ASP Criticized for Compounding Drugs Without Approval

August 8, 2016

A compounding operation in Texas has landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns.

American Specialty Pharmacy was cited in a warning letter for producing misbranded and adulterated drugs at its facility in Plano, Texas. The complaints, based on a 2014 inspection, were prompted in part by the facility compounding drugs without prescriptions.

The inspection also determined that the firm was producing domperidone products not approved for use in the U.S.

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