a licensee who has practiced pharmacy in another state for at least 1,000 hours within the two years prior to application, may resume active practice in this State upon payment of the renewal fee for the current biennial registration period. If the licensee has practiced for less than 1,000 hours, he or she must have completed 30 credits of continuing education within the two years prior to application, in addition to paying the renewal fee for the current biennial registration period. If a licensee has not practiced pharmacy in another state while he or she was inactive in New Jersey, he or she must submit evidence of having completed 15 credits of continuing education per year, to a maximum of 75 credits, and must pay the current renewal fee in order to resume active practice in this State.

The Board is proposing new rules at N.J.A.C. 13:39-2.19, which prohibit pharmacists from engaging in steering, and N.J.A.C. 13:39-2.20, which require pharmacists to comply with all rules and laws governing the practice of pharmacy. The text of these new rules currently appear as existing rules N.J.A.C. 13:39-4.17 and 4.18. The provisions of N.J.A.C. 13:39-4.17 and 4.18 apply to both pharmacists and permit holders. For clarification purposes, the Board has determined that separate rules on steering and compliance are necessary for pharmacists and permit holders and, as such, has proposed the new rules in Subchapter 2, for pharmacists. Existing rules N.J.A.C. 13:39-4.17 and 4.18 have been amended to make the provisions applicable to pharmacy permit holders only. The requirements imposed under both sets of rules, however, remain the same for pharmacists and permit holders.

As amended, Subchapter 3 contains all rules applicable to persons seeking licensure as pharmacists by reciprocity. Existing rule N.J.A.C. 13:39-3.7, which sets forth the limitations of reciprocal licensure, is proposed to be recodified at N.J.A.C. 13:39-3.1, with amendments. The Board is proposing a new subsection (b) which directs applicants for reciprocal licensure to the requirements set forth in N.J.A.C. 13:39-3.2, which must be satisfied prior to obtaining licensure. The Board is proposing a new rule at N.J.A.C. 13:39- 3.2, concerning the requirements for obtaining reciprocal licensure. A pharmacist currently licensed in another jurisdiction who wishes to obtain a license by reciprocity in New Jersey must submit a completed application and the license fee. The application must include evidence that the applicant is at least 18 years of age, is of good moral character, has engaged in the practice of pharmacy for at least 1,000 hours within the last two years, or has met the Board's internship requirements within the one-year period immediately preceding the date of application. In addition, the applicant must have obtained his or her initial licensure by examination and that license must be in good standing. The applicant must submit evidence that any other license granted to the applicant by another state has not been suspended or revoked. The applicant must also have graduated from a college of pharmacy that has been accredited by the American Council of Pharmaceutical Education (ACPE) or has been deemed ACPE-equivalent. The Board notes that these requirements are set forth in the new Pharmacy Practice Act at N.J.S.A. 45:14-53. The Board is proposing the new rule at this time because certain existing regulatory requirements set forth at N.J.A.C. 13:39-3.8 and 3.9, which concern license transfer, are inconsistent with the new statutory requirements for reciprocal licensure. The Board is proposing that existing rules N.J.A.C. 13:39-3.8 and 3.9 be repealed. The Board also notes that it is proposing, as part of N.J.A.C. 13:39-3.2, that applicants for licensure by reciprocity satisfy all license transfer requirements imposed by the National Association of Boards of Pharmacy (NABP), to ensure consistency with other state procedures on reciprocal licensure.

The Board is proposing several new rules in Subchapter 3 that mirror existing requirements contained in Subchapter 2. Applicants for licensure by reciprocity have always been required to comply with such requirements, but as written, the existing rules appear to apply only to applicants for licensure by examination. The proposed new rules clarify that the following requirements are also applicable to candidates for licensure by reciprocity: N.J.A.C. 13:39-3.3, concerning proof of character requirements; N.J.A.C. 13:39-3.4, concerning proof of identity; and N.J.A.C. 13:39-3.5, concerning violations of the Pharmacy Act. The Board is also proposing a new rule at N.J.A.C. 13:39-3.6, concerning criminal history background checks for reciprocity applicants, which mirrors the new rule proposed in Subchapter 2 for applicants seeking licensure by examination. As a result, the Board is repealing existing rule N.J.A.C. 13:39-3.10, concerning a reciprocity applicant's record of law observance. The Board is also repealing existing rules N.J.A.C. 13:39-3.12, concerning physical and mental competency requirements for reciprocity applicants, and N.J.A.C. 13:39-3.13, which requires applicants for reciprocal licensure to obtain an application from the Board, because the provisions are unnecessary in light of proposed new rule N.J.A.C. 13:39-3.2.

Existing rule N.J.A.C. 13:39-3.14, which requires applicants for reciprocal licensure to take the MJPE, is proposed to be recodified as N.J.A.C. 13:39- 3.7, with technical changes. Existing rules N.J.A.C. 13:39-3.15, concerning biennial registration renewal, N.J.A.C. 13:39-3.16, concerning issuance of duplicate licenses, and N.J.A.C. 13:39-3.17, concerning reinstatement, are proposed to be repealed because such rules are not applicable to reciprocal licensure applicants. The rules are only applicable to persons who have already been issued a license. Relevant portions of these existing rules have been incorporated into proposed new rules N.J.A.C. 13:39-2.16 and 2.17, and as part of the proposed amendments to N.J.A.C. 13:39-2.11.

The rules in Subchapter 3A concern continuing education requirements. The Board is proposing that N.J.A.C. 13:39-3A.1, which requires licensees to complete 30 credits of continuing education per biennial renewal period, be amended to require three of the 30 credits to be obtained in New Jersey pharmacy law. The Board believes that such a requirement will help to ensure that pharmacists are familiar with all aspects of New Jersey law relevant to their professional practice. The three credit pharmacy law requirement will become effective for the biennial renewal period commencing May 2005 and thereafter. The Board is proposing that the following rules in Subchapter 3A be readopted without change: N.J.A.C. 13:39-3A.2, concerning the criteria continuing education credits; N.J.A.C. 13:39-3A.3, concerning credit hour calculations; N.J.A.C. 13:39-3A.4, concerning credit hour reporting procedures; N.J.A.C. 13:39-3A.5, concerning waiver of continuing education requirements; N.J.A.C. 13:39-3A.6, concerning the responsibilities of continuing education sponsors; and N.J.A.C. 13:39-3A.7, concerning monitoring of continuing education courses.

Subchapter 4 contains all rules applicable to pharmacy permit holders. Existing rule N.J.A.C. 13:39-4.7 is proposed to be recodified at N.J.A.C. 13:39-4.1, with amendments to clarify the intended meaning of the rule. The rule sets forth requirements for permit eligibility and application procedures for new pharmacies. The Board has amended subsection (c) to include limited liability partnerships and limited liability companies to the list of entities that may obtain a pharmacy permit. The Board has also amended subsection (g), which currently provides that before a permit may be issued to an applicant, the Board shall inspect and approve the new pharmacy as compliant with premises, fixtures and equipment requirements of the chapter, to provide that the premises, fixtures and equipment of the new pharmacy will be inspected to ensure compliance with the subchapter requirements, as well as with all relevant statutes, regulations and ordinances. Existing rules N.J.A.C. 13:39-4.1 and 4.2, which concern the issuance and display of permits, respectively, are proposed to be recodified at N.J.A.C. 13:39-4.2 and 4.3, without change. Existing rule N.J.A.C. 13:39-4.3, which establishes requirements for the continued operation of a pharmacy upon the death of an owner, is proposed to be recodified at N.J.A.C. 13:39-4.4. The Board is amending N.J.A.C. 13:39-4.4 to clarify that if the operation of the pharmacy is to continue following the death of an owner, the heirs of the decedent must comply with all requirements necessary to effectuate a change of ownership under Board rules. Existing rule N.J.A.C. 13:39-4.4, which establishes the requirements for changes of ownership, is proposed to be recodified at N.J.A.C. 13:39-4.5, with amendments. The Board has amended N.J.A.C. 13:39-4.5 to provide that upon a change of ownership, the new owner must ensure that all prescription and profile records of the previous pharmacy are maintained consistent with the Board's current recordkeeping requirements. The Board is proposing this amendment in order to ensure continuity in record retention during such permit changes. The Board is also proposing to amend subsection (a) of N.J.A.C. 13:39-4.5, which currently provides, in part, that before a permit may be issued, the Board shall inspect and approve as compliant with the rules of the chapter, the fixtures, equipment and inventory of the pharmacy. The proposed amendments provide that the premises, fixtures and inventory of the new pharmacy will be inspected to ensure compliance with the subchapter requirements, and with all relevant statutes, regulations and ordinances.

Existing rules N.J.A.C. 13:39-4.5, concerning changes to corporate officers or stockholders, and N.J.A.C. 13:39-4.6, concerning remodeling of premises, are proposed to be recodified at N.J.A.C. 13:39-4.6 and 4.7, respectively, with amendments in order to improve the clarity of the rules. The Board is also proposing to amend N.J.A.C. 13:39-4.7(a) and (b) to provide that before a permit may be issued for a new pharmacy location or for a pharmacy that has been remodeled, the Board must inspect and approve the premises, fixtures, equipment and inventory of the new or remodeled pharmacy to ensure compliance with the subchapter requirements, and with all relevant statutes, regulations and ordinances. The Board is proposing that N.J.A.C. 13:39-4.8, which concerns discontinued pharmacies, be readopted with clarifying amendments. The rule, which establishes requirements for pharmacies seeking to discontinue providing services, is also being amended to clarify that whenever a pharmacy is terminated, the Board shall be notified of the location of the pharmacy's prescription records. Existing rule N.J.A.C. 13:39-5.7, concerning the availability of records when a pharmacy ceases operation, is proposed to be recodified at N.J.A.C. 13:39-4.9, with technical amendments. The rule is being included in this Subchapter 4, in light of its subject matter.

The Board is proposing to amend existing rule N.J.A.C. 13:39-4.9, concerning the required hours of operation for pharmacies, which is being recodified at N.J.A.C. 13:39-4.10, to require a pharmacy to post a notice indicating any temporary changes in the opening or closing hours of the pharmacy, or indicating a temporary closing of the pharmacy will occur. In addition, the Board is proposing to amend N.J.A.C. 13:39-4.10 to provide that any temporary closing of a pharmacy for more than 24 hours shall be reported to and approved by the Board. Notification to the Board must include plans for accessing patient records. A temporary closing of more than 24 hours without prior Board approval will result in the pharmacy being classified a discontinued pharmacy, requiring the pharmacy to comply with business discontinuation procedures. Existing rule N.J.A.C. 13:39-4.10, concerning the issuance of replacement permits, is proposed to be recodified at N.J.A.C. 13:39-4.11, with clarifying amendments. Existing rule N.J.A.C. 13:39-4.11, concerning pharmacy name changes, is proposed to be recodified at N.J.A.C. 13:39-4.12, with clarifying changes. Existing rule N.J.A.C. 13:39-4.12, which concerns the reproduction of pharmacy permits, is proposed to be recodified at N.J.A.C. 13:39-4.13 and is being amended to clarify that a permit may only be photocopied for State agencies and other business entities with whom the permit holder does pharmacy related business. The rule has also been amended to provide that any reproduction of a pharmacy permit for any unlawful purpose shall subject a permit holder to disciplinary action. N.J.A.C. 13:39-4.13, which establishes requirements for obtaining information from the Board, is proposed to be repealed. The requirements in the rule are superseded by requirements imposed under the Open Public Records Act, P.L. 2001, c.404, N.J.S.A. 47:1A-1 et seq.

Existing rule N.J.A.C. 13:39-4.15, dealing with the permitting of pharmacy departments, is proposed to be recodified at N.J.A.C. 13:39-4.14, with various amendments. The Board has amended the rule to delete all references to "prescription department" because such terminology is misleading. The appropriate name for a permitted area which is less than the total store area of the enterprise is a "pharmacy department." The rule has also been amended to clarify that a permitted pharmacy department is subject to all retail pharmacy permit requirements set forth throughout the chapter. As currently written, the rule could be incorrectly construed to require pharmacy permit holders to comply with only the requirements in N.J.A.C. 13:39-4.14. The Board is also proposing the deletion of the requirement currently set forth in paragraph (b)3, which prohibits prescriptions from being accepted, or prescription medication from being dispensed, when a registered pharmacist is not present within the department. The Board believes that such a requirement is overly restrictive. The rule would not allow a patient to drop off a prescription to be filled, or to pick up a prescription medication that had previously been checked by the pharmacist, if the pharmacist was not present. The rule is also being amended to require that the name of the registered pharmacist-in-charge be posted in plain view at the entrance to the department. The proposed amendment will help to ensure that this information is readily available to consumers. The remaining rules in Subchapter 4 are proposed to be recodified with technical changes. N.J.A.C. 13:39-4.16, which concerns the issuance of specialized permits, N.J.A.C. 13:39-4.17, which prohibits steering, and N.J.A.C. 13:39-4.18, which requires permit holders to comply with all laws and regulations concerning the practice of pharmacy, are proposed to be recodified at N.J.A.C. 13:39-4.15, 4.16 and 4.17, respectively.

The Board notes that on January 5, 2004, it proposed a new rule, to be codified at N.J.A.C. 13:39-5.10, concerning procedures that must be followed by pharmacies wishing to engage in centralized prescription handling. The proposal appeared in the New Jersey Register at 36 N.J.R. 11(a). The Board is currently in the process of adopting this regulation and it anticipates that the new rule will become effective prior to the adoption of this proposed readoption with amendments. The Board intends to recodify proposed new rule N.J.A.C. 13:39-5.10 upon adoption as N.J.A.C. 13:39-4.19. The Board also notes that as part of the centralized prescription handling proposal, it has also proposed amendments to current rules N.J.A.C. 13:39-3.18 and 5.9, which will also be recodified upon adoption.

As amended, Subchapter 5 contains all rules relating to retail pharmacy facilities. The Board is proposing a new rule at N.J.A.C. 13:39-5.1 to clarify the purpose and scope of the subchapter. N.J.A.C. 13:39-5.1 provides that the rules in Subchapter 5 apply to all retail pharmacies and retail pharmacy departments. Existing rule N.J.A.C. 13:39-7.1, concerning pharmacy access and egress, is proposed to be recodified at N.J.A.C. 13:39-5.2, with amendments to improve the clarity of the rule. N.J.A.C. 13:39-7.2, concerning the display of signs, is proposed to be recodified at N.J.A.C. 13:39-5.3, with amendments for clarification purposes. The Board is also amending N.J.A.C. 13:39-5.3 to require pharmacies to post the name of the registered pharmacist-in-charge on the entrance to the pharmacy in such a way that is visible to the public. The Board is also amending N.J.A.C. 13:39-5.3 to require all pharmacies to post the name of the registered pharmacist-in- charge on the entrance to the pharmacy, so that this information is visible to the public. Existing rule N.J.A.C. 13:39-7.3, concerning spatial requirements of the prescription area, and N.J.A.C. 13:39-7.4, concerning prescription counter requirements, are proposed to be recodified at N.J.A.C. 13:39-5.4 and 5.5, respectively, with amendments to improve the clarity of the rules. Existing rule N.J.A.C. 13:39-7.5, concerning the prescription sink area, is proposed to be recodified at N.J.A.C. 13:39-5.6, and is amended to delete the sink requirements applicable to institutional satellite pharmacies and institutional and retail pharmacy admixture anterooms. Such requirements are repetitive of provisions contained in Subchapters 9 and 11, which deal generally with institutional pharmacies and admixture compounding in retail and institutional pharmacies. The Board is amending N.J.A.C. 13:39- 5.8(a)4, which requires the maintenance of a properly safeguarded storage place for Schedule II controlled substances, to require the maintenance of a securely locked, substantially constructed storage place for such medications. The Board believes that the proposed amendment is necessary to ensure the proper maintenance of Schedule II medications in the pharmacy. In addition, the Board is amending N.J.A.C. 13:39-5.8(a)5 and 6, which currently require the maintenance of a separate Class A prescription balance and a set of metric weights, to require the maintenance of a Class A prescription balance which includes a set of metric weights.

Existing rule N.J.A.C. 13:39-7.6, concerning storage and stock requirements, is proposed to be recodified at N.J.A.C. 13:39-5.7, with clarifying amendments. The Board is also proposing that existing rule N.J.A.C. 13:39-7.7 be recodified at N.J.A.C. 13:39-5.8, with amendments to improve the clarity of the rule. The Board is also proposing to amend recodified rule N.J.A.C. 13:39-5.8 to require pharmacies to maintain assorted prescription containers and child safety closure or caps as part of the pharmacy's minimum stock requirements.

Existing rules N.J.A.C. 13:39-7.8, concerning the cleanliness of the prescription area, and N.J.A.C. 13:39-7.9, which prohibits the placement of televisions in the prescription area, are proposed to be recodified at N.J.A.C. 13:39-5.9 and 5.10, respectively, without change. Existing rule N.J.A.C. 13:39-7.11, which concerns the use of balances and scales, is proposed to be recodified at N.J.A.C. 13:39-5.11, with technical changes. The Board is also proposing that existing rule N.J.A.C. 13:39-6.5, which concerns the storage of prescription legend drugs and controlled substances, be recodified at N.J.A.C. 13:39-5.12. The Board is proposing to amend N.J.A.C. 13:39-5.12, which restricts the display of prescription legend drugs and controlled dangerous substances in a pharmacy, to restrict the storage of such medications. The Board believes that restricting the storage of such medications, as opposed to the display of the medications, will ensure a greater level of protection against unauthorized public access to the medications.

As amended, Subchapter 6 includes all rules relevant to the duties of the registered pharmacist-in-charge and other pharmacy personnel. The Board is proposing a new rule at N.J.A.C. 13:39-6.1 to establish the purpose and scope of the subchapter. N.J.A.C. 13:39-6.1 provides that the requirements in the subchapter shall apply to all retail pharmacies, retail pharmacy departments, institutional pharmacies and nuclear pharmacies in the State. Existing rule N.J.A.C. 13:39-3.18, which sets forth the duties of the registered pharmacist-in-charge, is being recodified at N.J.A.C. 13:39-6.2, with several amendments, including many technical changes. The Board is amending the rule to clarify that every pharmacy must name a licensed pharmacist who is in good standing as the registered pharmacist-in-charge of the pharmacy. No pharmacy shall operate without a registered pharmacist-in- charge for longer than 30 days. Whenever the registered pharmacist-in-charge is absent from the pharmacy for more than 30 days, the pharmacy must employ an interim registered pharmacist-in-charge. The register pharmacist-in-charge must be a full-time employee, who is employed for a minimum of 35 hours per week. The Board believes that such requirements will help to ensure accountability with regard to the pharmaceutical services that are provided by the pharmacy.

The Board is also proposing to amend N.J.A.C. 13:39-6.2(e), which currently provides that whenever a registered pharmacist assumes the duties of the registered pharmacist-in-charge of a pharmacy, the pharmacist must notify the Board of such action. The Board is proposing to amend subsection (e) to also require notification to the Board whenever a pharmacist's duties as the registered pharmacist-in-charge are terminated. In addition, the Board is amending subsection (e) to impose this notification requirement upon the pharmacy permit holder, as well as the registered pharmacist-in-charge.

The Board is also proposing several amendments to subsection (f) of N.J.A.C. 13:39-6.2. Proposed amendments to paragraph (f)1 require the registered pharmacist-in-charge to ensure that adequate staffing is present to fulfill the needs of the pharmacy. Proposed amendments to paragraph (f)2 require the registered pharmacist-in-charge to ensure that accurate records of all prescription medications received and dispensed by the pharmacy are maintained. Proposed amendments to paragraph (f)3 require the registered pharmacist-in-charge to ensure that policies are in place regarding the accurate dispensing and labeling of prescriptions. Proposed amendments to paragraph (f)4 require the registered pharmacist-in-charge to ensure that the security of the prescription area and its contents is maintained at all times. The registered pharmacist-in-charge must report any thefts or diversions of controlled substances to the Office of Drug Control and the Drug Enforcement Administration. Proposed amendments to paragraph (f)5 clarify that only pharmacists, and interns and externs working under the immediate personal supervision of a pharmacist, may provide professional consultation with patients and physicians. In addition, paragraph (f)6 is amended to clarify that only pharmacists, interns and externs, and pharmacy technicians acting within the scope of their employment consistent with N.J.A.C. 13:39-6.6, may accept renewal authorizations for prescriptions.

Paragraphs (f)7 and 8, which require the pharmacist-in-charge to ensure that dispensed medications are properly labeled and that the name of the pharmacist- in-charge is posted on the entrance to the pharmacy, are proposed to be deleted. Existing paragraphs (f)9 and 10 are proposed to be recodified as (f)7 and 8. Recodified paragraph (f)7, which currently prohibits the maintenance of any misbranded, deteriorated or outdated drugs in a pharmacy's active stock, is amended to also prohibit the maintenance of adulterated and improperly stored drugs, or any drugs marked as samples. Existing paragraphs (f)11 and 12, which require the pharmacist-in-charge to ensure that the pharmacy dispenses all medications generally prescribed to patients in the pharmacy's trading area, and to notify the Board of the termination of his or her duties as a pharmacy's registered pharmacist-in-charge, are proposed to be deleted. Existing paragraph (f)13, which requires the registered pharmacist-in-charge to ensure compliance with all statutes, rules and regulations governing the practice of pharmacy, is proposed to be recodified as (f)9, and is amended to clarify that the pharmacy and all pharmacy personnel must comply with all Federal and State laws and rules relating to the practice of pharmacy.

The Board is proposing that existing rule N.J.A.C. 13:39-6.3, which requires identification tags to be worn by all licensees, be readopted with amendments to clarify that all personnel working in the pharmacy must now wear such identification tags. The Board believes that the proposed amendments are necessary in order to ensure that all pharmacy personnel, including pharmacists, pharmacy technicians, and clerical staff are easily identifiable to members of the general public. The Board is proposing a new rule at N.J.A.C. 13:39-6.4, which authorizes pharmacists to take meal breaks. The new rule provides that a sole pharmacist on duty may take a 30-minute meal break while working in a pharmacy provided that the pharmacist remains on the premises, and that he or she is accessible for emergencies and/or counseling. The pharmacy must remain open during the meal break for the receipt of new written prescriptions and for the dispensing of prescription medications which have been checked by the pharmacist. A sign must be posted during the meal break, informing consumers that the pharmacist is available for emergencies and counseling. The Board is proposing that existing rule N.J.A.C. 13:39-6.2, concerning the preparation and compounding of prescriptions by pharmacy interns and externs, be recodified at N.J.A.C. 13:39-6.5, with amendments. The Board is amending the rule to include a specific reference to pharmacy technicians in order to authorize them to prepare or compound prescriptions under the immediate personal supervision of a registered pharmacist. The proposed amendment will make the rule consistent with existing regulatory and statutory provisions. The Board is also proposing that the rule be amended to clarify that the registered pharmacist who is supervising the work of such persons be responsible for the accuracy and appropriateness of the filled prescription. Existing rule N.J.A.C. 13:39-6.4, which concerns the filling of prescriptions by "supportive personnel," is proposed to be repealed, in light of the fact that pharmacy technicians are now included within the scope of recodified rule N.J.A.C. 13:39-6.5. In addition, the Board is proposing that N.J.A.C. 13:39-6.6, concerning foreign prescriptions, be repealed. Similar language is being proposed in recodified rule N.J.A.C. 13:39-7.1 and is discussed below.

Existing rule N.J.A.C. 13:39-6.7, concerning the duties of supportive personnel, is proposed to be recodified at N.J.A.C. 13:39-6.6, with its heading amended as "Pharmacy technicians." In addition to various technical amendments, the Board is proposing amendments to make the rule consistent with the provisions of the new Pharmacy Practice Act at N.J.S.A. 45:14-80. The proposed amendments will clarify and expand the list of duties that may appropriately be performed by pharmacy technicians, consistent with these new statutory requirements. Currently, supportive personnel are permitted by rule to assist the pharmacist in clerical matters. Supportive personnel may also count, weigh, measure or pour prescription medications under the pharmacist's direct supervision. The proposed amendments provide a more detailed list of activities that pharmacy technicians may perform, in addition to a clear delineation of impermissible activities. The Board believes that the proposed amendments will give licensees more guidance as to how such individuals may be utilized in the practice of pharmacy.

The Board is also proposing amendments to existing rule N.J.A.C. 13:39-6.7, which currently provides that a pharmacist may not supervise more than two pharmacy technicians at any one time. Currently, this ratio of one pharmacist to two technicians may not be exceeded under any circumstances. The proposed amendments, however, provide that if a pharmacy seeks to employ technicians in a ratio greater than 1:2, all technicians hired above the 1:2 ratio must be appropriately trained. To satisfy this requirement, the pharmacy may employ pharmacy technicians who have passed the National Pharmacy Technician Certification Examination, or the pharmacy may conduct its own pharmacy technician training program which satisfies the requirements of the rule. The Board believes that if such requirements are satisfied, the pharmacy should be permitted to employ a greater number of technicians to work under the supervision of a single pharmacist. The Board believes that the requirements outlined in the proposed amendments will help to ensure that if a pharmacy chooses to employ more technicians than currently allowed by the one to two ratio, those technicians will be appropriately trained and have sufficient instruction in the tasks and functions they are permitted to perform. Specifically, a pharmacy wishing to employ pharmacy technicians in a ratio that exceeds 1:2 must maintain a detailed policy and procedure manual with regard to pharmacy technician functions, pursuant to subsection (f). The pharmacist-in- charge must review the policies and procedures manual at least every two years, pursuant to subsection (g), and must amend the manual if necessary. Documentation of this review must be made available to the Board upon request.

Subchapter 7, Pharmacy Facility and Records, is proposed to be given a new heading "Drug Dispensing and Prescription Records." The subchapter contains all rules relevant to medication dispensing and the maintenance of prescription records. The current provision in N.J.A.C. 13:39-5.1, which prohibits a prescriber's prescription blank from bearing the imprint of the name of any pharmacy or bearing the name and address of any authorized prescriber under N.J.S.A. 45:14-1, is proposed to be deleted because such requirements are now contained in the rules governing the New Jersey Uniform Prescription Blanks Program, set forth at N.J.A.C. 13:45A-27. Existing rule N.J.A.C. 13:39- 5.1, concerning the use of imprinted prescription blanks, is proposed to be recodified at N.J.A.C. 13:39-7.1, with amendments. The proposed amendments clarify that a pharmacist may only fill a written prescription issued in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank, except in the case of prescriptions that are sent by facsimile or electronic means. The Board is also proposing that N.J.A.C. 13:39-7.1 be amended to provide that a pharmacist may only fill a prescription issued by an authorized prescriber licensed to write prescriptions in the United States or any territory of the United States. This provision clarifies the requirement current articulated in N.J.A.C. 13:39-6.6, concerning the filling of foreign prescriptions. Existing rule N.J.A.C. 13:39-5.2, concerning lack of directions on a prescription, is proposed to be recodified at N.J.A.C. 13:39-7.2. The proposed amendments to N.J.A.C. 13:39-7.1 also provide that prescriptions, other than those specified in the amended rule, may not be filled by any pharmacy in New Jersey. The Board is deleting subsection (b) of the rule, which authorizes the pharmacist to add directions or cautionary labels to dispensed medications. Similar language is being proposed as part of recodified rule N.J.A.C. 13:39-7.12, which sets forth prescription container labeling requirements. The Board believes that the provision is more appropriately included in this labeling rule. The Board is proposing that existing rule N.J.A.C. 13:39-5.3, concerning authorization for renewal prescriptions, be recodified, without change, at N.J.A.C. 13:39-7.3.

The Board is proposing a new rule at N.J.A.C. 13:39-7.4, concerning emergency dispensing of certain medications, which incorporates the provisions of existing N.J.A.C. 13:39-6.1(b). The rule provides that in the absence of a current, valid prescription, a pharmacist may dispense up to a 72-hour supply of a chronic maintenance drug (excluding controlled substances) or a device, if in the pharmacist's professional judgment, refusal would endanger the health or welfare of the patient. The rule requires the pharmacist to ascertain by direct communication with the patient or the patient's caregiver, that the medication or device was prescribed for the patient. The pharmacist must document this communication and must require the patient or caregiver to present suitable identification and sign a statement attesting to the need for the dispensing prior to providing the medication. The Board believes that the proposed new rule will benefit consumers by ensuring that in emergency situations, patients will have access to chronic or maintenance medications until they are able to obtain a new prescription.

The Board is proposing that existing rule N.J.A.C. 13:39-5.4, which requires Federal Food and Drug Administration (FDA) approval for dispensed medications, be recodified at N.J.A.C. 13:39-7.5, with amendments. The Board is proposing an amendment to the rule concerning the storage and dispensing of investigational new drugs. The proposed amendment provides that when such investigational drugs, which lack FDA approval, are provided in cooperation with the principal investigator, the dispensing of such drugs will not be construed to be a violation of the rule. The Board notes that this provision is currently included in N.J.A.C. 13:39-9.13 and applies to the dispensing of investigational drugs by institutional pharmacies. The Board believes that the inclusion of the provision in N.J.A.C. 13:39-7.5 is necessary in order to afford retail pharmacies the same opportunity as institutional pharmacies to participate in investigational drug research. The amendment further provides that any pharmacy participating in experimental research must comply with regulations promulgated by the Federal Department of Health and Human Services, 45 C.F.R. Part 46, which the Board has incorporated by reference. The Federal regulations ensure the formal review and monitoring of biomedical research involving human subjects. In accordance with such regulations, research may be approved, require modifications, or may be disapproved. The purpose of the Federal oversight is to ensure, both in advance and through frequent review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. The regulations ensure that procedures are used which are consistent with appropriate research design and that the research does not expose subjects to unnecessary or unreasonable risk. The regulations require that informed consent be obtained and documented from each research subject, and that privacy protections are afforded to research participants. The regulations also impose additional requirements upon research projects designed to protect the rights and welfare of vulnerable population groups, such as women, children, prisoners, those with mental disabilities, and persons who are economically or educationally disadvantaged. Existing rule N.J.A.C. 13:39-5.6, which concerns the recordation by the pharmacist of the filled prescription, is proposed to be recodified at N.J.A.C. 13:39-7.6, with amendments to improve the clarity of the rule. Subsection (j) has been recodified as subsection (c) in order to better organize the rule. Existing subsection (c), recodified as subsection (d), has been amended to require documentation identifying the handwritten initials and handwritten signature of each pharmacist to be retained by the pharmacy for a period of six years from the pharmacist's last date of employment. The Board is also proposing that existing subsections (d) through (h) of the rule be deleted. Subsections (d), (e) and (f), concerning prescriptions for controlled substances, have been included, with clarifying amendments, as part of proposed new rule N.J.A.C. 13:39-7.9, which concerns the filing and storage of controlled substances. Subsections (g) and (h), which impose requirements for the use of electronic data processing systems, are repetitive of other provisions in the rule, as amended, and are unnecessary. Existing subsection (i) is proposed to be recodified as subsection (e) with amendments to specify how long records must be maintained.

Existing rule N.J.A.C. 13:39-5.5, which concerns issuing copies of prescriptions, is proposed to be recodified at N.J.A.C. 13:39-7.7, with clarifying amendments to subsections (a) and (b). The Board notes that subsections (c), (d) and (e), which deal with prescription transfers, have been deleted, and that similar provisions have been included in proposed new rule N.J.A.C. 13:39-7.8, which deals exclusively with prescription transfers between pharmacies. In addition to clarifying the prescription transfer requirements in existing rule N.J.A.C. 13:39-5.5, proposed new rule N.J.A.C. 13:39-7.8 provides that a prescription for a Schedule II controlled substance may not be transferred, and that a prescription for a Schedule III, IV or V controlled substance may only be transferred once, pursuant to regulations promulgated by the Department of Health and Senior Services. The proposed new rule also clarifies that a prescription may be transferred between pharmacies by electronic means provided the pharmacies satisfy the requirements of the Board's electronic transfer of prescription rule. Proposed new rule N.J.A.C. 13:39-7.9, as noted above, recodifies portions of the Board's existing rule N.J.A.C. 13:39-5.6, concerning storage of controlled substance prescriptions, with amendments. Existing rule N.J.A.C. 13:39-5.8A, concerning the transmission of prescriptions by facsimile, is proposed to be recodified at N.J.A.C. 13:39-7.10, without change. Existing rule N.J.A.C. 13:39-5.8B, regarding electronically transmitted prescriptions, is proposed to be recodified at N.J.A.C. 13:39-7.11, with amendments. The Board is proposing two new subsections to the rule. New subsection (k) provides that two or more permit holders may establish a common electronic filing system to maintain dispensing information. This provision is currently found in N.J.A.C. 13:39-5.5(d). New subsection (l) clarifies that the section shall not be construed to preclude the electronic transfer of information between pharmacies for purposes of prescription transferring. This amendment will make the rule consistent with proposed new rule N.J.A.C. 13:39-7.8.

Existing rule N.J.A.C. 13:39-5.9, which establishes labeling requirements, is proposed to be recodified at N.J.A.C. 13:39-7.12, with amendments. The Board is proposing a new subsection (c), which provides that the pharmacist may add directions or cautionary labels to prescription containers when, in the judgment of the pharmacist, such labels are necessary. As noted above, this amendment reiterates the provision currently in N.J.A.C. 13:39-5.2 which is being deleted from that rule. Existing rule N.J.A.C. 13:39-6.1, which concerns the use of a pharmacist's professional judgment in dispensing medications, is proposed to be recodified at N.J.A.C. 13:39-7.13, with amendments. As noted above, existing subsection (b), which concerns the dispensing of an emergency supply of medications, is proposed to be deleted, because the provision has been included in proposed new rule N.J.A.C. 13:39- 7.4.

Existing rule N.J.A.C. 13:39-6.8, concerning the advertising and sale of prescription drugs, is proposed to be recodified, with clarifying amendments, at N.J.A.C. 13:39-7.14. The Board is proposing to amend subsection (e) of N.J.A.C. 13:39-7.14, which currently provides that a pharmacist must provide price information over the telephone upon request by any consumer, to clarify that the price information which must be provided is the usual and customary price information provided for non-third party, or cash-paying, customers. In addition, the Board is also amending subsection (f) of N.J.A.C. 13:39-7.14 to delete the provision which prohibits advertisements from relying upon techniques to obtain attention that demonstrate a clear and intentional lack of relevance to the selection of professional services, as the Board believes that the provision is unclear and does not provide licensees with appropriate guidance regarding permissible advertising activities. Existing rule N.J.A.C. 13:39-6.9, which imposes restrictions on the sale of Schedule V over-the-counter controlled substances, is proposed to be recodified at N.J.A.C. 13:39-7.15, without change.

Existing rule N.J.A.C. 13:39-7.10, which establishes requirements for the return of prescription medications, is proposed to be recodified, with amendments, at N.J.A.C. 13:39-7.16. The Board is proposing amendments to the rule in order to clarify confusion that currently exists regarding when medications which have been dispensed to a patient may be accepted back by the pharmacy. Subsection (a) has been amended to clarify that prescription medication that has been correctly dispensed to a patient may be accepted for return by the pharmacist, but the medication shall not be placed back in the pharmacy's active stock for reuse or resale. The Board has determined, however, that medications which have been prepared for patients but which have not been dispensed may be placed back in a pharmacy's active stock if certain conditions are satisfied. Proposed new subsection (c) of the rule authorizes a pharmacy to reuse or resell medications, which in the professional judgment of the pharmacist are eligible for re-dispensing, provided various conditions are satisfied. An eligible medication is one which is able to be consumed by a patient within the original time frame established for the medication's stability and expiration. Un-dispensed medication may not be placed in manufacturers' stock containers of different lot numbers and/or with different expiration dates. In circumstances in which a prescription medication cannot be properly returned to the original manufacturers' container, the medication must be held in the pharmacy in the labeled container in which it has been repackaged. The new subsection also imposes other requirements upon pharmacists in order to ensure patient safety when medications are returned to active stock, including prohibiting the dispensing of repackaged medication which lacks an original lot number and expiration date beyond six months from the date the medication was originally dispensed.

Existing rule N.J.A.C. 13:39-7.12, concerning the disposal of unwanted drugs, is proposed to be recodified at N.J.A.C. 13:39-7.17, without change. Existing rule N.J.A.C. 13:39-7.13, concerning outdated and sample drugs, is proposed to be recodified, with amendments to improve the clarity of the rule, at N.J.A.C. 13:39-7.18. The Board is amending N.J.A.C. 13:39-7.18, which currently prohibits the stocking in a pharmacy of any outdated, misbranded, deteriorated or adulterated drugs, to also preclude the stocking of drugs which have been improperly stored. The proposed amendment also clarifies that the prohibition outlined in the rule applies to the dispensing of such medications, as well as the stocking of the drugs in the pharmacy. Existing rule N.J.A.C. 13:39-7.14, which sets forth requirements for the patient profile record system, is proposed to be recodified at N.J.A.C. 13:39-7.19, with amendments. The Board is proposing to amend subsection (e), which concerns patient counseling, to provide that the absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided, consistent with the statutory requirement set forth in the new Pharmacy Practice Act at N.J.S.A. 45:14-68. The Board is also proposing amendments to subsection (f) to clarify that if the patient profile system is maintained as part of an electronic data processing system, the system must have the capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years.

Subchapter 8 sets forth requirements for pharmacy intern and extern training sites. N.J.A.C. 13:39-8.1, which contains definitions of relevant terms used throughout the subchapter, is proposed to be readopted with a technical amendment to the definition of "pharmacy intern." In addition, the Board is amending the definition of "certified preceptor" to delete the reference to "extern" because responsibility for the supervision of pharmacy externs rests with the schools of pharmacy where such externs are enrolled, and not with Board-approved pharmacy preceptors. N.J.A.C. 13:39-8.2, which concerns preceptor application procedures and responsibilities, is also proposed to be readopted with amendments. The Board is amending paragraph (a)2, which currently requires a pharmacist seeking to be a certified preceptor to furnish evidence of his or her record of law observance, to require the applicant to submit evidence that he or she has not been convicted of a crime or offense relating adversely to the practice of pharmacy or involving moral turpitude, and has not been the subject of disciplinary action taken by a professional board resulting in the suspension, revocation or surrender of his or her license. The Board believes the amended language provides more direction to pharmacists regarding what type of information must be submitted as part of the preceptor application process. Submission of this type of evidence will help the Board to ensure that only the most qualified applicants are selected as preceptors. The Board is also proposing amendments to subsection (c) which will require the certified preceptor to submit a detailed written report to the Board outlining an intern's progress. The Board notes that it has deleted references in the rule to "faculty preceptors" because requirements for such preceptors are imposed by the schools of pharmacy which administer the externship programs. The Board is also proposing that subsection (d), which provides that the compounding and dispensing of prescriptions by a pharmacy intern or extern must be done under the direct supervision of a registered pharmacist, be deleted because the provision is duplicative of the requirements contained in recodified rule N.J.A.C. 13:39-6.5.

N.J.A.C. 13:39-8.3, which establishes pharmacy training site requirements, is proposed to be readopted without change. N.J.A.C. 13:39-8.4, concerning internship and externship practical experience requirements, is proposed to be readopted with clarifying amendments. The Board also notes that it has clarified the section to provide that the colleges of pharmacy that are referenced in the rule must be ACPE accredited schools. N.J.A.C. 13:39-8.5, concerning change in intern status, is proposed to be readopted without change. N.J.A.C. 13:39-8.6, concerning the Committee on Pharmacy Internship and Externship, is proposed to be repealed. Although the Committee will continue to exist, the Board believes that its membership and organization should not be the subject of regulatory action. Rather, decisions affecting this Committee, as is the case with all other Board committees, should be made by the Board in its administrative capacity.

The Board is also proposing that N.J.A.C. 13:39-8.7, which requires pharmacy interns to maintain logs of their progress, be repealed. The Board does not believe that intern logs provide a reliable source of information by which to evaluate the progress of individual interns. Moreover, the Board believes that the information obtained from the detailed reports that must now be filed by certified preceptors, pursuant to N.J.A.C. 13:39-8.2, as amended, will provide the Board with sufficient information with which to evaluate an intern's progress and aptitude.

Subchapter 9 establishes requirements for pharmaceutical services for health care facilities. The Board is proposing a new rule at N.J.A.C. 13:39-9.1, to clarify the purpose and scope of the subchapter. The new rule provides that all retail pharmacies which contract to provide pharmaceutical services for health care facilities, and all institutional pharmacies which provide pharmaceutical services for their own health care systems, are subject to the requirements of the subchapter. In addition, the new rule clarifies that an institutional pharmacy filling prescriptions for outpatient use shall comply with all retail pharmacy requirements of Chapter 39. Existing rule N.J.A.C. 13:39-9.1, containing definitions for various terms used throughout the subchapter, is proposed to be recodified at N.J.A.C. 13:39-9.2, with amendments. In addition to the technical amendments, the Board is proposing that the definition for "unit use packaging" be amended to provide that if there is more than one product in a single unit, the package must contain a physical description of each medication in the single unit. The definition of "health care facility" is amended to refer to a facility that has been licensed by the Department of Health and Senior Services. The Board believes that the current definition, which defines a health care facility as a place where patients and/or residents are cared for under a common roof, too narrowly defines facility and may unintentionally exclude some facilities from the ambit of the rules in Subchapter 9. The Board believes that this additional information will help to ensure that the correct medications are being administered as part of single unit use administrations.

Existing rule N.J.A.C. 13:39-9.2, which provides for the licensure of institutional pharmacies, is proposed to be recodified, with technical amendments, at N.J.A.C. 13:39-9.3. The Board is proposing that existing rule N.J.A.C. 13:39-4.14, which concerns contract pharmaceutical services for health care institutions, be recodified at N.J.A.C. 13:39-9.4, with technical amendments. For organizational purposes, existing rule N.J.A.C. 13:39-9.19, concerning advisory committees, is proposed to be recodified without change at N.J.A.C. 13:39-9.5, and existing rule N.J.A.C. 13:39- 9.20, concerning the Pharmacy and Therapeutics Committee, is proposed to be recodified at N.J.A.C. 13:39-9.6, with amendments. The Board has amended N.J.A.C. 13:39-9.6 to clarify that a Pharmacy and Therapeutics Committee must only be maintained if required by Department of Health and Senior Services regulations. In addition, the Board has added a new subsection providing that in health care facilities which are not required to have a Pharmacy and Therapeutics Committee, the pharmacist-in-charge, in cooperation with the health care facility, must create policies and procedures to direct the pharmaceutical services of the facility. The written policies and procedures shall be made available to the Board. Existing rule N.J.A.C. 13:39-9.21, concerning institutional pharmacy staffing, and N.J.A.C. 13:39-9.3, concerning control of the pharmacy services within the health care facility, are proposed to be recodified at N.J.A.C. 13:39-9.7 and 9.8, respectively, with technical amendments. Existing rule N.J.A.C. 13:39-9.4, concerning generally applicable requirements for pharmaceutical services, is proposed to be recodified at N.J.A.C. 13:39-9.9, without change.

Existing rule N.J.A.C. 13:39-9.5, concerning pharmaceuticals generally, is proposed to be recodified at N.J.A.C. 13:39-9.10, with amendments. The Board is proposing to include in N.J.A.C. 13:39-9.10 several provisions currently included in N.J.A.C. 13:39-9.13 because the provisions also concern pharmaceuticals. Subsections (c), (e) and (f) of N.J.A.C. 13:39-9.10 are amended to include provisions from N.J.A.C. 13:39-9.13 regarding maintenance of medications, investigational drugs and controlled substances within a facility, respectively. The existing provision in N.J.A.C. 13:39-9.10(e), requiring the pharmacist-in-charge to maintain control over all dispensed drugs within a system, is being moved to recodified rule N.J.A.C. 13:39-9.23, which concerns security of medications with a health care facility. Existing rule N.J.A.C. 13:39-9.6, concerning drug disbursements, written orders and outpatient prescriptions, is proposed to be recodified at N.J.A.C. 13:39- 9.11, with amendments. Subsection (c) of the rule, which currently requires abbreviations and chemical symbols used in medication orders to be included on a standard list approved by the medical staff of the health care facility, is amended to require the Pharmacy and Therapeutics Committee to develop a list of unapproved or unacceptable abbreviations and symbols which shall not be used in the facility. Medication orders involving symbols or abbreviations shall only be dispensed consistent with this list. The Board is proposing this change in order to make the provision consistent with current health care facility practices throughout the State. In addition, subsection (e), which concerns prescriptions written for employees of a health care facility or their dependents, or for outpatients of the facility's clinics, is proposed to be deleted because it is duplicative of the standards established in proposed new rule N.J.A.C. 13:39-9.1.

Existing rule N.J.A.C. 13:39-9.7, which establishes requirements for drug disbursements and oral orders, is proposed to be recodified at N.J.A.C. 13:39-9.12, with technical amendments. Existing rule N.J.A.C. 13:39-9.8, concerning compounding, is proposed to be repealed. The provisions of the rule, however, have been included in recodified rule N.J.A.C. 13:39-11.5, which sets forth general requirements for compounding preparations. Existing rules N.J.A.C. 13:39-9.9, which require monitoring of patient drug therapies, and N.J.A.C. 13:39-9.10, which concern medications dispensed in an unfinished form, are proposed to be recodified at N.J.A.C. 13:39-9.13 and 9.14, without change. Existing rule N.J.A.C. 13:39-9.11, which concerns drug labeling, is proposed to be recodified at N.J.A.C. 13:39-9.15. The Board is proposing that the last sentence of the section, which requires that the dispensing and labeling of outpatient prescriptions conform to N.J.S.A. 45:14-14, be deleted because the statutory reference is unnecessary. Existing rule N.J.A.C. 13:39-9.12, which concerns the use of a patient's own medication within the health care facility, is proposed to be recodified at N.J.A.C. 13:39-9.16, with a technical amendment. As noted above, existing rule N.J.A.C. 13:39-9.13, dealing with investigational and controlled drugs, is being repealed and the provisions are being included in recodified rule N.J.A.C. 13:39-9.10.

Existing rule N.J.A.C. 13:39-9.14, concerning drug dispensing devices, is proposed to be recodified, with technical changes, at N.J.A.C. 13:39-9.17. The Board is also proposing to delete subsection (h) of the rule, which provides that the pharmacist shall be responsible for checking the drugs in the drug-dispensing devices for expiration date and misbranding, because a similar provision is now contained in recodified rule N.J.A.C. 13:39-9.23, discussed below. Existing rule N.J.A.C. 13:39-9.15, which concerns the disposal of unused medications, is proposed to be recodified at N.J.A.C. 13:39-9.18, with amendments to improve the clarity of the rule. The Board is also amending paragraph (a)4 of recodified rule N.J.A.C. 13:36-9.18, which currently provides that the record of disposal for unused or nonadministered dispensed controlled dangerous substances must be disposed of in accordance with the written protocol of the health care facility, to require such disposal to be conducted with the written protocol of the health care facility, to require such disposal to be conducted consistent with all local, State and Federal laws and regulations. Existing rule N.J.A.C. 13:39-9.16, concerning records and reports, is proposed to be recodified, with amendments, at N.J.A.C. 13:39- 9.19. The amendment proposed to subsection (a) of the rule, concerning the provision of adequate storage space for records, is currently included in existing rule N.J.A.C. 13:39-9.23. The Board has included the provision in N.J.A.C. 13:39-9.19 to make the requirements for retention of records more comprehensive and easier to follow. The Board is also amending paragraph (b)3 of the rule to provide that the oldest four years of inpatient profile record information must be retrievable in two weeks and that the most recent one year of information must be immediately retrievable, in order to make the rule consistent with other Board rules throughout the chapter on document retention and production. Existing rule N.J.A.C. 13:39-9.17, concerning drug information and education, is proposed to be recodified, with technical amendments, at N.J.A.C. 13:39-9.20. Existing rule N.J.A.C. 13:39-9.18, concerning after hours access to the institutional pharmacy, is proposed to be recodified at N.J.A.C. 13:39-9.21, with amendments. The Board is proposing that subsection (f) of the rule, which requires certain records to be maintained for one year, be amended to require that the records be retained for five years, in order to make the rule consistent with other document retention and production rules throughout Chapter 39.

Existing rule N.J.A.C. 13:39-9.22, which establishes requirements for the pharmacist's staff in an institution, is proposed to be repealed because the Board cannot dictate staffing requirements in health care institution. N.J.A.C. 13:39-9.23, which is currently reserved, is proposed to be deleted. Existing rule N.J.A.C. 13:39-9.24, concerning pharmacy facilities, is proposed to be recodified at N.J.A.C. 13:39-9.22, with technical amendments. Existing rule N.J.A.C. 13:39-9.25, concerning storage and security, is proposed to be recodified, with amendments, at N.J.A.C. 13:39-9.23. As noted above, N.J.A.C. 13:39-9.23 has been amended to include deleted provisions from recodified rule N.J.A.C. 13:39-9.10 requiring the pharmacist-in-charge to maintain control over all dispensed drugs within a system. In addition, N.J.A.C. 13:39-9.23 includes a new provision concerning procedures for the removal of outdated and recalled drugs, which was previously included in existing rule N.J.A.C. 13:39-9.13. As noted above, N.J.A.C. 13:39-9.13 is proposed to be deleted as part of this proposal. Existing rule N.J.A.C. 13:39-9.26, which establishes equipment requirements, is proposed to be recodified at N.J.A.C. 13:39-9.24, without change.

Existing rule N.J.A.C. 13:39-9.27, concerning decentralized pharmacies, is proposed to be recodified, with amendments, at N.J.A.C. 13:39-9.25. The Board is amending the rule, which currently provides that medications may not be dispensed from a decentralized pharmacy without a pharmacist present, to clarify that if a decentralized pharmacy is closed, a licensed nurse may dispense medications from the pharmacy in accordance with the written policies and procedures of the institution. The Board is also amending the rule to require institutions operating decentralized pharmacies to notify the Board, in writing, of the existence or discontinuation of each decentralized pharmacy location. The Board will no longer require institutions to file remodeling applications in order to operate decentralized pharmacies, nor will the Board continue to require decentralized pharmacies to maintain the minimum equipment set forth in subsection (d), which is being deleted. The Board believes that a remodeling application is not necessary given the fact that the health care system has already been issued an institutional pharmacy permit. In addition, the minimum equipment to be maintained in a decentralized pharmacy within an institution will vary depending on the type of services to be provided by the particular pharmacy. The Board is also proposing several new requirements as part of recodified rule N.J.A.C. 13:39-9.25. The amended rule now requires all decentralized pharmacies to comply with the medication inspection requirements set forth in N.J.A.C. 13:39-9.23, and to comply with all requirements applicable to fully permitted institutional pharmacies, consistent with the pharmaceutical services provided by the decentralized pharmacy.

The Board is proposing a new rule at N.J.A.C. 13:39-9.26 concerning valid medication orders. The proposed new rule provides that only medication orders issued by an authorized prescriber licensed to write medication orders in the United States or any territory of the United States shall be considered valid medication orders, and that such orders shall be filled consistent with New Jersey law. All other medication orders shall not be filled by a pharmacy in New Jersey. This new rule, which is intended to provide guidance to pharmacists filling prescriptions for a health care facility, is consistent with recodified rule N.J.A.C. 13:39-7.1, which establishes similar requirements for pharmacists working in a retail pharmacy setting. Existing rule N.J.A.C. 13:39-5.8, which imposes requirements upon a health care facility for filing of prescriptions and medication orders transmitted by technological devices, is proposed to be recodified at N.J.A.C. 13:39-9.27, with clarifying amendments. The Board is amending subsection (c) of the rule to provide that medication orders for narcotic Schedule II controlled substances written for direct administration to patients by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion which are transmitted by facsimile shall serve as the original medication order. The proposed amendment is necessary to make the Board's rule consistent with the federal requirements for facsimile transmission of Schedule II medication orders set forth in 21 C.F.R. 1306.11(d), (e), (f) and (g).

Subchapter 10 contains rules for using automated medication systems. N.J.A.C. 13:39-10.1, which sets forth the purpose and scope of the subchapter, N.J.A.C. 13:39-10.2, which defines automated medication systems, and N.J.A.C. 13:39-10.4, 10.6, 10.7 and 10.8, which require the establishment of written policies for system operation, quality assurance, recovery and preventative maintenance, respectively, are proposed to be readopted without change. N.J.A.C. 13:39-10.3, which authorizes the use of such systems, and N.J.A.C. 13:39-10.5, which establishes personnel training requirements, are proposed to be readopted with technical amendments.

As amended, Subchapter 11 contains requirements for compounding preparations in both retail and institutional pharmacy settings. Currently, the requirements in Subchapter 11 are applicable only to sterile product compounding. The Board, however, is proposing to amend the subchapter in order to make several of the rules generally applicable to the compounding of both sterile and non-sterile products in such settings. The Board believes that such amendments are necessary in order to provide guidance to pharmacists on the standards that must be followed when compounding non-sterile preparations. The Board, therefore, is proposing that N.J.A.C. 13:39-11.1, which sets forth the purpose and scope of the subchapter, be amended to clarify that the rules in the subchapter will apply to all retail and institutional pharmacies which compound and dispense sterile and/or non-sterile preparations. N.J.A.C. 13:39-11.2, which defines relevant terms used throughout the subchapter, is being amended to update several of the definitions in order to make them consistent with current industry standards. The Board is amending the current definitions of "class 100," "class 1,000" and "class 10,000" air quality conditions to reflect the current International Organization for Standardization (ISO) pronouncements concerning air room particulate cleanliness classes in clean rooms and clean zones. These standards have been endorsed by the General Service Administration of the Federal government. N.J.A.C. 13:39-11.3, regarding the proper environment for sterile compounding services, is proposed to be amended to encompass non-sterile compounding. Specifically, the rule is amended to provide that compounding of non-sterile preparations must take place in a compounding environment designated especially for such purposes.

Existing rule N.J.A.C. 13:39-11.4 establishes time frames by which pharmacies throughout the State that engage in sterile compounding must comply with the rules in Subchapter 11. The Board is proposing to repeal N.J.A.C. 13:39-11.4 because the time frames established in the rule have all expired, and all pharmacies engaging in sterile compounding are currently subject to the rules in the subchapter. Existing rule N.J.A.C. 13:39-11.5, which sets forth general requirements for permit holders seeking authority to engage in sterile compounding, is proposed to be recodified at N.J.A.C. 13:39-11.4, with amendments. The Board is proposing that the rule be amended to require permit holders to notify the Board 60 days prior to beginning the compounding of sterile preparations. Currently, permit holders must notify the Board 30 days prior to beginning sterile compounding activities. The Board believes that this additional time is necessary in order to ensure that the Board can process a permit holder's request and provide the required approval in a timely fashion. The Board is also proposing that N.J.A.C. 13:39-11.6, which sets forth the responsibilities of the pharmacist-in-charge and the permit holder when engaging in the compounding of preparations, be recodified at N.J.A.C. 13:39-11.5, with amendments. The proposed amendments to the rule clarify that the pharmacist-in-charge shall supervise all sterile and/or non-sterile compounding. In order to supervise sterile compounding operations, the pharmacist-in-charge must be trained in aseptic manipulation skills. In addition, the Board is proposing to amend the rule to provide that the preparation and compounding of sterile products may only be performed by licensed pharmacists who have been trained in aseptic manipulation skills, or by appropriately trained pharmacy technicians, interns or externs working under the direction of such pharmacists. The rule is also being amended to provide that the preparation and compounding of non-sterile products may only be performed by licensed pharmacists or by pharmacy technicians, interns or externs working under the supervision of a licensed pharmacist. The Board also notes that several provisions originally contained in existing rule N.J.A.C. 13:39-9.8, concerning general compounding requirements, which is proposed to be deleted as part of this proposal, have been included in recodified rule N.J.A.C. 13:39-11.5. These requirements include procedures for the formation of products in response to special drug needs and batch compounding, as well as procedures for maintaining the integrity of packaged materials.

Existing rule N.J.A.C. 13:39-11.8, concerning the use of supportive personnel, is proposed to be recodified, with clarifying amendments, at N.J.A.C. 13:39-11.6. The Board is also proposing that the requirements in the rule be made applicable to pharmacies engaging in non-sterile compounding in order to ensure consistency regarding the use of such personnel in the compounding process. N.J.A.C. 13:39-11.7, which established training requirements, is proposed to be readopted with clarifying amendments. The training requirements of the rule continue to apply only to persons engaged in the compounding of sterile products. The Board notes, however, that it will be proposing training requirements for persons engaged in non-sterile compounding in the future. Existing rules N.J.A.C. 13:39-11.9, concerning batch preparation, N.J.A.C. 13:39-11.10, concerning documentation, and N.J.A.C. 13:39-11.11, concerning prescription labels, are proposed to be recodified at N.J.A.C. 13:39-11.8, 11.9, and 11.10, with amendments to clarify the meanings of the rules. The Board is proposing that the requirements in these rules be made applicable to both sterile and non-sterile compounded preparations.

Existing rule N.J.A.C. 13:39-11.12, concerning the "use by date" of sterile compounded preparations, is proposed to be recodified at N.J.A.C. 13:39- 11.11, with amendments. The Board is proposing that subsection (a) be amended to provide that the "use by date" of a sterile compounded preparation not exceed 30 days. Existing rule N.J.A.C. 13:39-11.13, concerning handling, packaging and delivery of compounded preparations, is proposed to be recodified at N.J.A.C. 13:39-11.12, with amendments which will make the rule applicable to both sterile and non-sterile compounded preparations.

Existing rules N.J.A.C. 13:39-11.14, concerning the maintenance of policy and procedure manuals, N.J.A.C. 13:39-11.15, concerning quality assurance programs, and N.J.A.C. 13:39-11.16, concerning patient profile records, are proposed to be recodified at N.J.A.C. 13:39-11.13, 11.14 and 11.15, respectively, with clarifying amendments. The Board is also proposing to amend N.J.A.C. 13:39-11.13(c) to eliminate the requirement that the pharmacist-in- charge review the referenced policies and procedures manual annually. The Board has determined that annual review of these policies and procedures manuals is not necessary and is overly burdensome. The proposed amendment requires the review to be conducted at least once every two years. The Board notes that the amended rules continue to be applicable only to sterile compounded preparations and that the Board may consider making such requirements applicable to pharmacies that engage in non-sterile product preparation in the future. Existing rules N.J.A.C. 13:39-11.17, 11.18, 11.19, 11.20, 11.21, 11.22, 11.23 and 11.24, which concern various aspects of the controlled environment specifications imposed upon pharmacies engaging in sterile product compounding, are proposed to be recodified at N.J.A.C. 13:39-11.16, 11.17, 11.18, 11.19, 11.20, 11.21, 11.22 and 11.23, respectively, with clarifying amendments. The Board notes that N.J.A.C. 13:39-11.19(e)1, which currently requires a clean room to contain a laminar airflow hood or a suitable HEPA filter system, is amended to provide that the laminar airflow hood and the HEPA filter system must be ISO class 5 or better. The Board is proposing these amendments in order to ensure that its clean room requirements are consistent with ISO recommendations. The amended rules continue to be applicable only to sterile compounded preparations.

Existing rules N.J.A.C. 13:39-11.25, concerning library references, N.J.A.C. 13:39-11.26, concerning the disposal of drugs and materials, and N.J.A.C. 13:39-11.27, concerning security of the compounding area, are proposed to be recodified at N.J.A.C. 13:39-11.24, 11.25 and 11.26, respectively, with clarifying amendments. As amended, the rules are applicable to pharmacies engaging in both sterile and non-sterile compounding.

The rules in Subchapter 12 establish requirements for nuclear pharmacies. N.J.A.C. 13:39-12.1 contains definitions for relevant terms used throughout the subchapter. The definition of "direct supervision" is being deleted and replaced with a definition of "immediate personal supervision" in order to make the terminology consistent with the proposed changes to the definition in N.J.A.C. 13:39-1.2, discussed above. The remaining definitions in N.J.A.C. 13:39-12.1 are proposed to be readopted without change. N.J.A.C. 13:39-12.2, which establishes general requirements for pharmacies providing radiopharmaceutical services, is proposed to be readopted with technical amendments, to reflect a change in terminology. N.J.A.C. 13:39-12.3, 12.4 and 12.5, concerning requirements for nuclear pharmacists, for space and equipment, and for quality control procedures, are propose to be readopted, without change.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a) 5.

Social Impact

The Board believes that the existing rules, which have been in effect for the past five years, have protected the health, safety and welfare of the citizens of New Jersey by identifying those individuals who are qualified and legally authorized to engage in the practice of pharmacy. These rules establish the requisite standards of licensure in the State and positively affect the regulated community by clarifying the varied aspects of pharmacy practice for the benefit of all licensees, permit holders and applicants for licensure. The readoption of N.J.A.C. 13:39 is essential in order for the Board to continue to regulate the practice of pharmacy, to identify those individuals who are qualified to render pharmaceutical services, and to ensure that every licensee, permit holder and applicant is aware of the procedures involved with licensure.

The readoption of N.J.A.C. 13:39 continues accepted standards of pharmaceutical practice, and by so doing, provides licensees, permit holders and applicants for licensure a clear and comprehensive set of rules to guide them in their professional practice. Applicants for licensure will benefit by having a set of rules which govern the manner in which they may qualify for licensure. Licensees will benefit from the rules proposed for readoption, as a result of the uniform standards that will be applied throughout the profession. Permit holders will benefit by having clear and comprehensive standards which govern the operation and maintenance of permitted facilities, whether they be retail, institutional or nuclear pharmacies.

The Board also believes that the rules proposed for readoption will have a positive impact upon the general public by continuing to safeguard public health and safety, by ensuring the maintenance of professional practice standards which will enable licensees and permit holders to provide the highest quality professional service in the dispensing of medications.

Moreover, the Board believes that the proposed amendments to N.J.A.C. 13:39 will have a positive impact upon the licensed community and upon the consumers they serve. Specifically, the Board believes that the proposed recodification of the rules in Chapter 39 will make the rules easier to find and, therefore, easier to follow. In addition, the Board believes that the proposed amendments and new rule in Subchapter 2 will help to clarify the obligations and responsibilities imposed upon licensed pharmacists, particularly in terms of biennial licensure renewal, reinstatement from administrative and disciplinary suspensions, and the election of inactive licensure status. The Board also believes that the proposed amendments and new rules in Subchapter 3 will benefit applicants seeking licensure by reciprocity by providing guidance to such individuals regarding the standards they must meet in order to qualify for a New Jersey license. The proposed amendments to the rules in Subchapter 4 will also have a positive impact upon pharmacy permit holders by clarifying acceptable business practices and by delineating the professional standards that must be upheld by pharmacies.

The Board also believes that the proposed amendments and new rule in Subchapter 5 will help to ensure that all retail pharmacies operating in the State comply with minimum facility requirements. In addition, the proposed amendments and new rules in Subchapter 6 will help to clarify the responsibilities and obligations of registered-pharmacists-charge, as well as other pharmacy personnel, particularly pharmacy technicians, in terms of the duties they are authorized to perform. The proposed amendments and new rules in Subchapter 7 will provide guidance to pharmacists concerning appropriate practice standards which must be maintained relating to medication dispensing. The Board also believes that the proposed amendments to the rules in Subchapter 7 will help to ensure that prescription drug files are maintained in an appropriate manner so that such records will be easily accessible to both patients and the Board.

The Board believes that the proposed amendments to Subchapter 8 will have a positive impact upon interns and externs by clarifying the existing rules in order to ensure that preceptors, interns and externs are cognizant of their respective responsibilities. Moreover, the Board believes that the proposed amendments and new rules in Subchapter 9, which clarify the responsibilities and obligations of pharmacies and pharmacists dispensing medications in health care facilities, will have a positive impact upon such pharmacies and pharmacists, as well as upon consumers, by ensuring that appropriate measures are taken when medications are prepared and dispensed in such facilities.

The proposed amendments and new rules in Subchapter 11 will also have a positive impact upon pharmacies and pharmacists throughout the State which engage in the compounding of sterile and/or non-sterile products. The proposed amendments and new rules will clarify the obligations and responsibilities imposed upon facilities and licensees that engage in such activities, and as a result, will help to ensure that the compounding of such products is done only pursuant to the strict standards established in the rules. The proposed amendments and new rules will, therefore, help to ensure the integrity of the sterile and non-sterile products compounded and dispensed to patients throughout the State.

Economic Impact

The Board has reviewed its financial position and has determined that its fee schedule, N.J.A.C. 13:39-1.3, is sufficient to comport with the requirements of N.J.S.A. 45:1-3.2, which provides that professional boards in the State must collect revenues necessary to fund reasonable and necessary expenses, but prohibits the collecting of funds which exceed such expenses. Thus, readoption of the existing rules will enable the Board to continue to appropriately execute its functions without generating a surplus. The Board notes that the amendments it is proposing to the fee schedule will not result in any significant impact upon the Board's financial position. The proposed deletion of the fees currently listed for the NAPLEX and MJPE examinations, as well as the fee for score transfers, will not impact the Board because such fees are not established or collected by the Board. The fees are set by, and must be remitted to, the national entity which administers the examinations and serves as a repository for applicant grades. In addition, the Board notes that the proposed fee of $25.00 for a formal verification of licensure or permit status is a nominal amount that will be used to offset the administrative expenses that will be borne by the Board in providing verification documentation to licensees, permit holders or other licensing agencies.

The Board anticipates that the proposed readoption of the current rules in Chapter 39 will not impose any new or additional costs upon applicants for licensure or permits, licensees, permit holders or consumers. The proposed readoption of the existing rules will continue the economic impact that the rules have had on such persons for the past five years.

The rules in Subchapter 1 will continue to economically impact licensees and permit holders to the extent that such persons are required to remit the fees specified in N.J.A.C. 13:39-1.3. Licensees and permit holders may also be economically impacted by the readoption of N.J.A.C. 13:39-1.5 to the extent that such persons are required to remit payment of any penalties imposed by the Board pursuant to the schedule established in the rule.

The rules in Subchapter 2 will continue to have an economic impact upon applicants for licensure as pharmacists to the extent that applicants will incur costs associated with passing the required licensure examinations, and in submitting the required licensure application and supporting materials to the Board for its review. The Board notes that many of the rules currently contained in Subchapter 3, concerning licensure requirements for pharmacists, are proposed to be recodified in Subchapter 2. The readoption of these rules will continue to economically impact licensees to the extent that licensees will incur costs associated with notifying the Board of any change in their personal or professional information on file with the Board, as is required under the rules of the subchapter. Licensees seeking verification of their licensure information or seeking duplicate licenses will also experience an economic impact as a result of the proposed readoption because they will be required to remit the fees imposed by the Board for such services.

Subchapter 3A will continue to have an economic impact upon licensees to the extent that they will incur costs associated with satisfying the continuing education requirements set forth in the subchapter. The proposed readoption of the rules in Subchapter 3A will also have an economic impact upon sponsors of continuing education courses or programs to the extent that sponsors will incur administrative expenses associated with submitting the documentation required to obtain Board approval for their courses or programs.

Subchapter 4 will continue to have an economic impact upon applicants for pharmacy permits and upon holders of such permits. Applicants for permits will incur costs associated with submitting the required application and supporting materials to the Board for its review. Pharmacy permit holders will also be economically impacted as a result of the readoption of the rules in Subchapter 4 to the extent that they incur costs associated with notifying the Board of any changes in ownership or location of the permitted establishment.

The rules currently codified in Subchapter 5, 6 and 7, and which are proposed to be recodified throughout various subchapters, will continue to have an economic impact upon pharmacy permit holders to the extent that pharmacies may only fill prescriptions and dispense medications consistent with the requirements set forth in the rules. Permit holders will be economically impacted as a result of the readoption of the rules in these subchapters to the extent that they incur costs associated with ensuring compliance with the facility, equipment, supply, record retention, and personnel requirements imposed under the rules.

Subchapter 8 will continue to impose economic costs upon pharmacy interns and licensees that serve as preceptors in pharmacy internship programs to the extent that interns and licensees will incur administrative costs associated with applying to the Board for internship approval and in submitting the documentation required for periodic board.

The rules proposed for readoption in Subchapter 9 will continue to have an economic impact upon pharmacies which provide pharmaceutical services for health care facilities, whether such pharmacies hold institutional or retail pharmacy permits, to the extent that such pharmacies will incur administrative expenses associated with ensuring compliance of the facility, equipment, supply, record retention and personnel requirements of the subchapter.

The proposed readoption of the rules in Subchapter 10 will have an economic impact upon any permit holder who chooses to utilize automated medication systems in the filing of prescriptions and the dispensing of medications. Permit holders will continue to incur costs associated with personnel training and system maintenance requirements imposed under the subchapter.

Subchapter 11 will continue to have an economic impact upon retail and institutional pharmacy permit holders who perform sterile admixture services. Permit holders will incur costs associated with ensuring that the facilities and equipment utilized in compounding prescriptions, and the personnel that perform such services, comply with the requirements set forth in the rules.

The proposed readoption of the rules in Subchapter 12 will continue to have an economic impact upon permit holders who provide radiopharmaceutical services to the extent that such permit holders will incur costs associated with ensuring compliance with the facility, equipment, supply and personnel requirements imposed under the rules of the subchapter.

The Board does not anticipate any new or additional economic impact that may be imposed upon applicants for licensure or permits, licensees, permit holders or consumers as a result of the proposed amendments and new rules, with the exception of the following. Proposed new rules N.J.A.C. 13:39-2.6 and 3.6, which require applicants for licensure by examination and by reciprocity to undergo criminal history background checks, will require such applicants to remit all fees associated with obtaining criminal history record information. In addition, proposed new rules N.J.A.C. 13:39-2.16 and 2.17, concerning licensure renewal, suspension and reinstatement, may have an economic impact upon licensees, to the extent that licensees who submit their renewal applications within 30 days after their license expiration date must submit a late fee, in addition to the standard license renewal fee charged by the Board. In addition, licensees who have had their licenses suspended for failure to renew within 30 days after the license expiration date will incur additional costs if they wish to have their license reinstated. A licensee seeking reinstatement within five years of the date his or her license expired must submit a renewal application, all past delinquent renewal fees, a reinstatement fee any outstanding penalties imposed by the Board and evidence of having completed all delinquent continuing education credits. A licensee seeking reinstatement five years or more following license suspension must also retake the MJPE and NAPLEX examinations. Moreover, applicants seeking reinstatement from a disciplinary suspension must submit a reinstatement application, reinstatement and renewal fees, and evidence of having met all conditions previously imposed upon the pharmacist by Board order. Proposed new rule N.J.A.C. 13:39-2.18, concerning inactive licensure status, may also have an economic impact upon licensees who choose to renew their licenses with the inactive designation, to the extent that such persons must bear the costs associated with completing requisite continuing education requirements if they wish to resume active practice.

Proposed new rule N.J.A.C. 13:39-3.2, which sets forth requirements for obtaining reciprocal licensure, may have an economic impact upon pharmacists licensed in other jurisdictions who wish to be licensed in New Jersey, to the extent that they may incur administrative costs associated with submitting the required documentation called for in the new rule. The proposed amendments to N.J.A.C. 13:39-4.10, which require a pharmacy to notify the Board of any temporary closing, may have an economic impact upon permit holders, to the extent that failure to report such a closing may result in the pharmacy being deemed discontinued, thereby prohibiting the pharmacy from reopening for business. In addition, proposed new rule N.J.A.C. 13:39-6.4, which will allow pharmacies to dispense medications when the pharmacist is out during the 30 minute meal break now provided for under the rule, if the medication has been pre-checked by the pharmacist, may have an economic impact upon pharmacies to the extent that the rule will allow pharmacies to remain open for business when a registered pharmacist will not be on duty. Similarly, the proposed amendments to N.J.A.C. 13:39-6.2, which require the registered pharmacist- in-charge to be a full-time employee, employed for a minimum of 35 hours per week, may have an economic impact upon permitted pharmacies, to the extent that the amendments will require pharmacies to retain the services of a registered pharmacist-in-charge for the minimum amount of time specified in the rule.

The Board also believes that the proposed amendments to N.J.A.C. 13:39-6.6, concerning pharmacy technicians, may have an economic impact upon pharmacies throughout the State, to the extent that pharmacies wishing to utilize technicians in numbers greater than the current 1:2 ratio may incur administrative costs associated with the education and training requirements for such personnel set forth in the rule. The proposed amendments to N.J.A.C. 13:39-6.6 may also have an economic impact upon pharmacies throughout the State to the extent that pharmacies may now augment their work force with a larger number of pharmacy technicians, which could result in greater productivity. The proposed amendments to N.J.A.C. 13:39-7.16, which will allow pharmacies to place back into their active stock any medications prepared for patients, but which were not dispensed, may have an economic impact upon pharmacies in the State, to the extent that pharmacies will be able to resell such medications provided the safety requirements set forth in the rule are satisfied.

The proposed amendment to N.J.A.C. 13:39-9.6, which provides that all health care facilities that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health and Senior Services rules, must create and maintain written policies and procedures for the provision of pharmaceutical services in the facility, may have an impact upon facilities which do not currently have such policies and procedures in place.

The proposed amendments and new rules in Subchapter 11, regarding standards for retail and institutional pharmacies engaging in sterile and non-sterile compounding, may have an economic impact upon pharmacies performing such activities. Pharmacies which currently provide sterile compounding services may be economically impacted by the proposed amendments and new rules, to the extent that such pharmacies may incur costs associated with reviewing and amending their sterile compounding procedures to ensure compliance with new requirements set forth in the rules. In addition, pharmacies which currently provide non-sterile compounding services, and which have until now not been subject to any of the rules in Subchapter 11, may also be economically impacted as a result of the proposed amendments and new rules, to the extent that they incur costs in bringing their non-sterile compounding procedures and operations in line with the requirements set forth in the subchapter.

Federal Standards Statement

A Federal standards analysis is not required because the rules proposed for readoption with amendments and the proposed new rules are governed by N.J.S.A. 45:14-1 et seq. and are not subject to any Federal standards or requirements. Although the rules in N.J.A.C. 13:39 are not subject to any mandatory Federal requirements or standards, where deemed appropriate, the Board has incorporated Federal standards. Specifically, the Board notes that the requirements for the facsimile and electronic transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:39-7.10, 7.11 and 9.27 are consistent with the Federal Drug Enforcement Administration standards articulated at 21 C.F.R. ß ß 1306.11 and 1306.21.

Jobs Impact

The Board does not anticipate that the rules proposed for readoption with amendments or the proposed new rules will affect either the number of candidates applying for licensure or the number of licensees or permit holders authorized to engage in the practice of pharmacy. Therefore, the Board does not anticipate that the rules proposed for readoption with amendments or the proposed new rules will result in an increase or decrease in the number of jobs in the State. It is possible, however, that the proposed amendments to N.J.A.C. 13:39-6.6, which will authorize pharmacies to retain pharmacy technicians in numbers beyond the current one pharmacist to two technician ratio, may have an impact upon the number of jobs available for pharmacy technicians throughout the State, to the extent that pharmacies may seek to augment their professional staff with additional technicians, consistent with the requirements articulated in the rule.

Agriculture Industry Impact

The Board does not believe that the rules proposed for readoption with amendments or the proposed new rules will have any impact upon the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to provide a description of the types and an estimate of the number of small businesses to which the proposed readoption with amendments and proposed new rules will apply. Currently, the Board licenses approximately 12,741 pharmacists and issues permits to approximately 1,984 pharmacies. If Board licensees and permit holders are considered "small businesses," within the meaning of the Act, then the following analysis applies.

The Act requires the Board to set forth reporting, recordkeeping and other compliance requirements of the rules proposed for readoption with amendments and the proposed new rules, including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs of the proposed readoption with amendments and new rules, to outline the manner in which it has designed the rules proposed for readoption with amendments and new rules to minimize any adverse economic impact upon small businesses, and to set forth whether the rules proposed for readoption with amendments and new rules establish differing compliance requirements for small businesses.

The rules proposed for readoption with amendments and new rules will impose various reporting, recordkeeping and compliance requirements upon Board licensees and permit holders. These requirements are discussed in the Summary statement above.

No additional professional services will be needed to comply with the rules proposed for readoption with amendments and new rules. In addition, the Board does not believe that there will be any significant, additional economic impact upon licensed pharmacists and pharmacy permit holders as a result of the proposed readoption with amendments and new rules. The costs of compliance with the rules proposed for readoption with amendments and new rules are discussed in the Economic Impact statement above. The Board believes that the rules proposed for readoption with amendments and new rules should be uniformly applied to all licensees and permit holders in order to ensure the health, safety and welfare of the general public in the provision of pharmaceutical services and, therefore, no differing compliance requirements for any licensees or permit holders are provided based upon the size of the business, other than distinctions reflected with respect to the type of pharmacy being operated.

Smart Growth Impact

The Board does not believe that the rules proposed for readoption or the proposed new rules will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Recodification Table

N.J.A.C. 13:39

Existing Rules Proposed Recodification
1.1 Purpose and scope 1.1
1.2 Definitions 1.2
1.3 Fee schedule 1.3
1.4 Payment of penalties 1.4
1.5 Hearings 1.5
2.1 Examinations; grades 2.1
2.2 Education requirements 2.2
2.3 Application to be filed 2.3
2.4 (Reserved) Deleted
2.5 (Reserved) Deleted
2.6 (Reserved) Deleted
2.7 Age requirement 2.4
2.8 Proof of character 2.5
2.9 Proof of identity of applicant 2.7
2.10 Alleged violations of the Pharmacy Act 2.8
3.1 License 2.10
3.2 Duplicate license 2.11
3.3 Change of name 2.12
3.4 Change of address of record 2.13
3.5 Certification of records 2.14
3.6 Reproduction of original license prohibited 2.15
3.7 Limitation of reciprocal licensure 3.1
3.8 Basic requirement for transfer of licensure Repealed
3.9 Out-of-State practice requirement for transfer of license from a mutually reciprocating state Repealed
3.10 Clear record of law observance Repealed
3.11 Foreign graduates 2.9
3.12 Physical and mental competence of reciprocal licensees Repealed
3.13 Preliminary application Repealed
3.14 Multistate Jurisprudence Pharmacy Examination: reciprocal licensure 3.7
3.15 Biennial registration renewal Repealed
3.16 Duplicate renewal license Repealed
3.17 Reinstatement in good standing Repealed
3.18 Registered pharmacist-in-charge 6.2
3A.1 Continuing education credit hour requirements 3A.1
3A.2 Criteria for continuing education credit 3A.2
3A.3 Continuing education credit hour calculations 3A.3
3A.4 Continuing education credit hour reporting procedure 3A.4
3A.5 Waiver of continuing education requirements 3A.5
3A.6 Responsibilities of continuing education sponsors 3A.6
3A.7 Monitoring of continuing education programs or courses 3A.7
4.1 Issuance of permits 4.2
4.2 Display of permits 4.3
4.3 Death of owner or partner 4.4
4.4 Change of ownership 4.5
4.5 Change of corporate officers or stockholders of public companies 4.6
4.6 Change of location; remodeling of premises 4.7
4.7 New pharmacies; eligibility and application 4.1
4.8 Discontinued pharmacies 4.8
4.9 Business hours 4.10
4.10 Duplicate permit 4.11
4.11 Change of name 4.12
4.12 Reproduction of permits 4.13
4.13 Certification of records Repealed
4.14 Contract pharmaceutical services 9.4
4.15 Retail permit; prescription department or pharmacy department 4.14
4.16 Permits; specialized permits 4.15
4.17 Steering prohibited 4.16
4.18 Responsibilities of pharmacists and permit holders 4.17
5.1 Imprinted prescription blanks Repealed
5.2 Lack of directions on original prescription 7.2
5.3 Authorization for renewal of prescriptions 7.3
5.4 Approval of FDA necessary 7.5
5.5 Copies of prescriptions; transfers 7.7
5.6 Record of pharmacist filling prescription 7.6
5.7 Availability of records upon termination of business 4.9
5.8 Prescriptions and medication orders transmitted by technological devices in an institution 9.27
5.8A Prescriptions transmitted by facsimile 7.10
5.8B Electronically transmitted prescriptions 7.11
5.9 Labeling 7.12
5.10 Procedures for Centralized Prescription Handling 4.19
6.1 Professional judgment in dispensing drugs 7.13
6.2 Prescription prepared, compounded or dispensed by pharmacy externs or interns 6.5
6.3 Identification tag 6.3
6.4 Direct supervision of dispensing and compounding Repealed
6.5 Restriction on display of prescription legend drugs and controlled dangerous substances 5.12
6.6 Foreign prescriptions Repealed
6.7 Supportive personnel 6.6
6.8 Advertising and sale of prescription drugs 7.14
6.9 Restriction on sale of Schedule V over-the-counter controlled substances 7.15
7.1 Retail pharmacy access and egress 5.2
7.2 Retail pharmacy signs 5.3
7.3 Spatial requirement of a retail pharmacy prescription area 5.4
7.4 Prescription counter 5.5
7.5 Prescription area sink 5.6
7.6 Storage and adequate stock 5.7
7.7 Minimum equipment and facilities 5.8
7.8 Cleanliness, orderliness and sanitation 5.9
7.9 Television in prescription area prohibited 5.10
7.10 Return of prescription medication 7.16
7.11 Prescription balances, scales, weights and automatic counting devices 5.11
7.12 Disposal of unwanted drugs 7.17
7.13 Outdated drugs or drugs marked "sample" 7.18
7.14 Patient profile record system 7.19
8.1 Definitions 8.1
8.2 Preceptor certification application; procedures; responsibilities 8.2
8.3 Pharmacy training site requirements 8.3
8.4 Internship and externship practical experience 8.4
8.5 Change in intern status 8.5
8.6 Committee on Pharmacy Internship and Externship Repealed
8.7 Pharmacist intern log Repealed
9.1 Definitions 9.2
9.2 Licensure of institutional pharmacies 9.3
9.3 Control of institutional pharmaceutical services 9.8
9.4 Pharmaceutical services 9.9
9.5 Pharmaceuticals 9.10
9.6 Drug disbursement; written orders; outpatient prescriptions 9.11
9.7 Drug disbursement; oral orders 9.12
9.8 Compounding Repealed
9.9 Monitoring of patient drug therapy 9.13
9.10 Medication not dispensed in finished form 9.14
9.11 Drug labeling 9.15
9.12 Use of patient's own medication 9.16
9.13 Investigational drugs; removal of outdated and recalled drugs; drug supply; controlled dangerous substances Repealed
9.14 Drug-dispensing devices 9.17
9.15 Disposal of unused medications 9.18
9.16 Records and reports 9.19
9.17 Drug information and education 9.20
9.18 After hours access to the institutional pharmacy 9.21
9.19 Advisory committees 9.5
9.20 Pharmacy and Therapeutics Committee 9.6
9.21 Institutional pharmacy staff 9.7
9.22 Pharmacist staff Repealed
9.23 (Reserved) Deleted
9.24 Pharmacy facilities; space 9.22
9.25 Storage and security 9.23
9.26 Equipment 9.24
9.27 Institutional decentralized pharmacies 9.25
10.1 Purpose and scope 10.1
10.2 "Automated medication system" definition 10.2
10.3 Authority to use automated medication system 10.3
10.4 Written policies and procedures of operation 10.4
10.5 Personnel training requirements 10.5
10.6 Written program for quality assurance 10.6
10.7 Written plan for recovery 10.7
10.8 Written program for preventative maintenance of automated medication system 10.8
11.1 Purpose and scope 11.1
11.2 Definitions 11.2
11.3 Sterile admixture services; environment 11.3
11.4 Compliance Repealed
11.5 General requirement 11.4
11.6 Pharmacist in charge and permitholders' responsibilities 11.5
11.7 Training requirements 11.7
11.8 Supportive personnel; required supervision 11.6
11.9 Batch preparation 11.8
11.10 Documentation 11.9
11.11 Information required to appear on prescription label 11.10
11.12 Expiration date of sterile preparation 11.11
11.13 Handling, packaging and delivery 11.12
11.14 Policy and procedure manual 11.13
11.15 Quality assurance program 11.14
11.16 Patient profile records 11.15
11.17 Controlled environment: use, access, location;temperature 11.16
11.18 Controlled environment: construction 11.17
11.19 Controlled environment: stocking, maintenance and supplies 11.18
11.20 Controlled environment: clean room 11.19
11.21 Controlled environment: anteroom 11.20
11.22 Vertical air laminar flow hoods 11.21
11.23 Laminar air flow hoods not in a clean room 11.22
11.24 Controlled environment: self-contained sterile glove boxes 11.23
11.25 Library references 11.24
11.26 Disposal of drugs and materials 11.25
11.27 Security 11.26
12.1 Definitions 12.1
12.2 General requirements for pharmacies providing radiopharmaceutical service 12.2
12.3 General requirements for a nuclear pharmacist 12.3
12.4 Minimum requirements for space, equipment, supplies, and library 12.4
12.5 Quality control 12.5

Proposed New Rules

2.6 Criminal history background check

2.16 Biennial license renewal; administrative suspension

2.17 Reinstatement from administrative and disciplinary license suspensions

2.18 Inactive licensure

2.19 Steering prohibited

2.20 Responsibilities of pharmacists

3.2 Requirements for reciprocal licensure of pharmacist currently licensed in another jurisdiction

3.3 Proof of character

3.4 Proof of identity of applicant

3.5 Alleged violations of the Pharmacy Act

3.6 Criminal history background check

5.1 Purpose and scope

6.1 Purpose and scope

6.4 Meal breaks

7.1 Valid prescriptions; out-of-State prescriptions

7.4 Emergency dispensing

7.8 Transfer of prescriptions between pharmacies

7.9 Filing and storage of controlled substance prescriptions

9.2 Purpose and Scope

9.26 Valid medication orders; out-of-State medication orders

Full text of the proposed readoption may be found in the New Jersey Administrative Code at N.J.A.C. 13:39.

Full text of the proposed repeals may be found in the New Jersey Administrative Code at N.J.A.C. 13:39-3.8, 3.9, 3.10, 3.12, 3.13, 3.15, 3.16, 3.17, 4.13, 5.1, 6.4, 6.6, 8.6, 8.7, 9.8, 9.13, 9.22 and 11.4.

Full text of the proposed amendments and new rules follow :

SUBCHAPTER 1. GENERAL PROVISIONS

<< NJ ADC 13:39-1.1 >>

13:39-1.1 Purpose and scope

(a) (No change.)

(b) This chapter shall apply to all registered pharmacies, pharmacists, pharmacist applicants, interns, externs, <<-supportive personnel->> <<+ pharmacy technicians+>> and anyone within the jurisdiction of the Board of Pharmacy.

<< NJ ADC 13:39-1.2 >>

13:39-1.2 Definitions

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.

"Address of record" means an address designated by a licensee <<-which is part of the public record and which may be disclosed upon request->>. "Address of record" may be a licensee's home, business or mailing address, but shall not be a post office box <<+unless the licensee also provides another address which includes a street, city, state and zip code+>>.

...

<<-"Direct supervision" means that the registered pharmacist shall be physically present in the compounding/dispensing area where the supportive personnel are performing delegated duties, and shall conduct in-process and final checks of all steps in preparation, compounding, and dispensing of drugs. This supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.->>

...

<<+"Immediate personal supervision" means that the registered pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.+>>

...

<<+"Pharmacy technician" means an individual employed by a pharmacy whose responsibilities do not require professional judgment in the preparation and distribution of medications and who works under the immediate personal supervision of a pharmacist in compliance with N.J.A.C. 13:39-6.6. For purposes of this definition, interns and externs are not pharmacy technicians.+>>

...

<<-"Supportive personnel" means those persons who perform pharmaceutical functions under the direct supervision of a registered pharmacist. Interns and externs are specifically excluded from this definition.->>

<< NJ ADC 13:39-1.3 >>

13:39-1.3 Fee schedule

(a) The following fees shall be charged by the Board:

1. For pharmacists as follows:

i. Application for licensure $125.00.

ii. Verification of licensure 25.00.

iii. Application for reciprocity 125.00.

iv. Application for reinstatement

(1) Disciplinary suspension 225.00.

(2) Administrative suspension (To be determined by future rulemaking)

v.-vii. (No change.)

viii. Inactive license renewal (To be determined by future rulemaking)

ix. (No change.)

x. Replacement of initial wall license 40.00.

xi.-xiii. (No change.)

2. For pharmacies as follows:

i. Pharmacy permits

(1) (No change.)

(2) Annual permit renewal 175.00.

(3) Change of ownership/name 275.00.

(4) (No change.)

ii. Replacement of annual permit 25.00.

iii. (No change in text.)

iv. Verification of permit 25.00.

<< NJ ADC 13:39-1.4 >>

13:39-1.4 Payment of penalties

(a) Any penalties levied by the Board <<-must->> <<+shall+>> be paid within <<-30->> <<+10+>> calendar days of the <<-receipt->> <<+ finalization+>> of a penalty letter or final order of the Board unless otherwise prescribed by statute or terms of a final order.

(b) Failure to comply with this rule <<-will->> <<+may+>> result in action by the Board according to the provisions of N.J.S.A. 45:1-24.

<< NJ ADC 13:39-1.5 >>

13:39-1.5 <<-Hearings->> <<+Opportunity to be heard+>>

(a) Any time the Board seeks to impose a disciplinary sanction upon a licensee, the licensee may request <<-a hearing->> <<+an opportunity to be heard by the Board+>>.

(b) <<-Any hearings held->> <<+When demonstrated facts are in dispute, a hearing+>> shall be conducted pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

SUBCHAPTER 2. <<-APPLICANT QUALIFICATIONS AND EXAMINATIONS->> <<+ LICENSURE+>> REQUIREMENTS

<< NJ ADC 13:39-2.1 >>

13:39-2.1 Examinations; <<-grades->> <<+score+>>

(a) The examination for licensure by the Board shall be the North American Pharmacist Licensure Examination (NAPLEX). An applicant shall attain a passing <<-grade->> <<+score+>> of not less than 75. If an applicant fails the examination, he or she shall be required to repeat the examination.

(b) The applicant shall also pass the Multistate Jurisprudence Pharmacy Examination (MJPE). A passing <<-grade->> <<+score+>> of not less than 75 shall be attained. If an applicant fails the examination, he or she shall be required to repeat the examination.

(c) If the applicant should fail either the NAPLEX or the MJPE three times, the Board may direct the applicant to take remedial courses at an accredited school or college of pharmacy prior to retaking the <<-field->> <<+ failed+>> examination(s).

<< NJ ADC 13:39-2.2 >>

13:39-2.2 Education requirements

(a) (No change.)

(b) Before being admitted to the <<+NAPLEX AND MJPE+>> examination<<+ s+>>, either a transcript of the applicant's record or a certificate by the registrar of the school or college of pharmacy attended must be supplied stating that the applicant has either graduated or has completed all of the requirements for graduation. If the transcript or certificate does not state that the applicant has graduated or has completed all the graduation requirements, the Board may require other forms of proof to be supplied by the applicant.

<< NJ ADC 13:39-2.3 >>

13:39-2.3 Application <<-to be filed->> <<+for examinations+>>

An applicant for the NAPLEX and MJPE examinations shall file an application for such examinations at least 30<<--->>days prior to the date of the <<+ respective+>> examination unless the 30<<+-+>>day requirement is waived by the Board because of extenuating circumstances. The <<-required fees as prescribed->> <<+application fee set forth+>> in N.J.A.C. 13:39-1.3 shall also be submitted.

<< NJ ADC 13:39-2.4 >>

<<-13:39-2.4 (Reserved)->>

<< NJ ADC 13:39-2.5 >>

<<-13:39-2.5 (Reserved)->>

<< NJ ADC 13:39-2.6 >>

<<-13:39-2.6 (Reserved)->>

<< NJ ADC 13:39-2.7 >>

<< NJ ADC 13:39-2.4 >>

13:39-<<-2.7->><<+2.4+>> (No change in text.)

<< NJ ADC 13:39-2.8 >>

<< NJ ADC 13:39-2.5 >>

13:39-<<-2.8->><<+2.5+>> Proof of character

(a) An applicant for the NAPLEX and MJPE examinations shall submit, in advance, an application containing evidence of good moral character which is an ongoing requirement for licensure, and evidence that he or she:

1. <<-Is not a chronic or persistent inebriate->> <<+Is not presently engaged in drug or alcohol use that is likely to impair the ability to practice pharmacy with reasonable skill and safety. For purposes of this section, the term "presently" means at this time or any time within the previous 365 days+>>;

<<-2. Is not addicted to the use of any controlled dangerous substance or other habit-forming drug;->>

<<-3.->><<+2.+>> (No change in text.)

<<-4. Has not been convicted of violating the provisions of any law relating to the sale of liquors;->>

Recodify existing 5.-7. as 3.-5. (No change in text.)

<< NJ ADC 13:39-2.6 >>

<<+13:39-2.6 Criminal history background check+>>

<<+An applicant for initial licensure as a pharmacist in the State shall submit his or her name, address and fingerprints for purposes of a criminal history background check to be conducted by the State of New Jersey pursuant to N.J.S.A. 45:1-28 et seq., P.L. 2002, c. 104, to determine whether criminal history record information exists which may be considered by the Board in determining whether the applicant shall be licensed in the State.+>>

<< NJ ADC 13:39-2.9 >>

<< NJ ADC 13:39-2.7 >>

13:39-<<-2.9->><<+2.7+>> Proof of identity of applicant

An applicant for the NAPLEX and MJPE examinations <<-must->> <<+ shall+>> submit to the Board 30 days in advance of the date of the <<- written->> examination<<+s+>> a passport photograph mounted on a document to be supplied by the Board requesting certain identification information.

<< NJ ADC 13:39-2.10 >>

<< NJ ADC 13:39-2.8 >>

13:39-<<-2.10->><<+2.8+>> (No change in text.)

<< NJ ADC 13:39-2.11 >>

<< NJ ADC 13:39-2.9 >>

13:39-<<-3.11->><<+2.9+>> <<-Foreign graduates->> <<+Applicants educated in a foreign country+>>

(a)-(c) (No change.)

<<+(d) Notwithstanding (a) through (c) above, the provisions of this section shall not apply to any pharmacist applicant who has graduated from a pharmacy school which has been accredited by the American Council of Pharmaceutical Education (ACPE), or has graduated from a pharmacy school that has been accredited by a program that has been deemed ACPE-equivalent by ACPE.+>>

<< NJ ADC 13:39-3.1 >>

<< NJ ADC 13:39-2.10 >>

13:39-<<-3.1->><<+2.10+>> <<-License->> <<+Authorization to practice; display of license+>>

<<+(a)+>> An applicant who has successfully <<-passed->> <<+ satisfied+>> all Board <<-examinations->> <<+requirements for licensure and has been approved by the Board to be licensed+>> shall receive an authorization signed by the Executive Director of the Board granting the applicant the right to practice pharmacy in the State of New Jersey until such time as an initial license may be issued. <<+The licensee shall maintain such authorization on his or her person at all times while engaging in the practice of pharmacy until the initial license is issued.+>>

<<+(b) Upon issuance of a license, the initial wall license and current biennial renewal license shall be conspicuously displayed in the registered pharmacist's principal place of employment.+>>

<<+(c) A registered pharmacist who is employed by more than one licensed pharmacy in the State shall maintain the wallet-sized license issued by the Board on his or her person when he or she is working at a location where his or her wall license and current biennial renewal license are not on display.+>>

<< NJ ADC 13:39-3.2 >>

<< NJ ADC 13:39-2.11 >>

13:39-<<-3.2->><<+2.11+>> <<-Duplicate->> <<+Replacement+>> license

A <<-duplicate->> <<+replacement initial+>> license <<- may->> <<+or renewal license shall+>> be issued by the Board upon payment of a fee as prescribed in N.J.A.C. 13:39-1.3 and upon submission of proof of the applicant's identity and reasonable proof of the loss or destruction of the <<-original->> <<+initial+>> license <<+or renewal license,+>> or upon return of the damaged <<-original->> <<+initial+>> license <<+or renewal license+>> to the Board.

<< NJ ADC 13:39-3.3 >>

<< NJ ADC 13:39-2.12 >>

13:39-<<-3.3->><<+2.12+>> Change of name

If a registered pharmacist legally changes <<-his or her->> <<+the+>> name<<-, the name change shall be recorded in the Board's records->> <<+ under which he or she engages in the practice of pharmacy, the pharmacist shall notify the Board within 30 days of such change+>>. The registered pharmacist shall submit original proof of the change of name or a certified copy of the court order or marriage certificate which <<-will->> <<+shall+>> be retained by the Board. When a <<-duplicate->> <<+replacement+>> license is issued, the <<-original->> <<+initial+>> license <<- must->> <<+shall+>> be returned for cancellation <<-along with the->> <<+and the pharmacist shall remit the+>> required fee as prescribed in N.J.A.C. 13:39-1.3.

<< NJ ADC 13:39-3.4 >>

<< NJ ADC 13:39-2.13 >>

13:39-<<-3.4->><<+2.13+>> Change of address of record<<+; service of process+>>

<<+(a)+>> A registered pharmacist shall notify the Board in writing of any change in his or her address of record within 30 days.

<<+(b) Failure to notify the Board of any change in a registered pharmacist's address of record pursuant to (a) above may result in disciplinary action in accordance with N.J.S.A. 45:1-21(h) and N.J.A.C. 13:45C-1.3, and the imposition of penalties set forth in N.J.S.A. 45:1-25.+>>

<<+(c) Service of any administrative complaint or other Board-initiated process at a registered pharmacist's address of record shall be deemed adequate notice for the purposes of N.J.A.C. 1:1-7.1 and the commencement of any disciplinary proceedings.+>>

<< NJ ADC 13:39-3.5 >>

<< NJ ADC 13:39-2.14 >>

13:39-<<-3.5->><<+2.14+>> <<-Certification->> <<+ Verification+>> of <<-records->> <<+licensure+>>

A <<-certification->> <<+verification+>> that the license of a registered pharmacist is in good standing shall be supplied by the Board upon <<+written+>> request and <<+upon payment of the fee set forth in N.J.A.C. 13:39-1.3+>>.

<< NJ ADC 13:39-3.6 >>

<< NJ ADC 13:39-2.15 >>

13:39-<<-3.6->><<+2.15+>> Reproduction of <<-original->> <<+ initial+>> license prohibited

The <<-original->> <<+initial+>> wall license, biennial license or wallet-sized license issued by the Board to any pharmacist shall not be reprinted, photographed, photostated, duplicated or reproduced by any other means either in whole or in part, except as provided in N.J.A.C. 13:39-<<- 3.16->><<+2.11+>>.

<< NJ ADC 13:39-2.16 >>

<<+13:39-2.16 Biennial license renewal; administrative suspension+>>

<<+(a) A pharmacist shall renew his or her license for a period of two years from the last expiration date. The pharmacist shall submit a renewal application to the Board, along with the renewal fee set forth in N.J.A.C. 13:39-1.3, prior to the date of license expiration. A pharmacist who submits a renewal application within 30 days following the date of license expiration shall submit the renewal fee, as well as the late fee set forth in N.J.A.C. 13:39-1.3. A pharmacist who fails to submit a renewal application within 30 days of license expiration shall have his or her license suspended without a hearing. Such suspension shall be deemed an administrative suspension.+>>

<<+(b) A pharmacist who continues to engage in the practice of pharmacy with a suspended license shall be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et seq.+>>

<<+(c) The Board shall send a notice of renewal to each pharmacist at least 60 days prior to the expiration of the license. If the notice to renew is not sent at least 60 days prior to the expiration date, no monetary penalties or fines shall be imposed upon the pharmacist for failure to renew.+>>

<< NJ ADC 13:39-2.17 >>

<<+13:39-2.17 Reinstatement from administrative and disciplinary license suspensions+>>

<<+(a) A pharmacist who has had his or her license administratively suspended pursuant to N.J.A.C. 13:39-2.16 may apply to the Board for reinstatement within five years following the date of license expiration. A pharmacist applying for reinstatement shall submit:+>>

<<+1. A renewal application, including an affidavit of employment listing each job held during the period of license suspension, including the names, addresses, and telephone numbers of each employer;+>>

<<+2. All past due renewal fees set forth in N.J.A.C. 13:39-1.3;+>>

<<+3. A reinstatement fee set forth in N.J.A.C. 13:39-1.3;+>>

<<+4. Any outstanding penalties imposed by the Board; and+>>

<<+5. Evidence of having completed all delinquent continuing education credits consistent with the requirements of N.J.A.C. 13:39-3A to a maximum of five years or 75 credits.+>>

<<+(b) If the license has been administratively suspended for a period of more than five years, a pharmacist applying for reinstatement shall satisfy all requirements in (a)1 through 4 above and shall pass the MJPE and the NAPLEX.+>>

<<+(c) A pharmacist who has had his or her license suspended pursuant to disciplinary action taken by the Board may apply to the Board for reinstatement of his or her license at the conclusion of the suspension period. A pharmacist applying for reinstatement from a disciplinary suspension shall submit:+>>

<<+1. A reinstatement application, including an affidavit of employment listing each job held during the period of license suspension, including the names, addresses, and telephone numbers of each employer;+>>

<<+2. A reinstatement fee set forth in N.J.A.C. 13:39-1.3;+>>

<<+3. The applicable renewal fee(s) set forth in N.J.A.C. 13:39-1.3; and+>>

<<+4. Evidence of having met all conditions imposed by the Board pursuant to the disciplinary and/or reinstatement order(s).+>>

<< NJ ADC 13:39-2.18 >>

<<+13:39-2.18 Inactive licensure+>>

<<+(a) A pharmacist may, upon application to the Board, choose inactive status. A pharmacist electing inactive status shall not engage in the practice of pharmacy in New Jersey for the entire biennial registration period. A licensee on inactive status may resume the practice of pharmacy in New Jersey upon application to the Board consistent with the following requirements:+>>

<<+1. If a licensee was practicing pharmacy in another state where he or she is licensed, and practiced for at least 1,000 hours within the two years immediately prior to the date of application for return to active status, the licensee shall remit payment of the renewal fee for the current biennial registration period set forth in N.J.A.C. 13:39-1.3;+>>

<<+2. If a licensee was practicing pharmacy in another state where he or she is licensed, but practiced for less than 1,000 hours within the two years immediately prior to the date of application for return to active status, the licensee shall submit evidence of having completed 30 credits of continuing education, consistent with the requirements set forth in N.J.A.C. 13:39- 3A.1, within the two years immediately prior to the date of application. The licensee shall also remit the renewal fee for the current biennial registration period set forth in N.J.A.C. 13:39-1.3; and+>>

<<+3. If a licensee has not practiced pharmacy in another state during the inactive period, the licensee shall submit evidence of having completed 15 credits of continuing education per year, consistent with the requirements set forth in N.J.A.C. 13:39-3A to a maximum of 75 credits. At least 30 credits shall have been completed within the two years immediately prior to the date of application to return to active status. The licensee shall also remit the renewal fee for the current biennial registration period set forth in N.J.A.C. 13:39-1.3.+>>

<< NJ ADC 13:39-2.19 >>

<<+13:39-2.19 Steering prohibited+>>

<<+It shall be unlawful for a pharmacist to enter into an arrangement with a health care practitioner who is licensed to issue prescriptions for the purpose of directing or diverting patients to or from a specified pharmacy or restraining in any way a patient's freedom of choice to select a pharmacy.+>>

<< NJ ADC 13:39-2.20 >>

<<+13:39-2.20 Responsibilities of pharmacists+>>

<<+(a) All pharmacists shall be responsible for compliance with all the rules, regulations and laws governing the practice of pharmacy.+>>

<<+(b) Any pharmacist found to have violated the Pharmacy Act, N.J.S.A. 45:14-1 et seq., and the rules in this chapter, shall be subject to disciplinary action.+>>

SUBCHAPTER 3. LICENSURE <<-OF PHARMACISTS->> <<+BY RECIPROCITY+>>

(Agency Note: N.J.A.C. 13:39-3.1 through 3.6 are proposed for recodification with amendments as N.J.A.C. 13:39-2.10 through 2.15.)

<< NJ ADC 13:39-3.7 >>

<< NJ ADC 13:39-3.1 >>

13:39-<<-3.7->><<+3.1+>> Limitation of reciprocal licensure

(a) (No change.)

<<+(b) An applicant for reciprocal licensure shall submit an application to the Board demonstrating satisfaction of the requirements set forth in N.J.A.C. 13:39-3.2.+>>

<<-(b)->><<+(c)+>> (No change in text.)

<< NJ ADC 13:39-3.2 >>

<<+13:39-3.2 Requirements for reciprocal licensure of pharmacist currently licensed in another jurisdiction+>>

<<+(a) In order for a pharmacist currently licensed in another jurisdiction to obtain a license by reciprocity in this State, an applicant shall submit a completed application and the licensure fee set forth in N.J.A.C. 13:39-1.3. The completed application shall include evidence that:+>>

<<+1. The applicant has attained the age of 18;+>>

<<+2. The applicant is of good moral character and satisfies the requirements of N.J.A.C. 13:39-3.3;+>>

<<+3. The applicant has engaged in the practice of pharmacy for a period of at least 1,000 hours within the last two years or has met the internship requirements set forth at N.J.A.C. 13:39-8, within the one-year period immediately preceding the date of application;+>>

<<+4. The applicant obtained initial licensure by examination and that the license is in good standing;+>>

<<+5. Any other license granted to the applicant by any other state has not been suspended, revoked or otherwise restricted for any reason except the failure to renew or for the failure to obtain the required continuing education credits in any state where the applicant is currently licensed but not engaged in the practice of pharmacy; and+>>

<<+6. The applicant has graduated and received a professional degree from a college or school of pharmacy that has been accredited by the American Council of Pharmaceutical Education (ACPE), or has graduated from a pharmacy school that has been accredited by a program that has been deemed ACPE-equivalent by ACPE.+>>

<<+(b) In addition to the requirements set forth in (a) above, an applicant for licensure by reciprocity shall also satisfy all licensure transfer requirements imposed by the National Association of Boards of Pharmacy.+>>

<< NJ ADC 13:39-3.3 >>

<<+13:39-3.3 Proof of character+>>

<<+(a) An applicant for licensure by reciprocity shall submit, as part of his or her licensure application, evidence that he or she:+>>

<<+1. Is not presently engaged in drug or alcohol use that is likely to impair the ability to practice pharmacy with reasonable skill and safety. For purposes of this section, the term "presently" means at this time or any time within the previous 365 days;+>>

<<+2. Has not been convicted of violating any law of this State or any other state of the United States relating to controlled dangerous substances or other habit-forming drugs;+>>

<<+3. Has not been convicted of violating any law relating to the practice of pharmacy;+>>

<<+4. Has not been convicted of a crime involving moral turpitude; and+>>

<<+5. Has not had his or her license suspended or revoked in the last five years as a result of any disciplinary proceedings in this or any other jurisdiction which proved the applicant to be in violation of any laws, rules or regulations pertaining to the practice of pharmacy, and that the applicant is not currently under such suspension or revocation.+>>

<< NJ ADC 13:39-3.4 >>

<<+13:39-3.4 Proof of identity of applicant+>>

<<+An applicant for licensure by reciprocity shall submit a passport photograph mounted on a document to be supplied by the Board requesting certain identification information.+>>

<< NJ ADC 13:39-3.5 >>

<<+13:39-3.5 Alleged violations of the Pharmacy Act+>>

<<+If an applicant for licensure by reciprocity is being investigated for any alleged violation of the Pharmacy Act, N.J.S.A. 45:14-1 et seq., the Board in its discretion may deny the applicant a license to engage in the practice of pharmacy in this State.+>>

<< NJ ADC 13:39-3.6 >>

<<+13:39-3.6 Criminal history background check+>>

<<+An applicant for licensure by reciprocity in the State shall submit his or her name, address and fingerprints for purposes of a criminal history background check to be conducted by the State of New Jersey pursuant to N.J.S.A. 45:1-28 et seq., P.L. 2002, c.104, to determine whether criminal history record information exists which may be considered by the Board in determining whether the applicant shall be licensed in the State.+>>

<< NJ ADC 13:39-2.9 >>

<< NJ ADC 13:39-3.11 >>

(Agency Note: N.J.A.C. 13:39-3.11 is proposed for recodification with amendments as N.J.A.C. 13:39-2.9.)

<< NJ ADC 13:39-3.7 >>

<< NJ ADC 13:39-3.14 >>

13:39-<<-3.14->><<+3.7+>> Multistate Jurisprudence Pharmacy Examination<<-: reciprocal licensure->>

(a) An applicant for reciprocal licensure shall pass the Multistate Jurisprudence Pharmacy Examination. A passing <<-grade->> <<+score+>> of not less than 75 shall be attained. If an applicant fails the examination, he or she <<-will->> <<+shall+>> be required to repeat the examination.

(b) (No change.)

<< NJ ADC 13:39-3.18 >>

<< NJ ADC 13:39-6.2 >>

(Agency Note: N.J.A.C. 13:39-3.18 is proposed for recodification with amendments as N.J.A.C. 13:39-6.2.)

SUBCHAPTER 3A. CONTINUING EDUCATION

<< NJ ADC 13:39-3A.1 >>

13:39-3A.1 Continuing education credit hour requirements

(a) Each applicant for biennial license renewal shall complete a minimum of 30 credits of continuing education during the preceding biennial period, except that the Board shall not require completion of continuing education credits for an applicant's initial license renewal. At least 10 of the continuing education credits shall be obtained through didactic instruction. For purposes of this paragraph, "didactic instruction" means in-person instruction and may include telephonic or electronic instruction that is interactive, but shall not include videotaped instruction. <<+For the biennial renewal period commencing May 2005 and thereafter, at least three continuing education credits shall be obtained in New Jersey pharmacy law.+>>

(b) (No change.)

SUBCHAPTER 4. PHARMACY PERMIT<<-S->> <<+REQUIREMENTS+>>

<< NJ ADC 13:39-4.7 >>

<< NJ ADC 13:39-4.1 >>

13:39-<<-4.7->><<+4.1+>> New pharmacies; eligibility and application

(a)-(b) (No change.)

(c) The permit application shall bear the exact trade name, if any; the corporate names, if any; the name and addresses of the owners and operators, if a sole proprietorship <<-or->><<+,+>> partnership<<+, limited liability partnership or limited liability company+>>; the names and addresses of all officers and stockholders and the names and addresses of all <<-principles->> <<+principals+>> duly licensed to write prescriptions if the pharmacy is <<-a non-publicly held->> <<+not a publicly traded+>> corporation; and the names and addresses of the officers, if a publicly <<-held->> <<+traded+>> corporation.

(d) (No change.)

(e) No person <<-or other->><<+,+>> business entity <<+or equity holder of the business entity+>> shall be eligible for a new permit or a renewal thereof who is not of high moral character or against whom there is pending any indictment or any alleged violation of local, State or Federal law pertaining to the practice of pharmacy or the dispensing of controlled dangerous substances or any drug under N.J.S.A. 24:21-2.

(f) (No change.)

(g) Before a permit may be issued to an applicant, the Board shall inspect and approve<<-, as in compliance with this chapter,->> the premises, fixtures and equipment of the new pharmacy <<+to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances+>>.

(h) (No change.)

<< NJ ADC 13:39-4.3 >>

<< NJ ADC 13:39-4.4 >>

Recodify existing N.J.A.C. 13:39-4.1 and 4.2 as <<+4.2 and 4.3+>> (No change in text.)

<< NJ ADC 13:39-4.3 >>

<< NJ ADC 13:39-4.4 >>

13:39-<<-4.3->><<+4.4+>> Death of owner or partner

In the case of death of an individual owner or a partner, the permit issued to the deceased owner or to the partnership is terminated and shall be returned to the Board pursuant to N.J.A.C. 13:39-4.8. If the operation of the pharmacy is to be continued, the estate or heirs of the deceased partner and/or the remaining partners shall <<-apply immediately for a new permit on a form prescribed and furnished by the Board and pay a fee pursuant to N.J.A.C. 13:39-1.3->> <<+comply with the requirements set forth at N.J.A.C. 13:39-4.5+>>.

<< NJ ADC 13:39-4.4 >>

<< NJ ADC 13:39-4.5 >>

13:39-<<-4.4->><<+4.5+>> Change of ownership

<<+(a)+>> Whenever there is any change in ownership of the business entity holding a permit to operate a pharmacy, the new ownership of such entity shall apply for a new permit on a form prescribed and furnished by the Board and pay a fee pursuant to N.J.A.C. 13:39-1.3. The new owner<<+(s)+>> of such entity shall not operate a pharmacy under an existing permit for more than 60 days following a change in ownership. Before a permit may be issued to the new owner<<+(s)+>> of the business entity, the Board shall inspect and approve<<-, as in compliance with this chapter,->> the fixtures, equipment and inventory of the pharmacy <<+to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances,+>> and shall require evidence of the transfer of ownership and an inventory of controlled substances being transferred to the new owner(s).

<<+(b) Upon a change in ownership pursuant to (a) above, the new ownership of such entity shall ensure that the prescription and profile records of the previous pharmacy are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of acquisition.+>>

<< NJ ADC 13:39-4.5 >>

<< NJ ADC 13:39-4.6 >>

13:39-<<-4.5->><<+4.6+>> Change of corporate officers or stockholders of <<-public companies->> <<+a publicly traded corporation+>>

If there is a change of registered agents or officers or a change of stock ownership involving 10 percent or more of the outstanding stock <<+of a publicly traded corporation+>>, the corporation shall file an affidavit with the Board within 30 days indicating the changes that have taken place and any other information requested by the Board.

<< NJ ADC 13:39-4.6 >>

<< NJ ADC 13:39-4.7 >>

13:39-<<-4.6->><<+4.7+>> Change of location; remodeling of premises

(a) Whenever a pharmacy or licensed establishment changes location, the pharmacy or licensed establishment shall apply for a new permit on a form prescribed and furnished by the Board. The pharmacy or licensed establishment shall pay a fee for the new permit pursuant to N.J.A.C. 13:39-1.3. The permit holder shall not operate a pharmacy under an existing permit for more than 60 days following a change of location. Before a permit may be issued to the permit holder for the new location, the Board shall inspect and approve<<-, as in compliance with this chapter,->> the premises, fixtures, equipment and inventory of the new location <<+to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances+>>.

(b) Prior to the remodeling of a pharmacy, pharmacy department or licensed establishment, where such remodeling entails a physical change of location <<+or size+>> of the prescription area within the premises or a change of the physical specifications of the licensed premises <<-or the compounding area->>, it shall be necessary to notify the Board at least 30 days in advance on a form prescribed by the Board. The permit holder shall not operate a pharmacy under an existing permit for more than 60 days following the remodeling of a pharmacy. Within 60 days of the remodeling, the Board shall inspect and approve<<-, as in compliance with this chapter,->> the premises, fixtures, equipment and inventory of the remodeled pharmacy <<+to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances+>>.

<< NJ ADC 13:39-4.1 >>

<< NJ ADC 13:39-4.7 >>

(Agency Note: N.J.A.C. 13:39-4.7 is proposed for recodification with amendments as N.J.A.C. 13:39-4.1.)

<< NJ ADC 13:39-4.8 >>

13:39-4.8 Discontinued pharmacies

(a) Whenever a pharmacy is terminated by suspension, retirement or death of the owner, sale or other cause including insolvency, <<+the permit holder shall remove+>> all drug signs <<-shall be removed->> from both the inside and outside of the discontinued pharmacy <<-and the->> <<+and shall notify the Board of the location of prescription records. The+>> permit <<+holder+>> shall <<-be returned->> <<+return the permit+>> to the Board for cancellation within 30 days of the closing. Prescription records and other information may be requested by the Board as outlined in N.J.A.C. 13:39-<<-5.6->><<+7.6+>>.

(b) Whenever a pharmacy is to be discontinued, <<-it shall be the responsibility of->> the permit holder <<-to->> <<+shall+>> immediately notify by telephone the State Board of Pharmacy, the <<+Office of+>> Drug Control <<-Program in the State Department of Health->> and the Drug Enforcement Administration of the proposed closing at least 15 days beforehand, followed by a letter in writing to those agencies. All medication (both prescription legend and controlled drugs) shall remain on the licensed pharmacy premises with all licenses and registrations in effect until such medications are disposed of in the manner prescribed by the above agencies.

<< NJ ADC 13:39-5.7 >>

<< NJ ADC 13:39-4.9 >>

13:39-<<-5.7->><<+4.9+>> Availability of records upon termination of business

(a) <<-Where->> <<+When+>> a pharmacy ceases operation as the result of a suspension, retirement or death of the owner, sale or other cause including insolvency, the licensee, or the one responsible for supervising the disposition of the practice, shall make every effort to notify patrons of their right to retrieve currently valid prescriptions and the location of the prescriptions and profile records for a six-month period following notice, using all of the following methods:

1.-3. (No change.)

<< NJ ADC 13:39-4.9 >>

<< NJ ADC 13:39-4.10 >>

13:39-<<-4.9->><<+4.10+>> Business hours<<+; unauthorized closing+>>

(a) (No change.)

(b) If any <<+permanent+>> changes are made in the opening or closing hours of a pharmacy or other Board-licensed establishment, the Board office shall be notified in writing of these changes within 30 days.

<<+(c) A notice shall be conspicuously displayed on the exterior of any pharmacy or other Board-licensed establishment indicating any temporary changes in the opening or closing hours of the pharmacy or establishment, or indicating a temporary closing of the pharmacy or establishment whenever such changes occur.+>>

<<+(d) Any temporary closing of a pharmacy or other Board-licensed establishment for more than 24 hours shall be reported to and approved by the Board. Notification to the Board shall include contingency plans for accessing patient records. Any temporary closing of more than 24 hours without prior Board approval shall result in the pharmacy being deemed a discontinued pharmacy requiring compliance with the requirements of N.J.A.C. 13:39- 4.8.+>>

<< NJ ADC 13:39-4.10 >>

<< NJ ADC 13:39-4.11 >>

13:39-<<-4.10->><<+4.11+>> <<-Duplicate->> <<+Replacement+>> permit

A <<-duplicate->> <<+replacement+>> permit may be issued by the Board upon payment of a fee pursuant to N.J.A.C. 13:39-1.3 and submission of an affidavit describing the loss or destruction of the permit originally issued, or upon return of the damaged permit.

<< NJ ADC 13:39-4.11 >>

<< NJ ADC 13:39-4.12 >>

13:39-<<-4.11->><<+4.12+>> Change of name

(a) (No change.)

(b) <<-An->> <<+The Board shall issue an+>> amended permit bearing the new name <<-may be obtained->> upon return of the <<-original->> permit <<+bearing the previous name+>> to the Board for cancellation and payment of the permit fee as prescribed in N.J.A.C. 13:39-1.3.

<< NJ ADC 13:39-4.12 >>

<< NJ ADC 13:39-4.13 >>

13:39-<<-4.12->><<+4.13+>> Reproduction of permits

<<+(a)+>> Any permit issued by the Board for the operation of a pharmacy or other board-licensed establishment<<-, with the exception of single copies to->> <<+may only be photocopied for+>> State agencies <<-shall not be printed, photographed, photostated, duplicated or reproduced by any other means either in whole or in part, without the express authorization of the Board->> <<+and other business entities with whom the permit holder does pharmacy related business+>>.

<<+(b) Any reproduction of a pharmacy permit by a permit holder for any unlawful purpose shall subject a permit holder to disciplinary action pursuant to N.J.S.A. 45:1-21.+>>

<< NJ ADC 13:39-4.13 >>

<<-13:39-4.13 Certification of records->>

<<-A certification of any of the information not obtained by the Board on a confidential basis, which appears in the Board records and concerns the ownership or registration of a pharmacy or other Board-licensed establishment, will be supplied only upon written request and payment of a certification fee as prescribed in N.J.A.C. 13:39-1.3.->>

(Agency Note: N.J.A.C. 13:39-4.14 is proposed for recodification with amendments as N.J.A.C. 13:39-9.4.)

<< NJ ADC 13:39-4.15 >>

<< NJ ADC 13:39-4.14 >>

13:39-<<-4.15->><<+4.14+>> <<-Retail permit; prescription department or->> <<+Permitting of+>> pharmacy department

(a) If the area for which a pharmacy permit is sought is less than the total store area of the enterprise, the area subject to permit shall be known as the <<-"Prescription Department" or->> "Pharmacy Department."

(b) The holder of a permit to operate a <<-prescription or->> pharmacy department and the registered pharmacist-in-charge of the department shall <<+comply with all requirements in this chapter and shall also+>> be subject to the following additional requirements:

1. The <<-prescription or->> pharmacy department shall be constructed so as to enable the closing off and securing of the department from the main store area. The department shall be separated from the main store area by a secured barrier or partition extending from the floor or fixed counter to the ceiling of either the department or main store and attached thereto. Any entrance to the <<-prescription or->> pharmacy department shall be capable of being locked and connected to a security device or other Board approved security system.

2. The registered pharmacist on duty shall be responsible for keeping the <<-prescription->> <<+pharmacy+>> department secure and locked and the alarm system turned on at all times when he or she <<-does not have full vision or control of the department or when he or she->> is not present within the department<<-. Only the registered pharmacist-in-charge of the licensed premises->><<+, except as provided in N.J.A.C. 13:39-6.4, and+>> shall be responsible for the security of the keys to the department.

<<-3. No prescription shall be accepted or prescription medication supplied to anyone during the period that a registered pharmacist is not present within the department.->>

<<-4.->><<+3.+>> All medications requiring supervision of a pharmacist, including dispensed medication, shall remain within the confines of the department when the pharmacist is not in the <<- prescription->> <<+pharmacy+>> department.

<<-5.->><<+4.+>> The hours that the department is open <<+and the name of the registered pharmacist-in-charge+>> shall be posted in plain view at the entrance to the department and at the public entrance to the enterprise containing the department.

<<-6.->><<+5.+>> When the enterprise in which the department is located maintains different store hours from the pharmacy <<-or prescription->> department, all advertising, announcements, signs or statements indicating store hours and the presence of the pharmacy <<-or prescription->> department shall clearly and distinctly indicate the hours that the department is open.

<<-7.->><<+6.+>> The <<-prescription->> <<+pharmacy+>> department shall have a published telephone number different from that of the establishment in which the department is located. No extensions of this phone shall be located outside the department.

<<-8.->><<+7.+>> <<-The name of registered pharmacist-in-charge shall be posted so as to be visible from outside of the department.->> The telephone number of the registered pharmacist-in-charge shall be available in the office of the manager of the establishment.

<<-9.->><<+8.+>> There shall be provided a secure area for the receiving of prescription drugs from suppliers. No prescription drug shall be accepted from any supplier during the hours the <<-prescription or->> pharmacy department is closed unless adequate security for the storage of department shipments has been provided <<-and approved by the Board->>.

<<-10.->><<+9.+>> (No change in text.)

<< NJ ADC 13:39-4.16 >>

<< NJ ADC 13:39-4.15 >>

13:39-<<-4.16->><<+4.15+>> (No change in text.)

<< NJ ADC 13:39-4.17 >>

<< NJ ADC 13:39-4.16 >>

13:39-<<-4.17->><<+4.16+>> Steering prohibited

It shall be unlawful for <<-a pharmacist or->> a pharmacy permit holder to enter into an arrangement with a health care practitioner who is licensed to issue prescriptions<<-, or with any health care facility->> for the purpose of directing or diverting patients to or from a specified pharmacy or restraining in any way a patient's freedom of choice to select a pharmacy.

<< NJ ADC 13:39-4.18 >>

<< NJ ADC 13:39-4.17 >>

13:39-<<-4.18->><<+4.17+>> Responsibilities of <<-pharmacists and->> permit holders

(a) All <<-pharmacists and all->> permit holders <<-are->> <<+shall be+>> responsible for compliance with all the rules, regulations and laws governing the practice of pharmacy.

(b) Any <<-pharmacist and any->> permit holder may be held liable for violations of the <<+Pharmacy+>> Act<<+, N.J.S.A. 45:14-1 et seq.,+>> and <<-these->> <<+the+>> rules <<+in this chapter+>> and may be subject to disciplinary action.

SUBCHAPTER 5. <<-PRESCRIPTIONS->> <<+RETAIL FACILITY REQUIREMENTS+>>

(Agency Note: The sections within N.J.A.C. 13:39-5 are proposed for recodification or recodification with amendments as follows: N.J.A.C. 13:39- 5.2 and 5.3 as 7.2 and 7.3; 5.4 as 7.5; 5.5 as 7.7; 5.6 as 7.6; 5.7 as 4.9, 5.8 as 9.27; 5.8A, 5.8B and 5.9 as 7.10, 7.11 and 7.12; and 5.10 as 4.19.)

<< NJ ADC 13:39-5.1 >>

<<+13:39-5.1 Purpose and scope+>>

<<+The rules in this subchapter shall apply to all retail pharmacies and retail pharmacy departments in the State. For purposes of this subchapter, "pharmacy" means a retail pharmacy or a retail pharmacy department.+>>

<< NJ ADC 13:39-7.1 >>

<< NJ ADC 13:39-5.2 >>

13:39-<<-7.1->><<+5.2+>> <<-Retail pharmacy->> <<+Pharmacy+>> access and egress

<<-Retail pharmacies->> <<+Pharmacies+>> shall <<-be required to->> maintain entrances which are easily and safely accessible to the general public. Access to and egress from the pharmacy shall not be such that the public must traverse or traffic through any <<-enterprise->> <<+ area+>> in which prescriptions are <<-generated->> <<+prepared+>>.

<< NJ ADC 13:39-7.2 >>

<< NJ ADC 13:39-5.3 >>

13:39-<<-7.2->><<+5.3+>> <<-Retail pharmacy->> <<+Pharmacy+>> signs

<<+(a)+>> <<-Retail pharmacies->> <<+Pharmacies+>> shall <<-be required to->> post a sign on the exterior of the building or a sign which is otherwise visible from a public roadway, conspicuously identifying the existence of a pharmacy on the premises, unless prohibited by lease agreement <<+or municipal ordinance+>>. In such case, a copy of the lease <<-must->> <<+or ordinance shall+>> be furnished to the Board.

<<+(b) Pharmacies shall post the name of the registered pharmacist-in-charge on the entrance to the pharmacy in such a way as to be visible to the public.+>>

<< NJ ADC 13:39-7.3 >>

<< NJ ADC 13:39-5.4 >>

13:39-<<-7.3->><<+5.4+>> Spatial requirement of <<-a retail->> pharmacy prescription area

(a) For pharmacies in operation prior to July 1, 1963, the space devoted to the prescription area and laboratory shall not be less than 10 percent of the main floor area of the pharmacy <<-or drugstore->>, and in no instance shall it be less than 50 square feet. If the main floor area of such pharmacy exceeds 1,200 square feet, the 10 percent requirement does not apply and the minimum requirement for the prescription area shall not be less than 120 square feet.

(b) For all other <<-retail->> pharmacies including pharmacies subject to the provisions of (a) above which are moving to a new location, the prescription area must occupy exclusively a minimum of 150 square feet.

<< NJ ADC 13:39-7.4 >>

<< NJ ADC 13:39-5.5 >>

13:39-<<-7.4->><<+5.5+>> Prescription counter

<<-There->> <<+Pharmacies+>> shall <<-be->> <<+contain+>> a prescription counter or counters on which to work, and the free working space shall not be less than 18 inches in width and not less than 12 total feet in length. This minimum working surface shall be kept clear at all times for the <<+processing and/or+>> compounding of prescriptions <<-and other pharmaceutical manufacturing->>.

<< NJ ADC 13:39-7.5 >>

<< NJ ADC 13:39-5.6 >>

13:39-<<-7.5->><<+5.6+>> Prescription area sink

An adequate sink with hot and cold running water shall be provided in the prescription area<<+,+>> <<-of retail and institutional pharmacies,->> easily accessible to the prescription counter. <<-A similarly equipped sink shall be easily accessible to institutional satellite pharmacies as well as institutional and retail pharmacy intravenous admixture anterooms.->>

<< NJ ADC 13:39-7.6 >>

<< NJ ADC 13:39-5.7 >>

13:39-<<-7.6->><<+5.7+>> Storage and adequate stock

There shall be sufficient shelf, drawer or cabinet space within the prescription area for proper storage of <<-a representative stock of prescription labels, an assorted stock of prescription containers, an adequate stock of->> prescription drugs and chemicals and the <<+minimum equipment+>> required <<-equipment->> <<+pursuant to N.J.A.C. 13:39- 5.8+>>.

<< NJ ADC 13:39-7.7 >>

<< NJ ADC 13:39-5.8 >>

13:39-<<-7.7->><<+5.8+>> Minimum equipment and facilities

(a) The following minimum <<-amount of->> equipment and facilities shall be required to be in every prescription area, and this equipment shall be stored so as to be readily accessible and shall be kept in a clean condition:

1.-3. (No change.)

4. <<-Properly safeguarded->> <<+Securely locked, substantially constructed+>> storage place for Schedule II controlled substances if not dispersed;

5. Class A prescription balance <<+with a complete set of metric weights+>> or equivalent electronic weighing device;

<<-6. Set of metric weights;->>

<<-7. Devices->> <<+6.+>> <<+Volumetric devices+>> capable of measuring 0.3 ml to 500 ml;

Recodify existing 8.-16. as <<+7.-15.+>> (No change in text.)

<<-17.->><<+16.+>> Suppository mold; <<-and->>

<<-18.->><<+17.+>> Two Drug Utilization Review Council Placards and the current Drug Utilization Review Council Formulary<<-.->><<+; and+>>

<<+18. Assorted stock of prescription containers and child safety closures or caps.+>>

<< NJ ADC 13:39-7.8 >>

<< NJ ADC 13:39-7.9 >>

<< NJ ADC 13:39-5.9 >>

<< NJ ADC 13:39-5.10 >>

Recodify existing N.J.A.C. 13:39-7.8 and 7.9 as <<+5.9 and 5.10+>> (No change in text.)

<< NJ ADC 13:39-7.11 >>

<< NJ ADC 13:39-5.11 >>

13:39-<<-7.11->><<+5.11+>> Prescription balances, scales, weights and automatic counting devices

All pharmacies shall <<-prove to the satisfaction of the Board that->> <<+have+>> all balances, scales, weights and automatic counting devices <<-have been annually->> inspected <<+every 12 months+>> by the Department of Weights and Measures of the municipality or county in which <<- such->> <<+the+>> pharmacy<<-, drugstore,->> or other Board-licensed establishment is located, and <<-that->> such balances, scales, weights and automatic counting devices <<-have been->> <<+shall be+>> properly sealed by the applicable authority.

<< NJ ADC 13:39-6.5 >>

<< NJ ADC 13:39-5.12 >>

13:39-<<-6.5->><<+5.12+>> Restriction on <<-display->> <<+ storage+>> of prescription legend drugs and controlled dangerous substances

Prescription legend drugs, devices and controlled dangerous substances shall not be <<-displayed->> <<+stored+>> in the <<-licensed establishment->> <<+pharmacy+>> in such a manner that they can be accessible to the public.

SUBCHAPTER 6. <<-DISPENSING AND ADVERTISING DRUGS->> <<+REGISTERED PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL+>>

<< NJ ADC 13:39-6.1 >>

<<+13:39-6.1 Purpose and scope+>>

<<+The rules in this subchapter shall apply to all pharmacies and pharmacy departments in the State. For purposes of this subchapter, "pharmacy" means a retail pharmacy or a retail pharmacy department, an institutional pharmacy or a nuclear pharmacy.+>>

<< NJ ADC 13:39-3.18 >>

<< NJ ADC 13:39-6.2 >>

13:39-<<-3.18->><<+6.2+>> Registered pharmacist-in-charge

<<+(a) Every pharmacy shall name a pharmacist licensed and in good standing in New Jersey as the registered pharmacist-in-charge of the pharmacy. No pharmacy shall operate without a registered pharmacist-in-charge for longer than 30 days.+>>

<<+(b) Whenever the registered pharmacist-in-charge is absent from the pharmacy for more than 30 days, the registered pharmacist-in-charge and the permit holder shall notify the Board of the name of the registered pharmacist who shall act as the interim registered pharmacist-in-charge.+>>

<<-(a)->><<+(c)+>> (No change in text.)

<<-(b) There shall not be more than one registered pharmacist-in-charge of any one pharmacy or pharmacy department.->>

<<-(c)->><<+(d)+>> Whenever there is a change of a registered pharmacist-in-charge of a pharmacy or other Board-licensed establishment, <<- the incoming registered pharmacist-in-charge shall take->> an inventory of all controlled dangerous substances as defined in N.J.A.C. 8:65-10.1 through 10.5 <<+shall be performed consistent with the requirements of N.J.A.C. 8:65-5.4 and 5.5+>>.

<<-(d)->><<+(e)+>> Whenever a registered pharmacist assumes <<+or terminates+>> the duties <<-of->> <<+as+>> a registered pharmacist-in-charge of a pharmacy or other Board-licensed establishment, <<-he or she->> <<+the registered pharmacist-in-charge and the permit holder+>> shall so advise the Board in writing within 30 days by completing a form provided by the Board.

<<-(e)->><<+(f)+>> A registered pharmacist-in-charge shall be <<+a full-time employee, employed for a minimum of 35 hours per week and shall be+>> physically present in the pharmacy or pharmacy department for that amount of time necessary to <<-ensure the fulfilling of the following responsibilities->> <<+supervise and ensure that+>>:

1. <<-Employment and supervising personnel in a prescription department->> <<+Adequate staffing is present to fulfill the needs of the pharmacy+>> or pharmacy department;

2. <<-Maintaining accurate->> <<+Accurate+>> records of all prescription medication received and dispensed <<+are maintained+>>;

3. <<-Ensuring that medication dispensed conforms with the prescription received->> <<+Policies are in place regarding accurate dispensing and labeling of prescriptions and that such policies are followed+>>;

4. <<-Maintaining the security->> <<+Security+>> of the prescription area and its contents <<-which includes->> <<+are maintained at all times, including+>> the restriction of persons unauthorized by the pharmacist on duty from being present in the prescription area while the pharmacist is temporarily absent but within the premises <<+and the reporting of any thefts and/or diversions of controlled substances are reported upon discovery to the Office of Drug Control and the Drug Enforcement Administration pursuant to Federal and State requirements, consistent with the requirements of N.J.A.C. 8:65-2.5(d)+>>;

5. <<-Ensuring that only->> <<+Only+>> pharmacists and interns or externs under <<-direct->> <<+immediate personal+>> supervision provide professional consultation with patients and physicians;

6. <<-Ensuring that only->> <<+Only+>> pharmacists, interns or externs accept telephone prescriptions <<+and only pharmacists, interns or externs, or pharmacy technicians consistent with the requirements of N.J.A.C. 13:39-6.6(b), accept+>> renewal authorizations;

<<-7. Ensuring that all dispensed medication is properly labeled;->>

<<-8. Ensuring the use of prescription labels naming the registered pharmacist-in-charge;->>

<<-9. Ensuring the posting of the name of the registered pharmacist-in-charge on the entrance to the pharmacy or pharmacy department in such a way as to be visible to the public;->>

<<-10. Prohibiting the presence of->> <<+7. No+>> misbranded, deteriorated<<+, adulterated, improperly stored+>> or outdated drugs <<+ or any drugs marked "sample" or with any like designation or meaning are dispensed or present+>> in the active stock in the pharmacy;

<<-11. Operating the->> <<+8. The+>> prescription area <<+is maintained+>> in an orderly and sanitary manner; <<+and+>>

<<-12. Ensuring the dispensing of all medication generally prescribed to patients in the trading area of the licensed premises or as required by the specialty for which the pharmacy holds a permit;->>

<<-13. Notifying the Board in writing within 30 days when his or her duties as registered pharmacist-in-charge terminate at a specific location; and->>

<<-14. Ensuring compliance with all->> <<+9. The pharmacy and all pharmacy personnel comply with all Federal and State+>> statutes, rules and regulations governing the practice of pharmacy.

<< NJ ADC 13:39-6.1 >>

<< NJ ADC 13:39-6.2 >>

<< NJ ADC 13:39-6.5 >>

<< NJ ADC 13:39-7.13 >>

(Agency Note: N.J.A.C. 13:39-6.1 is proposed for recodification with amendments as N.J.A.C. 13:39-7.13. N.J.A.C. 13:39-6.2 is proposed for recodification with amendments as N.J.A.C. 13:39-6.5.)

<< NJ ADC 13:39-6.3 >>

13:39-6.3 Identification tag

<<-Each licensee->> <<+All personnel working in the pharmacy+>> shall wear an identification tag which shall include at least the <<- pharmacist's->> <<+person's+>> first name<<-, the first initial of his or her last name, and the designation "Pharmacist"->> <<+and job title+>>.

<< NJ ADC 13:39-6.4 >>

<<+13:39-6.4 Meal breaks+>>

<<+(a) A sole pharmacist on duty may take a 30-minute meal break while working in a pharmacy consistent with the following requirements:+>>

<<+1. The pharmacist shall remain in the pharmacy or, in the case of a pharmacy department, in the pharmacy department building, and shall be accessible for emergencies or for counseling, if requested;+>>

<<+2. The pharmacy shall remain open during the meal break for the receipt of new written prescriptions and for the dispensing of prescription medications which have been checked by the pharmacist; and+>>

<<+3. A sign shall be posted in the pharmacy stating "Pharmacist on meal break, but available for emergencies and counseling."+>>

<< NJ ADC 13:39-6.2 >>

<< NJ ADC 13:39-6.5 >>

13:39-<<-6.2->><<+6.5+>> Prescription prepared<<-,->> <<+or+>> compounded <<-or dispensed->> by pharmacy externs<<+,+>> <<-or->> interns <<+or pharmacy technicians+>>

A pharmacy intern<<+,+>> <<-or->> extern <<+or technician+>> may prepare<<-,->> <<+or+>> compound <<-or dispense->> prescriptions only under the <<-direct->> <<+immediate personal+>> supervision of a registered pharmacist of this State. <<+The registered pharmacist shall be personally responsible for the accuracy and appropriateness of the filled prescription.+>>

<< NJ ADC 13:39-6.7 >>

<< NJ ADC 13:39-6.6 >>

13:39-<<-6.7->><<+6.6+>> <<-Supportive personnel->> <<+Pharmacy technicians+>>

<<-(a) Supportive personnel may assist the registered pharmacist in a clerical manner such as the retrieving of prescription files, profile cards, and other such records, the typing of labels and the completing of prescription receipts and other such forms.->>

<<-(b) Supportive personnel shall not interpret a prescription order or consult with a patient or prescriber or the agent of the prescriber. Supportive personnel may, however, count, weigh, measure, or pour prescription medication under the direct supervision of the registered pharmacist as long as the contents and finished-product are verified by a registered pharmacist.->>

<<+(a) Pharmacy technicians may assist the registered pharmacist in performing the following tasks:+>>

<<+1. Retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy;+>>

<<+2. Data entry;+>>

<<+3. Label preparation; and+>>

<<+4. The counting, weighing, measuring, pouring and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system.+>>

<<+(b) Pharmacy technicians may accept authorization from a patient for a prescription refill, or from a physician or his or her agent for a prescription renewal, provided that the prescription remains unchanged. For purposes of this section, "prescription refill" means the dispensing of medications pursuant to a prescriber's authorization provided on the original prescription. For purposes of this section, "prescription renewal" means the dispensing of medications pursuant to a practitioner's authorization to fill an existing prescription that has no refills remaining.+>>

<<+(c) Pharmacy technicians shall not:+>>

<<+1. Receive new verbal prescriptions;+>>

<<+2. Interpret a prescription or medication order for therapeutic acceptability and appropriateness;+>>

<<+3. Verify dosage and directions;+>>

<<+4. Engage in prospective drug review;+>>

<<+5. Provide patient counseling;+>>

<<+6. Monitor prescription usage;+>>

<<+7. Override computer alerts without first notifying the pharmacist;+>>

<<+8. Transfer prescriptions from one pharmacy to another pharmacy; or+>>

<<+9. Violate patient confidentiality.+>>

<<-(c) There shall be no->> <<+(d) Except as provided in (e) below, a pharmacist shall not supervise+>> more than two <<-supportive personnel->> <<+pharmacy technicians+>><<-, not including cashier, stocking and clerical help, being supervised by one pharmacist->> at any given time. Those personnel who do computer processing of prescriptions are to be included in the <<-2 to 1->> <<+1 to 2+>> ratio.

<<+(e) A pharmacy that wishes to employ a registered pharmacist to pharmacy technician ratio greater than 1:2 shall:+>>

<<+1. Establish written job descriptions, task protocols, and policies and procedures that pertain to the duties performed by the pharmacy technician;+>>

<<+2. Ensure and document that each pharmacy technician passes the National Pharmacy Technician Certification Examination and fulfills the requirements to maintain this status, or completes a program which includes a testing component and which has been approved by the Board as satisfying the criteria set forth in (f) below;+>>

<<+3. Ensure that each pharmacy technician is knowledgeable in the established job descriptions, task protocols, and policies and procedures in the pharmacy setting in which the technician is to perform his or her duties;+>>

<<+4. Ensure that the duties assigned to any pharmacy technician do not exceed the established job descriptions, task protocols, and policies and procedures, nor involve any of the prohibited tasks in (c) above.+>>

<<+5. Ensure that each pharmacy technician receives in-service training before the pharmacy technician assumes his or her responsibilities and maintain documentation thereof;+>>

<<+6. Require and maintain on site a signed patient confidentiality statement from each technician;+>>

<<+7. Provide immediate personal supervision as defined in N.J.A.C. 13:39-1.2; and+>>

<<+8. Provide the Board, upon request, with a copy of the established job descriptions, task protocols, and policies and procedures for all pharmacy technician duties.+>>

<<+(f) If the pharmacist to pharmacy technician ratio exceeds 1:2, the pharmacy shall maintain a policy and procedure manual with regard to pharmacy technicians which shall include the following:+>>

<<+1. Supervision by a pharmacist;+>>

<<+2. Confidentiality safeguards of patient information;+>>

<<+3. Minimum qualifications;+>>

<<+4. Documentation of in-service education and/or on-going training and demonstration of competency, specific to practice site and job function;+>>

<<+5. General duties and responsibilities of pharmacy technicians;+>>

<<+6. Retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy;+>>

<<+7. All functions related to prescription processing;+>>

<<+8. All functions related to prescription legend drug and controlled substance ordering and inventory control;+>>

<<+9. Prescription refill and renewal authorization;+>>

<<+10. Procedures dealing with documentation and records required for controlled drug substance and prescription legend drugs;+>>

<<+11. Procedures dealing with medication errors, including classification of medication errors;+>>

<<+12. Pharmacy technician functions related to automated systems;+>>

<<+13. Functions that may not be performed by pharmacy technicians, including at a minimum those functions listed in (c) above; and+>>

<<+14. A form signed by the pharmacy technician which verifies that the manual has been reviewed by the technician.+>>

<<+(g) The pharmacist in charge shall review at least every two years and, if necessary, amend the policy and procedure manual. Documentation of the review shall be made available to the Board upon request.+>>

<<-(d) Supportive personnel shall wear an identification tag, which shall include at least their first name, the first initial of their last name, and title.->>

<<-(e)->><<+(h)+>> On yearly pharmacy permit renewal applications, the pharmacy shall list the name and address of all <<-supportive personnel->> <<+pharmacy technicians+>> which it currently employs.

<<-(f)->><<+(i) +>>When <<-supportive personnel->> <<+pharmacy technicians+>> are engaged in any <<-activity permitted by (b) above->> <<+permitted activities+>>, the <<-supervising->> registered pharmacist<<+(s)+>> shall be responsible for all the activities of the <<-supportive personnel->> <<+pharmacy technicians+>>.

(Agency Note: N.J.A.C. 13:39-6.8 is proposed for recodification with amendments as N.J.A.C. 13:39-7.14. N.J.A.C. 13:39-6.9 is proposed for recodification as N.J.A.C. 13:39-7.15.)

SUBCHAPTER 7. <<-PHARMACY FACILITY AND RECORDS->> <<+DRUG DISPENSING AND PRESCRIPTION RECORDS+>>

<< NJ ADC 13:39-5.2 >>

<< NJ ADC 13:39-5.3 >>

<< NJ ADC 13:39-5.3 >>

<< NJ ADC 13:39-5.4 >>

<< NJ ADC 13:39-5.5 >>

<< NJ ADC 13:39-5.6 >>

<< NJ ADC 13:39-5.7 >>

<< NJ ADC 13:39-5.8 >>

<< NJ ADC 13:39-5.9 >>

<< NJ ADC 13:39-5.10 >>

<< NJ ADC 13:39-7.1 >>

<< NJ ADC 13:39-7.2 >>

<< NJ ADC 13:39-7.3 >>

<< NJ ADC 13:39-7.4 >>

<< NJ ADC 13:39-7.5 >>

<< NJ ADC 13:39-7.6 >>

<< NJ ADC 13:39-7.7 >>

<< NJ ADC 13:39-7.8 >>

<< NJ ADC 13:39-7.9 >>

(Agency Note: N.J.A.C. 13:39-7.1 through 7.9 are proposed for recodification with amendments as N.J.A.C. 13:39-5.2 through 5.10.)

<< NJ ADC 13:39-7.1 >>

<<+13:39-7.1 Valid prescriptions; out-of-State prescriptions+>>

<<+(a) A pharmacist shall only fill a written prescription issued in New Jersey if the prescription is on a New Jersey Uniform Prescription Blank pursuant to N.J.S.A. 45:14-14.4 and N.J.A.C. 13:45A-27, except as provided in N.J.A.C. 13:39-7.10 and 7.11.+>>

<<+(b) A pharmacist shall only fill a prescription issued by an authorized prescriber licensed to write prescriptions in the United States or any territory of the United States. Such prescriptions orders shall be filled pursuant to New Jersey law.+>>

<<+(c) Prescriptions, other than those listed in (a) and (b) above, shall not be filled by a pharmacy in New Jersey.+>>

<< NJ ADC 13:39-5.2 >>

<< NJ ADC 13:39-7.2 >>

13:39-<<-5.2->><<+7.2 +>>Lack of directions on original prescription

<<-(a)->> If the prescriber fails to include on the original prescription directions to the patient for use of the medication, the registered pharmacist shall make a documented attempt to contact the prescriber to obtain such directions. In cases where the prescriber cannot be contacted, the registered pharmacist shall indicate on the label the words "use as directed" or "as ordered by the physician" or similar words to the same effect.

<<-(b) When, in the judgment of the pharmacist, directions to the patient or cautionary messages are necessary, either for clarification or to ensure proper administration of the medication, the pharmacist may add such directions or cautionary messages to those indicated by the prescriber on the original prescription.->>

<< NJ ADC 13:39-5.3 >>

<< NJ ADC 13:39-7.3 >>

13:39-<<-5.3->><<+7.3 +>>(No change in text.)

<< NJ ADC 13:39-7.4 >>

<<+13:39-7.4 Emergency dispensing+>>

<<+(a) In the absence of a current, valid prescription, a pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a chronic maintenance drug (except controlled dangerous substances) or device if, in his or her professional judgment, refusal would endanger the health or welfare of the patient, provided the following conditions are satisfied:+>>

<<+1. The pharmacist first ascertains to the best of his or her ability, by direct communication with the patient or caregiver, that such a medication or device was prescribed for that patient by order of a licensed practitioner; and+>>

<<+2. The pharmacist documents the communication and requires the patient or caregiver to provide suitable identification and sign a statement attesting to the need before dispensing.+>>

<< NJ ADC 13:39-5.4 >>

<< NJ ADC 13:39-7.5 >>

13:39-<<-5.4->><<+7.5 +>>Approval of FDA necessary

<<+(a) +>>No drug or medicine other than a compounded prescription order shall be sold or dispensed in any pharmacy within the State of New Jersey until such drug or medicine has received <<-an approved NDA, ANDA, INDA->> <<+ New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (INDA)+>> or other Federal Food and Drug Administration approval<<+, where required+>>.

<<+(b) The storage and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters the dispensing of such drugs shall not be construed to be a violation of (a) above. A pharmacy participating in experimental research shall comply with Federal Department of Health and Human Services regulations, 45 C.F.R. Part 46, Protection of Human Subjects of Research; incorporated by reference herein, as amended and supplemented.+>>

<< NJ ADC 13:39-5.6 >>

<< NJ ADC 13:39-7.6 >>

13:39-<<-5.6->><<+7.6 +>>Record of pharmacist filling prescription

(a) A registered pharmacist who fills or compounds a prescription or who supervises the filling or compounding of a prescription by an intern <<- or->><<+,+>> extern<<+, or pharmacy technician+>> shall place his or her signature or readily identifiable initials <<+or other personal identifier+>> on the <<-face of the->> original prescription <<+or in the electronic data processing system+>>. <<-In using an electronic data processing system, the initials of the pharmacist responsible for the filled prescription shall also be recorded.->>

(b) A registered pharmacist who refills a prescription shall place his or her signature or readily identifiable initials <<+or other personal identifier+>> on the reverse side of the original prescription <<-next to the date of the refill and the amount dispensed in refilling the prescription if it is different from the original amount prescribed->> <<+or in the electronic data processing system. Each time a prescription is refilled, the date of the refill and the amount dispensed shall also be recorded on the original prescription or in the electronic data processing system+>>. <<-In using an electronic data processing system, the identical refill information shall also be recorded.->>

<<+(c) Initials and/or access code number(s) of the pharmacist responsible for the filled prescription shall be entered into the system each time a prescription is filled or refilled. Computer programs which automatically generate a pharmacist's initials without requiring a direct entry by the pharmacist responsible for the filled prescription at the time of dispensing are prohibited.+>>

<<-(c)->><<+(d) +>><<-A record->> <<+Appropriate documentation+>> identifying <<-such->> <<+handwritten+>> initials with the <<+handwritten+>> signature and <<+printed+>> name <<-and address->> of the pharmacist shall be maintained <<+by the pharmacy+>> for a period of <<-five->> <<+six+>> years after the <<- termination->> <<+last date+>> of employment <<-of said pharmacist->>.

<<-(d) Prescriptions for all controlled substances listed in schedule II shall be maintained in a separate prescription file.->>

<<-(e) Except when they are kept in a separate file, prescriptions for all controlled substances listed in schedules III, IV and V shall be stamped in red ink in the lower right corner with the letter "C" no less than one-inch high.->>

<<-(f) Prescriptions for all controlled substances listed in schedules III, IV and V shall be maintained in a single file separate from all other prescriptions, unless an electronic data processing system is utilized which meets the requirements of (i) below. If such an electronic data processing system is utilized, prescriptions for all substances listed in schedules III, IV and V shall be filed either in the prescription file for controlled substances listed in schedule II or in the usual consecutively numbered prescription file for noncontrolled substances.->>

<<-(g) If an electronic data processing system is utilized in connection with the dispensing of medication and the required recording of prescription information, a means acceptable to the Board shall be utilized to identify the pharmacist or intern or extern dispensing the medication.->>

<<-(h) In using an electronic data processing system, the pharmacist in charge shall maintain a document log. The document log shall be maintained at the pharmacy for a period of five years after the date of the last entry. The five years of record information, including refills, shall be kept in such a manner as to be sight-readable within two weeks. The most recent one year of record information shall be immediately retrievable.->>

<<-(i)->><<+(e) +>><<-In using an electronic data processing system, the system shall have the capability of producing sight-readable documents of all->> <<+All prescription records, including+>> original and refilled prescription data, and<<-, in addition,->> the number of refills authorized by the prescriber <<+shall be maintained+>> for a period of not less than five years. <<-Five years of record information shall be maintained in such a manner so as to be sight-readable within two weeks. The most recent one year of record information shall be immediately reviewable on-line and available in printed form within three business days. The term "sight-readable", as it appears in all rules of the Board, shall mean that the Board or Attorney General shall be able to examine and read the record of information. During the course of an on-site inspection, the record may be read from a cathode ray tube (CRT), microfiche, microfilm, hard copy printout or other Board acceptable method. For the purpose of administrative proceedings before the Board, records shall be provided in a paper printout form.->> <<+The oldest four years of record information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of a record information shall be immediately retrievable and readable.+>>

<<-(j) Initials and/or access code number(s) of the dispensing pharmacist and intern or extern, if applicable, shall be entered into the system each time a prescription is filled or refilled. Computer programs which automatically generate a pharmacist's initials without requiring a direct entry by the dispensing pharmacist at the time of dispensing are prohibited.->>

<< NJ ADC 13:39-5.5 >>

<< NJ ADC 13:39-7.7 >>

13:39-<<-5.5->><<+7.7 +>>Copies of prescriptions<<-; transfers->>

(a) <<+A pharmacy shall immediately comply with the patient's request for copies of prescriptions.+>> Copies of prescriptions issued directly to the patient <<-by the pharmacy where the medication was dispensed, pursuant to the receipt of the prescription,->> shall state in letters at least equal in size to those describing the medication dispensed, the underlined statement: "COPY--FOR INFORMATION ONLY." <<-A pharmacist shall immediately comply with the patient's request for copies of prescriptions that are marked: "COPY--FOR INFORMATION ONLY."->>

(b) Presentation of a <<-prescription label->> <<+labeled prescription container+>> or a prescription marked "COPY--FOR INFORMATION ONLY" shall be for information purposes only and <<+shall+>> have no legal status as a valid prescription order. The <<-recipient->> pharmacist <<+in receipt+>> of such copy or <<-prescription label->> <<+labeled prescription container+>> shall contact the prescribing practitioner <<+for a new prescription+>> or <<-transferor->> <<+the last dispensing+>> pharmacy <<-and obtain all information required by (c)2 below for authorization to dispense the prescription, which is the same as obtaining an original prescription order->> <<+to transfer the prescription pursuant to N.J.A.C. 13:39-7.8+>>.

<<-(c) A copy of a prescription may be transferred by telephone or electronic transfer by pharmacists between pharmacies for the purpose of refill dispensing provided that:->>

<<-1. The transferor pharmacist invalidates the prescription on file as of the date the copy is transferred by writing "VOID" on its face, and records on the back of the invalidated prescription order that a copy has been issued, the date of issuance of such copy, to which pharmacy and pharmacist, and the initials of the pharmacist issuing the transferred prescription order.->>

<<-2. The transferee pharmacist, upon receiving such prescription directly from another pharmacist, records the following:->>

<<-i. The name, address and original prescription number of the pharmacy from which the prescription was transferred;->>

<<-ii. The name of the transferor pharmacist;->>

<<-iii. All information constituting a prescription order, including the following:->>

<<-(1) Date of issuance of original prescription;->>

<<-(2) Original number of refills authorized on original prescription;->>

<<-(3) Complete refill record from original prescription;->>

<<-(4) Date of original dispensing;->>

<<-(5) Number of valid refills remaining.->>

<<-3. The transferee pharmacist informs the patient that the original prescription has been cancelled at the pharmacy from which it was obtained.->>

<<-(d) When a copy of a prescription is issued by telephone, refill authorizations shall be cancelled on the original prescription and the fact that a copy has been issued shall be noted on the original prescription along with the date the copy was issued. Two or more permit holders may establish a common electronic filing system to maintain required dispensing information and the required documentation, pursuant to N.J.A.C. 13:39-5.6.->>

<<-(e) When a patient, or his or her properly authorized representative, requests the transfer of a valid prescription between pharmacies, a pharmacist shall immediately comply with the patient's request. "Properly authorized representative" means a patient's spouse, next of kin, legal guardian, attorney or third party insurer where permitted by law.->>

<< NJ ADC 13:39-7.8 >>

<<+13:39-7.8 Transfer of prescriptions between pharmacies+>>

<<+(a) When a patient, the patient's caregiver, or a pharmacy acting on behalf of a patient or caregiver requests the transfer of a valid prescription between pharmacies, a pharmacy shall immediately comply with the patient's request.+>>

<<+(b) Except as provided in (c) and (d) below, a prescription may be transferred between pharmacies, consistent with this section, for one year from the date the prescription was written, provided refills of the prescription are available.+>>

<<+(c) A prescription for a Schedule II controlled substances may not be transferred.+>>

<<+(d) A prescription for a Schedule III, IV or V controlled substance may be transferred between pharmacies, consistent with this section, one time only, pursuant to N.J.A.C. 8:65-7.14(h) and 7.18(d).+>>

<<+(e) A prescription may be transferred electronically by pharmacists between pharmacies for the purpose of refill dispensing consistent with the requirements in N.J.A.C. 13:39-7.11.+>>

<<+(f) A prescription may be transferred by telephone between pharmacies for the purpose of refill dispensing provided that:+>>

<<+1. The sending pharmacy invalidates the prescription on file as of the date the prescription is transferred and records on the back of the invalidated prescription order or in the electronic system the following:+>>

<<+i. That the prescription has been transferred and the date of transfer;+>>

<<+ii. The name of the pharmacy to which the prescription was transferred;+>>

<<+iii. The name or personal identifier of the pharmacist, intern or extern to whom the prescription was transferred; and+>>

<<+iv. The initials or personal identifier of the pharmacist, intern, or extern issuing the transferred prescription order;+>>

<<+2. The receiving pharmacy, upon receiving such prescription directly from another pharmacy, records the following:+>>

<<+i. The name, address and original prescription number of the pharmacy from which the prescription was transferred;+>>

<<+ii. The name or personal identifier of the sending pharmacist, intern or extern ;+>>

<<+iii. All information constituting a prescription order, as well as the following:+>>

<<+(1) Date of issuance of original prescription;+>>

<<+(2) Date of original dispensing;+>>

<<+(3) Original number of refills authorized on original prescription;+>>

<<+(4) Complete refill record from original prescription;+>>

<<+(5) Number of valid refills remaining; and+>>

<<+3. The receiving pharmacist, intern, extern or technician informs the patient or caregiver that the original prescription has been cancelled at the sending pharmacy.+>>

<< NJ ADC 13:39-7.9 >>

<<+13:39-7.9 Filing and storage of controlled substance prescriptions+>>

<<+(a) Prescriptions for all controlled substances listed in Schedule II shall be maintained in a separate prescription file.+>>

<<+(b) Prescriptions for all controlled substances listed in Schedules III, IV and V shall be maintained in a separate prescription file for such controlled substances only or in such form that they are readily retrievable from other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than one-inch high and filed either in the prescription file for controlled substances listed in schedule II or in the usual consecutively numbered prescription file for non-controlled substances.+>>

<< NJ ADC 13:39-5.8A >>

<< NJ ADC 13:39-7.10 >>

13:39-<<-5.8A->><<+7.10 +>>(No change in text.)

<< NJ ADC 13:39-5.8B >>

<< NJ ADC 13:39-7.11 >>

13:39-<<-5.8B->><<+7.11 +>>Electronically transmitted prescriptions

(a)-(j) (No change.)

<<+(k) Two or more permit holders may establish a common electronic filing system to maintain required dispensing information.+>>

<<+(l) Nothing in this section shall be construed to preclude the electronic transfer of information between pharmacies for purposes of transferring prescriptions pursuant to N.J.A.C. 13:39-7.8.+>>

<< NJ ADC 13:39-5.9 >>

<< NJ ADC 13:39-7.12 >>

13:39-<<-5.9->><<+7.12 +>>Labeling

(a) (No change.)

(b) In addition to the requirements set forth in (a) above, the dispense<<+ d+>> container for any product shall bear all auxiliary labeling as recommended by the manufacturer <<-and/or as deemed appropriate in the professional judgment of the dispensing pharmacist->>.

<<+(c) When, in the judgment of the pharmacist, directions to the patient or cautionary messages are necessary, either for clarification or to ensure proper administration, storage or use of the medication, the pharmacist may add such directions or cautionary messages to those indicated by the prescriber on the original prescription.+>>

<< NJ ADC 13:39-6.1 >>

<< NJ ADC 13:39-7.13 >>

13:39-<<-6.1->><<+7.13 +>>Professional judgment in dispensing drugs

<<-(a)->> The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional judgment, the prescription is outside the scope of practice of the prescriber; or if the pharmacist has sufficient reason to question the validity of the prescription; or to protect the health and welfare of the patient.

<<-(b) A pharmacist may dispense an supply (no more than a 72-hour quantity) of a chronic maintenance drug (except controlled dangerous substances) or device in the absence of a current valid prescription, if, in his or her professional judgment, refusal would endanger the health or welfare of the patient.->>

<<-1. The pharmacist must first ascertain to the best of his or her ability, by direct communication with the patient, that such a medication or device was prescribed for that patient by order of a licensed practitioner.->>

<<-2. The pharmacist shall document the communication and require the patient to provide suitable identification and sign a statement attesting to the need before dispensing.->>

<<-3. A patient's signature is not required for refilling of a previously valid prescription.->>

<< NJ ADC 13:39-6.8 >>

<< NJ ADC 13:39-7.14 >>

13:39-<<-6.8->><<+7.14 +>>Advertising and sale of prescription drugs

(a)-(d) (No change.)

(e) Upon request by any consumer, the pharmacist shall <<-be required to->> give <<+usual and customary+>> price information <<+for a non-third party paying customer+>> over the telephone and shall stipulate the effective period of the price quotation.

(f) All advertisements shall be predominantly informational and shall not be misleading, confusing or false. Any advertisement demeaning the quality of professional services rendered by another licensee or permittee shall be prohibited. <<-No advertisement shall rely in any way on techniques to obtain attention that demonstrate a clear and intentional lack of relevance to the selection of professional services.->>

<< NJ ADC 13:39-6.9 >>

<< NJ ADC 13:39-7.15 >>

13:39-<<-6.9->><<+7.15+>> (No change in text.)

<< NJ ADC 13:39-7.10 >>

<< NJ ADC 13:39-7.16 >>

13:39-<<-7.10->><<+7.16 +>>Return of prescription medication

(a) <<-No prescription->> <<+Prescription+>> medication <<+correctly dispensed to a patient may be accepted for return by the pharmacist but+>> shall <<+not+>> be placed in stock for reuse or resale<<+,+>> <<- which has been returned after dispensing to a patient,->> except as provided in N.J.A.C. 13:39-<<-9.15(a)2->><<+9.18(a)2+>>.

(b) <<-Notwithstanding the provisions of (a) above, prescription->> <<+ Prescription+>> medication incorrectly dispensed to a patient shall be accepted for return by the pharmacist and shall not be placed back in stock for reuse or resale.

<<+(c) Prescription medication which has been prepared for a patient, but which has not been dispensed to the patient, may be placed back in stock for reuse or resale provided that:+>>

<<+1. In the professional judgment of the pharmacist, the prescription medication is eligible for re-dispensing. Eligible medications are those medications that are able to be consumed by a patient within the original time frame established for the medication's stability and expiration. Products that have a limited shelf life and/or that have not been stored consistent with manufacturers' storage requirements may not be re-dispensed;+>>

<<+2. The prescription medication shall not be placed in manufacturers' stock containers of different lot numbers and/or with different expiration dates;+>>

<<+3. Manufacturers' stock containers shall not be over-filled;+>>

<<+4. In those circumstances in which prescription medications cannot be properly returned to the original manufacturers' stock containers, the medication shall be held in the pharmacy in the labeled container in which it has been repackaged;+>>

<<+5. If the manufacturer or the FDA orders a recall of a drug product, the pharmacist shall assume products held in labeled containers without lot numbers are included in the recall and proceed accordingly; and+>>

<<+6. Medications held for re-dispensing shall be used as soon as possible. Such medications, lacking original lot numbers and expiration dates, shall not be dispensed to patients beyond six months from the date the medications were originally prepared for dispensing. Re-dispensed medications shall be marked with the same use by date as the medication which was originally prepared for dispensing.+>>

(Agency Note: N.J.A.C. 13:39-7.11 is proposed for recodification with amendments as N.J.A.C. 13:39-5.11.)

<< NJ ADC 13:39-7.12 >>

<< NJ ADC 13:39-7.17 >>

13:39-<<-7.12->><<+7.17 +>>(No change in text.)

<< NJ ADC 13:39-7.13 >>

<< NJ ADC 13:39-7.18 >>

13:39-<<-7.13->><<+7.18 +>>Outdated drugs or drugs marked "sample"

No outdated, misbranded, deteriorated<<+,+>> <<-or->> <<+improperly stored or+>> adulterated drugs, or any drugs marked "sample" or with any like designation or meaning shall be <<+dispensed or+>> placed or maintained in active stock for use or sale.

<< NJ ADC 13:39-7.14 >>

<< NJ ADC 13:39-7.19 >>

13:39-<<-7.14->><<+7.19 +>>Patient profile record system

(a) (No change.)

(b) The following information shall be recorded in the PPRS:

1.-7. (No change.)

8. Pharmacist's comments relevant to the patient's drug therapy<<-, including any failure of the patient to accept the pharmacist's offer to counsel->>.

(c)-(d) (No change.)

(e) Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record either in a manual or electronic data processing system before dispensing the medication, to determine the possibility of a potentially significant drug interaction, reaction or misutilization of the prescription. Upon determining a potentially significant drug interaction, reaction or misutilization, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and/or the prescriber.

1.-2. (No change.)

3. A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation. <<+The absence of any record of a failure to accept the pharmacist's offer to counsel shall be presumed to signify that the offer was accepted and that the counseling was provided.+>>

4.-9. (No change.)

(f) A patient profile record <<-must->> <<+shall+>> be maintained for a period of not less than five years from the date of the last entry in the profile record. <<+In using an electronic data processing system, the system shall have the capability of producing retrievable and readable documents of all original and refilled prescription data for a period of not less than five years, including the number of refills authorized by the prescriber.+>> The oldest four years of record information shall be maintained in such a manner so as to be <<-sight-readable->> <<+retrievable and readable+>> within two weeks. The most recent one year of a record information <<-must->> <<+ shall+>> be immediately retrievable <<+and readable+>>.

(g)-(j) (No change.)

SUBCHAPTER 8. PHARMACY TRAINING SITES

<< NJ ADC 13:39-8.1 >>

13:39-8.1 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

"Certified preceptor" means a pharmacist registered in this State who assumes the responsibility to supervise and tutor a pharmacy intern <<-or extern->> as outlined in N.J.A.C. 13:39-8.2.

...

"Pharmacy intern" means any person who has graduated from an American Council of Pharmaceutical Education approved school or college of pharmacy, or if a foreign pharmacy graduate, any person who has satisfied the requirements of N.J.A.C. 13:39-<<-3.11->><<+2.9+>>, who is employed in an approved training pharmacy for the purpose of acquiring accredited practical experience and who has first registered for said purposes with the Board.

...

<< NJ ADC 13:39-8.2 >>

13:39-8.2 Preceptor <<-certification->> application<<-;->> procedures; responsibilities

(a) A registered pharmacist who wishes to be a certified preceptor shall apply to the Board and shall furnish evidence that he or she:

1. (No change.)

2. Has <<-a record of law observance->> <<+not been convicted of a crime or offense relating adversely to the practice of pharmacy or involving moral turpitude, and has not been the subject of disciplinary action taken by a professional board resulting in the suspension, revocation or surrender of a license or the placement of significant limitations on such license+>>.

(b) (No change.)

(c) The certified preceptor in a pharmacy training site <<-or a faculty preceptor->> shall <<-report to->> <<+provide+>> the Board <<-upon request on->> <<+with a detailed written report outlining+>> the progress<<+,+>> <<-and->> aptitude <<+and readiness to practice+>> of any pharmacy intern <<-or extern->> under his or her supervision <<+at the conclusion of the internship+>>.

<<-(d) The compounding and dispensing of all prescriptions and drugs by the pharmacy intern or extern must be done under the direct supervision of a registered pharmacist.->>

<<-(e)->><<+(d) +>>(No change in text.)

<< NJ ADC 13:39-8.4 >>

13:39-8.4 Internship and externship practical experience

(a) (No change.)

(b) In lieu of the requirements set forth in (a)1 above, an applicant may obtain up to 1,000 hours practical experience by completion of a structured, college-credited externship and clinical pharmacy clerkship program of an <<+ American Council of Pharmaceutical Education+>> accredited college of pharmacy. <<-Such programs shall first be approved by the Board.->>

(c) In cases of a structured, college-credited externship and clinical pharmacy clerkship program, where less than 1,000 hours are accepted and approved by the Board, the balance of hours to make a total of 1,000 shall be gained through completion of a structured internship, conducted after graduation from an <<+American Council of Pharmaceutical Education+>> accredited college of pharmacy and supervised by a certified preceptor with each week of practical experience consisting of no less than 20 hours and no more than 45 hours of actual service per week.

(d) A <<-Board-approved->> college of pharmacy externship program shall provide that no less than 75 percent of the hours credited toward the practical experience requirement of the Board be gained in settings in which there is direct involvement with consumers or patients, registered pharmacists, and other licensed health care practitioners such as physicians, dentists and nurses under the supervision of a certified or faculty preceptor. Not more than 45 hours of <<-Board-accredited->> experience shall be acquired per week.

(e) (No change.)

(f) The pharmacy college shall certify that the requirements of (b) above have been met. <<-The Board shall provide appropriate forms for such certification.->>

SUBCHAPTER 9. PHARMACEUTICAL SERVICES <<-WITHIN->> <<+FOR+>> HEALTH CARE FACILITIES

<< NJ ADC 13:39-9.1 >>

<<+13:39-9.1 Purpose and scope+>>

<<+(a) The rules in this subchapter shall apply to all retail pharmacies which contract to provide pharmaceutical services for healthcare facilities and to all institutional pharmacies which provide pharmaceutical services for their own health care system.+>>

<<+(b) An institutional pharmacy filling prescriptions for outpatient use shall comply with all retail pharmacy requirements of this chapter.+>>

<< NJ ADC 13:39-9.1 >>

<< NJ ADC 13:39-9.2 >>

13:39-<<-9.1->><<+9.2 +>>Definitions

The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

...

"Health care facility" means a place <<-where patients and/or residents are cared for under a common roof such as hospitals, long term care facilities, and establishments similar to those delineated in N.J.S.A. 45:14-32->> <<+ licensed by the Department of Health and Senior Services pursuant to N.J.S.A. 26:2H-1 et seq+>>.

...

"Pharmacy and Therapeutics Committee" means the active standing committee of the institution or health care facility which is the organizational line of communication and liaison between the medical and pharmacy staff and which acts to review and promote rational drug therapy and utilization in the facility. <<-Its organization and function are described under N.J.A.C. 13:39-9.20.->>

...

"Unit use packaging" means a single unit use medication provided in sealed packaging which contains the following information for each <<- dose->> <<+unit in the package+>>:

1. (No change.)

2. Strength <<+and/or quantity and/or volume, where appropriate+>>;

3. (No change.)

4. <<-Beyond use->> <<+Use by+>> date; <<-and->>

5. Manufacturer or repackager<<-.->><<+; and+>>

<<+6. If there is more than one product in the single unit, a physical description of each medication in the single unit.+>>

<< NJ ADC 13:39-9.2 >>

<< NJ ADC 13:39-9.3 >>

13:39-<<-9.2->><<+9.3 +>>Licensure of institutional pharmacies

(a) Any institutional pharmacy as defined under N.J.A.C. 13:39-<<- 9.1->><<+9.2+>> shall be registered with and possess an institutional permit issued by the Board. The permit shall be conspicuously displayed in the facility's pharmacy. The institutional pharmacy is subject to and shall be conducted in accordance with all existing State and Federal rules and regulations.

(b) (No change.)

<< NJ ADC 13:39-4.14 >>

<< NJ ADC 13:39-9.4 >>

13:39-<<-4.14->><<+9.4 +>>Contract pharmaceutical services<<+; institutional permit required+>>

An institutional permit is required for any area within an institution <<- where drugs are stored, manufactured or compounded and which is->> serviced by an outside vendor that performs <<+on-site+>> pharmaceutical services as defined in N.J.A.C. 13:39-1.2.

<< NJ ADC 13:39-9.19 >>

<< NJ ADC 13:39-9.5 >>

13:39-<<-9.19->><<+9.5 +>>(No change in text.)

<< NJ ADC 13:39-9.20 >>

<< NJ ADC 13:39-9.6 >>

13:39-<<-9.20->><<+9.6 +>>Pharmacy and Therapeutics Committee<<+; applicability; polices and procedures+>>

<<+(a)+>> In all health care facilities providing pharmaceutical services to patients, an active standing committee of the institution entitled the Pharmacy and Therapeutics Committee or other appropriate name shall be established <<+if required pursuant to Department of Health and Senior Services rules set forth at N.J.A.C. 8:43G-23+>>. A Pharmacy and Therapeutics Committee shall be multidisciplinary and include a pharmacist.

<<+(b) In all health care facilities providing pharmaceutical services to patients that are not required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of Health and Senior Services rules set forth at N.J.A.C. 8:43G-23, the pharmacist-in-charge, in cooperation with the health care facility, shall create policies and procedures as needed to provide pharmaceutical services to the health care facility. The written policies and procedures shall be available to the Board.+>>

<< NJ ADC 13:39-9.21 >>

<< NJ ADC 13:39-9.7 >>

13:39-<<-9.21->><<+9.7 +>>Institutional pharmacy staff

The institutional pharmacy shall be staffed by sufficient, competent personnel in keeping with the size, scope and complexity of the pharmaceutical services provided <<+consistent with the requirements of N.J.A.C. 13:39-6.2(f) 1+>>.

<< NJ ADC 13:39-9.3 >>

<< NJ ADC 13:39-9.8 >>

13:39-<<-9.3->><<+9.8 +>>Control of <<-institutional pharmaceutical->> <<+health care facility pharmacy+>> services<<+; responsibilities of the registered pharmacist-in-charge+>>

(a) (No change.)

(b) If a health care facility does not have an institutional pharmacy on its premises or chooses to utilize the services of a pharmacy outside the <<- institution->> <<+health care system+>>, it may enter into an agreement with a <<+retail+>> pharmacy licensed by the Board. The registered pharmacist-in-charge of <<-that->> <<+the retail+>> pharmacy <<-and the designated pharmacist of the institution, if appropriate,->> shall direct, control, supervise and be responsible for the pharmaceutical services provided to the facility.

(c) (No change.)

<< NJ ADC 13:39-9.4 >>

<< NJ ADC 13:39-9.9 >>

13:39-<<-9.4->><<+9.9+>> (No change in text.)

<< NJ ADC 13:39-9.5 >>

<< NJ ADC 13:39-9.10 >>

13:39-<<-9.5->><<+9.10 +>>Pharmaceuticals<<+; drug supply; investigational drugs; controlled dangerous substances+>>

(a) The pharmacist-in-charge shall be responsible for determining the specifications for drugs and pharmaceutical preparations used in the treatment of patients of the facility as to quality, quantity and source of supply. An authorized purchasing agent and/or materials manager and/or pharmacy buyer of the facility may perform the actual procurement. In such a case, the purchase shall be <<-approved->> <<+supervised+>> by the pharmacist-in-charge or his or her designee, who shall be a pharmacist.

(b) (No change.)

(c) The institutional pharmacy shall have an adequate inventory of drugs and biologicals to assure timely initiation of routine, and disaster drug therapy<<-;->><<+. Limited quantities of drugs shall be placed under controlled conditions in locations within the facility to assure immediate access by authorized licensed health care personnel for use in an emergency situation. Written policies and procedures for the maintenance, content, control and accountability of drugs supplied and located throughout the facility shall be developed by the registered pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.+>>

(d) The storage and dispensing of all Investigational New Drugs shall be a pharmaceutical service provided in cooperation with, and in support of the principal investigator. Under these parameters<<+,+>> the dispensing of these drugs shall not be construed to be a violation of N.J.A.C. 13:39-<<- 5.4->><<+7.5(a)+>>. A facility participating in experimental research involving residents must be in compliance with Federal Department of Health and Human Services regulations, 45 C.F.R. Part 46, Protection of Human Subjects of Research<<+, which is incorporated by reference herein, as amended and supplemented+>>.

<<-(e) The pharmacist-in-charge shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service of the facility. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by supportive personnel and co-signed by the supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, supportive personnel are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the hospital.->>

<<+(e) Investigational drugs shall be properly labeled and stored in the pharmacy until dispensed. Essential information on the investigational drug shall be maintained in the pharmacy. The investigational drug may be administered only after basic chemical, pharmaceutical and pharmacological information has been made available to all concerned and all the requirements of the Food and Drug Administration and the facility are satisfied.+>>

<<+(f) Controlled dangerous substances shall be purchased, received, stored, dispensed, administered, recorded and controlled in accordance with State and Federal laws and regulations. Written policies and procedures concerning control, use and accountability of controlled drugs shall be developed by the registered pharmacist-in-charge.+>>

<< NJ ADC 13:39-9.6 >>

<< NJ ADC 13:39-9.11 >>

13:39-<<-9.6->><<+9.11 +>>Drug disbursement; written orders; outpatient prescriptions

(a) The pharmacist shall review the prescriber's original order, a direct copy thereof, or <<-an electro-mechanical->> <<+a+>> facsimile before any initial dose of medication is dispensed, except as provided for in N.J.A.C. 13:39-<<-9.9->><<+9.13+>>.

(b) (No change.)

(c) <<-Orders involving abbreviations and chemical symbols shall be carried out only if the abbreviations and symbols are included on a standard list that has been approved by the medical staff.->> <<+The Pharmacy and Therapeutics Committee shall develop a list of unapproved or unacceptable abbreviations and symbols which shall not be used in the facility. Orders involving symbols or abbreviations shall only be dispensed consistent with this list.+>>

(d) When appropriate, the pharmacist shall make necessary entries into the patient medical record relative to drug use <<-after consultation with the prescriber->> <<+in accordance with health care facility policies+>>.

<<-(e) Prescriptions written for employees of the institution or their dependents, or for outpatients of the facility's clinic, shall conform to the prescription requirements of N.J.S.A. 45:14-14.->>

<< NJ ADC 13:39-9.7 >>

<< NJ ADC 13:39-9.12 >>

13:39-<<-9.7->><<+9.12 +>>Drug disbursement; oral orders

(a) The <<-mandatory requirements->> <<+provisions+>> of this section shall be implemented in accordance with the policy and protocols of the Pharmacy and Therapeutics Committee.

(b) A pharmacist shall receive oral orders only from an authorized prescriber. Such orders shall be immediately recorded and signed by the person receiving the order on the <<-prescriber's->> <<+medication+>> order sheet or into the electronic data processing system.

(c)-(d) (No change.)

(e) The pharmacist may release to the patient at discharge any remaining medication in a multiple dose container (for example, inhalers, multiple dose injectable medications such as insulin, topical preparation, drops, ointments, and topical irrigation solutions), provided that the pharmacist:

1. (No change.)

2. Counsels the patient prior to discharge from the hospital or medical facility pursuant to N.J.A.C. 13:39-<<-7.14->><<+7.19+>>; and

3. (No change.)

Recodify existing N.J.A.C. 13:39-9.9 and 9.10 as <<+9.13 and 9.14+>> (No change in text.)

<< NJ ADC 13:39-9.11 >>

<< NJ ADC 13:39-9.15 >>

13:39-<<-9.11->><<+9.15 +>>Drug labeling

Labeling of medications, other than intravenous solutions, shall be in conformance with written policies and procedures controlling the drug distribution system in use within the facility and in accord with current acceptable standards of pharmaceutical practice. <<-Dispensing and labeling of outpatient prescriptions shall conform to N.J.S.A. 45:14-14.->>

<< NJ ADC 13:39-9.12 >>

<< NJ ADC 13:39-9.16 >>

13:39-<<-9.12->><<+9.16 +>>Use of patient's own medication

(a) No drugs shall be administered to a patient except those provided through the pharmacy <<-and except->> <<+or+>> as provided by written policies and procedures developed by the registered pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.

(b) (No change.)

<< NJ ADC 13:39-9.14 >>

<< NJ ADC 13:39-9.17 >>

13:39-<<-9.14->><<+9.17 +>>Drug-dispensing devices

(a) (No change.)

(b) Packaging and labeling of medication for drug-dispensing devices, when done in the facility, shall be performed under the <<-direct->> <<+ immediate personal+>> supervision of a pharmacist in the employ of or under contract to the facility.

(c) Stocking of the drug-dispensing devices with prepackaged medications shall be performed by or under the <<-direct->> supervision of a pharmacist.

(d) The cleanliness of the drug dispensing devices shall be maintained by a pharmacist or by a person under the <<-direct->> supervision of a pharmacist.

(e) Controlled substances and other medications to which, in the professional judgment of the registered pharmacist-in-charge, access should be limited, shall be secured within the drug dispensing device to limit access to single medications only and shall be checked and documented by the pharmacist or his or her designee who shall be a licensed professional, every 24 hours. Other than a pharmacist, only authorized registered nurses, licensed practical nurses, physicians, authorized prescribers or designated pharmacy <<- supportive personnel->> <<+technicians, interns and externs+>> shall have access to the medication in each drug-dispensing device. The activity regarding all medication, including the identity of the person accessing the medication, shall be recorded and available to the pharmacist.

(f)-(g) (No change.)

<<-(h) The pharmacist shall be responsible for checking the drugs in the drug-dispensing devices at least monthly for expiration date, misbranding, physical integrity, security and accountability.->>

<< NJ ADC 13:39-9.15 >>

<< NJ ADC 13:39-9.18 >>

13:39-<<-9.15->><<+9.18 +>>Disposal of unused medications

(a) Written policies and procedures governing unused medications shall be established and implemented by the registered pharmacist-in-charge and shall comply with the following requirements:

1. All medications where the drug source, <<+lot or+>> control number<<+,+>> or expiration <<+or use by+>> date are missing, shall be sent to the pharmacy for final disposition, or shall be disposed of by the health care facility according to its written protocol.

2.-3. (No change.)

4. The record of disposal of unused or nonadministered dispensed controlled dangerous substances expended or wasted either by accident or intent shall be signed and cosigned and witnessed by a licensed nurse, physician or pharmacist and disposed of by the health care facility according to its written protocol <<+and consistent with all local, State and Federal laws and regulations+>>.

<< NJ ADC 13:39-9.16 >>

<< NJ ADC 13:39-9.19 >>

13:39-<<-9.16->><<+9.19 +>>Records and reports

(a) Records of the pharmaceutical services of the facility shall be the responsibility of the registered pharmacist-in-charge. <<+Adequate storage for pharmacy records shall be provided. Records not currently in use need not be stored in the pharmacy, but the storage facilities shall be secure, and the records shall be readily retrievable by the pharmacy staff and authorized inspectors.+>> These records shall be <<-maintained and->> made available to persons authorized to inspect them under State and Federal statutes and regulations. <<+Patient records shall be kept confidential.+>>

(b) The <<-institutional->> pharmacy shall maintain a patient profile record for each patient receiving drug therapy in accordance with N.J.A.C. 13:39-<<-7.14->><<+7.19+>> and as follows:

1. (No change.)

2. All notations made on the inpatients' profile records by <<-supportive personnel->> <<+pharmacy technicians, interns and externs+>> shall be verified and countersigned<<+, either manually or electronically,+>> by the supervising pharmacist.

3. The inpatient profile record shall be filed and stored <<-in a readily retrievable manner->> for five years following patient discharge. <<+The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be immediately retrievable and readable.+>>

(c)-(e) (No change.)

(f) The registered pharmacist-in-charge shall be responsible for maintaining a system by which all reported adverse drug reactions are recorded and reviewed by the Pharmacy and Therapeutics Committee<<+, where applicable, and are submitted to all appropriate State and local agencies consistent with State and local laws and regulations+>>.

<< NJ ADC 13:39-9.17 >>

<< NJ ADC 13:39-9.20 >>

13:39-<<-9.17->><<+9.20 +>>Drug information and education

(a) The registered pharmacist-in-charge shall be responsible for maintaining drug standards, references and sources of drug information current and adequate to meet the needs of the pharmacists, physicians, nurses, other health care personnel, and patients of the facility. Reference texts shall include, but not be limited to, those required by the Board under N.J.A.C. 13:39-<<- 7.7->><<+5.8+>>.

(b)-(c) (No change.)

<< NJ ADC 13:39-9.18 >>

<< NJ ADC 13:39-9.21 >>

13:39-<<-9.18->><<+9.21 +>>After hours access to the institutional pharmacy

(a)-(e) (No change.)

(f) All records in (d) above shall be kept by the pharmacy for <<- one->> <<+five+>> year<<+s+>>. <<+The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be immediately retrievable and readable.+>>

(Agency Note: N.J.A.C. 13:39-9.19 is proposed for recodification as N.J.A.C. 13:39-9.5. N.J.A.C. 13:39-9.20 and 9.21 are proposed for recodification with amendments as N.J.A.C. 13:39-9.6 and 9.7.)

<< NJ ADC 13:39-9.23 >>

<<-13:39-9.23 (Reserved)->>

<< NJ ADC 13:39-9.24 >>

<< NJ ADC 13:39-9.22 >>

13:39-<<-9.24->><<+9.22 +>>Pharmacy facilities; space

(a) (No change.)

(b) The facilities shall include, but are not limited to, those requirements provided in N.J.A.C. 13:39-<<-7.3->><<+5.4+>> through <<- 7.7->><<+5.8+>>.

(c) (No change.)

<< NJ ADC 13:39-9.25 >>

<< NJ ADC 13:39-9.23 >>

13:39-<<-9.25->><<+9.23 +>>Storage and security

(a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in the health care facility.

1.-3. (No change.)

4. The drugs throughout the facility shall be maintained under adequate storage conditions including proper lighting, ventilation and temperature control as required by the <<-United States Pharmacopoeia/ National Formulary->> <<+drug manufacturer+>>.

<<-5. Adequate storage for pharmacy records shall be provided. Records not currently in use need not be stored in the pharmacy, but the storage facilities must be secure, and the records shall be readily retrievable by the pharmacy staff and authorized inspectors. Patient records shall be kept confidential.->>

<<+(b) The pharmacist-in-charge shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, misbranding, physical integrity, security and accountability of all drugs dispensed for use. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by the pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the hospital.+>>

<<+(c) Procedures shall be established to assure the immediate and efficient removal of all outdated and recalled drugs from patient care areas and from the active stock of the pharmacy. The registered pharmacist-in-charge shall develop written policies and procedures governing the removal from the facility of outdated or recalled drugs.+>>

<< NJ ADC 13:39-9.26 >>

<< NJ ADC 13:39-9.24 >>

13:39-<<-9.26->><<+9.24 +>>(No change in text.)

<< NJ ADC 13:39-9.27 >>

<< NJ ADC 13:39-9.25 >>

13:39-<<-9.27->><<+9.25 +>>Institutional decentralized pharmacies

(a) <<-Institutional->> <<+An institutional+>> decentralized <<- pharmacies, that is,->> <<+pharmacy or a+>> "satellite <<- pharmacies->> <<+pharmacy+>>", means <<-areas->> <<+an area+>> within <<-the->> <<+a+>> health care <<-institution->> <<+system that has been issued an institutional permit and is in a location+>> other than the original <<-institutional permit->> <<+permitted+>> location, where the preparation<<-,->> <<+or+>> dispensing<<-, and->> <<+ or+>> compounding of medications <<-are->> <<+is+>> performed. <<- Medication shall not be dispensed without a pharmacist present.->>

<<+(b) Medication shall not be dispensed from a decentralized pharmacy without a pharmacist present, except that, when the decentralized pharmacy is closed, a licensed nurse may dispense medication in accordance with the written policies and procedures of the institution.+>>

<<-(b) Institutions utilizing or desiring to utilize institutional decentralized pharmacies shall file a remodeling application to the Board to conduct a decentralized pharmacy.->> <<+(c) Institutions operating decentralized pharmacies shall notify the Board, in writing, of the existence of, and the discontinuation of, each decentralized pharmacy location.+>>

<<-(c)->><<+(d)+>> Institutional decentralized pharmacies <<- will->> <<+shall+>> be subject to normal Board inspections.

<<-(d) The minimum equipment requirement for an institutional decentralized pharmacy shall be the following:->>

<<-1. An up-to-date, comprehensive pharmaceutical reference text(s) and suitable reference texts encompassing the general practice of pharmacy, drug interactions, drug product composition and patient counseling. Unabridged computerized versions of these reference texts shall be acceptable;->>

<<-2. Patient profile record system;->>

<<-3. Properly safeguarded storage place if necessary for Schedule II controlled dangerous substances if not dispersed;->>

<<-4. A refrigerator if necessary for the exclusive storage of biologicals and other medicinal products requiring refrigeration;->>

<<-5. Labels; and->>

<<-6. A sink with hot and cold running water exclusive of restroom facilities shall be easily accessible to institutional decentralized pharmacy personnel.->>

<<+(e) Inspections of all medications in a decentralized institutional pharmacy shall be performed consistent with the requirements of N.J.A.C. 13:39-9.23.+>>

<<+(f) Institutional decentralized pharmacies shall comply with all requirements in this subchapter applicable to the pharmaceutical services provided by the decentralized pharmacy, as determined by the registered pharmacist-in-charge.+>>

<< NJ ADC 13:39-9.26 >>

<<+13:39-9.26 Valid medication orders; out-of-State medication orders+>>

<<+(a) Only medication orders issued by an authorized prescriber licensed to write medication orders in the United States or any territory of the United States shall be considered valid medication orders and such medication orders shall be filled pursuant to New Jersey law.+>>

<<+(b) Medication orders, other than those listed in (a) above, shall not be filled by a pharmacy in New Jersey.+>>

<< NJ ADC 13:39-5.8 >>

<< NJ ADC 13:39-9.27 >>

13:39-<<-5.8->><<+9.27 +>>Prescriptions and medication orders transmitted by technological devices in an institution

(a) (No change.)

(b) A registered pharmacist filling prescriptions under an institutional permit for employees of the institution and their dependents and for <<-out-patients who are treated by staff members of the institution in their respective clinics, as permitted pursuant to N.J.S.A. 45:14-32,->> <<+ eligible outpatients+>> may accept for dispensing prescriptions for all substances other than Schedule II controlled dangerous substances which have been transmitted by technological device, under the following conditions only:

1. Before releasing to other than an <<-in-patient->> <<+inpatient+>> of a health care facility, as defined in N.J.A.C. 13:39-<<-9.1->><<+ 9.2+>>, any prescription medication for a controlled dangerous substance listed in Schedules III, IV or V, the pharmacist shall obtain and file the original signed prescription.

2. (No change.)

(c) A registered pharmacist who is authorized to fill inpatient medication orders, as defined in N.J.A.C. 13:39-<<-9.1->><<+9.2+>>, in an institutional pharmacy may accept all inpatient medication orders, including orders for Schedule II substances, which have been transmitted by technological device. Medication orders for narcotic Schedule II controlled substances written for long-term care facility residents or hospice patients <<+or for direct administration to patients by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion,+>> which are transmitted by facsimile, shall serve as the original written medication orders, in accordance with the provisions of 21 C.F.R. 1306.11(d), (e), (f) and (g).

(d)-(g) (No change.)

SUBCHAPTER 10. AUTOMATED MEDICATION SYSTEMS

<< NJ ADC 13:39-10.3 >>

13:39-10.3 Authority to use automated medication system

(a) (No change.)

(b) The registered pharmacist in charge or the registered pharmacist under contract with a healthcare facility responsible for the dispensing of medications shall be responsible for the following:

1. (No change.)

2. Ensuring that medications in the automated medication system are inspected, at least monthly, for expiration <<+or use by+>> date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least monthly, for security and accountability;

3.-5. (No change.)

<< NJ ADC 13:39-10.5 >>

13:39-10.5 Personnel training requirements

The registered pharmacist in charge shall be responsible for ensuring that, prior to performing any services in connection with an automated medication system, all licensed practitioners and <<-supportive personnel->> <<+ pharmacy technicians, interns and externs+>> are trained in the pharmacy's standard operating procedures with regard to automated medication systems as set forth in the written policies and procedures of operation maintained pursuant to N.J.A.C. 13:39-10.4.

SUBCHAPTER 11. <<-STERILE ADMIXTURE SERVICES->> <<+COMPOUNDING+>> IN RETAIL AND INSTITUTIONAL PHARMACIES <<+FOR STERILE AND/OR NON-STERILE PREPARATIONS+>>

<< NJ ADC 13:39-11.1 >>

13:39-11.1 Purpose and scope

This subchapter shall apply to all retail and institutional pharmacies which<<-, on or after June 15, 1998,->> compound and dispense sterile<<- admixture products->> <<+and/or non-sterile preparations+>>.

<< NJ ADC 13:39-11.2 >>

13:39-11.2 Definitions

The following words and terms, when used in this subchapter, shall have the following meanings:

<<-"Class 100->> <<+"ISO class 5+>> air quality conditions" means conditions in which the air particle count is no greater than a total of <<- 100->> <<+3,520+>> particles of 0.5 micrometers and larger per cubic <<-foot of air->> <<+meter of air (100 particles per cubic foot)+>>.

<<-"Class 1,000->> <<+"ISO class 6+>> air quality conditions" means conditions in which the air particle count is no greater than a total of <<- 1,000->> <<+35,200+>> particles of 0.5 micrometers and larger per cubic <<-foot of air->> <<+meter of air (1,000 particles per cubic foot)+>>.

<<-"Class 10,000->> <<+"ISO class 7+>> air quality conditions" means conditions in which the air particle count is no greater than a total of <<- 10,000->> <<+352,000+>> particles of 0.5 micrometers and larger per cubic <<-foot of air->> <<+meter of air (10,000 particles per cubic foot)+>>.

...

<< NJ ADC 13:39-11.3 >>

13:39-11.3 Sterile <<-admixture->> <<+and non-sterile preparation+>> services; environment

<<+(a)+>> A sterile <<-admixture->> <<+preparation+>> service is one specializing in the compounding and dispensing of sterile <<- products->> <<+preparations+>> upon receipt of a valid prescription or medication order. Such compounding shall take place in the confines of a controlled environment as required by N.J.A.C. 13:39-<<-11.17->><<+ 11.16+>>; or when circumstances permit as set forth in N.J.A.C. 13:39-<<- 11.12(c)->><<+11.11(c)+>>, in a laminar hood, as provided by N.J.A.C. 13:39-<<-11.23->><<+11.22+>>, or in a glove box, as provided by N.J.A.C. 13:39-<<-11.24->><<+11.23+>>.

<<+(b) Compounding of non-sterile preparations shall take place in a compounding environment designated specifically for that purpose.+>>

<< NJ ADC 13:39-11.5 >>

<< NJ ADC 13:39-11.4 >>

13:39-<<-11.5->><<+11.4 +>>General requirement <<+for compounded sterile preparations; pre-approval+>>

An applicant or permitholder who wishes to <<-prepare->> <<+ compound+>> sterile <<-admixtures->> <<+preparations+>> shall notify the Board at least <<-30->> <<+60+>> days prior to commencement <<-of preparation of any sterile admixture products,->> and <<-must->> <<+ shall+>> receive approval from the Board before commencing <<+compounding of+>> sterile <<-admixture->> preparation<<+s+>>.

<< NJ ADC 13:39-11.6 >>

<< NJ ADC 13:39-11.5 >>

13:39-<<-11.6->><<+11.5 +>>Pharmacist in charge and permitholders' responsibilities

(a) <<-That section of a pharmacy which provides a->> <<+The pharmacist-in-charge shall supervise all+>> sterile <<-admixture service shall be under the direct supervision of a pharmacist licensed to practice in this State->> <<+and/or non-sterile compounding. For purposes of supervising sterile compounding, the pharmacist-in-charge shall be trained in aseptic manipulation skills.+>>

(b) The pharmacist in charge shall have the responsibility, in that section of the pharmacy <<-which provides this special service->> <<+where sterile and/or non-sterile preparations are compounded,+>> for, at a minimum, the following:

1. <<-Preparation->> <<+Compounding+>> of <<-sterile admixtures compounded->> <<+all preparations+>> within the pharmacy or pharmacy satellite<<+, including compounding of individual medication orders or prescriptions, the formulation of products in response to special drug needs and batch compounding+>>;

2. Storage of all materials pertinent to the <<+compounding of+>> preparation<<+s+>> <<-of sterile admixtures->>, including drugs, chemicals and biologicals, and the establishment of specifications for procurement of the materials <<+in accordance with State and Federal laws and regulations+>>;

3. <<-Labeling->> <<+Ensuring that all packaging and labeling+>> of all <<-containers of sterile admixture preparations->> <<+drugs+>> compounded with the pharmacy <<+are performed under the immediate personal supervision of a pharmacist+>>;

4. Recording all transactions of the pharmacy as may be applicable to State, Federal and local laws and rules, as may be necessary to maintain accurate control over, and accountability for, all pharmaceutical materials; <<- and->>

5. Ensuring that <<+preparation and compounding of sterile preparations is performed+>> only <<+by+>> licensed pharmacists <<-meeting the requirements of (a) above, or supportive personnel->> <<+who have been trained in aseptic manipulation skills, or by pharmacy technicians, interns or externs who have been trained in aseptic manipulation skills working+>> under <<-direct->> <<+the immediate personal+>> supervision of <<-an IV trained->> <<+a+>> licensed pharmacist <<-as defined in N.J.A.C. 13:39-11.8(a), prepare, compound and dispense the sterile admixture preparations.->> <<+trained in aseptic manipulation skills;+>>

<<+6. Ensuring that preparation and compounding of non-sterile preparations is performed only by licensed pharmacists or by pharmacy technicians, intern or externs working under the immediate personal supervision of a licensed pharmacist; and+>>

<<+7. Establishing procedures for maintaining the integrity and manufacturer's control identity of packaged material. The packaging records shall be initialed by the supervising pharmacist.+>>

<< NJ ADC 13:39-11.8 >>

<< NJ ADC 13:39-11.6 >>

13:39-<<-11.8->><<+11.6 +>><<-Supportive personnel;->> <<+ Pharmacy technicians, interns and externs;+>> required supervision

(a) Dispensing pharmacists shall provide <<-direct->> <<+immediate personal+>> supervision to <<-supportive personnel->> <<+pharmacy technicians, interns or externs+>> who are performing delegated sterile <<- admixture tasks->> <<+and non-sterile preparation compounding+>>. The ratio of dispensing pharmacists to <<-supportive personnel->> <<+pharmacy technicians+>> shall not exceed 1:2 at any given time <<+unless all of the requirements of N.J.A.C. 13:39-6.6(d) and (e) are met+>>.

<<-1. For the purpose of this subchapter, "direct supervision" means that the dispensing pharmacist shall be present in the pharmacy dispensing area whenever supportive personnel are compounding sterile admixture products, and shall conduct checks of all steps in preparation, compounding and dispensing of sterile admixture products.->>

<<-2.->><<+1. +>>(No change in text.)

(b) The dispensing pharmacist may delegate to <<-supportive personnel->> <<+pharmacy technicians, interns or externs+>> only the following tasks: recording of the prescription, selection of the drugs, container and diluent, typing of labels and compounding of <<-the sterile admixture->> <<+preparations+>>. The dispensing pharmacist shall ensure that each task has been performed correctly in the dispensing process.

<< NJ ADC 13:39-11.7 >>

13:39-11.7 Training requirements <<+for compounding sterile preparations+>>

(a) The pharmacist in charge and all personnel involved in <<+ compounding+>> sterile <<-admixture->> preparation<<+s+>> shall have practical or academic training in sterile <<-product->> <<+ preparation+>> compounding, clean room technology, laminar flow technology, and quality assurance techniques. Such training shall be documented for each person before that individual begins to compound sterile <<- products->> <<+preparations+>> and annually thereafter. That documentation shall be maintained by the permitholder for five years and made available to the Board upon request.

(b) The pharmacist in charge shall be responsible for ensuring that, prior to <<-performing delegated->> <<+compounding+>> sterile <<-admixture services->> <<+preparations+>>, all <<-supportive->> personnel are trained and can successfully demonstrate:

1. Comprehensive knowledge of the pharmacy's standard operating procedures with regard to <<+compounding+>> sterile <<-admixture services->> <<+preparations+>> as set forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C. 13:39-<<- 11.14->><<+11.13+>>;

2.-3. (No change.)

(c) At least annually, the pharmacist in charge shall be responsible for testing the aseptic technique of all personnel involved in <<+ compounding+>> sterile <<-product->> preparation<<+s+>> by means of a test batch of culture media, media fill or the equivalent. Test results shall be maintained for five years, and shall be made available for the Board's inspection upon request. Individuals who fail to demonstrate acceptable aseptic technique shall be prohibited from engaging in sterile <<-product->> preparation <<+compounding+>> until demonstrating acceptable technique by means of a test batch of culture media, media fill or the equivalent.

<< NJ ADC 13:39-11.6 >>

<< NJ ADC 13:39-11.8 >>

(Agency Note: N.J.A.C. 13:39-11.8 is proposed for recodification with amendments as N.J.A.C. 13:39-11.6.)

<< NJ ADC 13:39-11.9 >>

<< NJ ADC 13:39-11.8 >>

13:39-<<-11.9->><<+11.8+>> Batch preparation

Pharmacists and <<-supportive personnel->> <<+pharmacy technicians, interns and externs+>> may <<-prepare->> <<+compound+>> sterile <<- products->> <<+and non-sterile preparations+>> consistent with the provisions of N.J.A.C. 13:39-<<-11.8->><<+11.6+>> in a quantity that is supported by prior valid prescription <<+or medication+>> orders before receiving a valid written prescription or medication order, provided the pharmacist can document a history of valid prescriptions subsequently received shortly thereafter or medication orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship, and provided they maintain the prescription on file for all such products dispensed at the pharmacy as required by state law. The pharmacist shall document the batch preparation process in accordance with N.J.A.C. 13:39-<<- 11.10(e)->><<+11.9(d)+>>.

<< NJ ADC 13:39-11.10 >>

<< NJ ADC 13:39-11.9 >>

13:39-<<-11.10->><<+11.9 +>>Documentation

(a) Consistent with the provisions of N.J.A.C. 13:39-<<-11.6->><<+ 11.5+>>, the dispensing pharmacist shall ensure that <<-the sterile admixture product has->> <<+compounded preparations have+>> been properly prepared, labeled, controlled, stored, dispensed and distributed in accordance with the provisions of this subchapter.

(b) The pharmacist in charge shall be responsible for ensuring that policies and procedures exist so that all aspects of the dispensing process set out in <<-(e)->><<+(d)+>> below are documented and that the pharmacist responsible for each preparation can be identified.

<<-(c) The retail dispensing pharmacist shall be responsible for completing a form which documents the completion of each of the steps of the compounding process in (e) below. The tracking document(s) shall be initialed by the individual(s) who completed each step.->>

<<-(d)->><<+(c) +>>The <<-institutional->> dispensing pharmacist shall assure that appropriate documentation is maintained to track completion of <<+each of+>> the steps of the compounding process set out in <<- (e)->><<+(d)+>> below.

<<-(e)->><<+(d) +>>Compounding steps which shall be documented are as follows:

1. Receipt of prescription <<+or medication order+>>;

2. Recording of prescription <<+or medication order+>> in the patient record profile system, pursuant to N.J.A.C. 13:39-<<-11.16->><<+ 11.15+>>;

3. (No change.)

4. Verification that all pharmacy sterile <<-admixture->> <<+ preparation+>> compounding is performed within a <<-class 100->> <<+ ISO class 5+>> laminar air flow hood or <<-class 100->> <<+ISO class 5+>> clean room and that proper aseptic procedures are being used at all times to prevent bacterial contamination of this product;

5. Verification that <<-residual components->> <<+ingredients+>> comply with the prescription <<+or medication order+>>;

6. Verification that the prescription <<+or medication order+>> label complies with the requirements of N.J.A.C. 13:39-<<-11.11->><<+ 11.10+>>; and

7. Verification that the prescription <<+or medication order+>> is complete and ready to be dispensed, including any necessary ancillary supplies.

<<-(f)->><<+(e) +>>The completed documentation shall be maintained for not less than five years from the date of the last entry in the record. The oldest four years of record information shall be maintained in such a manner so as to be <<-sight-readable->> <<+retrievable and readable+>> within two weeks. The most recent one year of a record <<-must->> <<+shall+>> be <<+immediately+>> retrievable <<+and readable+>> within 24 hours.

<< NJ ADC 13:39-11.11 >>

<< NJ ADC 13:39-11.10 >>

13:39-<<-11.11->><<+11.10 +>>Information required to appear on prescription label

(a) The dispensed container for any <<-sterile admixture product->> <<+ compounded preparation+>> shall bear a permanently affixed label with at least the following information:

1. The date and<<+, for sterile preparations, the+>> time prepared;

2.-4. (No change.)

<<-5. The name of the base solution;->>

<<-6.->><<+5.+>> The name and quantity of <<-drug(s) added->> <<+all ingredients+>>;

<<-7.->><<+6.+>> The name or identifying code of the pharmacist who checked or prepared the <<-sterile admixture product->> <<+compounded preparation+>>;

<<-8.->><<+7.+>> (No change in text.)

<<-9. The pharmacy's Drug Enforcement Administration (DEA) number, if the sterile admixture product contains any controlled dangerous substances;->>

<<-10.->><<+8.+>> The <<-expiration->> <<+use by+>> date and<<+, for sterile preparations, the use by+>> time <<-of the sterile admixture product->> (If no time is stated, it is presumed to be 11:59 P.M. of the stated <<-expiration->> <<+use by+>> date)<<-;->><<+.+>>

Recodify existing 11.-13. as <<+9.-11.+>> (No change in text.)

<< NJ ADC 13:39-11.12 >>

<< NJ ADC 13:39-11.11 >>

13:39-<<-11.12->><<+11.11 +>><<-Expiration->> <<+Use by+>> date of sterile preparation

(a) The <<-expiration->> <<+use by+>> date of a sterile <<-admixture product->> <<+compounded preparation+>> shall be 24 hours or as otherwise stated by the manufacturer or current literature at the time of preparation<<+, but shall not exceed 30 days after preparation.+>>

(b) Any <<-expiration->> <<+use by+>> date that extends beyond 24 hours or the manufacturer's expiration date shall be substantiated by documentation satisfactory to the Board.

(c) In an institutional pharmacy, any sterile <<-admixture product->> <<+compounded preparation+>> which is prepared under the pharmacy's control in a <<-class 100->> <<+ISO class 5+>> laminar air flow hood which is <<-in an environment->> <<+not in a clean room and+>> which meets the requirements of N.J.A.C. 13:39-<<-11.23->><<+ 11.22+>>, shall be labeled to indicate that administration to a patient shall be initiated and completed within 28 hours of the beginning of the preparation time. If such a <<-product->> <<+compounded preparation+>> is prepared by closed-system aseptic transfer of a single, sterile, nonpyrogenic, finished medication obtained from licensed manufacturers into sterile final containers (for example, syringes, minibags, portable infusion-device cassettes), then the <<-product->> <<+compounded preparation+>> shall be labeled to indicate that administration to a patient shall be completed within the time recommended by the manufacturer but not exceeding 30 days after preparation. A closed system aseptic transfer is one which does not permit exposure of the pharmaceutical components to the environment, and shall be prepared in a <<- class 100->> <<+ISO class 5+>> laminar air flow hood.

<< NJ ADC 13:39-11.13 >>

<< NJ ADC 13:39-11.12 >>

13:39-<<-11.13->><<+11.12+>> Handling, packaging and delivery

(a) The pharmacy shall be responsible for the proper handling and packaging of compounded <<-sterile->> preparations for delivery from the pharmacy to the patient in order to assure and maintain <<-sterility and->> <<+integrity, efficacy,+>> stability<<+, and, where applicable, sterility,+>> of these preparations. <<-To ensure the integrity and efficacy of compounded sterile admixture products, the->> <<+The+>> pharmacist in charge shall ensure that:

1.-3. (No change.)

<< NJ ADC 13:39-11.14 >>

<< NJ ADC 13:39-11.13 >>

13:39-<<-11.14->><<+11.13 +>>Policy and procedure manual <<+for compounded sterile preparations+>>

(a) The pharmacist in charge shall maintain a policy and procedure manual which shall set forth in detail the licensee's standard operating procedures with regard to <<+compounded+>> sterile <<-admixture services->> <<+ preparations+>>.

(b) The policy and procedure manual shall include policies and procedures governing the following:

1. (No change.)

2. Security measures ensuring that the premises where <<+compounded+>> sterile <<-admixture->> drugs are present are secured, so as to prevent access by unauthorized personnel;

3.-4. (No change.)

5. Reference materials as set out in N.J.A.C. 13:39-<<-7.7->><<+ 5.8+>> and <<-11.25->><<+11.24+>>;

6. (No change.)

7. Patient recordkeeping as set forth in N.J.A.C. 13:39-<<- 11.16->><<+11.15+>>;

8. (No change.)

9. A quality assurance program as set forth in N.J.A.C. 13:39-<<- 11.15->><<+11.14+>>;

10.-11. (No change.)

12. Documentation as set forth in N.J.A.C. 13:39-<<-11.10->><<+ 11.9+>>;

13.-18. (No change.)

(c) The pharmacist in charge shall review <<+at least every two years+>> and, if necessary, amend the policy and procedure manual <<-on at least an annual basis->> <<+as needed+>>. Documentation of the <<-annual->> review shall be made available to the Board upon request.

<< NJ ADC 13:39-11.15 >>

<< NJ ADC 13:39-11.14 >>

13:39-<<-11.15->><<+11.14+>> Quality assurance program <<+for compounded sterile preparations+>>

(a) This section shall apply both to commercially available sterile drug products that are dispensed to patients without compounding or other manipulation, and to sterile <<-admixture products,->> <<+ preparations+>> which, prior to dispensing, have been in any way repackaged, reconstituted, diluted, admixed, blended, or otherwise manipulated (collectively referred to as "compounded").

(b) The dispensing pharmacist shall ensure that the <<+compounded+>> sterile <<-admixture product->> <<+preparation+>> retains its quality attributes within acceptable limits through a written quality assurance program. The quality assurance program shall require at least that:

1. A reasonable effort shall be made by the dispensing pharmacist to assure that <<+compounded+>> sterile <<-admixture products->> <<+ preparations+>> shall be kept under appropriate controlled conditions at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration as set forth by the product manufacturer, with each <<+compounded+>> sterile <<-admixture product->> <<+preparation+>> dispensed;

2. The quality assurance program encompasses all phases of sterile <<- admixture product->> <<+compounding, including+>> preparation, distribution, storage, administration, and directions for use for each type of product dispensed;

3. (No change.)

4. Air and surface sampling for microbial organisms in <<-class 100->> <<+ISO class 5+>> laminar air flow hoods and <<-class 1,000->> <<+ISO class 6+>> clean rooms is done twice annually and at any time when microbial contamination is suspected pursuant to United States Pharmacopoeia/ National Formulary guidelines;

5. Laminar air flow hoods shall be certified every six months<<+, and every time they are moved,+>> by an independent certification company;

6. The <<-class 1,000->> <<+ISO class 6+>> clean room and <<-class 10,000->> <<+ISO class 7+>> anteroom shall be certified every six months by an independent certification company; and

7. All unused drugs and materials used in the <<-preparation of sterile admixture products->> <<+compounding of sterile preparations+>>, including antineoplastic agents, are disposed of properly in accordance with accepted professional standards and applicable laws, including the Medical Waste Act (N.J.S.A. 13:1E-48.1 et seq., P.L. 1989, c.34).

<< NJ ADC 13:39-11.16 >>

<< NJ ADC 13:39-11.15 >>

13:39-<<-11.16->><<+11.15+>> Patient profile records <<+for compounded sterile preparations+>>

(a) The pharmacist in charge shall ensure that a patient profile record is maintained and monitored for each patient. The patient profile record shall include, but is not limited to, the following:

1. Available medical information consistent with N.J.A.C. 13:39-<<- 7.14->><<+7.19+>>; and

2. (No change.)

(b)-(c) (No change.)

<< NJ ADC 13:39-11.17 >>

<< NJ ADC 13:39-11.16 >>

13:39-<<-11.17->><<+11.16 +>>Controlled environment <<+for compounded sterile preparations+>>: use, access, location; temperature

(a) The pharmacy shall have a designated area for sterile <<-product->> preparation <<+compounding+>>, known as the "controlled environment," consisting of a clean room and an anteroom unless the pharmacy meets the requirements of N.J.A.C. 13:39-<<-11.23->><<+11.22+>> or <<- 11.24->><<+11.23+>>.

(b) A controlled environment shall be:

1. (No change.)

2. Used only for the <<-preparation->> <<+compounding+>> of sterile <<-products->> <<+preparations+>>, or such other tasks that require a controlled environment;

3.-4. (No change.)

<< NJ ADC 13:39-11.18 >>

<< NJ ADC 13:39-11.17 >>

13:39-<<-11.18->><<+11.17 +>>Controlled environment <<+for compounded sterile preparations+>>: construction

(a)-(j) (No change.)

<< NJ ADC 13:39-11.19 >>

<< NJ ADC 13:39-11.18 >>

13:39-<<-11.19->><<+11.18 +>>Controlled environment <<+for compounded sterile preparations+>>: stocking, maintenance and supplies

(a)-(d) (No change.)

(e) The controlled environment area shall contain the following supplies:

1.-5. (No change.)

6. Any and all supplies necessary for the aseptic <<-preparation->> <<+ compounding+>> of sterile <<-admixture products->> <<+ preparations+>>.

<< NJ ADC 13:39-11.20 >>

<< NJ ADC 13:39-11.19 >>

13:39-<<-11.20->><<+11.19 +>>Controlled environment <<+for compounded sterile preparations+>>: clean room

(a)-(c) (No change.)

(d) Appropriate environmental control devices capable of maintaining <<- class 1,000->> <<+ISO class 6+>> air-quality conditions during normal activity shall be in place.

(e) The clean room shall contain the following equipment:

1. <<-A->> <<+An ISO class 5 or better+>> laminar airflow hood or <<+a+>> suitable <<+ISO class 5 or better+>> HEPA filter system;

2.-3. (No change.)

<< NJ ADC 13:39-11.21 >>

<< NJ ADC 13:39-11.20 >>

13:39-<<-11.21->><<+11.20 +>>Controlled environment <<+for compounded sterile preparations+>>: anteroom

(a) The anteroom shall have an air quality of <<-Class 10,000->> <<+ISO class 7+>> or better.

(b) (No change.)

(c) A refrigerator, as required by United States Pharmacopoeia Standards, shall be reasonably accessible to the anteroom to ensure the integrity of the <<+compounded+>> sterile <<-admixture product->> <<+ preparations+>>, but shall not be located within the controlled environment.

<< NJ ADC 13:39-11.22 >>

<< NJ ADC 13:39-11.21 >>

13:39-<<-11.22->><<+11.21+>> Vertical air laminar flow hoods <<+for compounded sterile preparations+>>

(a) Pharmacies shall compound antineoplastic agents and other hazardous substances in <<-a class 100->> <<+an ISO class 5+>> vertical air laminar flow hood.

(b) (No change.)

<< NJ ADC 13:39-11.23 >>

<< NJ ADC 13:39-11.22 >>

13:39-<<-11.23->><<+11.22+>> Laminar air flow hoods not in a clean room <<+for compounded sterile preparations+>>

Institutional pharmacy <<-class 100->> <<+ISO class 5+>> laminar air flow hoods not located in a clean room may only be located in an area which is maintained under sanitary conditions and traveled by persons engaging in <<+ the compounding of+>> sterile <<-product->> preparation<<+s+>>. Such hoods shall be certified by an independent certification company prior to use when first installed or after being moved and at six-month intervals.

<< NJ ADC 13:39-11.24 >>

<< NJ ADC 13:39-11.23 >>

13:39-<<-11.24->><<+11.23+>> Controlled environment <<+for compounded sterile preparations+>>: self-contained sterile glove boxes

Self-contained <<-class 10 to class 100->> <<+ISO class 5+>> glove boxes, barrier isolation technology or the equivalent not located in a clean room may only be located in an area which is maintained under sanitary conditions and traveled by persons engaging in <<+the compounding of+>> sterile <<-product->> preparation<<+s+>>. Such boxes shall be certified by an independent certification company prior to use when first installed or after being moved and at six-month intervals.

<< NJ ADC 13:39-11.25 >>

<< NJ ADC 13:39-11.24 >>

13:39-<<-11.25->><<+11.24+>> Library references

In addition to the minimum reference library mandated in N.J.A.C. 13:39-<<-7.7->><<+5.8+>>, each <<-sterile admixture service->> <<+pharmacy engaged in compounding+>> shall contain recognized references pertinent to specialized <<-sterile admixture practice->> <<+ compounding preparations+>>.

<< NJ ADC 13:39-11.26 >>

<< NJ ADC 13:39-11.25 >>

13:39-<<-11.26->><<+11.25 +>>Disposal of drugs and materials

All unused drugs and materials used in the <<-preparation of sterile admixture products->> <<+compounding of preparations+>>, including antineoplastic agents, shall be disposed of properly in accordance with accepted professional standards and applicable laws, including the Medical Waste Act (N.J.S.A. 13:1E-48.1 et seq., P.L. 1989, c.34), so as not to endanger the public health.

<< NJ ADC 13:39-11.27 >>

<< NJ ADC 13:39-11.26 >>

13:39-<<-11.27->><<+11.26 +>>Security

The <<-sterile admixture->> <<+compounding+>> area and its contents and other areas where <<-sterile admixture drugs->> <<+compounded preparations+>> are present shall be secured, so as to prevent access by unauthorized personnel.

SUBCHAPTER 12. NUCLEAR PHARMACIES

<< NJ ADC 13:39-12.1 >>

13:39-12.1 Definitions

The following words and terms when used in this subchapter shall have the following meanings, unless the context clearly indicates otherwise.

...

<<-"Direct supervision" means that a qualified nuclear pharmacist shall be physically present in the compounding/dispensing area where the supportive personnel are performing delegated duties, and shall conduct in-process and final checks of all steps in preparation, compounding, and dispensing of drugs. This supervision shall include, but is not limited to, the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.->>

...

<<+"Immediate personal supervision" means that the registered pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, and the finished label.+>>

...

<< NJ ADC 13:39-12.2 >>

13:39-12.2 General requirements for pharmacies providing radiopharmaceutical service

(a) The application for a specialized retail permit to operate a pharmacy providing radiopharmaceutical services shall only be issued to a site employing a qualified nuclear pharmacist. All personnel performing tasks in the preparing and distribution of drugs shall be under the <<-direct->> <<+immediate personal+>> supervision of the nuclear pharmacist who shall be responsible for all nuclear operations of the licensed area and shall be in personal attendance at all times when the nuclear pharmacy is open for business.

(b)-(k) (No change.)

(l) A qualified nuclear pharmacist shall have the authority to delegate to any qualified and properly trained person or persons, acting under his or her <<- direct->> <<+immediate personal+>> supervision, any nuclear pharmacy act which a reasonable and prudent pharmacist would find is within the scope of sound pharmaceutical judgment to delegate. Such delegation may only occur if, in the professional opinion of the qualified nuclear pharmacist, the act may be properly and safely performed by the person to whom the pharmacy act is delegated. The delegated act may only be performed in its customary manner, not in violation of other statutes. The person to whom a nuclear pharmacy act is delegated shall not hold himself or herself out to the public as being authorized to practice pharmacy.



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