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NEW JERSEY REGISTER
VOLUME 34, NUMBER 19
MONDAY, OCTOBER 7, 2002
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY
PURPOSE AND SCOPE; DEFINITIONS, REGISTERED PHARMACIST-IN-CHARGE; MEAL BREAKS;
RECORD OF PHARMACIST FILLING PRESCRIPTION; PRESCRIPTIONS PREPARED OR COMPOUNDED
BY PHARMACY EXTERNS, INTERNS OR PHARMACY TECHNICIANS; PHARMACY TECHNICIANS;
PHARMACEUTICALS; COMPOUNDING; DRUG-DISPENSING DEVICES; RECORDS AND REPORTS;
PHARMACY STAFF; PERSONNEL TRAINING REQUIREMENTS; PHARMACIST IN CHARGE AND
PERMITHOLDERS' RESPONSIBILITIES; TRAINING REQUIREMENTS; PHARMACY TECHNICIANS,
REQUIRED SUPERVISION; BATCH PREPARATION; INFORMATION REQUIRED TO APPEAR ON
PRESCRIPTION LABEL; POLICY AND PROCEDURE MANUAL; DEFINITIONS; GENERAL
REQUIREMENTS FOR PHARMACIES PROVIDING RADIOPHARMACEUTICAL SERVICE


Pre-Proposed Amendments: N.J.A.C. 13:39-1.1, 1.2, 3.18, 5.6, 6.2, 6.4, 6.7, 9.5, 9.8, 9.14, 9.16, 9.22, 10.5, 11.6, 11.7, 11.8, 11.9, 11.11, 11.14, 12.1 and 12.2

Pre-Proposed New Rule: N.J.A.C. 13:39-3.19

Authorized By: State Board of Pharmacy, Debora Whipple, Executive Director.

Authority: N.J.S.A. 45:14-1 et seq.
Pre-Proposal Number: PPR 2002-2.

Submit written comments by November 6, 2002 to:

Debora Whipple, Executive Director

State Board of Pharmacy

124 Halsey Street

PO Box 45013

Newark, New Jersey 07101

Take notice that the State Board of Pharmacy (the Board) is considering proposing amendments to the existing Board rules concerning the duties and responsibilities of pharmacy technicians. Currently, the Board rules refer to those persons who perform pharmaceutical functions under the direct supervision of a pharmacist as "supportive personnel." Over time, however, the term "supportive personnel" has taken on a more expansive meaning among members of the regulated community, and currently 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 Board is considering replacing all references to the term "supportive personnel" with the term "pharmacy technician," as "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.

In addition to the proposed change in terminology, the Board is also considering proposing amendments to clarify and expand the list of duties that may appropriately be performed by pharmacy technicians. 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 Board believes that a more detailed list of activities that pharmacy technicians may perform, in addition to a clear delineation of impermissible activities, should be provided in order to give licensees more guidance as to how such individuals may be utilized in the practice of pharmacy.

The Board is also considering proposing amendments to the pharmacist to technician ratio rule, 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 Board believes, however, that if a pharmacy employs pharmacy technicians who have passed the National Pharmacy Technician Certification Examination, or if a pharmacy conducts its own pharmacy technician training program which satisfies the requirements of the rule, and if the pharmacy meets certain other requirements, such as the maintenance of a policies and procedures manual which delineates the specific duties of the technician, 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 contemplated amendment will help ensure that if a pharmacy chooses to employ more technicians than currently allowed by the one to two ratio, that those technicians will be appropriately trained and have sufficient instruction in the tasks and functions they are permitted to perform.

The Board is also contemplating proposing a new rule that would allow pharmacists to take meal breaks while working in a pharmacy or pharmacy department, provided certain conditions are satisfied, in order to address concerns raised by many members of the regulated community concerning this issue. The Board will also propose various technical amendments to the rules in subchapter 39, in order to clarify the requirements of the existing rules.

The Board invites all interested parties to submit comments and suggestions concerning this pre-proposal. Such public comments and suggestions will be considered by the Board in formulating a formal proposal which will again be subject to public comment prior to final adoption.

Full text of the pre-proposal follows:

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.

<<-"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 the 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 judgement 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. 13:39-6.7. 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.->>

SUBCHAPTER 3. LICENSURE OF PHARMACISTS

<< NJ ADC 13:39-3.18 >>

13:39-3.18 Registered pharmacist-in-charge

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

(e) A registered pharmacist-in-charge shall be physically present in the pharmacy or pharmacy department for that amount of time necessary to ensure the fulfilling of the following responsibilities:

1.-4. (No change.)

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

6. Ensuring that only pharmacists, interns or externs accept telephone prescriptions and renewal authorizations <<+except as provided in N.J.A.C. 13:39-6.7(b)+>>;

7.-14. (No change.)

<< NJ ADC 13:39-3.19 >>

<<+13:39-3.19 Meal breaks+>>

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

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

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

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

SUBCHAPTER 5. PRESCRIPTIONS

<< NJ ADC 13:39-5.6 >>

13:39-5.6 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 on the <<-face of the->> original prescription. In using an electronic data processing system, the initials <<+or other personal identifier+>> of the pharmacist responsible for the filled prescription shall also be recorded.

(b)-(j) (No change.)

SUBCHAPTER 6. DISPENSING AND ADVERTISING DRUGS

<< NJ ADC 13:39-6.2 >>

13:39-6.2 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 13:39-6.4 >>

13:39-6.4 <<-Direct supervision of dispensing and compounding->> <<+ (Reserved)+>>

<<-The registered pharmacist supervising the activities of supportive personnel shall be physically present in the compounding/dispensing area and shall be personally responsible for the accuracy of the filled prescription.->>

<< NJ ADC 13:39-6.7 >>

13:39-6.7 <<-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.->>

<<+(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.+>>

(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.->> <<+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)->><<+(d)+>> <<-There shall be no->> <<+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->> <<+1:2+>> 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 as needed. Documentation of the review shall be made available to the Board upon request.+>>

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

<<-(e)->><<+(i)+>> 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)->><<+(j)+>> 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+>>.

SUBCHAPTER 9. PHARMACEUTICAL SERVICES WITHIN HEALTH CARE FACILITIES

<< NJ ADC 13:39-9.5 >>

13:39-9.5 Pharmaceuticals

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

(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->> <<+pharmacy technicians+>> 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->> <<+pharmacy technicians+>> 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.

<< NJ ADC 13:39-9.8 >>

13:39-9.8 Compounding

(a) Compounding of individual medication orders or prescriptions, the formulation of special drug needs and all bulk compounding (sterile or non- sterile) shall be done by or under the <<-direct->> <<+immediate personal+>> supervision of a pharmacist.

(b) (No change.)

(c) All prepackaging and labeling of drugs shall be done by or under the <<- direct->> <<+immediate personal+>> supervision of a pharmacist. Procedures shall be established for maintaining the integrity and manufacturer's control identity of prepackaged material. The prepackaging records shall be initialed by the supervising pharmacist.

<< NJ ADC 13:39-9.14 >>

13:39-9.14 Drug-dispensing devices

(a) (No change.)

(b) Packing 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+>> 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)-(h) (No change.)

<< NJ ADC 13:39-9.16 >>

13:39-9.16 Records and reports

(a) (No change.)

(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 and as follows:

1. (No change.)

2. All notations made on the inpatients' profile records by <<-supportive personnel->> <<+pharmacy technicians+>> shall be verified and countersigned by the supervising pharmacist.

3. (No change.)

(c)-(f) (No change.)

<< NJ ADC 13:39-9.22 >>

13:39-9.22 <<-Pharmacist->> <<+Pharmacy+>> staff

(a) The institutional <<-pharmacist->> <<+pharmacy+>> staff shall include the following:

1.-3. (No change.)

4. <<-Supportive and clerical personnel->> <<+Pharmacy technicians+>> who shall work under the <<-direct->> <<+immediate personal+>> supervision <<-and control->> of a registered pharmacist as provided in N.J.A.C. 13:39-<<-6.4->><<+6.2+>> and 6.7.

SUBCHAPTER 10. AUTOMATED MEDICATION SYSTEMS

<< 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+>> 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 IN RETAIL ANDINSTITUTIONAL PHARMACIES

<< NJ ADC 13:39-11.6 >>

13:39-11.6 Pharmacist in charge and permitholders' responsibilities

(a) That section of a pharmacy which provides a sterile admixture service shall be under the <<-direct->> <<+immediate personal+>> supervision of a pharmacist licensed to practice in this State.

(b) The pharmacist in charge shall have the responsibility, in that section of the pharmacy which provides <<-this special->> <<+sterile admixture+>> service<<+s+>> for, at a minimum, the following:

1.-4. (No change.)

5. Ensuring that only licensed pharmacists meeting the requirements of (a) above, or <<-supportive personnel->> <<+pharmacy technicians+>> under <<-direct->> <<+the immediate personal+>> supervision of an IV trained licensed pharmacist as defined in N.J.A.C. 13:39-11.8(a), prepare<<-,->> <<+and+>> compound <<-and dispense->> the sterile admixture preparations.

<< NJ ADC 13:39-11.7 >>

13:39-11.7 Training requirements

(a) (No change.)

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

1.-3. (No change.)

(c) (No change.)

<< NJ ADC 13:39-11.8 >>

13:39-11.8 <<-Supportive personnel->> <<+Pharmacy technicians+>>; required supervision

(a) Dispensing pharmacists shall provide <<-direct->> <<+immediate personal+>> supervision to <<-supportive personnel->> <<+pharmacy technicians+>> who are performing delegated sterile admixture tasks. 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. 13:39-6.7(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+>> only the following tasks: recording of the prescription, selection of the drugs, container and diluent, typing of labels and compounding of the sterile admixture. The dispensing pharmacist shall ensure that each task has been performed correctly in the dispensing process.

<< NJ ADC 13:39-11.9 >>

13:39-11.9 Batch preparation

Pharmacists and <<-supportive personnel->> <<+pharmacy interns, externs and pharmacy technicians+>> may prepare sterile products consistent with the provisions of N.J.A.C. 13:39-11.8 in a quantity that is supported by prior valid prescription 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).

<< NJ ADC 13:39-11.11 >>

13:39-11.11 Information required to appear on prescription label

(a) The dispensed container for any sterile admixture product shall bear a permanently affixed label with at least the following information:

1.-8. (No change.)

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

<<-10.->><<+9.+>> The <<-expiration->> <<+use by+>> date and 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)<<-;->><<+.+>>

<<+i. For purposes of this paragraph, "use by date" means the earlier of one year from the date of dispensing or the expiration date on the manufacturer's container. Within six months following the effective date of this section, the label shall contain the phrase "use by" followed by the product's use by date.+>>

Recodify existing 11.-13. as <<+10.-12.+>> (No change in text.)

<< NJ ADC 13:39-11.14 >>

13:39-11.14 Policy and procedure manual

(a)-(b) (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.

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.->>

<< 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.)

(1) 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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Posted October 7, 2002