apothecary health solutions/right value drug stores, llc – FDA Warning Letter, Nov 12, 2019

The FDA issued a Warning Letter to Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop, an outsourcing facility, following an inspection from October 28 to November 12, 2019. The facility, registered under section 503B of the FDCA, was found to have produced drug products that failed to meet the conditions for exemptions from certain FDCA provisions.

Key violations include: 1. **Labeling Deficiencies:** Drug product labels for Estradiol Pellet 6mg and Testosterone Pellet 25mg did not include the National Drug Code (NDC) number, and their containers lacked directions for use, violating section 503B(a)(10) of the FDCA. 2. **Incomplete Product Reporting:** The initial registration report in July 2019 failed to identify all compounded drug products from the previous six months, including various Testosterone, Estradiol, and HCG injections/pellets, violating section 503B(b)(2). 3. **Failure to Report Adverse Events:** The facility did not submit an adverse event report within the required 15 calendar days for a patient diagnosed with (b)(6) after receiving compounded Testosterone pellets, violating section 503B(b)(5) and 21 CFR 310.305.

These failures mean the compounded drug products are not eligible for exemptions