Mississippi Administrative Code › Title 30 - Professions and Occupations › Part 3001 - MISSISSIPPI PHARMACY PRACTICE REGULATIONS › Article XXVII - NUCLEAR/RADIOLOGIC PHARMACY

Current through June 25, 2024
In addition to all other applicable sections of the
				Mississippi Code of 1972, ARTICLE XXVII of the Mississippi Board of Pharmacy
				Regulation pertains specifically to nuclear pharmacy and
				radiopharmaceuticals.
1. DEFINITIONS
A. Authentication of product history means,
			 but is not limited to, identifying the purchasing source, the ultimate fate,
			 and any intermediate handling of any component of a
			 radiopharmaceutical;
B. A nuclear
			 pharmacy is a pharmacy providing the services of storing, compounding,
			 dispensing, labeling or distributing radiopharmaceuticals;
C. Practice of Nuclear Pharmacy means a
			 patient-orient 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 radiopharmaceuticals and other related
			 drugs.
D. A qualified licensed
			 professional means an individual (such as a physician, nurse, or technologist)
			 who possesses a current state license if applicable, and who has sufficient
			 training and experience to safely handle radiopharmaceuticals as defined by the
			 Mississippi State Department of Health, Division of Radiological
			 Health;
E. A qualified nuclear
			 pharmacist means a currently licensed pharmacist in the state of Mississippi
			 who is certified by the Mississippi State Department of Health, Division of
			 Radiological Health, or who meets the following standards:
(1) Minimum standards of training for
			 "authorized user status" of radioactive materials as defined by Mississippi
			 State Department of Health, Division of Radiological Health;
(2) Completed a minimum of two hundred (200)
			 contact hours of instruction in nuclear pharmacy and the safe handling and the
			 use of radioactive materials from a program approved by the Mississippi Board
			 of Pharmacy, and United States Nuclear Regulatory Commission or Agreement State
			 Agency, with emphasis in the following areas:
(a)Radiation Physics and
			 Instrumentation;
(b)Radiation
			 Protection;
(c)Mathematics of
			 Radioactivity;
(d)Radiation
			 Biology;
(e)Radiopharmaceutical
			 Chemistry.
(3) Attain a
			 minimum of five hundred (500) hours of clinical nuclear pharmacy training under
			 the supervision of a qualified nuclear pharmacist.
F. Nuclear pharmacy technician means a person
			 who works under the supervision of a qualified nuclear pharmacist and who is
			 currently registered with the Mississippi Board of Pharmacy. The duties and
			 responsibilities of these personnel must be consistent with their training and
			 experience.
G. Radiopharmaceutical
			 is any substance defined as a drug in Section 201(g) (1) of the Federal Food,
			 Drug and Cosmetic Act which also contains unstable nuclei which undergo
			 spontaneous disintegration with the emission of nuclear radiation.
			 Radiopharmaceuticals also include any non-radioactive reagent kit or
			 radionuclide generator which is intended to be used in the preparation of
			 radiopharmaceutical doses.
H.
			 Radiopharmaceutical Service means, but shall not be limited to the procurement,
			 storage, handling, compounding, quality control testing, dispensing, delivery,
			 recordkeeping, and disposal of radiopharmaceutical and other drugs as well as
			 quality control procedure, radiological health activities, any consulting
			 activities associated with the use of radiopharmaceuticals, health physics and
			 any other activities required for provision of pharmaceutical care.
I. Radiopharmaceutical Compounding means the
			 preparation, mixing assembling, packaging, or labeling of a reagent kit or
			 biological substance with radioactivity.
J. Radiopharmaceutical quality control means,
			 but is not limited to, the performance of appropriate chemical, biological and
			 physical tests on potential and prepared radiopharmaceuticals and the
			 interpretation of the resulting data to determine their suitability for use in
			 humans or animals.
Assurance that variances in the processes are clearly
				identified, assessed and improved upon if necessary is required for adequate
				quality control. All quality control procedures must be a set of planned,
				defined and systematic activities to provide adequate confidence that the
				product optimally fulfils professional expectations and requirements.
K. The restricted area of a
			 Nuclear Pharmacy is an area with limited access for the purpose of protecting
			 individuals against the undue risks from exposure to radiation and radioactive
			 materials. Generally, the restricted area(s) consists of the
			 compounding/dispensing area, radioactive material storage area and radioactive
			 dose return or breakdown area.