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Allowing Compounding Pharmacies to Address Drug Shortages

Author(s):  Broughel James

Issue:  Mar/Apr 2022 - Volume 26, Number 2
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Abstract:  The U.S. has entered a new age of supply chain challenges, and while many of these challenges were unpredictable consequences of the COVID-19 pandemic, there are also some predictable shortages, including those that arise in the modern prescription drug market. In an effort to combat these foreseeable events, compounding pharmacies, or compounders, have the wherewithal to step in and address drug shortages when they occur. Whether they are able to assist, however, ultimately hinges not on their capabilities, but on whether they are allowed to assist under federal law.

Related Keywords: James Broughel, PhD, drug shortages, supply chain, Covid-19 pandemic, public policy, U.S. Food and Drug Administration, FDA Guidance for Industry, Federal Food, Drug, and Cosmetic Act section 503A, Federal Food, Drug, and Cosmetic Act section 503B, American Society of Health Systems Pharmacists, legislation

Related Categories: LEGAL, SUPPORT, PROFESSIONAL ISSUES

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