ACRX Specialty Pharmacy Inc. – FDA Warning Letter, Mar 20, 2019

An FDA inspection of ACRX Specialty Pharmacy, Inc. from February to March 2019 revealed significant violations concerning compounded sterile drug products. The firm failed to meet Section 503A conditions of the FDCA, specifically by compounding drug products without valid, individually-identified patient prescriptions, such as for "Office Use." This renders these products ineligible for exemptions from new drug approval, adequate labeling, and CGMP requirements.

Furthermore, the inspection identified serious deficiencies in sterile drug production, leading to adulterated products under FDCA Section 501(a)(2)(A) due to insanitary conditions. These included poor aseptic processing practices (e.g., contaminated gowning, improper material transfer, open doors), inadequate smoke studies, and media fills not simulating worst-case conditions. Additionally, the ineligible drug products were adulterated under Section 501(a)(2)(B) due to numerous CGMP violations (21 CFR parts 210 and 211), including failures in establishing procedures for preventing microbiological contamination, environmental monitoring, equipment maintenance, stability testing, quality control unit responsibilities, and comprehensive laboratory testing for sterility, pyrogens, and final specifications. The ineligible drug products were also misbranded under FDCA Section 502(f)(1) for lacking adequate directions for use.

While the firm ceased "Office Use" orders and proposed some corrective actions, many were deemed inadequate or lacked sufficient documentation, particularly regarding aseptic processing and environmental controls. The FDA strongly recommends a comprehensive assessment of operations, potentially with a third-party consultant. Failure to promptly correct these violations within 15 working days may result in legal action, including seizure and injunction.