24 Del. Admin. Code §§ 2500-13.0
The Practice of Nuclear/Radiological Pharmacy is hereby recognized as a specialty of Pharmacy practice, regulated by the Delaware Board of Pharmacy. As such, the following rules are included to address those areas specific or unique to this specialty practice. Nuclear/Radiological Pharmacy Practice refers to patient-oriented and institutional services that embody 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 drugs.
"Authentication of Product History" means, but is not limited to, identifying the purchase sources, and any handling of any Component of a radiopharmaceutical.
"Internal Test Assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the product.
"Nuclear Pharmacy" means a Pharmacy providing radiopharmaceutical services or, as provided in Section 3 "Qualified Nuclear Pharmacist" means a currently licensed Pharmacist in the State of Delaware, who is certified as a Nuclear Pharmacist by a certification Board recognized by the Delaware Board of Pharmacy, or who meets the following standards set by the Delaware Board of Pharmacy:
Satisfied the minimum standards of training for "authorized user status" of radioactive material as included in the Nuclear Regulatory Commission (NRC) licensure guide.
Completed a minimum of 200 contact hours of instruction in nuclear Pharmacy and the safe handling and the use of radioactive materials from a program approved by the NRC or the Office of Radiation Control (ORC), with emphasis in the following areas: radiation physics and instrumentation; radiation protection; mathematics of radioactivity; radiation biology; and radiopharmaceutical chemistry.
Attained a minimum of 500 hours of clinical nuclear Pharmacy training under the supervision of a qualified nuclear Pharmacist.
"Radiopharmaceutical Quality Assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential 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.
"Radiopharmaceutical Service" means, but is not limited to, the procurement, storage, handling preparation, labeling, quality assurance testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceuticals and other drugs.
"Radiopharmaceuticals" are radioactive drugs as defined by the FDA.
24 Del. Admin. Code §§ 2500-13.0