Historically, compounding pharmacies have been regulated and licensed by state boards of pharmacy. However, due to the attention created by the New England Compounding Center case and the resulting meningitis outbreak, the federal government is once again proposing ways to regulate the industry.

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 all compounded drugs have to comply with the requirements of the FDCA such as the registration, new drug and manufacturing process.

The Senate Proposal's use and inclusion of the term "compounded drug" in the definition of "new drug" is interesting considering the proposed legislation creates two classes of compounding pharmacies as discussed below. Including all "compounded drugs" as a "new drug" is extremely broad and would include any compounded drug, even those compounded by a "traditional compounder."

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