Possible Legislative Changes To Compounding Pharmacies


Often times it seems that compounding pharmacies operate in a "gray area" between state legislative oversight and federal legislative oversight. However, due to the attention created by several sterile compounding pharmacies, the federal government is once again proposing ways to regulate the compounding pharmacy industry.

The U.S. Senate recently drafted proposed legislation ("Senate Proposal") targeting compounding pharmacies. The Senate Proposal contains some fundamental changes to compounding pharmacies. For example, the proposed legislation includes compounded drugs within the definition of a "new drug" under the Federal Food, Drug and Cosmetic Act ("FDCA"). This inclusion would create a presumption that compounded drugs have to comply with the burdensome requirements of the FDCA for registration of a new drug and complying with certain manufacturing processes.

Originally Published in Birmingham Medical News - November 15, 2013.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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