FDA WARNING_LETTER - Duren Health Mart Pharmacy - November 14, 2018

On November 1, 2019, the FDA issued a Warning Letter to Duren Health Mart Pharmacy following an inspection from November 6-14, 2018. The inspection revealed that drug products produced by the pharmacy failed to meet the conditions for exemption under Section 503A of the FDCA, putting patients at risk.

Specifically, the pharmacy compounded drug products using domperidone, which is not eligible for 503A exemptions as it lacks a USP/NF monograph, is not an FDA-approved drug component, and is not on the 503A bulks list. This renders these products unapproved new drugs, misbranded, and subject to CGMP regulations.

The inspection also identified significant violations, causing drug products to be adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions. These included distributing non-sterile products made with expired ingredients, failing to confirm water quality, using unsuitable and modified equipment, and inadequate cleaning of utensils and glassware. Furthermore, the firm failed to investigate unexplained discrepancies or batch failures, violating 21 CFR 211.192, making ineligible drug products adulterated under Section 501(a)(2)(B). The ineligible drug products were also misbranded under Section 502(f)(1) as they lacked adequate directions for use.

The FDA acknowledged the firm's voluntary cessation