Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy
FDA issued a warning letter to Belmar Pharma Solutions / Drug Depot, LLC dba APS Pharmacy (Palm Harbor, FL) following a June 2022 inspection, finding that the compounding pharmacy produced drug products using bulk drug substances ineligible under section 503A of the FDCA — specifically substances lacking USP/NF monographs, not components of FDA-approved drugs, and not on the 503A bulks list — and sourced from unregistered establishments. As a result, the compounded products were deemed unapproved new drugs and misbranded under sections 505 and 502(f)(1) of the FDCA. FDA warned that continued non-compliant compounding could result in seizure and injunction, and required a written corrective-action response within 15 working days.
Flagged claims (4)
their labeling fails to bear adequate directions for their intended uses.
Your firm compounded drug products using bulk drug substances, including (b)(4) and (b)(4), that are not eligible for the exemptions provided by section 503A(a), because the bulk drug substances are not the subject of applicable USP or NF monographs, are not components of FDA-approved human drugs, and do not appear on the 503A bulks list.
Your firm compounded drug products using bulk drug substances manufactured by establishments, including (b)(4), which are not registered establishments under section 510 of the FDCA.
You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.
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.
Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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