Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

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.

Passage 3

You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.

Passage 4

The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.