FDA 483 - Montana Compounding Pharmacy P.C. - September 22, 2021

This FDA Form 483 documents observations from an inspection of a facility producing non-sterile drug products. The facility produced over (b)(4) non-sterile drug products in an approximately (b)(4) period, from (b)(4) to (b)(4). This included over (b)(4) highly potent drugs like testosterone, progesterone, and estrogen (e.g., RX# (b)(6) Bi-Est (8:2) - Progesterone - Testosterone 5 - 60 - 2.25 mg/gm (b)(4)), and over (b)(4) hazardous drugs such as Triodo-L-Thyronine (T3) and Thyroxine(L) (T4) (e.g., RX# (b)(6) Liothyronine Sodium (T3) 1:1000 (0.1%) (b)(4)).

The primary observation is the inadequate containment, segregation, and cleaning practices to prevent cross-contamination from highly potent and hazardous drugs. Specifically: a) The firm lacks controls, such as dedicated or segregated areas, to prevent contamination of the drug production area and cross-contamination of other drug products with highly potent and hazardous drugs. All non-sterile drugs are compounded using (b)(4) work benches, which do not adequately contain the (b)(4) bulk drug substances. b) The firm does not replace gowns between producing