Part V
Nuclear Pharmacies

18VAC110-20-220. General requirements for pharmacies providing radiopharmaceutical services.

A. A permit to operate a pharmacy providing radiopharmaceutical services shall be issued only to a qualified nuclear pharmacist as defined in 18VAC110-20-230. In emergency situations, in the absence of the nuclear pharmacist, he may designate one or more other qualified pharmacists to have access to the licensed area. These individuals may obtain single doses of radiopharmaceuticals for the immediate emergency and shall document such withdrawals in the control system.

B. Pharmacies providing ordinary pharmacy services in addition to radiopharmaceutical services shall comply with all regulations applicable to pharmacies in general. Pharmacies providing only radiopharmaceutical services shall comply with all regulations related to physical standards, sanitary conditions and security.

C. A. Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided and in compliance comply with standards and requirements of the Nuclear Regulatory Commission (NRC) and the Virginia Department of Health related to the staffing and operation of the facility.

D. B. Radiopharmaceuticals are to be dispensed only upon an order from a practitioner prescriber authorized to possess, use and administer radiopharmaceuticals.

1. Orders shall originate at an institution or healthcare facility licensed to receive and possess radiopharmaceuticals, and must contain all necessary information relative to the radiopharmaceutical, activity, time of calibration, and any special preparation or delivery instructions.

2. Orders for radiopharmaceuticals may be transmitted orally, by fax, or by electronic transmission by an authorized agent of the prescriber. If the fax or electronic transmission of the authorized agent is pursuant to an oral order from the prescriber, the transmitted document need not include the prescriber's signature, but must include the name of the agent.

E. C. The immediate outside container of a radioactive drug to be dispensed shall also be labeled in accordance with requirements of § 54.1-3410.1 B of the Code of Virginia.

F. D. The immediate inner container shall be labeled with: (i) the standard radiation symbol; (ii) the words "Caution--Radioactive Material"; and (iii) the serial number assigned to the order.

G. The amount of radioactivity shall be determined by radiometric methods for each individual dose immediately prior to dispensing.

H. E. Nuclear pharmacies may redistribute approved radioactive drugs if the pharmacy does not process the radioactive drugs in any manner nor violate the product packaging.

Statutory Authority

§54.1-103 and 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 4.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 16, Issue 21, eff. August 2, 2000; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 4, eff. December 11, 2008.

18VAC110-20-230. Qualification as a nuclear pharmacist. (Repealed.)

In order to practice as a nuclear pharmacist, a pharmacist shall possess the following qualifications:

1. Meet Nuclear Regulatory Commission (NRC) standards of training for medically used or radioactive by-product material.

2. Have received a minimum of 200 contact hours of didactic instruction in nuclear pharmacy.

3. Attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing nuclear pharmacy services, or in a structured clinical nuclear pharmacy training program in an approved school of pharmacy.

4. Submit to the board an affidavit of experience and training meeting the requirements of subdivisions 1, 2 and 3 of this section; documentation of NRC approval as an authorized nuclear pharmacist; or documentation of certification as a nuclear pharmacist by the American Pharmaceutical Association Board of Pharmaceutical Specialties.

Statutory Authority

§§ 54.1-2400, 54.1-3307, and 54.1-3312 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 4.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999.