1922 NUCLEAR PHARMACIES

1922.1 A pharmacy, institution, or other establishment that provides radiopharmaceutical services shall obtain from the Director a nuclear pharmacy license. The license to operate a nuclear pharmacy shall be conditioned upon approval of the United States Nuclear Regulatory Commission (NRC) where applicable.

1922.2 A license to operate a pharmacy providing radiopharmaceutical services shall only be issued to a qualified nuclear pharmacist as defined in § 1922.3.

1922.3 A qualified nuclear pharmacist shall:

(a) Be a currently licensed pharmacist in the District of Columbia;

(b) Have met the Nuclear Regulatory Commission standards of training for medically used or radioactive by-product material; and

(c) Be currently certified as a nuclear pharmacist by a certification board recognized by the Board; or in lieu of certification:

(1) Submit proof acceptable to the Board that the individual has completed a minimum of two hundred (200) contact hours of didactic instruction in nuclear pharmacy and the safe handling and the use of radioactive material from a program recognized by the Board; and

(2) Submit proof acceptable to the Board that the individual has completed a minimum of five hundred (500) hours of supervised 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.

1922.4 A qualified nuclear pharmacist shall be responsible for all operations of the nuclear pharmacy and shall be in personal attendance at all times that the nuclear pharmacy is open for business.

1922.5 A nuclear pharmacy shall be managed by a nuclear pharmacist (hereafter referred to "Responsible Nuclear Pharmacist ") who is licensed to practice pharmacy in the District of Columbia. A nuclear pharmacist shall not be the Responsible Nuclear Pharmacist for more than one nuclear pharmacy at a time.

1922.6 The Responsible Nuclear Pharmacist shall be assisted by a sufficient number of additional authorized nuclear pharmacists as may be required to operate the pharmacy competently, safely, and adequately to meet the needs of the patients of

the pharmacy.

1922.7 All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist.1922.8 The Responsible Nuclear Pharmacist shall designate in advance, one or more other licensed pharmacists to have access to the licensed area in emergency situations when a qualified nuclear pharmacist is not present. These pharmacists may obtain single doses of radiopharmaceuticals for the immediate emergency and shall document such withdrawals in the control system.1922.9 The Responsible Nuclear Pharmacist shall be responsible for, at a minimum, the following:- (a) Ensuring that radiopharmaceuticals are dispensed and delivered safely and accurately as prescribed;

- (b) Developing a system to ensure that all personnel responsible for compounding or supervising the compounding of radiopharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;

- (c) Establishing policies for procurement of drugs and devices and storage of all pharmaceutical materials including radiopharmaceuticals, components, used in the compounding of radiopharmaceuticals, and drug delivery practices;

- (d) Developing a system for the disposal and distribution of drugs from the pharmacy;

- (e) Developing a system for the compounding, sterility assurance, and quality control of sterile radiopharmaceuticals;

- (f) Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials including radiopharmaceuticals, required by applicable federal and District of Columbia laws and regulations;

- (g) Developing a system to ensure maintenance of effective controls against the theft or diversion of prescription drugs, and prescription records;

- (h) Ensuring that the pharmacy has a system to dispose of radioactive and cytotoxic waste in a manner so as not to endanger the public health;

1. (i) Developing and implementing written policies and procedures to ensure compliance with the applicable provisions of federal and District of Columbia laws and regulations;
2. (j) Notifying the Director of the occurrence of any of the following:
3. (1) Permanent closing of the pharmacy;
4. (2) Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;
5. (3) Any theft or loss of prescription drugs or medical devices from the pharmacy;
6. (4) Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;
7. (5) Disasters or accidents resulting in damage to the pharmacy facility, or inventory;
8. (6) Any theft, destruction, or loss of records required to be maintained by federal or District of Columbia law or regulation;
9. (7) Occurrences of significant adverse drug reactions; or
10. (8) Illegal use or disclosure of protected patient health information; and
11. (k) Ensuring the making or filing of any reports required by federal or District of Columbia laws or regulations.

1922.10 Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in the District or as otherwise defined by the Director.

1922.11 The Nuclear Pharmacy area shall be secured from unauthorized personnel.

1922.12 In a nuclear pharmacy providing ordinary pharmacy services in addition to radiopharmaceutical services, the nuclear pharmacy area shall be separate from the pharmacy areas for non-radioactive drugs and shall be secured from unauthorized personnel.

1922.13 All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area, occupying at least twenty-five (25) square feet of space, separate from and exclusive of the hot laboratory, compounding, dispensing, quality assurance and office areas.1922.14 Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials in accordance with all applicable federal and District of Columbia laws and regulations.1922.15 A nuclear pharmacy shall have the equipment and reference material required under § 1909 of this Title as well as all other applicable federal and District of Columbia laws and regulations.1922.16 Radiopharmaceuticals shall be dispensed only upon a prescription drug order from a practitioner authorized to possess, use, and administer radiopharmaceuticals.1922.17 A nuclear pharmacy shall dispense only radiopharmaceuticals which comply with acceptable standards of radiopharmaceutical quality assurance.1922.18 The immediate outside container (shield) of a radioactive drug to be dispensed shall bear the following information:- (a) The name and address of the nuclear pharmacy;

- (b) The name of the prescriber (authorized user);

- (c) The date of dispensing;

- (d) The serial number, lot number, or prescription number assigned to the radiopharmaceutical order;

- (e) The standard radiation symbol;

- (f) The name of the diagnostic procedure;

- (g) The words 'Caution: Radioactive Material';

- (h) The name of the radionuclide and chemical form;

- (i) The amount of radioactivity and the calibration date and time;

- (j) The expiration date and time;

1. (k) In the case of a diagnostic radiopharmaceutical, the patient's name or the words 'Per Physician's Order';
2. (l) In the case of a therapeutic radiopharmaceutical, the patient's name;
3. (m) The activity and date and time of assay;
4. (n) The volume, if in liquid form; and
5. (o) The requested activity and the calibrated activity.1922.19 The immediate inner container shall be labeled with:- (a) The standard radiation symbol;
6. (b) The words 'Caution-Radioactive Material'; and
7. (c) The serial number or prescription number assigned to the order.1922.20 Orders for radiopharmaceuticals, whether written or verbal, shall include at least the following information:- (a) The name of the institution or facility and the name of the person transmitting the order;
8. (b) The date that the radiopharmaceutical will be needed and the calibration time;
9. (c) The name or generally recognized and accepted abbreviation of the radiopharmaceutical;
10. (d) The dose or activity of the radiopharmaceutical at the time of calibration; and
11. (e) In the case of a therapeutic radiopharmaceutical or a radiopharmaceutical blood product, the name of the patient shall be obtained prior to dispensing.1922.21 The amount of radioactivity shall be determined by radiometric methods for each individual dose immediately prior to dispensing.1922.22 Beginning six (6) months after the effective date of these regulations, a nuclear pharmacy shall comply with applicable laws and regulations of District of Columbia and federal agencies, including the laws and regulations governing any

non-radioactive drugs, and any medical devices that may be dispensed, and all other requirements set forth in the current published editions of USP General Chapters 795, 797, 800 and 825 relevant to the type of compounding being undertaken.

SOURCE: Final Rulemaking published at 38 DCR 6734, 6761 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518, 10519 (November 12, 2010); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022).