FDA WARNING_LETTER - Brookfield Prescription Center Inc. dba MD Custom Rx - December 10, 2013

An FDA inspection of Brookfield Prescription Center Inc. dba MD Custom Rx from December 3-10, 2013, identified significant violations, resulting in a Form FDA 483 and this Warning Letter. The firm was not receiving valid prescriptions for individually-identified patients for a portion of its drug products, classifying them as unapproved new drugs (FDCA 505(a)) and misbranded (FDCA 502(f)(1)) due to inadequate directions for use. Serious deficiencies in sterile drug product practices were observed, including insanitary conditions like operators with exposed skin and non-sterile masks, and failure to demonstrate adequate hood protection, rendering sterile products adulterated (FDCA 501(a)(2)(A)). For drugs compounded without valid prescriptions, the firm was subject to CGMP regulations (21 CFR Parts 210 and 211), with numerous violations cited, leading to adulteration (FDCA 501(a)(2)(B)). These included failures in establishing appropriate sterile procedures, cleaning systems, personnel clothing, final product testing, stability testing, and separation of penicillin operations. A prior sterility failure also led to a product recall. The firm indicated discontinuing sterile drug production and committed to USP <795> compliance for non-sterile preparations. FDA strongly recommends a comprehensive assessment, potentially with a third-party consultant, and full implementation of 21 CFR Part 211 corrections before resuming any sterile operations. Failure to correct violations may result in legal action. A written response is required within 15 working days.