FDA WARNING_LETTER - Jacobs Pills, Inc. - February 28, 2017

On May 31, 2018, the FDA issued a Warning Letter to Jacobs Pills, Inc. dba The Healthy Choice Apothecary following an inspection from February 22-28, 2017. The inspection revealed that the firm produced drug products that failed to meet the conditions for exemption under Section 503A of the FDCA, and exhibited serious deficiencies in non-sterile drug product manufacturing practices.

Violations included: 1. **Failure to meet 503A conditions**: The firm did not receive valid prescriptions for individually-identified patients for a portion of compounded drugs. Additionally, drug products were compounded using melatonin, which is not subject to a USP/NF monograph, is not a component of an FDA-approved drug, and is not on the 503A bulks list. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements. 2. **Adulterated Drug Products (CGMP violations)**: Ineligible drug products were manufactured under significant CGMP violations, including failure to reject components not meeting specifications (21 CFR 211.84(e)), failure to ensure expiration dates were supported by stability testing (21 CFR 211.137(a)), and failure to establish and follow adequate written procedures for in-process controls and batch uniformity (21 CFR 211.110(a