Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
FDA issued a warning letter to Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop, a 503B-registered outsourcing facility in Texas, following a 2019 inspection. The facility failed to meet section 503B conditions by omitting National Drug Code numbers from labels (including Estradiol and Testosterone pellets), failing to report all compounded drug products upon initial registration, and submitting an adverse event report 35 days late for a serious event involving testosterone pellets. As a result, the compounded drug products were deemed unapproved new drugs and misbranded, with FDA warning that continued non-compliance could result in seizure and injunction.
Flagged claims (4)
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
your firm became aware of this adverse drug experience on September 26, 2019. An outsourcing facility must submit to FDA reports of all serious, unexpected adverse drug experiences associated with their compounded drug products as soon as possible, but no later than 15 calendar days after first receiving information about the adverse drug experience
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
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
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
FDA reminds you that drug products produced in a 503B-registered outsourcing facility must be labeled in accordance with section 503B as one of the conditions necessary to qualify for the exemptions under section 503B of the FDCA (Section 503B(a)(10), [21 U.S.C. § 353b(a)(10)]).
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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