Montana Compounding Pharmacy PC – FDA Warning Letter, Sep 20, 2016

The FDA issued a Warning Letter to Montana Compounding Pharmacy, P.C. dba Montana Compounding Pharmacy and Wellness Center, following an inspection from August 30 to September 20, 2016. The inspection revealed that the firm produced drug products that failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, and exhibited serious deficiencies in non-sterile drug product production, posing patient risks.

A key violation was the failure to receive valid prescriptions for individually-identified patients for a portion of distributed drug products from January to March 2016, a repeat violation from a December 2015 warning letter. This renders these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval requirements.

The firm's drug products were deemed adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions, including using non-pharmaceutical grade water contaminated with *Burkholderia cepacia*, observed vermin (fly) in production areas, and inadequate containment/cleaning for hazardous drug production, leading to cross-contamination risk. Ineligible drug products were also adulterated under Section 501(a)(2)(B) due to significant CGMP violations, such as failure to test components for purity/strength/quality and microbiological contamination, maintain clean facilities, design facilities to prevent contamination, and establish stability testing programs.

Additionally, the ineligible