prescription dispensing laboratories, inc. – FDA Warning Letter, May 11, 2018

On July 30, 2019, the FDA issued a Warning Letter to Prescription Dispensing Laboratories, Inc. dba PD Labs following an inspection from May 7-11, 2018. The inspection revealed that drug products compounded by PD Labs failed to meet the conditions for exemption under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), rendering them unapproved new drugs and misbranded.

Specifically, PD Labs compounded drug products using alpha-GPC, BPC-157 acetate, nicotinamide riboside chloride, panax ginseng (RG3), theacrine, and thymus. These substances are not subject to applicable USP or NF monographs, are not components of FDA-approved human drugs, and do not appear on the 503A bulks list. Consequently, these 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) regulations (Section 501(a)(2)(B)). The firm also compounded products with colloidal silver, which similarly lacks 503A exemption eligibility and has associated safety concerns.

The FDA stated that PD Labs' agreement to cease compounding theacrine and thymus was adequate, but their intent to continue compounding alpha-GPC, BPC-157 acetate, nicotinamide rib