FDA WARNING_LETTER - Rocky Mountain Pharmacy Inc - March 13, 2018

An FDA inspection of Rocky Mountain Pharmacy, Inc. from March 6-13, 2018, revealed serious deficiencies in drug production, leading to the issuance of a Form FDA 483. The firm's compounded drug products failed to meet the conditions of Section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for a portion of its products. Consequently, these "ineligible drug products" are not exempt from FDA approval (Section 505), adequate directions for use (Section 502(f)(1)), and CGMP compliance (Section 501(a)(2)(B)).

Further violations included drug products being adulterated under Section 501(a)(2)(A) due to insanitary conditions and under Section 501(a)(2)(B) due to significant CGMP violations. The ineligible drug products were also misbranded under Section 502(f)(1) because their labeling lacked adequate directions for use for laymen. Additionally, the firm stocked and used domperidone, a bulk drug substance not eligible for 503A exemptions. While some corrective actions were deemed adequate, the firm's response was deficient regarding non-pharmaceutical grade components. The FDA requires a written response within 15 working days detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply means future compounded drugs will be subject to full FDA regulations, including new drug approval and CGMP.