Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.

Joseph C. Hung, Samuel C. Augustine, Kenneth T. Cheng, Richard L. Green, Wade M. Hopkins, David L. Laven, Brigette R. Nelson, Neil A. Petry, James A. Ponto, Timothy M. Quinton, Dennis P. Swanson

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES: To provide background information related to the development of the Nuclear Pharmacy Compounding Guidelines, to discuss regulatory complexities related to radiopharmaceutical compounding practice, and to summarize the gaps in the current compounding regulations for radiopharmaceuticals. DATA SOURCES: The Guidelines closely follow the provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the monographs and chapters related to pharmacy compounding in the United States Pharmacopeia (USP), and the recommended guidelines published by the American Society of Health-System Pharmacists. SUMMARY: The Food and Drug Administration Modernization Act (FDAMA) of 1997 established parameters under which the compounding of drug products is appropriate and lawful, but these criteria expressly do not apply to radiopharmaceuticals. The Nuclear Pharmacy Compounding Practice Committee, a group of nuclear pharmacists convened by the American Pharmaceutical Association, developed the Nuclear Pharmacy Compounding Guidelines to establish a set of principles and guidelines for good radiopharmaceutical compounding practice. The intent of the new document is to provide guidance on radiopharmaceutical compounding practices that have evolved over the last 2 decades and to place them in an appropriate regulatory framework in accordance with previous enforcement policies and guidelines issued by the U.S. Food and Drug Administration (FDA) regarding the exemption of certain pharmacy practices from enforcement of adulteration, misbranding, and new drug requirements. CONCLUSION: The Nuclear Pharmacy Compounding Guidelines, recently released by APhA, is the first official document that provides realistic and practical compounding guidance for nuclear pharmacists. Even though the United States Court of Appeals for the Ninth Circuit recently ruled section 503A of the FD&C Act to be invalid in its entirety, and the Supreme Court upheld that ruling, the compliance policy guides issued by FDA in March 1992 and revised in May 2002 maintain guiding principles on pharmacy compounding similar to those stated in section 503A of the FD&C Act. The Nuclear Pharmacy Compounding Practice Committee is optimistic that the practical information contained in the Guidelines will assist state boards of pharmacy, FDA, and the United States Pharmacopeial Convention in setting appropriate standards for nuclear pharmacy compounding practice that will ensure the continued availability of high-quality compounded radiopharmaceuticals at reasonable cost.

Original languageEnglish
Pages (from-to)789-798
Number of pages10
JournalJournal of the American Pharmaceutical Association (Washington,D.C. : 1996)
Volume42
Issue number5
StatePublished - Sep 2002
Externally publishedYes

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Radiopharmaceuticals
Guidelines
United States Food and Drug Administration
Pharmacists
Pharmaceutical Preparations
Cosmetics
Drug Legislation
Modernization
Guideline Adherence
Drug products
Drug Compounding
Pharmacopoeias
Nuclear Pharmacy
Social Change
Availability
Networks (circuits)
Costs and Cost Analysis
Costs

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

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Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines. / Hung, Joseph C.; Augustine, Samuel C.; Cheng, Kenneth T.; Green, Richard L.; Hopkins, Wade M.; Laven, David L.; Nelson, Brigette R.; Petry, Neil A.; Ponto, James A.; Quinton, Timothy M.; Swanson, Dennis P.

In: Journal of the American Pharmaceutical Association (Washington,D.C. : 1996), Vol. 42, No. 5, 09.2002, p. 789-798.

Research output: Contribution to journalArticle

Hung, JC, Augustine, SC, Cheng, KT, Green, RL, Hopkins, WM, Laven, DL, Nelson, BR, Petry, NA, Ponto, JA, Quinton, TM & Swanson, DP 2002, 'Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.', Journal of the American Pharmaceutical Association (Washington,D.C. : 1996), vol. 42, no. 5, pp. 789-798.
Hung, Joseph C. ; Augustine, Samuel C. ; Cheng, Kenneth T. ; Green, Richard L. ; Hopkins, Wade M. ; Laven, David L. ; Nelson, Brigette R. ; Petry, Neil A. ; Ponto, James A. ; Quinton, Timothy M. ; Swanson, Dennis P. / Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines. In: Journal of the American Pharmaceutical Association (Washington,D.C. : 1996). 2002 ; Vol. 42, No. 5. pp. 789-798.
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abstract = "OBJECTIVES: To provide background information related to the development of the Nuclear Pharmacy Compounding Guidelines, to discuss regulatory complexities related to radiopharmaceutical compounding practice, and to summarize the gaps in the current compounding regulations for radiopharmaceuticals. DATA SOURCES: The Guidelines closely follow the provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the monographs and chapters related to pharmacy compounding in the United States Pharmacopeia (USP), and the recommended guidelines published by the American Society of Health-System Pharmacists. SUMMARY: The Food and Drug Administration Modernization Act (FDAMA) of 1997 established parameters under which the compounding of drug products is appropriate and lawful, but these criteria expressly do not apply to radiopharmaceuticals. The Nuclear Pharmacy Compounding Practice Committee, a group of nuclear pharmacists convened by the American Pharmaceutical Association, developed the Nuclear Pharmacy Compounding Guidelines to establish a set of principles and guidelines for good radiopharmaceutical compounding practice. The intent of the new document is to provide guidance on radiopharmaceutical compounding practices that have evolved over the last 2 decades and to place them in an appropriate regulatory framework in accordance with previous enforcement policies and guidelines issued by the U.S. Food and Drug Administration (FDA) regarding the exemption of certain pharmacy practices from enforcement of adulteration, misbranding, and new drug requirements. CONCLUSION: The Nuclear Pharmacy Compounding Guidelines, recently released by APhA, is the first official document that provides realistic and practical compounding guidance for nuclear pharmacists. Even though the United States Court of Appeals for the Ninth Circuit recently ruled section 503A of the FD&C Act to be invalid in its entirety, and the Supreme Court upheld that ruling, the compliance policy guides issued by FDA in March 1992 and revised in May 2002 maintain guiding principles on pharmacy compounding similar to those stated in section 503A of the FD&C Act. The Nuclear Pharmacy Compounding Practice Committee is optimistic that the practical information contained in the Guidelines will assist state boards of pharmacy, FDA, and the United States Pharmacopeial Convention in setting appropriate standards for nuclear pharmacy compounding practice that will ensure the continued availability of high-quality compounded radiopharmaceuticals at reasonable cost.",
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