FDA WARNING_LETTER - Montana Compounding Pharmacy PC - May 08, 2015

From April 28 to May 8, 2015, an FDA inspection of Montana Compounding Pharmacy P.C. revealed the firm was not receiving valid prescriptions for individually-identified patients for a portion of its drug products and had serious deficiencies in sterile drug production, posing patient risks. Consequently, drugs compounded without valid prescriptions were deemed misbranded under section 502(f)(1) of the FDCA due to lacking adequate directions for use. Additionally, sterile drug products were prepared under insanitary conditions, leading to adulteration under section 501(a)(2)(A) of the FDCA. Specific insanitary conditions included inadequate facility design (e.g., carpeted areas, pets), use of non-sterile/non-pharmaceutical grade components, absence of environmental monitoring, inadequate disinfection practices, use of non-sterile gloves, and failure to demonstrate adequate hood protection. Environmental samples confirmed microbial contamination. Furthermore, for drugs compounded without valid prescriptions, the firm violated numerous CGMP regulations (21 CFR Parts 210 and 211), causing adulteration under section 501(a)(2)(B) of the FDCA, including failures in facility cleanliness, component testing, environmental monitoring systems, cleaning/disinfection, personnel clothing, aseptic procedures, time limits, and final product testing. The firm voluntarily recalled sterile products and discontinued sterile compounding. If sterile production resumes, FDA recommends a comprehensive assessment, potentially with a third-party consultant, and correction of all insanitary conditions. If the firm continues to distribute drugs without valid prescriptions, it must implement CGMP corrections and address misbranding violations. The firm must respond within 15 working days, detailing corrective actions or confirming intent not to resume sterile production, to avoid potential legal action.