IACP has submitted comments to the Food & Drug Administration (FDA) regarding the Draft Guidance:Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act


 “IACP understands and supports the need to protect public health. However, when providing guidance, it is essential that FDA adheres to the plain language of statutes and Congressional intent to preserve patient and prescriber access to vital compounded medications. Providing clear direction as to the FDA’s thoughts regarding this important subject help not only guide Agency investigators during inspections but gives additional insight to the pharmacy industry as a whole on what the FDA expects from this practice of pharmacy.

IACP is concerned with several main points of the proposed guidance, which we outline below, and we look forward to starting a dialog with the Agency on proposed solutions to the issues raised by our Academy.”

Please click here to view IACP’s entire comments to FDA.

Email iacpinfo@iacprx.org with any questions.

International Academy of Compounding Pharmacists
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