N.J. Admin. Code § 13:39-12.2

Current through Register Vol. 56, No. 24, December 18, 2024

Section 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 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. Nuclear pharmacies shall maintain an audit trail that records and documents the unique and secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or extern(s) performing the radiopharmaceutical services, which are required to be performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the requirements of this chapter. The collection of demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2 i is not required to be, but may be, recorded in the audit trail. All entries to the audit trail made by a pharmacy technician, intern, or extern shall be reviewed and approved by the pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services performed. When more than one pharmacist is involved in performing radiopharmaceutical services pursuant to this subchapter, each pharmacist shall be responsible for the accuracy and appropriateness of the radiopharmaceutical services he or she performed or reviewed and approved, and his or her unique and secure user identifier(s) shall be recorded in the audit trail. Audit trail documentation shall be generated at the time each service is performed. Such documentation shall be maintained or stored in original hard copy form or in any other media that facilitates the reproduction of the original hard copy and shall be kept by the pharmacy for five years. The oldest four years of information shall be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but off-site facilities used to store such records shall be secure. Patient records shall be kept confidential, but shall be made available to persons authorized to inspect them under State and Federal statutes and regulations.

(b) Nuclear pharmacies shall have adequate space, commensurate with the scope of services required and provided, meeting minimal United States Nuclear Regulatory Commission or its successor's requirements and the requirements established by the State of New Jersey Bureau of Radiation Protection. The nuclear pharmacy shall be separate from the pharmacy areas for non-radioactive drugs and shall be inaccessible to all unauthorized personnel. All pharmacies handling radiopharmaceuticals shall be provided with a radioactive storage and decay area. A nuclear pharmacy dispensing radioactive drugs may be exempted from the general space requirements for pharmacies.

(c) The process used for handling radioactive materials by any license holder must involve appropriate procedures for the purchase, receipt, storage, manipulation, compounding, distribution, and disposal of radioactive materials. In order to ensure the public health, safety, and welfare, a nuclear pharmacy shall first meet the following general requirements:

1. The environment where the handling of radioactive materials takes place shall be properly ventilated so that radioactive materials cannot be airborne from that environment to other non-occupationally unrestricted areas;

2. The environment shall be properly located so that the receipt and dispersal of radioactive materials does not result in inadvertent and undesired contamination of other non-occupationally labeled areas;

3. The area shall be designed in such a manner that radioactive materials can be contained in given areas to ensure adequate safety and protection to personnel working in or near them and to insure proper operation of the corresponding assay equipment; and

4. Those engaged in the compounding of radiopharmaceuticals for injection shall comply with N.J.A.C. 13:39-11, 11A, and 11B, as applicable.

(d) Nuclear pharmacies shall maintain records of acquisition and disposition of all radioactive drugs in accordance with rules and regulations of the United States Nuclear Regulatory Commission.

(e) The immediate outer container of a radioactive drug to be dispensed shall be labeled with the following:

1. The standard radiation symbol;

2. The words, "CAUTION--RADIOACTIVE MATERIAL";

3. The radionuclide;

4. The chemical form;

5. The amount of radioactive material contained in millicuries or microcuries;

6. If a liquid, the volume in milliliters;

7. The requested calibration time for the radioactivity contained;

8. The name, address, and telephone number of the nuclear pharmacy;

9. The prescription number; and

10. The date and patient's name, if available.

(f) The immediate container shall be labeled with the following:

1. The standard radiation symbol;

2. The words, "CAUTION--RADIOACTIVE MATERIAL";

3. The name of the radiopharmaceutical.

(g) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.

(h) A nuclear pharmacist may transfer to authorized persons and United States Nuclear Regulatory Commission licensed medical practitioners radioactive materials not intended for drug use, in accordance with the regulations of the United States Nuclear Regulatory Commission or its successor. A nuclear pharmacy may furnish radiopharmaceuticals to these practitioners for patient use.

(i) Nuclear pharmacies shall comply with all applicable laws and regulations of Federal and State agencies including those laws and regulations governing non-radioactive drugs. For nuclear pharmacies handling radiopharmaceuticals exclusively, the Board of Pharmacy may waive rules pertaining to pharmacy permits for nonradiopharmaceuticals which requirements do not pertain to the practice of nuclear pharmacy.

(j) Radioactive drugs are to be dispensed only upon a non-refillable prescription order from a United States Nuclear Regulatory Commission licensed medical practitioner (or the designated agent) authorized to possess, use and administer radiopharmaceuticals.

(k) Prescription orders for delivery of radioactive drugs for use in the medical practice of a United States Nuclear Regulatory Commission licensed medical practitioner may be placed on a telephone answering and recording device, only if the practitioner (or the designated agent) is identified in such a manner that is clearly recognized by the nuclear pharmacist dispensing the radioactive drug.

(l) A qualified nuclear pharmacist shall have the authority to delegate to any qualified and properly trained person or persons, acting under his or her 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.

N.J. Admin. Code § 13:39-12.2

Amended by 49 N.J.R. 3761(a), effective 12/4/2017