Texas Drug Compounder Violates FDA’s Requirements

A Texas pharmacy is violating drug compounding requirements, the FDA said in a letter posted Aug. 2.

The pharmacy, American Specialty Pharmacy Inc. in Plano, Texas, is producing drugs that violate the Federal Food, Drug, and Cosmetic Act, the agency said in a warning letter dated June 28. The agency said the pharmacy isn’t receiving valid prescriptions for individually identified patients for a portion of its products, as is required for compounding pharmacies.

FDA investigators found the violations during an inspection in December 2014.

The letter is part of the Food and Drug Administration’s stepped-up enforcement in the drug compounding ...