FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Warns Montana Compounder Over Insanitary Conditions

June 5, 2019

The FDA issued a warning letter to a Montana compounding pharmacy for insanitary conditions and significant violations of good manufacturing practices.

Rocky Mountain Pharmacy of Bozeman also doled out gels and creams without valid prescriptions, the FDA said in the May 9 letter.

The warnings followed inspections from March 6 through March 13, when investigators found that potent “drug products were prepared without adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.” Specifically, the firm used non-dedicated equipment and utensils to produce drug product with no assurance that the cleaning process “can deactivate and remove residual drug product,” the agency said.

The compounder also failed to confirm its water quality and used non-pharmaceutical grade components, such as alcohol, when making non-sterile drug products.

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