FDA WARNING_LETTER - Hieber's Pharmacy - September 18, 2014

On September 29, 2015, the FDA issued a Warning Letter to Hieber's Pharmacy following an inspection from September 8-18, 2014. The inspection revealed the pharmacy was producing drug products without valid prescriptions for individually-identified patients and compounding domperidone products.

These actions violate the Federal Food, Drug, and Cosmetic Act (FDCA). Compounded drugs without individual prescriptions and those containing domperidone are not exempt under FDCA Section 503A, as domperidone is not a USP/NF monograph subject, an FDA-approved drug component, or on the Secretary's approved bulk drug list.

Consequently, these drugs are considered misbranded under Section 502(f)(1) because they lack adequate directions for use for a layman. Furthermore, the manufacture of drugs without individual prescriptions subjects the firm to FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211).

Significant CGMP violations were observed, rendering the drugs adulterated under Section 501(a)(2)(B). Violations included failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), lack of laboratory determination of conformance to specifications for sterile products (21 CFR 211.167(a)), inadequate stability testing programs (21 CFR 211