Compounding Pharmacies Anticipate Increased Federal (and Potentially State) Regulation
By EsqSocial Corporation 09/11/20
Last week, the U.S. Food and Drug Administration (FDA) took a significant step towards increased regulation of 503A human drug compounding pharmacies, which may cascade into additional state regulation. 503A compounding pharmacies are state-licensed pharmacies that provide drugs to clinicians according to a patient-specific prescription. Contrast 503A pharmacies that dispense drugs according to a patient-specific prescription with 503B pharmacies (also known as "outsourcing facilities") that can...
By: Wilson Sonsini Goodrich & Rosati