Boothwyn Pharmacy LLC

Warning LetterOpen

Arthur J. Dustman Chief Operating Officer Boothwyn Pharmacy LLC 221 Gale Ln Kennett Square , PA 19348 United States adustman@boothwyn.comFEI 1000076625Issued Jun 9, 2025Center for Veterinary Medicine

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000076625.

Violations4

Issue DateJun 9, 2025

Product TypeAnimal & Veterinary

StatusOpen

Letter Details

Firm: Boothwyn Pharmacy LLC
Location: Arthur J. Dustman Chief Operating Officer Boothwyn Pharmacy LLC 221 Gale Ln Kennett Square , PA 19348 United States adustman@boothwyn.com
FEI Number: 1000076625
Country: United States
Issue Date: June 09, 2025
Issuing Office: Center for Veterinary Medicine
Product Type: Animal & Veterinary
Status: Open

Summary

Boothwyn Pharmacy LLC, an animal drug compounder in Pennsylvania, was cited for producing and distributing unapproved new animal drugs and adulterated/misbranded animal drugs in violation of the Federal Food, Drug, and Cosmetic Act. During a September-October 2024 inspection, the FDA found that the pharmacy compounded approximately (b)(4) animal drug prescriptions from bulk drug substances without the required new animal drug applications for interstate commerce, and the company's November 2024 response failed to adequately address how it would cease this practice. The facility also had deficiencies in drug production practices documented on FDA Form 483, which remained unresolved regarding the legal pathway for producing compounded animal drugs.

Boothwyn Pharmacy LLC FDA Warning Letter, June 9, 2025