SECTION 535:15-17-3. Definitions

  The following words or terms, when used in this Subchapter, shall have the following meaning, unless the context clearly indicates otherwise:

"Authentication of Product History" means identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical or other drug.

"Nuclear Pharmacy" means a pharmacy which provides radiopharmaceutical services and shall be licensed by the Board as a retail pharmacy.

"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 radiopharmaceuticals and related drugs.

"Qualified Nuclear Pharmacist" means a pharmacist who holds a current license issued by the Board, and who is either listed as an authorized user on a radioactive material users license or certified as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties or satisfies each of the following requirements:

(A)   Meets minimal standards of training for status as an Authorized Nuclear Pharmacist (ANP), as specified by the Oklahoma Department of Environmental Quality Control, or if in another state the Nuclear Regulatory Commission, or appropriate agreement state nuclear regulatory agency.

(B)   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 -accredited college of pharmacy, or other training program recognized by the Nuclear Regulatory Commission, with the following subjects covered:

(i)   radiation physics and instrumentation,

(ii)   radiation protection,

(iii)   mathematics pertaining to the use and measurement of radioactivity,

(iv)   radiation biology,

(v)   radiopharmaceutical chemistry;

(C)   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, as described in the current American Pharmaceutical Association (APhA) Nuclear Pharmacy Practice Standards:

(i)   procuring radioactive materials,

(ii)   compounding radiopharmaceuticals,

(iii)   performing routine quality control procedures,

(iv)   dispensing radiopharmaceuticals,

(v)   distributing radiopharmaceuticals,

(vi)   implementing basic radiation protection procedures,

(vii)   consulting and educating the nuclear medicine community, patients, pharmacists, other health professionals, and the general public;

(D)   Keeps documentation of experience and training available in the pharmacy for Board review.

"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.

"Quality Control Testing" means the performance of appropriate chemical and physical tests on compounded radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals.

"Radiopharmaceutical Services" means, 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, any consulting activities associated with the use of radiopharmaceuticals, health physics, and any other activities required for provision of pharmaceutical care.

"Radiopharmaceutical" means any substance 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 product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

[Source: Added at 14 Ok Reg 3027, eff 7-11-97; Amended at 24 Ok Reg 2262, eff 7-1-07]