February 2022

Compounding Update: Status of FDA’s Compounding MOU

In the National Association of Boards of Pharmacy’s (NABP) Innovations publication, health care associate Jonathan Keller, PharmD, and Food and Drug Administration (FDA) regulatory associate Genevieve Razick discuss the FDA’s revised draft guidance for hospitals related to compounding.

The authors outline Wellness Pharmacy Inc., et al. v. Becerra, et al. and how the case represents the latest of the long-standing battle between FDA and compounding pharmacies regarding the issue of distinguishing between legitimate compounding versus new drug distribution. They further provide historical background on the regulation of compounded drugs.

Keller and Razick also explain that the final FDA’s Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products provides that the compounding of drugs by pharmacies located within signatory states will be exempt from the Food, Drug and Cosmetic Act’s new drug requirements. In conclusion, they address the plaintiffs’ challenge and the court’s decision that the final MOU is subject to the Regulatory Flexibility Act because it is a legislative rule.

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