The 14 January 2014 letter to Triangle Compounding Pharmacy comes after a February and March 2013 inspection of the company's Cary, NC, facility. The company reportedly compounds sterile drug products, and had already been the subject of a March 2013 FDA Form 483 outlining alleged deficiencies identified at the manufacturing facility after that same inspection.
503A ViolationsWhile there, FDA inspectors said they determined that the company was not receiving valid prescriptions for individually-identifiable patients—a violation of Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act). Regulators said that despite "conflicting judicial decisions regarding the applicability of Section 503A" at the time of the inspection, the relevant sections of 503A and the agency's own Compliance Policy Guidance (460.200) were both applicable and in effect.
"During the FDA inspection, investigators observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce," FDA wrote. "Based on this factor alone, those drugs were not entitled to the statutory exemptions for compounded drugs described in section 503A of the FDCA and did not qualify for the agency’s exercise of enforcement discretion set forth in the CPG."
FDA also noted that since the inspection, Congress and the president enacted the Drug Quality and Security Act (DQSA), which affirmed that the 503A restrictions against compounding products without a valid prescription are "applicable in every federal judicial circuit."
FDA also explained those authorities at length in a trio of guidance documents released in December 2013, and the Warning Letter—in addition to another released on the same day--appears to be the first instance of FDA expressing those authorities.
Sterility ConcernsBut even outside of the above complaints, FDA maintained that Triangle Compounding has more serious problems related to the sterility of its products.
"FDA investigators noted that your sterile drug products were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health," the agency wrote in its Warning Letter.
continue to read here