Empower Clinic Services, LLC dba Empower Pharmacy

FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy (Houston, TX), an outsourcing facility registered under section 503B, following a February–March 2020 inspection. The facility failed to meet multiple 503B conditions, including omitting required adverse event reporting contact information from drug product labels (e.g., Testosterone Cypionate, HCG, FSH, Menotropins), failing to submit complete biannual drug compounding reports, maintaining inadequate adverse event reporting procedures, and wholesaling compounded drugs through a third-party entity in violation of the prohibition on wholesaling. Because these conditions were not met, the compounded products are deemed unapproved new drugs and misbranded under the FDCA, and FDA warned that failure to correct violations may result in seizure or injunction.