FDA WARNING_LETTER - belmar pharma solutions, drug depot, llc., - June 17, 2022

On March 31, 2023, the FDA issued a Warning Letter to Drug Depot, LLC dba APS Pharmacy following an inspection from June 6-17, 2022. The inspection revealed that drug products compounded by the firm failed to meet the conditions for exemption under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).

Specifically, the firm compounded drug products using bulk drug substances, including (b)(4) and (b)(4), that are not eligible for 503A exemptions because they lack applicable USP/NF monographs, are not components of FDA-approved drugs, and are not on the 503A bulks list. Additionally, the firm used bulk drug substances from establishments, such as (b)(4), not registered under Section 510 of the FDCA.

These violations mean the compounded products are not exempt from FDA approval requirements (Section 505), labeling requirements for adequate directions for use (Section 502(f)(1)), and current good manufacturing practice (CGMP) compliance (Section 501(a)(2)(B)). Consequently, these "ineligible drug products" are considered unapproved new drugs and misbranded under the FDCA.

The FDA reviewed the firm's responses (July 12, August 15, September 30, 2022) but found they