Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop — FDA Warning Letter Findings

The product report submitted in December 2019 appears to identify all the drug products that you compounded during the previous 6-month period, including the products not reported upon initial registration in July 2019.

Some of your facility’s drug products did not include the National Drug Code number on the label (section 503B(a)(10)(A)(iii)(VIII) of the FDCA [21 U.S.C. § 353b(a)(10)(A)(iii)(VIII)]). For example, the drug product labels for Estradiol Pellet 6mg (NDC 71138-0006-01) and Testosterone Pellet 25mg (NDC 71138-1025-01) did not include the National Drug Code numbers. In addition, the container from which individual units of some of your facility’s drug products are removed for dispensing or for administration, including Estradiol Pellet 6mg and Testosterone Pellet 25mg, did not include directions for use (section 503B(a)(10)(B)(iii)) of the FDCA [21 U.S.C. §353b(a)(10)(B)(iii)]).

You provided documentation of a “revised Adverse Drug Event (ADE) SOP to include calendar invitations…to ensure report is submitted within 15-day requirement” and [r]etrained all employees on [this] ADE SOP.” Please note that we are unable to fully evaluate whether the aforementioned SOP is consistent with the content and format requirements established through regulation under section 310.305 of title 21, Code of Federal Regulations, because the documentation provided is…

Your facility failed to submit adverse event reports to FDA as required by section 503B(b)(5) and 21 CFR 310.305. Specifically, FDA received a report of an adverse drug experience from your firm on October 31, 2019, regarding a patient who was diagnosed with (b)(6) after administration of your compounded Testosterone 25mg, Testosterone 50mg, and Testosterone 87.5 mg pellets. However, your firm became aware of this adverse drug experience on September 26, 2019. An outsourcing…

The report your facility submitted to FDA upon initial registration, in July 2019, failed to identify all the drug products that you compounded during the previous 6-month period, including HCG Methylcobalamin B12 1000IU Injection, Testosterone Pellets-25mg, 37.5mg, 50mg, 100mg, & 200mg, Estradiol Pellets-6mg, 10mg, 12.5mg, & 15mg, Testosterone/Anastrozole Pellets-75mg/4mg & 100mg/4mg and Testosterone cypionate/ Testosterone propionate 200mg/10mg Injection.