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Focus on Regulation

Compromise Legislative Proposal on Regulation of Compounding Pharmacies Released

Last evening, House and Senate staff released a new legislative proposal that reflects their negotiated agreement on how to clarify the Food and Drug Administration’s (FDA) authority to regulate compounding pharmacies.

The legislation will resolve the 1st Amendment and severability issues relating to section 503A of the Food, Drug and Cosmetic Act.  These issues have previously impeded FDA’s efforts to take enforcement actions against pharmacies engaged in large scale commercial compounding.  With these changes, it is anticipated that FDA will move to limit the ability of pharmacies to compound large quantities of drugs without a prescription and further restrict them from making versions of commercially available drugs that are essentially copies of the marketed drug.  The bill also establishes new regulatory requirements for large scale compounders, which will now have to become registered “outsourcing facilities.”