Empower Clinic Services, LLC dba Empower Pharmacy – FDA Warning Letter, Mar 6, 2020

On October 15, 2021, the FDA issued a Warning Letter to Empower Clinic Services, LLC dba Empower Pharmacy, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from February 12 to March 6, 2020, which revealed that drug products produced by the facility failed to meet 503B conditions, thus losing exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Key violations included: 1. **Labeling Deficiencies:** Several injectable drug products (e.g., HCG, Testosterone Cypionate) lacked required adverse event reporting information (www.fda.gov/medwatch and 1–800–FDA–1088) on their containers, violating Section 503B(a)(10) of the FDCA. 2. **Incomplete Reporting:** The facility failed to submit complete drug product compounding reports in December 2019 and June 2020, as required by Section 503B(b)(2) of the FDCA. 3. **Inadequate Adverse Event Reporting Procedures:** The facility's procedures for adverse event reporting were deficient, lacking requirements for prompt investigation and 15-day follow-up reports for serious, unexpected adverse events, violating Section 503B(b)(5) of