Empower Clinic Services, LLC dba Empower Pharmacy — FDA Warning Letter Findings

Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations. 3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include a requirement to promptly investigate and submit a follow-up report regarding a serious, unexpected adverse event within 15 calendar days of receipt of new information or as requested by FDA. [Section 503B(b)(5) of the FDCA [21 U.S.C. §353b(b)(5)]; 21 CFR 310.305(c)(2)].

Some of your facility’s drug products, including HCG (LYO) 12,000 IU Injectable, Testosterone Cypionate in GSO (5ml) 200mg/ml Injectable, FSH (LYO) 1,500 IU Injectable, and Menotropins (HMG)(LYO) 500 IU Injectable, did not include the following information on the container to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800–FDA–1088. [Section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]].

Your facility compounded a drug product, (b)(4) , that was sold by an entity other than your firm, the outsourcing facility that compounded such drug [Section 503B(a)(8) of the FDCA [21 U.S.C § 353b(a)(8)]]. Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate…

Your facility failed to submit a complete report to FDA in December 2019 and again in June 2020, identifying all the drug products that you compounded during the previous 6-month period, including Leuprolide Acetate 40mcg/0.2ml 10ml Injectable. [Section 503B(b)(2) of the FDCA [21 U.S.C. §353b(b)(2)]].