| Pharmacy Compounding Primer for Physicians: Prescriber Beware. | |
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MedLine Citation:
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PMID: 23039281 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Since the development of federal standards for drug approval, the practice of medicine has historically involved the compounding of medications based on a physician's determination that a US FDA-approved product either did not exist, or could not be used for medical reasons. Today, prescriptions for non-FDA-approved compounded drugs may be driven by fanciful and largely unregulated pharmacy advertisements to physicians and patients and/or payer reimbursement policies, thus placing prescribers in the backseat for clinical decision making. This article outlines essential differences between FDA-approved drugs and compounded drugs and reasserts the primary medical role of physicians for determining what medical circumstances may necessitate treatment with non-FDA-approved products. In addition, liability concerns when prescribing non-FDA-approved drugs are discussed. While representing a US perspective, underlying principles apply globally in the setting of magistral and extemporaneous formulations produced outside national regulatory frameworks. |
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Authors:
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Sarah Sellers; Wulf H Utian |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-10-7 |
Journal Detail:
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Title: Drugs Volume: - ISSN: 0012-6667 ISO Abbreviation: Drugs Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-10-8 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7600076 Medline TA: Drugs Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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q-Vigilance LLC, North Barrington, IL, USA. |
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Descriptor/Qualifier:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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