Boothwyn Pharmacy LLC – FDA Warning Letter, Oct 22, 2024

Boothwyn Pharmacy, located at 221 Gale Lane, Kennett Square, PA, was inspected by the FDA from September 23 to October 22, 2024. The inspection revealed significant issues with the pharmacy"s practices in producing animal drugs, leading to the issuance of a Form FDA 483. Key violations included the production and distribution of unapproved new animal drugs compounded from bulk drug substances (BDS), which are considered adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, these drugs lacked the necessary approval or index listing required under section 512 of the FD&C Act, making them unsafe and adulterated under section 501(a)(5).

Additionally, the labeling of these drugs failed to provide adequate directions for use, rendering them misbranded under section 502(f)(1) of the FD&C Act. The pharmacy also distributed compounded drugs without specifying the animal species, posing potential risks to both animal and human health. Furthermore, Boothwyn Pharmacy was found to be compounding copies of FDA-approved or indexed products and producing drugs without patient-specific prescriptions, known as "office stock," both of which are enforcement priorities for the FDA.

The FDA requires Boothwyn Pharmacy to cease the production and distribution of these unapproved and misbranded animal drugs and to comply with the Current Good Manufacturing Practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act. The pharmacy must address these violations to avoid further regulatory action.