FDA WARNING_LETTER - United Pharmacy - August 18, 2017

The FDA issued a Warning Letter to United Pharmacy, LLC, following an inspection from August 14-18, 2017. The inspection revealed that the firm produced drug products that failed to meet the conditions for exemption under section 503A of the FDCA, specifically regarding sterile drug product practices, which posed patient risks.

Violations included compounding drugs with Growth Hormone Releasing Peptide 2 (GHRP-2), Growth Hormone Releasing Peptide 6 (GHRP-6), and chromium picolinate. These substances are not subject to USP/NF monographs, are not components of FDA-approved drugs, and are not on the 503A bulks list, rendering the compounded products ineligible for 503A exemptions from CGMP, adequate labeling, and FDA approval requirements.

The firm's drug products were deemed adulterated under section 501(a)(2)(A) due to insanitary conditions, evidenced by an adverse event report of tissue erosion from an injectable GAC product. Furthermore, FDA analysis of GAC samples found no glutamine, making the product adulterated under section 501(c) for differing from its purported strength. The ineligible drug products are also unapproved new drugs under sections 505(a) and 301(d), and misbranded under section 502(f)(1) as they lack adequate directions for use for self-diagnosis