Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.4 - General Requirements for a Pharmacy Providing Radiopharmaceutical Services

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy providing radiopharmaceutical services shall obtain
				a limited use pharmacy license pursuant to rule
				657-8.35 (155A)
				prior to commencing provision of services in this state.
(1)
Authorized nuclear
			 pharmacist.
The pharmacist in charge shall be an authorized nuclear
			 pharmacist and shall be responsible for, at a minimum, the requirements in rule
			 657-8.3
			 (155A). All personnel performing tasks in the preparation and distribution of
			 radioactive drugs shall be under the direct personal supervision of an
			 authorized nuclear pharmacist. An authorized nuclear pharmacist is responsible
			 for all operations of the pharmacy and, except in emergency situations, shall
			 be in personal attendance at all times that the pharmacy is open for
			 business.
(2)
Space
			 requirements.
Nuclear pharmacies shall have adequate space,
			 commensurate with the scope of services required and provided. The nuclear
			 pharmacy area shall be separate from the pharmacy areas for nonradioactive
			 drugs and shall be secured from unauthorized personnel. All pharmacies handling
			 radiopharmaceuticals shall provide a radioactive storage and product decay
			 area, occupying at least 25 square feet of space, separate from and exclusive
			 of the drug compounding, dispensing, quality assurance, and office
			 areas.
(3)
Personnel
			 appropriately trained.
The pharmacist in charge shall be responsible
			 for ensuring that all pharmacy personnel have been appropriately and adequately
			 trained for their assigned tasks.
(4)
Pharmacy support
			 persons.
A pharmacy support person shall register with the board
			 pursuant to the registration requirements of 657-Chapter 5. Alternatively, a
			 pharmacy support person may register with the board as a pharmacy technician
			 pursuant to the registration and national certification requirements of
			 657-Chapter 3.
(5)
Records
			 required.
Nuclear pharmacies shall maintain records of acquisition and
			 disposition of all radioactive drugs in accordance with rules of the board, the
			 public health department, and the environmental protection
			 commission.
(6)
Compliance
			 with laws.
Nuclear pharmacies shall comply with all applicable laws
			 and regulations of federal and state agencies, including those laws and
			 regulations governing nonradioactive drugs.
(7)
Prescription and office
			 use.
Radioactive drugs shall be dispensed only upon a prescription
			 order from a licensed medical practitioner authorized to possess, use and
			 administer radiopharmaceuticals. A nuclear pharmacy may also furnish
			 radiopharmaceuticals to practitioners for office use.
(8)
Outer-container label.
In addition to any of the board's labeling requirements for nonradioactive
			 drugs, the immediate outer container of a radioactive drug to be dispensed
			 shall also be labeled with:
a. The standard
			 radiation symbol;
b. The words
			 "Caution - Radioactive Material";
c. The name of the radionuclide;
d. The chemical form;
e. The amount of radioactive material
			 contained, in millicuries or microcuries;
f. If the radioactive drug is a liquid, the
			 volume in cubic centimeters;
g. The
			 requested calibration time for the amount of radioactivity contained.