# FDA WARNING_LETTER - prescription dispensing laboratories, inc.  - May 11, 2018

Source: https://www.keypedia.com/records/warning_letter/prescription-dispensing-laboratories-inc/f5960a42-abd3-4925-9d7b-f43c17ef201b

> FDA WARNING_LETTER for prescription dispensing laboratories, inc.  on May 11, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: prescription dispensing laboratories, inc. 
- Inspection Date: 2018-05-11
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/prescription-dispensing-laboratories-inc/ab8e0a62-5f5e-4280-830b-4288a4561038

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6