Radioactive pharmaceuticals require specialized techniques in their handling and testing in order that correct results may be obtained and hazards to personnel be minimized. All operations should be carried out or supervised by personnel having had expert training in handling radioactive materials.
The facilities for the production, use, and storage of radioactive pharmaceuticals are generally subject to licensing by the federal Nuclear Regulatory Commission, although in certain cases this authority has been delegated to state agencies. The federal Department of Transportation regulates the conditions of shipment of radioactive materials. State and local agencies often have additional special regulations. Each producer or user must be thoroughly cognizant of the applicable regulations of the federal Food, Drug, and Cosmetic Act, and any additional requirements of the U. S. Public Health Service and of state and local agencies pertaining to the articles concerned.
Definitions, special considerations, and procedures with respect to the Pharmacopeial monographs on radioactive drugs are set forth in this chapter.