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NEW JERSEY REGISTER
VOLUME 35, NUMBER 18
MONDAY, SEPTEMBER 15, 2003
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
ADMINISTRATIVE RULES OF THE DIVISION OF CONSUMER AFFAIRS
NEW JERSEY UNIFORM PRESCRIPTION BLANKS PROGRAM

Proposed New Rules: N.J.A.C. 13:45A-27

Authorized By: Division of Consumer Affairs, Reni Erdos, Director.

Authority: N.J.S.A. 45:14-14.1 et seq.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2003-367.

Submit comments by November 14, 2003 to:

Anthony Miragliotta, Deputy Director

Division of Consumer Affairs

124 Halsey Street

PO Box 45027

Newark, NJ 07101

The agency proposal follows:

Summary

The Director of the Division of Consumer Affairs (the Director) is proposing a new subchapter, as part of the administrative rules of the Division of Consumer Affairs (the Division), N.J.A.C. 13:45A, regarding the use of New Jersey Prescription Blanks (NJPBs) by licensed prescribers, healthcare facilities and pharmacies. The new subchapter also establishes rules for governing the manufacture and distribution of NJPBs by vendors approved by the Division. The Director is proposing the new subchapter pursuant to the requirements of the Uniform Prescription Blanks Act, P.L. 1996, c.154, N.J.S.A. 45:14-14.1 et seq. The Act provides that prescriptions issued by licensed prescribers and healthcare facilities must be written on uniform prescription blanks, which must be subject to stringent security controls. Pursuant to N.J.S.A. 45:14- 14.1 et seq., the Director is charged with the authority to approve all NJPB vendors and to ensure that licensed prescribers, healthcare facilities and pharmacies utilize NJPBs, when appropriate. The Director believes that the rules proposed as part of Subchapter 27 are necessary to ensure that NJPBs are manufactured and distributed in an appropriate manner, and that all licensed prescribers, healthcare facilities and pharmacies are aware of their obligations regarding the use of NJPBs.

Proposed new rule N.J.A.C. 13:45A-27.1 sets forth the purpose and scope of the new subchapter. The new rules will apply to all licensed prescribers authorized to write prescriptions, as well as to all licensed healthcare facilities, and also to all licensed pharmacies authorized to fill prescriptions or medication orders. The new rules will also apply to all vendors authorized to manufacture and distribute NJPBs. In N.J.A.C. 13:45A- 27.2, the Director is proposing definitions for the following terms: "address of record," "Division," "licensed healthcare facility," "licensed prescriber," "New Jersey Prescription Blank," "prescription" and "vendor," in order to make the use of such terms throughout Subchapter 27 clear.

Proposed new rule N.J.A.C. 13:45A-27.3 provides direction to licensed prescribers regarding the mandatory use of NJPBs. Subsection (a) provides that a written prescription issued by a licensed prescriber must appear on either the personal NJPB of the prescriber or on the NJPB of a licensed healthcare facility with which the prescriber is affiliated. If a prescriber intends to utilize the NJPB of a healthcare facility with which he or she is affiliated, the prescriber must ensure that the requirements of subsection (b) are satisfied. Subsection (b) requires a prescriber to ensure that the prescription is written for a patient who is treated at a facility, and that the name and license number of the prescriber appears, in a legible format, on the blank. In addition, the prescription must contain the prescriber's signature and his or her Federal Drug Enforcement Administration (DEA) registration number, if the prescription is for a controlled dangerous substance. In order to ensure the greatest level of security and control over such prescriptions, subsection (c) provides that a separate NJPB must be utilized for each prescription written for a controlled dangerous substance. As an added security measure, subsection (d) requires a licensed prescriber utilizing an NJPB which has been pre-printed with multiple drugs to cross off on the NJPB any drug that he or she is not prescribing at that time.

Subsections (e) and (f) of N.J.A.C. 13:45A-27.3 delineate the circumstances under which prescribers are exempt from the requirement to use an NJPB. Subsection (e) provides that prescriptions transmitted by the prescriber to a pharmacy verbally or by facsimile or modem need not be issued on an NJPB, provided that the prescriber informs the pharmacist of his or her license number and DEA number, if necessary, at the time of the prescription transmission. The pharmacist must also satisfy all requirements set out in the State Board of Pharmacy rules concerning the proper transmission of prescriptions. Paragraph (e)1 provides further direction to prescribers who are licensees of the State Board of Medical Examiners by requiring such prescribers to comply with the Board's rules concerning facsimile and electronic transmission of prescriptions. Subsection (f) exempts a prescriber from the requirement of using an NJPB if he or she is writing a prescription for a narcotic Schedule II controlled substance for a hospice patient, or a prescription for any Schedule II controlled substance for a long-term care facility patient. In order to qualify for this exemption, the prescription must be transmitted or prepared in compliance with all applicable DEA and Board of Pharmacy regulations. In addition, paragraph (f)1 provides that a prescriber licensed by the State Board of Medical Examiners writing such prescriptions must also comply with all Board of Medical Examiner requirements concerning facsimile and electronic transmission of prescriptions. The Director proposes this requirement in order to ensure uniformity with Federal regulations regarding such prescriptions.

Proposed new rule N.J.A.C. 13:45A-27.4 delineates the recordkeeping, reporting and security requirements imposed upon licensed prescribers and healthcare facilities utilizing NJPBs, and pharmacists receiving prescriptions on NJPBs. Subsection (a) requires all licensed prescribers and healthcare facilities to maintain accurate records regarding the ordering, receipt, storage, maintenance and distribution of NJPB pads. Subsection (b) requires all licensed prescribers and healthcare facilities to establish and implement a security protocol for the storage, maintenance and distribution of NJPBs. Subsection (c) similarly directs all licensed pharmacies to establish and implement a security protocol for the storage and maintenance of prescriptions issued on NJPBs. Pharmacies must ensure that such prescriptions are consecutively numbered and filed, consistent with the requirements imposed upon pharmacists pursuant to N.J.S.A. 45:14-15. Subsection (d) requires licensed prescribers and healthcare facilities to notify the Office of Drug Control in the Division whenever any NJPB in their possession has been lost, stolen or altered in any way. The vendor must notify the Division within 72 hours of becoming aware of the incident. The prescriber or the healthcare facility must also file an incident report with the Office of Drug Control within seven days of the initial notification.

Proposed new rule N.J.A.C. 13:45A-27.5 sets forth the requirements for using NJPBs for prescribers who are affiliated with a group practice. Pursuant to subsection (a), a group practice may utilize individual NJPB pads for each licensed prescriber associated with the practice, or it may utilize NJPB pads listing the multiple prescribers in the practice. If the practice chooses to use NJPB pads which list the multiple prescribers, the pads must contain check- off boxes to indicate which prescriber in the practice issued the prescription. Subsection (b) requires a group practice that uses NJPB pads listing multiple prescribers to obtain new NJPB pads within 30 days if the composition of the group practice changes. Any remaining NJPB pads of the former group practice must be destroyed and notice of such destruction must be provided to the Division. Pursuant to subsection (c), however, a group practice whose composition changes need not destroy the old NJPB pads if the composition of the practice is changed through the addition of a licensed prescriber. The newly formed group practice may continue to use the NJPBs of the former group practice, provided that the new member of the group practice utilizes a personal NJPB pad.

N.J.A.C. 13:45A-27.6(a) delineates the information vendors must submit to the Division as part of their application to become approved NJPB vendors. The application must include documentation regarding the applicant's experience in large volume printing and distribution, as well as documentation regarding the applicant's finances. The applicant must also submit organizational staffing plans, and a written description of the work output capacities of the physical plants to be used, the location and size of the plants, a list of the equipment, and security measures that will be implemented. If an applicant intends to subcontract any portion of the NJPB production, the applicant must also submit detailed information regarding the subcontractor. The applicant must also submit the name and address of a designated agent in New Jersey for service of process, notices and/or orders. All information submitted as part of a vendor application may be verified by the Division through an on-site inspection, pursuant to subsection (b) of N.J.A.C. 13:45A-27.6.

N.J.A.C. 13:45A-27.7 sets forth the vendor requirements regarding the manufacture and distribution of NJPBs, as well as vendor obligations regarding withdrawal or termination from the NJPB program. Subsection (a) provides that all NJPBs must be manufactured and distributed by approved vendors. Vendors must comply with the requirements of Subchapter 27 or with the NJPB program contract specifications that are provided by the Division upon acceptance into the program. Subsection (b) requires a vendor withdrawing from the NJPB program to provide 14 days written notice to the Division prior to such withdrawal. In addition, vendors who seek to voluntarily withdraw from the program must also provide 30 days written notice of their intended withdrawal to each licensed prescriber and healthcare facility which orders NJPBs from the vendor within the previous six months.

Subsection (c) of N.J.A.C. 13:45A-27.7 delineates vendor requirements regarding termination from the NJPB program by the Division. The Division may terminate a vendor for any inability to comply with the requirements of Subchapter 27 and with the contract specifications, provided the vendor is given 14 days written notice of the termination. The Division will provide the vendor with an opportunity to respond in writing to any alleged inability to comply with NJPB program requirements. Any vendor that is terminated by the Division must notify each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months of the termination, within seven days of receiving his or her termination notice.

Pursuant to N.J.A.C. 13:45A-27.7(d), any vendor that voluntarily withdraws or is terminated by the Division must destroy all materials related to the production or distribution of NJPBs, or must forward such materials to another approved vendor or to the Division within seven days of providing a notice of withdrawal or receiving a notice of termination. A vendor that voluntarily withdraws from the program but does not forward all materials to the Division must provide the Division with a certification verifying the destruction of the materials. In addition, subsection (e) requires a vendor that is terminated or has withdrawn from the program to submit to the Division a list of all licensed prescribers and healthcare facilities that ordered NJPB pads from the vendor within the previous six months, within seven days of the notice of withdrawal or termination. Pursuant to subsection (f), any person manufacturing or distributing NJPBs without approval of the Division will be subject to prosecution for theft and/or forgery by criminal authorities. Moreover, such persons will also be subject to an action to cease and desist, pursuant to subsection (g).

Proposed new rule N.J.A.C. 13:45A-27.8 sets forth the printing specifications with which vendors must comply in the production of NJPBs. Subsection (a) requires all vendors to manufacture NJPBs utilizing artwork disks obtained from the Division, to ensure uniformity necessary to facilitate identification of unauthorized prescriptions. Subsections (b) through (o) set forth with specificity the requirements for each side of the NJPB, including the information which must be imprinted on the blanks, as well as the optional information which may be imprinted upon the request of the licensed prescribers and healthcare facilities.

N.J.A.C. 13:45A-27.9 delineates the general obligations imposed upon approved vendors. Subsection (a) provides that a vendor may only produce NJPBs for licensed prescribers and healthcare facilities if the vendor has received a written request, which contains the original signature of the licensed prescriber, and the vendor verifies the prescriber's license is active and in good standing. The vendor must also verify the prescriber's address with the Division address database. A vendor may produce NJPBs with multiple names and license numbers for a group practice if the vendor receives a written request with the original signatures of all the licensed prescribers that wish to be listed on the blank, pursuant to subsection (b). In addition, the written request for the group practice must designate one licensed prescriber as the recipient of the NJPB shipment, for security purposes. Prior to printing or delivering any order of NJPBs, however, a vendor must ensure the identity and authority of a prescriber or healthcare facility to use to NJPBs, pursuant to subsection (c).

N.J.A.C. 13:45A-27.9(d) requires vendors to deliver NJPBs within 14 days of receipt of the initial order, or seven days for a reorder. The NJPBs must be delivered in sealed packets to the address of record on file with the Division through a secure delivery service. NJPBs for healthcare facilities may only be shipped to the healthcare facility official who was designated as the responsible party when the order was placed. If any discrepancy exists between the order delivery information and the address which appears on file with the Division, subsection (d) imposes a duty on the vendor to verify the prescriber's address information with the prescriber's licensing board. If the vendor cannot deliver the NJPBs within the time frame specified in the rule, the vendor must immediately notify the prescriber or healthcare facility of the delay. A licensed prescriber may pick up NJPBs at the vendor's place of business, pursuant to subsection (e), provided that the prescriber produces documentation verifying his or her identity and licensure status, and the vendor verifies the prescriber's signature. The vendor, however, remains at all times responsible for the security of NJPBs that are picked up at the vendor's place of business.

N.J.A.C. 13:45A-27.9(f) requires vendors to be capable of producing NJPBs in four distinct formats, so as to provide the greatest amount of flexibility for licensed prescribers. Subsection (g) requires vendors to assign and maintain a unique NJPB batch number for each order of NJPBs. Reorders must contain batch numbers sequentially greater than the batch number assigned to any previous order. Subsection (g) also provides vendors with a detailed description of how the batch numbers are to be formulated. In addition, under subsection (h), vendors are required to maintain an on-site computer database which must include detailed records for each licensed prescriber and healthcare facility receiving NJPB pads from the vendor. The database must be made available to the Division, upon request, on an ASCI format digital file.

Proposed new rule N.J.A.C. 13:45A-27.10 concerns the security requirements with which all NJPB vendors must comply. Subsection (a) requires a vendor to maintain secure production, storage and distribution facilities. Access to NJPBs and the materials used to produce them must be limited to authorized personnel only. All unfinished work related to the production of NJPBs and NJPB production materials must also be stored under controlled conditions. In addition, vendors must ensure that any damaged NJPBs are destroyed. Records indicating the date and method of destruction must be maintained. Any theft, loss, damage, alteration or unauthorized use of NJPBs must be reported to the Division within 72 hours of the vendor's discovery of the incident. Vendors shall also be responsible for producing NJPB exemplar samples for review by the Division upon request.

Subsection (a) of N.J.A.C. 13:45A-27.10 also sets forth a vendor's responsibilities concerning the subcontracting of NJPB work. Vendors are prohibited from subcontracting any portion of the NJPB production, unless the vendor obtains prior approval of the Division. Prior to obtaining Division approval, the vendor and the subcontractor must submit a signed form that states that the parties will abide by the contract specifications and the rules in Subchapter 27. Once a subcontractor has been approved, a vendor is prohibited from adding, transferring or discontinuing services of the subcontractor without further approval by the Division. The vendor must notify the Division in writing of any anticipated changes. Once the services of a subcontractor are discontinued, the vendor must retrieve all NJPB materials from the subcontractor and submit a certification to the Division verifying the retrieval.

N.J.A.C. 13:45A-27.11 requires vendors to maintain the confidentiality of all data and documents received from the Division, or accessed through the Division, relating to the production, storage and distribution of NJPBs. Vendors are required to certify that they will protect the confidentiality of all prescriber and healthcare facility data that they have obtained for the production of NJPBs. Moreover, vendors must return all documents, files and records supplied by the Division upon the vendor's termination or withdrawal from the NJPB program.

Proposed new rule N.J.A.C. 13:45A-27.12 concerns the enforcement of the rules in Subchapter 27. Subsection (a) requires all vendors to permit the Division, or its authorized representative, to inspect any facility used in the production, storage or distribution of NJPBs. The Division may inspect such facilities for a period of five years following a vendor's withdrawal or termination from the NJPB program. Subsection (b) requires all vendors to provide the Division, or its authorized representative, with access to all records relating to NJPB production and distribution. Vendors are obligated to maintain such records for at least five years after a vendor's withdrawal or termination from the program. The Director believes that the aforementioned inspections are a necessary component of the stringent security requirements mandated for NJPBs by the Act. A vendor who fails to comply with any of the requirements in Subchapter 27 or with the contract specifications may be suspended or terminated from the program, or may have conditions placed on his or her continued participation in the program, pursuant to subsection (c).

N.J.A.C. 13:45A-27.13 requires all currently approved vendors to apply for renewal of their approved vendor status within 90 days following the effective date of the section. Thereafter, all approved vendors must apply to the Division for renewal on a triennial basis.

The Director has determined that the comment period for this proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this proposal is excepted from the rulemaking calendar requirement.

Social Impact

The Director believes that the proposed new rules will have a positive impact upon licensed prescribers and healthcare facilities by clarifying their obligations with regard to the use of NJPBs. The proposed new rules provide guidance to prescribers and healthcare facilities regarding when NJPBs must be utilized, what information must be contained on a blank, and what information, if desired by a licensed prescriber, may be imprinted on a blank. The Director also believes that the proposed new rules will have a positive impact upon licensed pharmacies by ensuring that pharmacists are aware of their obligations with regard to the acceptance and maintenance of prescriptions issued on NJPBs. Moreover, the Director believes that the proposed new rules setting forth the various vendor requirements will have a positive impact upon applicants for approved vendor status and upon vendors who are accepted into the program, by providing them with sufficient guidance regarding the obligations that will be imposed upon them as participants in the program.

The Director believes that the proposed new rules will also have a positive impact upon New Jersey consumers, to the extent that the NJPB program and the rules that implement the program will help to deter fraud and abuse that results from altered or forged prescriptions.

Economic Impact

The Director believes that the proposed new rules may have an economic impact upon licensed prescribers and healthcare facilities to the extent that prescribers and healthcare facilities will be required to purchase NJPBs from approved vendors. The cost of purchasing NJPBs, however, will vary depending on the fees charged by approved vendors. In addition, licensed prescribers and healthcare facilities, as well as pharmacists and approved vendors, may experience an economic impact as a result of the proposed new rules to the extent that such individuals or entities may incur administrative costs which may be associated with implementing the recordkeeping, reporting, and security requirements imposed by the new rules. The Director, however, believes that any administrative expenses to be borne by such individuals and entities will be minimal, and that such costs will be outweighed by the benefit to consumers in ensuring that the production, storage and distribution of NJPBs are performed in a safe and secure manner.

Federal Standards Statement

A Federal standards analysis is not required because the proposed new rules are governed by N.J.S.A. 45:14-14.1 et seq., and are not subject to any Federal standards or requirements. Although the proposed new rules in Subchapter 27 are not subject to any mandated Federal requirements or standards, the Director has determined that licensed prescribers should comply with Federal DEA regulations concerning the transmission of prescriptions for narcotic Schedule II controlled substances for hospice patients, and prescriptions for Schedule II controlled substance for long-term care facility residents, in order to ensure uniformity in the transmission of such prescriptions. Therefore, N.J.A.C. 13:45A-27.3(f) provides that licensed prescribers must comply with the relevant provisions of the DEA regulations set forth in 21 C.F.R. 1306.11.

Jobs Impact

The Director believes that the proposed new rules implementing the NJPB program may result in the creation of a number of jobs in the State. The number of jobs that may be created, however, may vary depending on the number of vendors that are granted approved vendor status, and on the number of employees such vendors may choose to hire to fulfill their NJPB program obligations.

Agriculture Industry Impact

The Director does not believe that 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 Director to give a description of the types and an estimate of the number of small businesses to which the proposed new rules will apply. If, for purposes of the Act, licensed prescribers authorized to write prescriptions, licensed healthcare facilities authorized to issue prescription blanks, licensed pharmacies which fill prescriptions or medication orders, and vendors authorized to manufacture and distribute NJPBs are considered "small businesses" within the meaning of the Act, then the following analysis applies.

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

The proposed new rules impose various reporting, recordkeeping and compliance requirements upon licensed prescribers, licensed healthcare facilities, licensed pharmacies and vendors of NJPBs. N.J.A.C. 13:45A-27.3(a) requires a licensed prescriber to issue a written prescription on either his or her personal NJPB, or the NJPB of a licensed healthcare facility. In either case, the NJPB must be obtained from a vendor approved by the Division. N.J.A.C. 13:45A-27.3(b) requires a licensed prescriber who is affiliated with a licensed healthcare facility, and who wishes to use the NJPB of that facility, to ensure that the prescription is written for a patient treated at the facility. Moreover, the prescriber must ensure that his or her name and license number appear in a legible fashion on the blank, that the blank contains his or her signature, and that the blank contains his or her DEA registration number, if the prescription is for a controlled dangerous substance. N.J.A.C. 13:45A- 27.3(c) requires a prescriber to use a separate NJPB for each prescription he or she issues for a controlled dangerous substance. Subsection (d) of N.J.A.C. 13:45A-27.3 requires a licensed prescriber utilizing an NJPB pre- printed with multiple drugs to obliterate, by a cross-off procedure, any drug that is not being prescribed. N.J.A.C. 13:45A-27.3(e) exempts a licensed prescriber from the requirement of using an NJPB if he or she transmits a prescription to a pharmacy verbally, by facsimile or by electronic means, provided the prescriber has given the pharmacist his or her license number, and DEA number, if appropriate, at the time of prescription transmission. N.J.A.C. 13:45A-27.3(e)1 requires all prescribers licensed by the State Board of Medical Examiners to also comply with the Board's rules on facsimile and electronic transmissions of prescriptions. N.J.A.C. 13:45A-27.3(f) exempts a licensed prescriber from the requirement of using an NJPB when writing a prescription for a narcotic Schedule II controlled substance for a hospice patient, or any Schedule II controlled substance for a long-term care facility resident, provided the prescriber complies with DEA and State Board of Pharmacy requirements for such prescriptions. In addition, paragraph (f)1 requires prescribers licensed by the State Board of Medical Examiners writing such prescriptions to also comply with all Board of Medical Examiner requirements concerning facsimile and electronic transmission of prescriptions.

N.J.A.C. 13:45A-27.4(a) requires prescribers and healthcare facilities to maintain accurate records regarding the ordering, receipt, storage, maintenance and distribution of NJPBs. The records must contain the name and address of the vendor supplying the NJPB pads, the dates of the order and the receipt, the batch numbers of the pads, the date, quantity, and to whom the NJPB pads were distributed, the designation of the person responsible for handling the NJPBs, and the designation of a secure storage area for the pads. Subsection (b) of N.J.A.C. 13:45A-27.4 requires all licensed prescribers and healthcare facilities to establish and implement a security protocol for the storage, maintenance and distribution of the pads. N.J.A.C. 13:45A-27.4(c) requires all pharmacies to implement a security protocol for the storage and maintenance of all prescriptions issued on NJPBs. In addition, subsection (c) requires all pharmacies to consecutively number and file all prescriptions received on NJPBs, pursuant to the requirements of the Pharmacy Act, at N.J.S.A. 45:14- 15. N.J.A.C. 13:45A-27.4(d) requires licensed prescribers and healthcare facilities to report to the Office of Drug Control when any NJPB in their possession has been lost, stolen or altered. The Office of Drug Control must be notified within 72 hours of discovery of the problem. The licensed prescriber or healthcare facility must also file a written incident report with the Office of Drug Control, within seven days of the initial reporting of the incident.

N.J.A.C. 13:45A-27.5(a) allows prescribers affiliated with a group practice to use NJPBs that contain multiple prescriber names, provided that the NJPB pads contain check-off boxes to indicate which prescriber issued the prescription. Subsection (b) requires the group practice using an NJPB listing multiple prescribers to obtain new NJPBs within 30 days, if the composition of the group practice changes as a result of the departure of a group member. The newly formed group practice must destroy any old NJPBs and must file a form with the Office of Drug Control verifying this destruction.

N.J.A.C. 13:45A-27.6 requires an applicant for approved vendor status to submit an application to the Division, complete with all documentation specified in the rule. N.J.A.C. 13:45A-27.7(b) requires a vendor who intends to withdraw from the NJPB program to provide 14 days written notice of such action to the Division. In addition, a withdrawing vendor must provide written notice of the intended withdrawal, 30 days prior to taking such action, to each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months. Subsection (c) requires a vendor that is terminated by the Division, after appropriate notice and an opportunity to be heard, to notify in writing, within seven days of the termination, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months. Subsection (d) requires a vendor that has withdrawn or has been terminated from the program to either destroy all materials related to the production of NJPBs, or to forward such materials to another approved vendor within seven days of the withdrawal or termination. In addition, the vendor that does not forward the NJPB materials to another vendor must file with the Division a certification verifying that the materials were indeed destroyed or forwarded to an approved vendor. Subsection (e) requires the vendor that has withdrawn or has been terminated to provide the Division with a list of all licensed prescribers and healthcare facilities that ordered NJPB pads from the vendor within the past six months. The list must be submitted within seven days of the notice of withdrawal or termination.

N.J.A.C. 13:45A-27.8 provides that vendors may only produce NJPB pads pursuant to the detailed specifications delineated in subsections (a) through (o). N.J.A.C. 13:45A-27.9(a) requires that prior to accepting an order for the production of NJPBs, a vendor must obtain a signed request from the licensed prescriber, and the vendor must verify the prescriber's license and address with the Division. Pursuant to subsection (b), if the order is for a group practice, the vendor must obtain a written request signed by all the licensed prescribers that are to be included on the blank, and must also ensure that the request designates one licensed prescriber as the official recipient of the blanks. Vendors must also ensure the identity and authority of the prescriber or healthcare facility to utilize NJPBs prior to printing or delivering any of the blanks, pursuant to subsection (c). Subsection (d) requires a vendor to deliver NJPBs within 14 days of an initial order, and within seven days for a reorder. The deliveries must be made to the address of record on file with the Division. When delivering healthcare facility NJPBs, the vendor may only deliver the blanks to the official designated as the responsible party on the initial order form. The vendor must verify any discrepancy between the order delivery information and the prescriber's address with the appropriate licensing board within the Division. If a vendor is unable to deliver the blanks within the time specified by the rule, he or she must immediately notify the licensed prescriber or healthcare facility of the delay.

N.J.A.C. 13:45A-27.9(e) requires a vendor to verify the licensed prescriber's signature and demand documentation verifying the prescriber's identity and license status, when a prescriber chooses to pick up the blanks at the vendor's place of business. Subsection (f) requires vendors to be capable of producing NJPBs in four distinct formats. In addition, subsection (g) requires vendors to assign and maintain unique NJPB batch numbers for each order they receive from a licensed prescriber or healthcare facility. Vendors must also maintain an on-site computerized database containing the detailed information specified in the rule for each licensed prescriber and healthcare facility that orders NJPBs from the vendor. Vendors must make this database available to the Division, upon request, on an ASCI format digital file.

N.J.A.C. 13:45A-27.10(a) requires a vendor to ensure secure production, storage and distribution facilities. Access to NJPBs and the materials used in their production must be limited to authorized personnel only. A vendor may not subcontract any portion of NJPB production unless the vendor receives prior approval from the Division. Prior to being granted approval, the vendor and the subcontractor must sign a Division-supplied form which states that the parties agree to comply with all the requirements of Subchapter 27, as well as with the contract specifications. Once a subcontractor has been approved, a vendor may not add, transfer or discontinue services of the subcontract or without prior approval by the Division. Vendors must notify the Division in writing of the anticipated change. Once the change has been approved, within 14 days of the discontinuance of the subcontractor's services, the vendor must retrieve all NJPB materials from the subcontractor, and must submit a certification to the Division, verifying this retrieval. Vendors are also required to maintain detailed records regarding the destruction of all damaged NJPBs. Any theft, loss, damage, alteration or unauthorized use of NJPBs must be reported by the vendor to the Division, within 72 hours of discovery. Vendors are also required to produce NJPB exemplar samples for review by the Division upon request, pursuant to N.J.A.C. 13:45A-27.10(b).

N.J.A.C. 13:45A-27.11(a) requires vendors to maintain the confidentiality of all data, documents and records they have received from the Division, or have access to through the Division, relating to the production and distribution of NJPBs. Subsection (b) requires that prior to being accepted into the NJPB program, vendors must certify that they will protect the confidentiality of all data related to licensed prescribers for whom, and healthcare facilities for which, they print NJPBs. Vendors must return all documents and files supplied by the Division upon the vendor's withdrawal or termination from the program, pursuant to subsection (c).

N.J.A.C. 13:45A-27.12(a) and (b) require vendors to permit the Division to inspect any facility used by the vendor in the production, storage or distribution of NJPBs, and any records relating to the printing or distribution of NJPBs. Such inspections may be carried out for a period of five years after the vendor has withdrawn or has been terminated from the program.

N.J.A.C. 13:45A-27.13 requires all vendors to submit an application for renewal of their approved vendor status within 90 days following the effective date of the rule. Thereafter, vendors will have to apply for renewal of their approved status on a triennial basis.

No additional professional services will be needed to comply with the proposed new rules. The costs of compliance with the proposed new rules are discussed in the Economic Impact Statement above. The Director believes that the proposed new rules should be uniformly applied to all licensed prescribers, healthcare facilities and pharmacies, and all approved NJPB vendors, in order to ensure the public's health, safety and welfare in the use of uniform prescription blanks. Therefore, no differing compliance requirements for any businesses are provided based upon size.

Smart Growth Impact

The Director does not believe that 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.

Full text of the proposal follows:

SUBCHAPTER 27. <<-(RESERVED)->> <<+NEW JERSEY UNIFORM PRESCRIPTION BLANKS PROGRAM+>>

<< NJ ADC 13:45A-27.1 >>

<<+13:45A-27.1 Purpose and scope+>>

<<+(a) The rules in this subchapter implement the provisions of P.L. 1996, c.154, the Uniform Prescription Blanks Act, supplementing N.J.S.A. 45:14-14.1 et seq., an act regulating the practice of pharmacy in the State of New Jersey.+>>

<<+(b) The rules of this subchapter shall apply to the following:+>>

<<+1. All licensed healthcare practitioners authorized to write prescriptions for controlled dangerous substances, legend drugs or other items;+>>

<<+2. All healthcare facilities licensed pursuant to N.J.S.A. 26:2H-1 et seq., that are authorized to issue prescription blanks;+>>

<<+3. All licensed pharmacies which fill prescriptions or medication orders pursuant to N.J.A.C. 13:39; and+>>

<<+4. All vendors authorized to manufacture and distribute New Jersey Prescription Blanks pursuant to N.J.A.C. 13:45A-27.7.+>>

<< NJ ADC 13:45A-27.2 >>

<<+13:45A-27.2 Definitions+>>

<<+As used in this subchapter, the following words and terms have the following meanings unless the context clearly indicates otherwise:+>>

<<+"Address of record" means an address designated by a licensed prescriber which is part of the public record and which may be disclosed upon request. "Address of record" may be a licensed prescriber's home, business or mailing address, but shall not be a post office box.+>>

<<+"Division" means the New Jersey Division of Consumer Affairs.+>>

<<+"Licensed healthcare facility" means any facility licensed by the New Jersey Department of Health and Senior Services including hospitals, long-term care facilities, ambulatory care facilities, residential drug treatment facilities, and alcohol treatment facilities which have been, or are eligible to be assigned, a Division of Consumer Affairs uniform prescription blank unique provider number.+>>

<<+"Licensed prescriber" means any healthcare practitioner authorized by law to write prescriptions.+>>

<<+"New Jersey Prescription Blank (NJPB)" means a uniform, non-reproducible, non-erasable safety paper form developed by the Division pursuant to N.J.S.A. 45:14-14.6 which satisfies the specifications of N.J.A.C. 13:45A-27.8.+>>

<<+"Prescription" means an order for drugs or controlled dangerous substances, or any combination or mixture thereof, or other prescribed items, written or signed by a licensed prescriber for the diagnosis, treatment, prevention, or amelioration of disease, injury, pain, or physical condition in man or animals. For the purposes of this definition, the term "other prescribed items" includes eyewear, medical devices, orthotics and prosthetics, and syringes.+>>

<<+"Vendor" means any person authorized to manufacture and distribute NJPBs pursuant to the rules in this subchapter. For purposes of this definition, "person" means an individual, partnership, limited liability partnership, limited liability company, corporation or any other business entity.+>>

<< NJ ADC 13:45A-27.3 >>

<<+13:45A-27.3 NJPB required for prescriptions+>>

<<+(a) A written prescription issued by a licensed prescriber shall appear on either the personal NJPB of the licensed prescriber or the NJPB of a licensed healthcare facility obtained from a vendor approved by the Division pursuant to this subchapter.+>>

<<+(b) A licensed prescriber affiliated with a healthcare facility licensed pursuant to P.L. 1971, c.136 (N.J.S.A. 26:2H-1 et seq.), may use the NJPB of the licensed facility provided that:+>>

<<+1. The prescription is written for a patient treated at that healthcare facility;+>>

<<+2. The name and license number of the licensed prescriber is legibly written, typed, stamped, or otherwise affixed to the NJPB;+>>

<<+3. The prescription contains the signature of the licensed prescriber; and+>>

<<+4. If the prescription is for a controlled dangerous substance, the licensed prescriber's Federal Drug Enforcement Administration (DEA) registration number is legibly written, typed, stamped, or otherwise affixed to the NJPB.+>>

<<+(c) A separate NJPB shall be utilized for each prescription written for a controlled dangerous substance. No other medication shall appear on the prescription.+>>

<<+(d) If a licensed prescriber utilizes an NJPB pre-printed with multiple drugs, the prescriber shall obliterate, by a cross-off procedure, any drug that is not being prescribed.+>>

<<+(e) A prescription transmitted verbally or transmitted electronically by telephone, facsimile, modem, or other means to a pharmacy by a licensed prescriber shall be exempt from the requirement of utilizing an NJPB if the licensed prescriber provides the pharmacist with his or her license number and DEA number, as appropriate to the particular prescription, at the time of transmission of the prescription, and the pharmacist satisfies the requirements of N.J.A.C. 13:39-5.8, 5.8A or 5.8B.+>>

<<+1. A prescriber licensed by the State Board of Medical Examiners who transmits a facsimile or electronic prescription shall also comply with all requirements set forth in N.J.A.C. 13:35-7.4 and 7.4A.+>>

<<+(f) A licensed prescriber writing a prescription for a narcotic Schedule II controlled substance for a hospice patient, or a prescription for any Schedule II controlled substance for a long-term care facility resident, shall be exempt from the requirement of utilizing an NJPB if the prescription is transmitted or prepared in compliance with DEA regulations as set forth in 21 C.F.R. 1306.11(d), (e), (f) and (g), consistent with the requirements set forth at N.J.A.C. 13:39-5.8, 5.8A or 5.8B.+>>

<<+1. A prescriber licensed by the State Board of Medical Examiners writing a prescription for a narcotic Schedule II controlled substance for a hospice patient, or a prescription for any Schedule II controlled substance for a long-term care facility resident, shall also comply with all requirements set forth in N.J.A.C. 13:35-7.4 and 7.4A.+>>

<< NJ ADC 13:45A-27.4 >>

<<+13:45A-27.4 Recordkeeping, reporting, and security requirements for licensed prescribers, healthcare facilities, and pharmacists+>>

<<+(a) Licensed prescribers and healthcare facilities shall maintain records indicating the ordering, receipt, storage, maintenance, and distribution of NJPB pads. Such records shall include, at a minimum, the following:+>>

<<+1. The name and address of the vendor supplying the NJPB pads;+>>

<<+2. The date of order and receipt;+>>

<<+3. The batch numbers of the NJPB pads;+>>

<<+4. The date, the quantity, and to whom the NJPB pads were distributed at a group practice office or healthcare facility, if applicable;+>>

<<+5. The designation of a person responsible for the ordering, receipt, storage, maintenance, and distribution of the NJPB pads. NJPB pads shall not be ordered, received, stored, maintained or distributed by anyone other than the licensed prescriber or healthcare facility, or persons employed by the licensed prescriber or healthcare facility; and+>>

<<+6. The designation of a secure storage area for the NJPB pads.+>>

<<+(b) All licensed prescribers and healthcare facilities shall establish and implement a security protocol for the storage, maintenance, and distribution of NJPBs.+>>

<<+(c) All licensed pharmacies shall establish and implement a security protocol for the storage and maintenance of prescriptions issued on NJPBs and shall consecutively number and file such prescriptions pursuant to N.J.S.A. 45:14-15.+>>

<<+(d) Licensed prescribers and healthcare facilities shall notify the Office of Drug Control in the Division as soon as possible but no later than 72 hours of becoming aware that any NJPB in their possession has been lost, stolen, or altered in any way. An incident report shall be filed in writing with the Office of Drug Control within seven days after such notification on a form provided by the Office of Drug Control.+>>

<< NJ ADC 13:45A-27.5 >>

<<+13:45A-27.5 Group practice+>>

<<+(a) A group practice may utilize individual NJPB pads for each licensed prescriber affiliated with the practice, or may utilize NJPB pads listing multiple prescribers affiliated with the practice, provided that multiple prescriber NJPB pads contain check-off boxes to indicate which prescriber issued the prescription.+>>

<<+(b) A group practice using an NJPB listing multiple prescribers shall obtain new NJPBs within 30 days if the composition of the practice changes, except as provided in (c) below. Any remaining NJPBs of the former group practice shall be destroyed and the newly formed practice shall file an NJPB destruction form with the Office of Drug Control.+>>

<<+(c) If the composition of the group practice is changed through the addition of a licensed prescriber, the newly formed group practice may continue to use the NJPBs of the former group practice, provided that the licensed prescriber who becomes newly affiliated with the group obtains individual NJPBs with the information required pursuant to N.J.A.C. 13:45A-27.8.+>>

<< NJ ADC 13:45A-27.6 >>

<<+13:45A-27.6 Vendor application+>>

<<+(a) An applicant to become an approved NJPB vendor shall submit an application on a form supplied by the Division, which shall include the following:+>>

<<+1. Documentary evidence of experience in large volume printing and distribution activity;+>>

<<+2. Organizational staffing plans;+>>

<<+3. Documentation that the applicant is financially viable;+>>

<<+4. A written description of the work output capacities of the physical plant(s), the size and location of the plant(s), the equipment list, and security measures;+>>

<<+5. The subcontractor company name, address, telephone number, ownership, and equipment list and the details regarding the subcontractor's production of any portion of the NJPB, including the security that will be provided, if an applicant intends to subcontract any portion of the NJPBs; and+>>

<<+6. The name and address of a designated agent in New Jersey for service of process, notices and/or orders.+>>

<<+(b) All information submitted by the applicant may be verified by on-site inspection by the Division or its authorized representative.+>>

<< NJ ADC 13:45A-27.7 >>

<<+13:45A-27.7 Manufacture and distribution by approved vendors; withdrawal or termination from NJPB program+>>

<<+(a) NJPBs shall be manufactured and distributed by vendors approved by the Division pursuant to N.J.A.C. 13:45A-27.6. A vendor who has failed to comply with the requirements of this subchapter or the NJPB program contract specifications shall not be approved for the manufacture or distribution of NJPBs.+>>

<<+(b) A vendor may withdraw from the NJPB program upon 14 days written notice to the Division. A vendor that voluntarily withdraws from the program shall notify, in writing, at least 30 days prior to withdrawal, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months.+>>

<<+(c) An approved vendor may be terminated by the Division upon 14 days written notice for any inability to comply with the requirements as set forth in this subchapter or the NJPB program specifications. The Division shall provide the vendor with the opportunity to respond in writing to any allegation of an inability to comply with NJPB program requirements. A vendor that is terminated by the Division shall notify, in writing, within seven days of such termination, each licensed prescriber and healthcare facility that ordered NJPBs from the vendor within the previous six months.+>>

<<+(d) A vendor that voluntarily withdraws from the NJPB program or is terminated by the Division shall either destroy or forward all materials, computer disks, plates, mechanicals, negatives, and other equipment related to the production or distribution of NJPBs to another approved vendor or the Division within seven days of notice of withdrawal or termination. If the vendor that withdraws or is terminated from the NJPB program does not forward all materials related to the production and distribution of NJPBs to the Division, the vendor shall provide to the Division a certification verifying the destruction or disposition of such materials.+>>

<<+(e) A vendor that voluntarily withdraws from the program or is terminated by the Division shall submit to the Division a list of all licensed prescribers and healthcare facilities that ordered NJPB pads from the vendor within the previous six months. The list shall be submitted within seven days of notice of withdrawal or termination and shall include all the information that is required to be maintained in the vendor database pursuant to N.J.A.C. 13:45A-27.8.+>>

<<+(f) Any person manufacturing or distributing NJPBs without approval by the Division shall be subject to prosecution for theft and/or forgery by appropriate criminal authorities pursuant to N.J.S.A. 2C:20-2 and 2C:21-1 et seq.+>>

<<+(g) Any person manufacturing or distributing NJPBs without approval by the Division shall be subject to an action to cease and desist, and any other action authorized by law.+>>

<< NJ ADC 13:45A-27.8 >>

<<+13:45A-27.8 NJPB printing specifications+>>

<<+(a) Vendors shall manufacture all NJPBs utilizing artwork disks obtained from the Division.+>>

<<+(b) Each NJPB shall be:+>>

<<+1. Four inches by five and one-half inches in size; and+>>

<<+2. Printed on either 50-pound white offset smooth finish paper with a brightness of at least 85 or 20-pound paper with a brightness of at least 85.+>>

<<+(c) The front side of each NJPB shall be printed with the body copy (line work) in PMS 299 blue overprinted on a background of five percent of the blue (with an allowable variance no darker than PMS 300 blue).+>>

<<+(d) The background of the front side of each NJPB shall be a pantograph of the New Jersey State Seal reversed out of the blue screen and shall bleed on all four sides. A one and one-half inch State Seal shall be positioned centrally within the pantograph of State seals.+>>

<<+(e) The upper portion of the front side of each NJPB shall include the batch number, and the prescriber or healthcare facility name, the prescriber or healthcare facility address, which may be an address other than the address of record, but which shall not be a post office box, the license, certification or authorization number of the licensed prescriber, or the provider number of the healthcare facility, which shall all be printed in black ink.+>>

<<+(f) The prescribing area of the front side of each NJPB shall contain an "Rx" graphic circumscribed within a rectangle, printed in blue ink on the left hand side.+>>

<<+(g) The reverse side of each NJPB shall contain a pantograph of the New Jersey State Seal printed in PMS 332 green screened down to five percent (with an allowable variance up to PMS 333 green) which shall bleed on all four sides. A one and one-half inch State Seal shall be positioned centrally as on the front, except that it shall not be in reverse.+>>

<<+(h) Except as provided in (i) below, the front side of an NJPB may be imprinted with the name and license number of more than one licensed prescriber in the same licensing category provided that:+>>

<<+1. The name and license number of each licensed prescriber is printed in a seven point font or greater; and+>>

<<+2. The NJPB utilizes a printed method, such as a check-off box, to indicate which prescriber issued the prescription.+>>

<<+(i) NJPBs for physician assistants, certified nurse midwives and advanced practice nurses shall be imprinted only with the name and license number of the prescriber and his or her collaborating/ive physician.+>>

<<+(j) NJPBs for healthcare facilities shall be imprinted with sufficient space to allow a prescriber affiliated with the healthcare facility to write out his or her name, title, license number and collaborating/ive physician, if applicable, in the titlehead portion of the NJPB.+>>

<<+(k) At the request of a licensed prescriber or licensed healthcare facility, NJPBs may be pre-printed with the following:+>>

<<+1. Frequently used non-controlled prescription drugs. The prescription shall be printed in a seven point font or greater. The prescription may be pre-printed with several non-controlled drugs, delineated by check-off boxes, provided that separate directions for use, substitution, and refill instructions shall be clearly delineated for each drug prescribed;+>>

<<+2. A drug identifier bar code placed in the medication prescribing area, provided that the bar code shall not conceal any information contained in the medication prescribing area;+>>

<<+3. On the reverse side of the NJPB, any alternative practice address requested by the prescriber, with a check-off box to indicate the practice site at which the medication was prescribed. Vendors may utilize up to one half of the back of the NJPB to pre-print addresses, provided that at least three quarters of one inch remains at the top of the reverse side of the NJPB to permit the fastening of NJPB into pharmacy prescription binders;+>>

<<+4. The statement "NOT VALID FOR CONTROLLED SUBSTANCES" on the face of the NJPB in black ink;+>>

<<+5. DEA numbers; and+>>

<<+6. Consecutive numbers (serialized).+>>

<<+(l) In addition to the pre-printed requests set forth in (k) above, NJPBs may be printed to include the following special order requests in black ink only:+>>

<<+1. In the titlehead portion of the NJPB, the individual prescriber CDS or DEA numbers, Medicare Provider Numbers; Specialty Practice License numbers; fax numbers and/or more than one telephone number;+>>

<<+2. Special print, logotype lettering to designate the name of the healthcare facility or group practice on the first line of the NJPB titlehead; and+>>

<<+3. On the reverse side of the NJPB, a financial interest disclosure statement for licensees of the State Board of Medical Examiners, pursuant to N.J.A.C. 13:35-6.17.+>>

<<+(m) Any request for a pre-printed or special order NJPB not included in (k) or (l) above shall be approved by the Division before the NJPBs are produced.+>>

<<+(n) Vendors shall not produce NJPBs that contain logos, symbols, icons or graphics, or that contain ink that is of a different color than the colors specified in (a) above, or that contain pre-printed physician initials in the "Do Not Substitute" or "Substitution Permissible" portion of any NJPB.+>>

<<+(o) NJPBs shall be produced in prescription pads of 50 or 100 NJPBs per pad with chipboard backers.+>>

<< NJ ADC 13:45A-27.9 >>

<<+13:45A-27.9 Vendor requirements+>>

<<+(a) A vendor may produce NJPB pads for a licensed prescriber or licensed healthcare facility consistent with the requirements of N.J.A.C. 13:45A- 27.8, provided that:+>>

<<+1. The request for NJPBs is in writing and contains the original signature of the licensed prescriber; and+>>

<<+2. The vendor verifies that the prescriber's license is active and in good standing and the address of record in the Division's database or in notices sent to the vendors. The Division database shall be updated and provided to all authorized vendors on a quarterly basis.+>>

<<+(b) A vendor may produce NJPB pads for a group practice with the name and license number of more than one licensed prescriber, consistent with the requirements of N.J.A.C. 13:45A-27.8, provided that:+>>

<<+1. The request for NJPBs is in writing and contains the original signatures of all the licensed prescribers listed on the NJPB; and+>>

<<+2. The written request designates one licensed prescriber for receipt of the NJPB shipment.+>>

<<+(c) Vendors shall ensure the identity and authority of the prescriber or healthcare facility to utilize NJPBs prior to printing or delivering any order for NJPBs.+>>

<<+(d) Vendors shall deliver NJPBs within 14 days of receipt of an initial order, or seven days for a reorder, in sealed packets in minimum quantities of 500. Such deliveries shall be made to the address of record on file with a Division via a secure delivery service which is capable of tracking the shipment. Delivery of healthcare facility NJPBs shall be made only to the healthcare facility official designated as the responsible party when the order was placed, and only to the healthcare facility address. If a discrepancy exists between the order delivery information and the address which appears on file with the Division, the vendor shall verify the prescriber address information with the prescriber's licensing board. If a vendor is unable to deliver the NJPBs within the time specified above, the vendor shall immediately notify the licensed prescriber or the healthcare facility of the delay in the processing of the order.+>>

<<+(e) A licensed prescriber may pick up NJPBs at a vendor's place of business provided that:+>>

<<+1. The licensed prescriber provides documentation verifying his or her identity and licensure;+>>

<<+2. The vendor verifies the licensed prescriber's signature; and+>>

<<+3. The vendor remains responsible for the security of the NJPBs delivered in this manner.+>>

<<+(f) Vendors shall be capable of producing NJPBs in the following forms:+>>

<<+1. A single non-erasable NJPB form; and+>>

<<+2. A two-part carbonless NJPB form;+>>

<<+i. The top copy shall comply with the requirements of N.J.A.C. 13:45A-27.8;+>>

<<+ii. The second copy shall be yellow and may contain the prescriber information required pursuant to N.J.A.C. 13:45A-27.8;+>>

<<+3. Micro-perforated four inches by five and one half inches computer ready NJPBs imprinted with all the prescriber information required pursuant to N.J.A.C. 13:45A-27.8, which are capable of being computer printed from a laser printer cassette tray; and+>>

<<+4. Micro-perforated four inches by five and one half inches continuous pin-fed NJPBs imprinted with all the prescriber information required pursuant to N.J.A.C. 13:45A-27.8, which are capable of being computer printed through the use of dot-matrix or ink-jet printers.+>>

<<+(g) Vendors shall assign and maintain a unique NJPB batch number for each order of NJPBs from a licensed prescriber or licensed healthcare facility. Re- orders of NJPBs shall contain batch numbers sequentially greater than the batch number assigned to any previous order. Batch numbers shall consist of:+>>

<<+1. An alphabetic prefix assigned by the Division which represents the identity of the vendor;+>>

<<+2. The date of printing in the following order: year, month, and day; and+>>

<<+3. A number sequentially assigned by the vendor.+>>

<<+(h) Vendors shall maintain an on-site computerized database which shall:+>>

<<+1. Include the following data fields for each licensed prescriber and healthcare facility:+>>

<<+i. Name;+>>

<<+ii. Name of the organization;+>>

<<+iii. Name of the person designated to receive shipment;+>>

<<+iv. Address;+>>

<<+v. License number;+>>

<<+vi. Batch number;+>>

<<+vii. Quantity ordered;+>>

<<+viii. Date ordered; and+>>

<<+ix. Date shipped and delivery service utilized; and+>>

<<+2. Be made available upon request by the Division on an ASCI format digital file.+>>

<< NJ ADC 13:45A-27.10 >>

<<+13:45A-27.10 Vendor security requirements+>>

<<+(a) Vendors shall maintain secure production, storage, and distribution facilities. Security provisions shall include, at a minimum, the following:+>>

<<+1. All NJPBs are to be produced under tight security, in secure plants with access limited to authorized personnel. Any unfinished work related to the production of the NJPBs shall be stored under secure, controlled conditions.+>>

<<+2. NJPBs and materials used to produce NJPBs, including all disks, plates, negatives, and inventory goods, shall be stored at the vendor production site in a secure manner which protects against theft or loss;+>>

<<+3. Vendors shall not subcontract or assign any portion of the production of NJPBs without the prior approval of the Division;+>>

<<+4. If an applicant intends to subcontract any portion of NJPBs, the applicant shall provide the subcontractor company name, address, telephone number, ownership, and equipment list as part of the vendor's NJPB program application to the Division;+>>

<<+5. The subcontractor shall provide to the Division details regarding its production of any portion of the NJPBs and the security which will be provided. The vendor and the subcontractor shall sign and submit a completed form supplied by the Division which states that the parties understand and agree to the contract specifications and the regulations of this subchapter.+>>

<<+6. Vendors shall not add, transfer or discontinue the services of a subcontractor without prior approval by the Division. Vendors shall notify the Division of such changes in writing by mail, return receipt requested. Within 14 days of the discontinuance of the services of a subcontractor, an approved vendor shall retrieve all NJPB materials from the subcontractor and shall submit a certification to the Division verifying the retrieval;+>>

<<+7. Vendors shall assure that damaged NJPBs are destroyed and shall maintain records indicating the date and method of destruction; and+>>

<<+8. Vendors shall report to the Division any theft, loss, damage, alteration, or unauthorized use of NJPBs as soon as possible but no later than 72 hours of discovery.+>>

<<+(b) Vendors shall produce NJPB exemplar samples for review by the Division upon request.+>>

<< NJ ADC 13:45A-27.11 >>

<<+13:45A-27.11 Confidentiality+>>

<<+(a) Vendors shall maintain the confidentiality of all data, documents, files and computer records received from, or access through, the Division, relating to the production, storage and distribution of NJPBs.+>>

<<+(b) Vendors shall certify, prior to being granted approved vendor status, that they will protect the confidentiality of all data related to prescribers and healthcare facilities for whom they print NJPBs, and all data collected in order to accomplish any NJPB related function.+>>

<<+(c) Vendors shall return all documents, files and records supplied by the Division, and all copies thereof, upon the vendor's termination or voluntary withdrawal from the NJPB program.+>>

<< NJ ADC 13:45A-27.12 >>

<<+13:45A-27.12 Enforcement+>>

<<+(a) Vendors shall permit the Division or its authorized representative to inspect any facility utilized in the production, storage, or distribution of NJPBs. Inspections may be conducted for a period of five years following the withdrawal or termination of a vendor from the NJPB program.+>>

<<+(b) Vendors shall provide the Division or its authorized representative access to all records relating to the printing and distribution of NJPBs, including financial records. Such records shall be maintained for five years following a vendor's termination or voluntary withdrawal from the NJPB program.+>>

<<+(c) Failure to comply with any of the requirements of this subchapter or the contract specifications may result in suspension, the placement of conditions on, or the permanent termination of the vendor from the NJPB program consistent with the requirements of N.J.A.C. 13:45A-27.7.+>>

<< NJ ADC 13:45A-27.13 >>

<<+13:45A-27.13 Renewal of approved vendor status+>>

<<+Vendors shall submit an application for renewal of approved vendor status, on a form supplied by the Division, within 90 days following the effective date of this section and, thereafter, vendors shall apply for renewal of approved vendor status on a triennial basis.+>>

 

  

  

  

  

  

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