3 Colo. Code Regs. § 719-1-12.00.00

Current through Register Vol. 48, No. 1, January 10, 2025

Section 3 CCR 719-1-12.00.00 - NUCLEAR PHARMACY

12.00.10 Authorized handling. It is unlawful for any person to provide radiopharmaceutical services unless he or she is a nuclear pharmacist acting in accordance with Title 12, Article 280, C.R.S., and the Rules of the Board and rules of the Colorado Department of Public Health and Environment, with the exception of an authorized practitioner for administration to his patients. No person may receive, acquire, possess, use, transfer or dispose of any radioactive material except in accordance with the conditions of any radioactive material license required by the Colorado Department of Health pursuant to section 25-11-101et seq., C.R.S. The requirements of this Rule are in addition to, and not in substitution for, other applicable provisions of Rules of the Board and the State Radiation Control Agency.

12.00.20 Definitions.

12.00.21 "Nuclear prescription drug outlet" means a prescription drug outlet which deals with the preparation and delivery of radioactive material as defined in section 25-11-101, C.R.S.

12.00.22 "Nuclear pharmacist" means a pharmacist who holds an active pharmacist license with the Board and has met the standards of training and experience for "Authorized User Status" in handling radioactive materials in accordance with either the State Radiation Control Agency or the U.S. Nuclear Regulatory Commission.

12.00.23 "Radiopharmaceutical service" shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; 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 radiopharmaceuticals.

12.00.24 "Radiopharmaceutical" is any drug which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or protons and includes any such drug which is intended to be made radioactive. This definition includes non-radioactive reagent kits and nuclide generators which are 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.

12.00.25 "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history and the keeping of proper records.

12.00.26 "Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.

12.00.27 "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical.

12.00.28 "Authorized practitioner" means a practitioner authorized by law to possess, use and administer radiopharmaceuticals, acting within the scope of such authority.

12.00.30 Requirements For Nuclear Prescription Drug Outlets. A nuclear prescription drug outlet shall only be managed by a nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of a nuclear pharmacist. A nuclear pharmacist shall be in attendance at all times that the nuclear prescription drug outlet is open for business and shall be responsible for all operations of the registered area.

12.00.31 All nuclear prescription drug outlets shall have adequate space, commensurate with the scope of services required and provided. The nuclear prescription drug outlet area shall be separate from the areas for non-radioactive drugs and shall provide a radioactive storage and product decay area separate from and exclusive of the radioactive laboratory, compounding, dispensing, quality assurance and administrative area. Prior to registration, a nuclear prescription drug outlet that wishes to compound both radiopharmaceuticals and non-radiopharmaceuticals not directly pertaining to nuclear studies shall meet the space requirements set forth in Rule 5.01.31. If a nuclear prescription drug outlet wishes to compound only radiopharmaceuticals, it shall not be required to meet the space requirements set forth in Rule 5.01.31. All nuclear prescription drug outlets shall submit detailing drawing-to-scale floor plans to the Board that have been approved by the state radiation control agency before approval of the registration.

12.00.32 There shall be a professional reference library available in the nuclear prescription drug outlet. If an electronic library is provided, workstations must be provided in a compounding/dispensing area and must be readily available for use by staff, interns and Board personnel. This library shall contain current copies of the following:

(1) A Title 12, Article 280, C.R.S.; the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act;

(2) CRS Title 18, Article 18, the Uniform Controlled Substances Act of 1992;

(3) Board Rules;

(4)21 Code of Federal Regulations ("CFR") Part 1300 to End containing Drug Enforcement Administration rules relating to controlled substances;

(5) If compounding sterile products, Guide to Parenteral Admixtures or Handbook on Injectable Drugs or other comparable references as determined by the pharmacist manager;

(6) If compounding hazardous products, Technical Manual Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs or ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs;

(7) Any other references that the pharmacist manager of the prescription drug outlet may deem necessary; and

(8) The current rules of the State Radiation Control Agency and U.S. Nuclear Commission.

12.00.33 A nuclear prescription drug outlet shall comply with all applicable laws and regulations of federal and state agencies, including those laws and rules governing non-radioactive drugs.

12.00.34 A nuclear prescription drug outlet shall have adequate equipment commensurate with the scope of radiopharmaceutical services to be provided.

12.00.35 Nuclear prescription drug outlets which compound and dispense only radiopharmaceuticals shall be exempt from the security requirements of Rule 5.01.50 provided the following conditions are met:

a. Only individuals identified as having "Authorized User" status by the State Radiation Control Agency or the U.S. Nuclear Regulatory Commission may enter the compounding/dispensing area in the absence of a pharmacist and only for the purpose of equipment maintenance.

b. The nuclear prescription drug outlet maintains a written record documenting such entry detailing the following information:

1) Date and time of entry;

2) Authorized users name;

3) Reason for entry; and

4) Signature of pharmacist manager.

Such record shall be maintained on the premises and available for inspection for at least two years from the date of entry.

12.00.40 General Requirements for Nuclear Pharmacists. A nuclear pharmacist shall:

a. Be a pharmacist licensed to practice in Colorado;

b. Meet the standards of training and experience for "authorized user status" in handling of radioactive materials in accordance with either the State Radiation Control Agency or the U.S. Nuclear Regulatory Commission; and

c. Be specifically identified, by name, as an "authorized nuclear pharmacist" on either a radioactive materials license issued by the Colorado Department of Public Health and Environment or on a U.S. Nuclear Regulatory Commission master license.

12.00.45 Nuclear prescription drug outlets shall post, in a conspicuous area of the compounding / dispensing area of the outlet, and shall have readily available for inspection, the follow:

a. The original copy of the current registration with the pharmacy board;

b. The original copy, or a reference to its specific location in the outlet, of the most current radioactive materials license issued by the Colorado Department of Public Health and Environment;

c. A copy, or a reference to its specific location in the outlet, of the most current U.S. Nuclear Regulatory Commission master license which details a listing of its authorized nuclear pharmacists if the current radioactive license issued by the Colorado Department of Public Health and Environment references the outlet's U.S. Nuclear Regulatory Commission master license rather than detailing a listing of the outlet's authorized nuclear pharmacists itself; and

d. The outlet's current list of employees that complies with Rule 11.08.00.

12.00.64 Nuclear Compounding.

If a nuclear pharmacist compounds a preparation according to the manufacturer's labeling instructions, then further documentation is not required. All other compounded preparations require further documentation.

a. No expired components may be used in compounding. No component may be used which will expire prior to the beyond-use date of the final compounded product.

b. The compounding of sterile radiopharmaceuticals shall comply with Rule 21.00.00, including all recordkeeping requirements.

12.00.70 Dispensing.

a. A radiopharmaceutical shall only be dispensed pursuant to a valid, patient-specific prescription order that is issued by an authorized practitioner.

b. A nuclear prescription drug outlet shall only dispense radiopharmaceuticals which comply with acceptable standards of radiopharmaceutical assurance.

c. In addition to any labeling requirement of the Board for nonradiopharmaceuticals, the immediate outer container of the radiopharmaceutical to be dispensed shall also be labeled with:

(1) The standard radiation symbol;

(2) The words "Caution - Radioactive Material";

(3) The name of the radiopharmaceutical;

(3) The amount of radioactive materials contained, in millicuries or microcuries;

(4) If a liquid, the volume in milliliters;

(5) The requested calibration time for the amount of radioactivity contained; and

(6) Expiration data, if applicable.

d. The immediate inner container shall be labeled with:

(1) The standard radiation symbol;

(2) The words "Caution - Radioactive Material";

(3) The assigned serial number of the corresponding prescription order; and

(4) The name of the radiopharmaceutical.

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

12.00.71 Records of Dispensing.

a. In addition to any requirement of the board for non-radiopharmaceutical prescription orders, the prescription order shall include the following:

(1) Address of the authorized practitioner and/or the address where the prescription is to be administered;

(2) The name of radiopharmaceutical;

(3) The amount of radioactive materials contained, in millicuries or microcuries; and

(4) Calibration time for the amount of radioactivity contained.

For the purposes of this Rule, the prescription drug outlets may record the address on the order or maintain it in a readily retrievable format.

b. A hard copy of every prescription order shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such order. If a nuclear prescription drug outlet dispenses only radiopharmaceuticals, prescription orders will be deemed to be readily retrievable and available if they are filed according to the date of dispensing. If a nuclear prescription drug outlet dispenses both radiopharmaceuticals and non-radiopharmaceuticals not directly pertaining to nuclear studies, all prescription orders will be deemed to be readily retrievable and available if they are filed according to the numerical sequence of the serial numbers assigned pursuant to Rule 2.01.10.

12.00.72 Distribution.

a. A nuclear prescription drug outlet may distribute a compounded radiopharmaceutical to a practitioner authorized by law to prescribe the drug for the purposes of administration. Such distributions shall be limited to up to ten percent of the total number of drug dosage units dispensed and distributed on an annual basis by such outlet.

b. A nuclear prescription drug outlet may redistribute NDA approved radiopharmaceuticals if the outlet does not process the radiopharmaceuticals in any manner or violate the product packaging.

c. The immediate outer container of the radiopharmaceutical to be distributed shall be labeled with:

(1) The standard radiation symbol;

(2) The words "Caution - Radioactive Material";

(3) "RX Only";

(4) The name of Radiopharmaceutical;

(5) The amount of radioactive materials contained, in millicuries or microcuries;

(6) If a liquid, the volume in milliliters;

(7) The requested calibration time for the amount of radioactivity contained;

(8) Expiration data, if applicable;

(9) The assigned batch (lot) number;

(10) Specific route of administration;

(11) Storage directions; and

(12) The name and address of the prescription drug outlet.

d. The immediate inner container shall be labeled with:

(1) The standard radiation symbol;

(2) The words "Caution - Radioactive Material";

(3) The assigned batch (lot) number; and

(4) The name of the radiopharmaceutical.

12.00.73 Records of Distribution.

a. A nuclear prescription drug outlet shall maintain records of acquisition and distribution of all radiopharmaceuticals in accordance with Title 12 and Title 25, C.R.S.

b. A nuclear prescription drug outlet must retain verification of each practitioner's license from the jurisdiction in which licensed on a current basis for each practitioner to whom it distributes compounded radiopharmaceuticals.

c. A nuclear prescription drug outlet that distributes radiopharmaceuticals shall record the following:

(1) The name of the radiopharmaceutical;

(2) The amount of radioactive materials contained, in millicuries or microcuries;

(3) If a liquid, the volume in milliliters;

(4) The requested calibration time for the amount of radioactivity contained;

(5) The date of distribution;

(6) The name and address of the authorized practitioner and the address where the preparation is to be administered; and

(7) The name and address of the distributing outlet.

d. Records of distribution shall be retained at the outlet for a period of not less than two years from the date of distribution.

3 CCR 719-1-12.00.00

37 CR 18, September 25, 2014, effective 10/15/2014

38 CR 16, August 25, 2015, effective 9/14/2015

39 CR 04, February 25, 2016, effective 3/16/2016

39 CR 19, October 10, 2016, effective 11/14/2016

40 CR 04, February 25, 2017, effective 3/17/2017

40 CR 20, October 25, 2017, effective 11/14/2017

41 CR 16, August 25, 2018, effective 9/17/2018

42 CR 21, November 10, 2019, effective 11/30/2019

43 CR 10, May 25, 2020, effective 5/1/2020

43 CR 08, April 25, 2020, effective 5/15/2020

43 CR 15, August 10, 2020, effective 8/30/2020

43 CR 20, October 25, 2020, effective 11/14/2020

44 CR 04, February 25, 2021, effective 3/17/2021

44 CR 08, April 25, 2021, effective 5/15/2021

44 CR 21, November 10, 2021, effective 11/30/2021

45 CR 20, October 25, 2022, effective 9/29/2022

45 CR 21, November 10, 2022, effective 11/30/2022

46 CR 21, November 10, 2023, effective 11/30/2023