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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.