THE COMPOUNDING SHOP, INC. – FDA Warning Letter, Sep 3, 2013

The FDA issued a Warning Letter to The Compounding Shop, Inc. following inspections from March 18-22, 2013, and August 23-September 3, 2013. The inspections revealed significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations include: - **Lack of Valid Prescriptions:** The firm produced drug products without receiving valid prescriptions for individually-identified patients, violating Section 503A of the FDCA and the agency's Compliance Policy Guide 460.200. - **Domperidone Production:** The firm continued to produce domperidone drug products despite prior warnings in 2005. Domperidone is not subject to an applicable USP/NF monograph, is not a component of an FDA-approved human drug, and is not on a Secretary-developed list, making its compounded products ineligible for Section 503A exemptions. - **Insanitary Sterile Drug Production:** Serious deficiencies were observed in sterile drug product practices, including storing facility-dedicated clothing near a toilet, placing non-disinfected materials in an ISO 5 hood, personnel moving over open vials, hand-stoppering, and using non-sterile wipes/mats in an ISO 5 hood. These conditions render sterile products adulterated under FDCA Section 501(a)(2)(A). - **Lack of Testing