Arkansas Administrative Code › Agency 070 - Board of Pharmacy › Rule 070.00.98-002 - Regulation 38 - Nuclear Pharmacy

Current through Register Vol. 49, No. 6, June, 2024
REGULATION
		  38
NUCLEAR PHARMACY
The practice of nuclear pharmacy is hereby recognized as a
			 specialty of pharmacy practice regulated by the Arkansas State Board of
			 Pharmacy. As such, the following rules are included to address those areas
			 specific or unique to this specialty practice. These regulations are intended
			 to supplement the regulations of other state and federal agencies.
Definitions:
A. "Authentication of Product
		  History"-Identifying the purchasing source, the ultimate fate, and any
		  intermediate handling of any component of a radiopharmaceutical or other
		  drug.
B. "Nuclear Pharmacy"-A
		  pharmacy which provides radiopharmaceutical services, and shall be licensed by
		  the Arkansas State Board of Pharmacy.
C. "Practice of Nuclear Pharmacy"-A
		  patient-oriented service that embodies the scientific knowledge and
		  professional judgement required to improve and promote health through the
		  assurance of the safe and efficacious use of radiopharmaceuticals and other
		  drugs.
D. "Qualified Nuclear
		  Pharmacist"-A pharmacist who holds a current license issued by the Board of
		  Pharmacy, and who is certified as a Nuclear Pharmacist by a Certification Board
		  recognized by the Arkansas State Board of Pharmacy, or satisfies each of the
		  following requirements:
1. Meets minimal
		  standards of training for status as an authorized user of radioactive material,
		  as specified by the Arkansas Department of Health, Division of Radiation
		  Control and Emergency Management of the Nuclear Regulatory
		  Commission.
2. Has successfully
		  completed a minimum of 200 contact hours of instruction in nuclear pharmacy and
		  the safe handling and use of radioactive materials from a College of Pharmacy
		  approved by the Arkansas State Board of Pharmacy, or other training program
		  recognized by the Arkansas State Board of Pharmacy, with the minimum 200 hours
		  apportioned as follows:
a. Radiation Physics
		  and Instrumentation
b. Radiation
		  Protection
c. Mathematics
		  pertaining to the use and measurement of radioactivity
d. Radiation Biology
e. Radiopharmaceutical Chemistry
3. Has attained a minimum of 500
		  hours of clinical/practical nuclear pharmacy training under the supervision of
		  a qualified nuclear pharmacist in, but not limited to, the following areas:
a. Procuring radioactive materials
b. Compounding radiopharmaceuticals
c. Performing routine quality control
		  procedures
d. Dispensing
		  radiopharmaceuticals
e.
		  Distributing radiopharmaceuticals
f. Implementing basic radiation protection
		  procedures
g. Consulting and
		  educating the nuclear medicine community, pharmacists, other health
		  professionals, and the general public.
4. Has submitted an affidavit of experience
		  and training to the Board of Pharmacy.
E. "Quality Assurance Procedures"-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.
F. "Quality Control
		  Testing"-The performance of chemical, biological and physical tests on
		  compounded radiopharmaceuticals and the interpretation of the resulting data to
		  determine their suitability for use in humans and animals.
G. "Radiopharmaceutical"-Any drug which
		  exhibits spontaneous disintegration of unstable nuclei with the emission of
		  nuclear particles or photons and includes any non-radioactive reagent kit or
		  nuclide generator which is intended to be used in the preparation of any such
		  substance but which does not include drugs such as carbon-containing compounds
		  or potassium-containing salts which contain trace quantities of naturally
		  occurring radionuclides. The term also includes any biological product, which
		  is labeled with a radionuclide or intended solely to be labeled with a
		  radionuclide.
H.
		  "Radiopharmaceutical Services"-The procurement, storage, handling, compounding,
		  preparation, labeling, quality control testing, dispensing, distribution,
		  transfer, record keeping, and disposal of radiochemicals, radiopharmaceuticals,
		  and ancillary drugs, and also includes quality assurance procedures,
		  radiological health activities, and consulting activities associated with the
		  use of radiopharmaceuticals, health physics, and any other activities required
		  for provision of pharmaceutical care.
General Requirements for Pharmacies Providing
			 Radiopharmaceutical Services
A. A permit to operate a nuclear pharmacy,
		  providing radiopharmaceutical services, shall only be issued to a facility
		  employing a qualified nuclear pharmacist. All personnel performing tasks in the
		  preparation and distribution of radiopharmaceuticals and ancillary drugs shall
		  be under the direct supervision of a qualified nuclear pharmacist, who shall be
		  in personal attendance when the nuclear pharmacy is open for business. The
		  pharmacist-in-charge shall be responsible for all operations of the nuclear
		  pharmacy.
B. The permit to operate
		  a nuclear pharmacy is effective only so long as the nuclear pharmacy also holds
		  a current Arkansas Department of Health or Nuclear Regulatory Commission
		  license.
C. Nuclear pharmacies
		  shall have adequate space and equipment, commensurate with the scope of
		  services required and provided. All pharmacies handling radiopharmaceuticals
		  shall include, but not be limited to, the following areas: radiopharmaceutical
		  preparation/dispensing area; radioactive material shipping/receiving area;
		  radioactive material storage area; and radioactive waste decay area. The
		  application for a permit to operate a nuclear pharmacy shall include detailed
		  floor plans and no material change may be made without the permission of the
		  Board.
D. The nuclear pharmacy
		  professional service area shall be secured from unauthorized personnel and
		  must.be totally enclosed and lockable.
E. Nuclear pharmacies shall maintain records
		  of acquisition, inventory and disposition of all radioactive materials in
		  accordance with Board and Arkansas Department of Health or Nuclear Regulatory
		  Commission statutes and regulations.
F. Nuclear pharmacies shall compound and
		  dispense radiopharmaceuticals in accordance with accepted standards of
		  radiopharmaceutical quality assurance. The Board of Pharmacy recognizes that
		  the preparation of radiopharmaceuticals involves the compounding skills of the
		  nuclear pharmacist to assure that the final drug product meets accepted
		  professional standards.
G. A
		  radiopharmaceutical shall be dispensed only to a licensed practitioner
		  authorized by the Arkansas Department of Health or Nuclear Regulatory
		  Commission to possess, use, and administer such drug. A radiopharmaceutical
		  shall be dispensed only upon receipt of a prescription or medication order from
		  such licensed practitioner. Otherwise, a radiopharmaceutical may be transferred
		  to a person who is authorized to possess and use such drug for non-clinical
		  applications.
H. A nuclear
		  pharmacy, upon receipt of an oral prescription order for a radiopharmaceutical,
		  shall immediately have the prescription order reduced to writing, or recorded
		  in a data processing system, which writing or record shall contain at least the
		  following:
1. the name of the institution and
		  prescriber, or prescriber's agent;
2. the date of dispensing and the calibration
		  time of the radiopharmaceutical;
3.
		  the name of the procedure;
4. the
		  name of the radiopharmaceutical;
5.
		  the dose or quantity of the radiopharmaceutical;
6. the serial number assigned to the order
		  for the radiopharmaceutical;
7. any
		  specific instructions;
8. the
		  initials of the person who dispensed the order.
Orders for routine diagnostic radiopharmaceuticals, which have
			 been previously established by the nuclear pharmacist with the physician, may
			 be taken by a pharmacy technician and entered into the computer. The nuclear
			 pharmacist shall verify the label with the written order. However, whenever an
			 order is for a therapeutic or blood-product radiopharmaceutical, the
			 prescription order must be received by a nuclear pharmacist and the patient's
			 name must be obtained and recorded prior to dispensing.
I. The immediate outer container
		  shield of a radiopharmaceutical to be dispensed shall be labeled with:
1. the name and address of the
		  pharmacy;
2. the name of the
		  prescriber;
3. the date of
		  dispensing;
4. the serial number
		  assigned to the order for the radiopharmaceutical;
5. the standard radiation symbol;
6. the words "Caution Radioactive
		  Material";
7. the name of the
		  procedure;
8. the radionuclide and
		  chemical form;
9. the amount of
		  radioactivity and the calibration date and time;
10. if a liquid, the volume;
11. if a solid, the number of items or
		  weight;
12. if a gas, the number of
		  ampoules or vials;
13. molybdenum
		  99 content to USP limits; and
14.
		  the name of the patient or the words "Per Physician's Order" in the absence of
		  a patient name. The requirements of this sub-section shall be met when the name
		  of the patient is readily retrievable from the physician upon demand.
When the prescription is for a therapeutic or blood-product
			 radiopharmaceutical, the patient name shall appear on the label prior to
			 dispensing.
J.
		  The immediate inner container label of a radiopharmaceutical to be dispensed
		  shall be labeled with:
1. the standard
		  radiation symbol;
2. the words
		  "Caution Radioactive Material";
3.
		  the identity of the radionuclide;
4. the chemical form;
5. the name of the procedure; and
6. serial number of the
		  radiopharmaceutical.
K.
		  When a radiopharmaceutical is dispensed under the authority of an
		  Investigational New Drug Application (IND), the nuclear pharmacy records shall
		  include an investigator's protocol for the preparation of the
		  radiopharmaceutical, a copy of the Institutional Review Board approval form (or
		  letter), and a letter from the manufacturer (sponsor) indicating that the
		  physician requesting the radiopharmaceutical is a qualified
		  investigator.
L. Each nuclear
		  pharmacy shall have a current copy of state and applicable federal regulations
		  governing the safe storage, handling, use, dispensing, transport, and disposal
		  of radiopharmaceuticals.
Minimum Equipment:
The professional area of the pharmacy shall have the following
			 equipment:
A. Radionuclide Dose
		  Calibrator;
B.
		  Refrigerator;
C. Single or multiple
		  channel scintillation counter with well-type Nal(TI) or Ge(Li)
		  detector;
D. Radiochemical fume
		  hood and filter system with suitable air sampling equipment;
E. At least two GM survey meters (including
		  one high-range meter);
F.
		  Microscope and hemacytometer;
G.
		  Supplies to perform quality assurance testing;
H. Syringe and vial radiation
		  shields;
I. Lead-shielded drawing
		  station;
J. Decontamination
		  supplies;
K. Supplies to perform
		  quality assurance testing;
L. Lead
		  transport shields for syringes and vials; and
M. D.O.T. approved USA Type A, 7A approved
		  transport containers and other labels and supplies for shipping radioactive
		  materials. (10/14/98)