Beacon Hill Medical Pharmacy, P.C. – FDA Warning Letter, Jul 19, 2013

On September 24, 2014, the FDA issued a Warning Letter to Beacon Hill Medical Pharmacy, P.C. (dba) Rxtra Solutions Labs following an inspection from July 1-19, 2013. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations included: - **Lack of Valid Prescriptions:** A portion of drug products were produced and distributed without valid prescriptions for individually-identified patients, making them unapproved new drugs (Section 505(a) FDCA) and misbranded drugs (Section 502(f)(1) FDCA). - **Insanitary Conditions:** Sterile drug products were prepared, packed, or held under insanitary conditions, leading to adulteration (Section 501(a)(2)(A) FDCA). Examples include cleaning aseptic areas with soap, tap water, and non-sterile disinfectants; using non-sterile gloves for manual vial stoppering; and transferring partially stoppered vials unprotected to an unclassified area. - **CGMP Violations:** Significant Current Good Manufacturing Practice (CGMP) violations were observed, causing drug products without individual prescriptions to be adulterated (Section 501(a)(2)(B) FDCA). These included failures in: - Establishing and following written procedures to prevent microbiological