Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-3 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
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.
Added at 14 Ok Reg 3027,
				  eff 7-11-97; Amended at 24 Ok Reg 2262, eff
				  7-1-07