Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status

A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November.

Nine of the 11 drug GMP warning letters issued in 2014 that were posted by FDA through March went to injectable compounders.

The 2014 warning letters contain similar language explaining the regulatory policy environment that compounders are operating in, given the new authorities granted to FDA in DQSA (IPQ December 28, 2013).

The agency explains in the letters that at the time the recipients were inspected in 2013 prior to DQSA’s passage, there were “conflicting judicial decisions regarding the applicability of section 503A of the FDCA [21 U.S.C. § 353a], which exempts compounded drugs from several key statutory requirements if certain conditions are met.”  Title I of DQSA – referred to as the “Compounding Quality Act” (CQA) – the agency notes, amended that section of the Act by eliminating the advertising restrictions that had been the basis for the judicial conflicts.

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