NRC and FDA Regulations Affecting Nuclear Pharmacy Practice
dc.contributor.author | Petry, Neil A. | en_US |
dc.date.accessioned | 2010-04-14T14:20:33Z | |
dc.date.available | 2010-04-14T14:20:33Z | |
dc.date.issued | 1989 | en_US |
dc.identifier.citation | Petry, Neil (1989). "NRC and FDA Regulations Affecting Nuclear Pharmacy Practice." Journal of Pharmacy Practice 2(5): 306-313. <http://hdl.handle.net/2027.42/69138> | en_US |
dc.identifier.issn | 0897-1900 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/69138 | |
dc.description.abstract | Radiopharmaceuticals are radioactive drugs that are used in nuclear medicine practice for diagnosis and treatment of disease. Nuclear pharmacy practice is a patient-oriented pharmaceutical service that promotes the safe and efficacious use of radiopharmaceuticals and other drugs used in nuclear medicine, and is regulated jointly by a variety of federal, state, and local agencies. Given that the medical use of radiopharmaceuticals is highly regulated at multiple levels of government, it is not surprising that nuclear pharmacy practice is conducted in a complex regulatory environment. The purpose of this article is to provide a brief overview of this regulatory environment, primarily in terms of two important regulatory agencies involved (Nuclear Regulatory Commission and Food and Drug Administration), their primary authority and activities, and the regulations that must be satisfied in order to assure the safe and efficacious use of radiopharmaceuticals. | en_US |
dc.format.extent | 3108 bytes | |
dc.format.extent | 687249 bytes | |
dc.format.mimetype | text/plain | |
dc.format.mimetype | application/pdf | |
dc.publisher | Sage Publications | en_US |
dc.title | NRC and FDA Regulations Affecting Nuclear Pharmacy Practice | en_US |
dc.type | Article | en_US |
dc.subject.hlbsecondlevel | Pharmacy and Pharmacology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | University Hospital B1G412/ 0028, The University of Michigan Medical Center, 1500 E Medical Center Dr. Ann Arbor, MI 40109-0028 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/69138/2/10.1177_089719008900200509.pdf | |
dc.identifier.doi | 10.1177/089719008900200509 | en_US |
dc.identifier.source | Journal of Pharmacy Practice | en_US |
dc.identifier.citedreference | Nuclear Pharmacy Practice Standards: American Pharmaceutical Association, Washington, DC, 1984 | en_US |
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dc.identifier.citedreference | Food and Drug Administration: Radioactive new drugs and radioactive biologics. Termination of exemptions. Fed Reg 40:31298, July 25, 1975 | en_US |
dc.identifier.citedreference | Vandergrift, JF: Regulatory problems in nuclear medicine, in Hladik WB, Saha GB, Study KT (eds): Essentials of Nuclear Medicine Science. Baltimore, MD, Williams & Wilkins, 1987, pp 321-330 | en_US |
dc.identifier.citedreference | Kowalsky RJ, Perry JR: Licensing, regulatory control and radiation safety, in: Radiopharmaceuticals in Nuclear Medicine Practice. Norwalk, CT, Appleton & Lange, 1987, pp 473-500 | en_US |
dc.identifier.citedreference | Chilton HM, Witcofski RL: Regulations affecting radiopharmaceuticals, in: Nuclear Pharmacy: An Introduction to the Clinical Application of Radiopharmaceuticals. Philadelphia, PA, Lea & Febiger, 1986, pp 150-157 | en_US |
dc.identifier.citedreference | Nuclear Regulatory Commission: Regulation of medical uses of radioisotopes. Statement of general policy. Fed Reg 44:8242, February 9, 1979 | en_US |
dc.identifier.citedreference | Guide for the preparation of applications for medical use programs: Regulatory Guide 10.8 (Task FC 415-4), Revision 2. Washington, DC, Nuclear Regulatory Commission, August 1987 | en_US |
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dc.identifier.citedreference | Levine G., Massetti C., Malhi B.: A methodology for preparing pediatric doses of 99m Tc MAA for pulmonary perfusion studies. J Nucl Med Technol 8:94-96, 1980 | en_US |
dc.identifier.citedreference | Siegel BA: Radiopharmaceuticals and FDA: A clinician's perspective. J Nucl Med Technol 11:177-186,1983 | en_US |
dc.identifier.citedreference | Nuclear Pharmacy Guideline: Criteria for determining when to register as a drug establishment, Division of Drug Labeling and Compliance (HFN-310). Washington, DC, Center for Drugs and Biologics, Food & Drug Administration, May 1984 | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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