FDA WARNING_LETTER - Specialty Medicine Compounding Pharmacy, P.C. - November 05, 2013

On August 31, 2015, the FDA issued a Warning Letter to Specialty Medicine Compounding Pharmacy, P.C., following an inspection from October 21 to November 5, 2013. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and exhibited serious deficiencies in sterile drug production.

Violations included: - **Lack of Valid Prescriptions:** A portion of drug products were produced without valid prescriptions for individually-identified patients, making them ineligible for statutory exemptions under FDCA section 503A and misbranded under section 502(f)(1). - **Adulterated Products:** - Sterile drug products were prepared, packed, or held under insanitary conditions (e.g., exposed skin on operators' faces during gowning, failure to demonstrate adequate protection of ISO 5 area by hoods), leading to adulteration under section 501(a)(2)(A). - FDA testing of dextrose 50% injectable revealed mold in unopened vials, indicating adulteration under sections 501(a)(1) and 501(b) due to failure to meet USP standards for sterility, quality, and purity. - **Significant CGMP Violations (for drugs produced without individual prescriptions), causing adulteration under section 501(a)(2)(B):** 1. Failure to establish and follow