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.