Mo. Code Regs. tit. 20 § 2220-2.500

Current through Register Vol. 49, No. 21, November 1, 2024.

Section 20 CSR 2220-2.500 - Nuclear Pharmacy-Minimum Standards for Operation

PURPOSE: The board is amending all sections of the current rule to update, modernize, and clarify rule requirements.

PURPOSE: This rule defines minimum standards for the operation of nuclear pharmacies and the preparation, labeling, dispensing, delivering, compounding, and repackaging of radio pharmaceuticals pursuant to a prescription drug or medication order. This regulation is intended to supplement other regulations of the Board of Pharmacy, as well as those of other state and/or federal agencies.

(1) Definitions.

(A) "Agreement state" means any state that has entered into an agreement under subsection 274b of the Atomic Energy Act of 1954, as amended, in which the United States Nuclear Regulatory Commission has relinquished to such states the majority of its regulatory authority over source material, by product, and special nuclear material in quantities not sufficient to form a critical mass.

(B) "Authentication of product history" means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radio pharmaceutical or other drug.

(C) "Authorized address or location" means the building or buildings that are identified on the license and where by-product material may be received, prepared, used, or stored as defined by 10 CFR 35.2 or a temporary job site for providing mobile nuclear medicine services in accordance with 10 CFR 35.80.

(D) "Authorized nuclear pharmacist" (ANP) means a pharmacist who holds a current license issued by the board and who is either certified as a nuclear pharmacist by the Board of Pharmacy Specialties, has attained status as an authorized nuclear pharmacist, or an authorized user of radioactive material, as specified by the Nuclear Regulatory Commission or Agreement State regulations, including, but not limited to, 10 CFR 35.55, 35.57 and 35.59.

(E) "Contingency prescription drug order" means a radioactive prescription drug order issued for contingency material for a diagnostic purpose.

(F) "Controlled access area" means an area outside of the restricted area but inside the pharmacy, access to which will be limited to the public.

(G) "NRC" means the United States Nuclear Regulatory Commission.

(H) "Nuclear pharmacy" means the location that provides radio pharmaceutical services and where radio pharmaceuticals and chemicals within the classification of legend drugs, are prepared, compounded, repackaged, dispensed, stored, sold, or used for nuclear medicine procedures. The term "nuclear pharmacy" does not include the nuclear medicine facilities of hospitals or clinics where radio pharmaceuticals are compounded or dispensed to patients under the supervision of a licensed physician, authorized by the Nuclear Regulatory Commission or Agreement State regulations. Nothing in this rule shall be construed as requiring a licensed clinical laboratory, which is also licensed by the Nuclear Regulatory Commission or Agreement State to handle radioactive materials, to obtain the services of a nuclear pharmacist, or to have a pharmacy permit, unless the laboratory is engaged in the commercial sale or resale of radio-pharmaceuticals.

(I) "Nuclear pharmacy technician" means a person who has successfully completed a nuclear pharmacy technician training program provided by an accredited college program or meets the American Pharmacist's Association's (APhA) Guidelines for Nuclear Pharmacy Technician Training Program or an equivalent company sponsored program that meets APhA guidelines for nuclear pharmacy technician training.

(J) "Practice of nuclear pharmacy" means a patient-oriented service that embodies the scientific knowledge and professional judgment required to improve and promote health through the assurance of the safe and efficacious use of radio pharmaceuticals and other drugs.

(K) "Preparing of radio pharmaceuticals" means the addition of a radioactive substance, or the use of a radioactive substance in preparation of a single-dose or multiple-dose medication, pursuant to the prescription drug order/contingency prescription drug order. Such preparing of radiopharmaceuticals includes, but is not limited to, loading and eluting of radionuclide generators, using manufactured reagent kits to prepare radiopharmaceuticals, preparing reagent kits, aliquoting reagents, and conducting quality control tests of radiopharmaceuticals.

(L) "Prescription drug order" means a prescription drug order issued for a specific patient for a diagnostic or therapeutic purpose.

(M) "Quality control testing" means, but is not limited to, the performance of appropriate chemical, biological, physical, radiochemical, and radionuclidic purity tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.

(N) "Quality assurance procedures" means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of product history and maintenance of all records as required by pertinent regulatory agencies. handling of any component of a radiopharmaceutical or other drug.

(O) "Radiopharmaceutical" means any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term "radiopharmaceutical" also includes any biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

(P) "Radiopharmaceutical services" means, but not limited to, the procurement, storage, handling, compounding, preparation, repackaging, labeling, quality control testing, dispensing, delivery, transfer, record-keeping, and disposal of radiochemicals, radiopharmaceuticals, and ancillary drugs; the participation in radiopharmaceutical selection and radiopharmaceutical utilization review, and also includes quality assurance procedures, radiological healthcare activities, any consulting activities associated with the use of radiopharmaceuticals, and any other activities required for provision of radiopharmaceutical care; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation management, and control of a nuclear pharmacy.

(Q) "Restricted area" means an area within the pharmacy that is secured from the Controlled Access Area and to which access is limited for the purpose of protecting individuals against exposure to radiation and radioactive materials.

(R) "Therapeutic prescription drug order" means a radioactive prescription drug issued for a specific patient for a therapeutic purpose.

(S) "Unit dose container" (e.g., shield or "pig") means a container designed to hold doses of radiopharmaceutical agents and to prevent or minimize/reduce the emission of radiation or radioactive materials by using appropriate shielding materials.

(2) General Requirements for Pharmacies Providing Radiopharmaceutical Services.

(A) No person may receive, acquire, possess, prepare, compound, dispense, repackage, transfer, dispose of, or manufacture for sale or resale any radiopharmaceutical except in accordance with the provisions of this rule and the conditions of rules and regulations promulgated by the Nuclear Regulatory Commission or applicable Agreement State.

(B) Nuclear pharmacies shall post, in a conspicuous area of the pharmacy, a copy of the current registration with the Board of Pharmacy and a copy of the most current U.S. NRC or applicable Agreement State license which details a listing of its authorized nuclear pharmacists. A reference to its specific location within the pharmacy is acceptable.

(C) A nuclear pharmacy must have on file a copy of the current radioactive materials license for the licensed facility requesting any radiopharmaceutical before the radioactive drug is permitted to be dispensed to that facility. The radiopharmaceutical may only be delivered to the authorized addresses or locations listed in, or temporary job sites as authorized by, the NRC/Agreement State license. The authorized physician ordering radiopharmaceuticals is hereby recognized as the patient's authorized designee for delivery purposes. This section is an exemption for Class E pharmacies to 20 CSR 2220-2.013(2) Prescription Delivery Requirements, which details authorized delivery sites.

(D) Nuclear pharmacies shall comply with any applicable requirements of other governing agencies regarding its daily operations and the disposal of any biohazardous medical waste. Appropriately labeled and, when required shielded, disposal containers shall be used for radioactive and biohazardous waste from the preparation or the return of radiopharmaceuticals. Disposal of biohazardous waste shall comply with all applicable local, state, and federal requirements.

(E) Any reusable unit dose container that is returned shall be considered to be contaminated. No pharmacy shall utilize a reusable unit dose container for radioactive doses without either an effective process to decontaminate the container of biohazardous substances or an effective mechanism to avoid contamination of the container. No pharmacy may reuse a unit dose container that remains contaminated with blood or other biohazardous substances.

(F) A Class E pharmacy may accept returns and waste as authorized by the NRC/Agreement State regulations.

(3) Permits. Any pharmacy providing radiopharmaceutical services must obtain a Class E radiopharmaceutical permit from the board. Nuclear pharmacies preparing, compounding or repackaging sterile preparations must have Class H Sterile Product Compounding on their permit.

(A) A permit to operate a nuclear pharmacy shall only be issued to a person who is, or who employs, an authorized nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs shall be under the direct supervision of an authorized nuclear pharmacist. The pharmacist-in-charge shall be an authorized nuclear pharmacist and be responsible for all operations of the pharmacy.

(B) The permit to operate a nuclear pharmacy is effective only if the pharmacy also holds a current Nuclear Regulatory Commission and/or Agreement State radioactive materials license. Copies of the most recent regulatory inspection reports must be made available upon request to the board for inspection.

(C) The nuclear pharmacist-in-charge shall notify the Board of Pharmacy by letter of the outcome of any hearings under state or federal laws or regulations governing radioactive materials involving or against the pharmacy location licensed by the board. Notification must be within thirty (30) days of the date of the outcome.

(4) Space, Security, Record-Keeping and Equipment.

(A) Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services provided, and as required by the Nuclear Regulatory Commission or Agreement State radioactive materials license or as required by 20 CSR 2220-2.200 Sterile Compounding, 20 CSR 2220-2.400 Compounding Standards of Practice or other applicable rules of the board. Radionuclide generators shall be stored and operated in an ISO 8 or better classified area. All pharmacies handling radiopharmaceuticals shall include, but not be limited to, the following areas:

1. Radiopharmaceutical nonsterile and sterile preparation/dispensing area;

2. Radioactive material shipping/receiving area;

3. Radioactive material storage area; and

4. Radioactive waste decay area.

(B) The nuclear pharmacy restricted area shall be secured against unauthorized personnel and must be totally enclosed and lockable.

(C) Nuclear pharmacies shall maintain records of acquisition, inventory, preparing, compounding, repackaging, dispensing, distribution, and disposition of all radioactive drugs and other radioactive materials in accordance with State Board of Pharmacy and Nuclear Regulatory Commission or Agreement State rules/requirements.

(D) Nuclear pharmacies shall prepare, compound, repackage, and dispense radiopharmaceuticals in accordance with accepted standards of nuclear pharmacy practice and in compliance with 20 CSR 2220-2.200 Sterile Compounding and 20 CSR 2220-2.400 Compounding Standards of Practice. Appropriate safety and containment techniques for preparing, repackaging, and compounding radiopharmaceuticals shall be used in conjunction with the aseptic techniques required for sterile preparations. Only authorized nuclear pharmacists, intern pharmacists, and nuclear pharmacy technicians may prepare, compound, repackage, or dispense radiopharmaceuticals.

(E) Unless required by other rule or applicable law, all records required by this rule must be maintained for two (2) years and must be made available to the board or its representative upon request.

(5) Dispensing, Packaging, Labeling.

(A) A radiopharmaceutical shall be dispensed only to a a practitioner or facility authorized by the Nuclear Regulatory Commission or an Agreement State to possess, use and administer such drug, provided that a radiopharmaceutical may be transferred to a person who is authorized to possess the drug in accordance with the regulations of the NRC/Agreement State. A radiopharmaceutical shall not be dispensed directly to a patient. A nuclear pharmacy may distribute radionuclide elutions to other authorized users to meet a drug shortage.

(B) The amount of radioactivity shall be determined by dose calibrator, appropriate radiometric methods, or decay calculation methods for each individual dose immediately prior to dispensing.

(C) Radiopharmaceuticals are to be dispensed only upon a non-refillable prescription drug order or a contingency prescription drug order from a practitioner or facility authorized by the Nuclear Regulatory Commission or Agreement State to possess, use, and administer radiopharmaceuticals or the practitioner's/facility's designated agent. The prescription drug order/contingency prescription drug order must be taken by an authorized nuclear pharmacist, intern pharmacist, or nuclear pharmacy technician under the supervision of an authorized nuclear pharmacist. Only authorized nuclear pharmacists may receive verbal therapeutic prescription drug orders. The prescription record shall contain all information as required in 20 CSR 2220-2.018 Prescription Requirements and shall also include:

1. The date of dispensing and the calibration time of the radio-pharmaceutical; and

2. The patient's name for therapeutic prescription drug orders and blood-containing products.

(D) The unit dose container of a radiopharmaceutical to be dispensed shall be labeled with-

1. The name and address of the pharmacy;

2. The name and address of the authorized prescriber/facility where the prescription drug order/contingency prescription drug order is to be administered;

3. The date of dispensing and a unique readily retrievable identifier;

4. The standard radiation symbol;

5. The words "Caution Radioactive Material";

6. The name of the procedure, if known;

7. The name or generally recognized and accepted abbreviation of the radiopharmaceutical, radionuclide, and chemical form;

8. The requested amount of radioactivity at the calibration date and time;

9. The radiopharmaceutical beyond-use date;

10. The quantity dispensed;

11. If applicable, Molybdenum-99 content to United States Pharmacopoeia (USP) limits of <0.15uCi Mo-99 per 1mCi Tc-99m at time of administration or product expiration; and

12. The patient name or the words "Physician's Use Only," "Contingency Prescription Drug Order," "Per Physician's Order," or similar wording in the absence of a patient name. If no patient name is used, the pharmacy must be able to retrieve the name of the patient from the authorized prescriber/facility within three (3) days if requested. When the prescription is for a therapeutic or blood-containing radiopharmaceutical, the patient name shall appear on the label.

(E) The immediate inner container label of a radiopharma-ceutical to be dispensed shall be labeled with-

1. The standard radiation symbol;

2. The words "Caution Radioactive Material";

3. The identity of the radiopharmaceutical;

4. The unique, readily retrievable identifier of the radiopharmaceutical; and

5. The patient's name, if known or the words "Physician's Use Only," "Contingency Prescription Drug Order," "Per Physician's Order," or similar wording in the absence of a patient name.

(F) Radiopharmaceuticals approved by the United States Food and Drug Administration are not subject to the unit dose container labeling requirements in subsection (D) or the radiometric measurement requirements of this rule if the nuclear pharmacy does not process the radioactive drugs in any manner nor violate the original manufacturer product packaging/labeling.

(6) Reference Manuals. Each nuclear pharmacy shall have a current copy of, or electronic access to-

(A) Applicable reference materials commensurate with the scope of services provided;

(B) A current print or electronic edition of statutes and rules governing the pharmacy's practice, including, but not limited to, Chapters 338 and 195, RSMo, 20 CSR 2220 and, if applicable, 19 CSR 30 governing controlled substances; and

(C) Agreement State and/or NRC regulations governing the safe storage, handling, use, dispensing, transport, and disposal of radioactive material, including but not limited to Title 10 and Title 49 of the United States Code of Federal Regulations.

(7) Special Conditions.

(A) To comply with NRC exposure guidelines of keeping radiation exposure as low as reasonably achievable (ALARA), the required pharmacist verification of the preparation shall be deemed satisfied if a pharmacist has previously verified the correct ingredients and calculations. Additionally, a pharmacist must verify the accuracy of the prescription/drug order information used and the label information prior to dispensing.

(B) At its discretion, for a pharmacy preparing, compounding, repackaging, or dispensing radiopharmaceuticals the board may grant an exemption to regulation requirements that do not pertain to the practice of nuclear pharmacy for a time period designated by the board if such exemption is not contrary to other law and the exemption will provide equal or greater protection of the public safety, health, or welfare. Exemption requests must be submitted in writing and identify the specific exemption requested, the grounds for exemption, the requested exemption length, and any proposed procedures or safeguards for protecting the public safety, health, or welfare if the exemption is approved. If deemed appropriate, the board may grant an exemption to all nuclear pharmacies based on one (1) pharmacy's request.

20 CSR 2220-2.500

AUTHORITY: sections 338.210, 338.240, 338.250, 338.280, 338.330(3), RSMo 1994 and 338.220 and 338.350, RSMo Supp. 1997.* This rule originally filed as 4 CSR 220-2.500. Original rule filed Sept. 2, 1997, effective April 30, 1998. Moved to 20 CSR 2220-2.500, effective Aug. 28, 2006.

Amended by Missouri Register October 1, 2019/Volume 44, Number 19, effective 11/30/2019

*Original authority: 338.210, RSMo 1951; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997; 338.240, RSMo 1951; 338.250, RSMo 1951, amended 1990; 338.280, RSMo 1951, amended 1971, 1981; 338.330, RSMo 1989, amended 1993; and 338.350, RSMo 1989, amended 1993, 1995.