Corrective Action stated in recent FDA warning letters to compounding pharmacies is very informative about the FDA's future application of the DQSA.

C.  Corrective Actions

 

In your response to the Form FDA 483 dated March 7, 2013, you referenced your purported compliance with United States Pharmacopeia (USP)-National Formulary (NF) General Chapter <797>, “Pharmaceutical Compounding - Sterile Preparations.” As noted above, your firm has manufactured and distributed drugs without valid prescriptions for individually-identified patients, and the manufacture of such drugs is subject to FDA’s drug CGMP regulations, 21 CFR Parts 210 and 211. Your firm’s planned corrections do not meet the minimum requirements of 21 CFR part 211, and there is no assurance that the drug product(s) produced by your firm without valid prescriptions for individually-identified patients conform to these basic quality standards that ensure safety, identity, strength, quality, and purity. 

 

FDA strongly recommends that your management immediately undertake a comprehensive assessment of your manufacturing operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.

 

quoted from Warning Letter to Avella Deer Valley, Inc. 1/17/14.  See also Warning Letter to Triangle Compound 1/14/14 for additional indications of the FDA's future application of the DQSA.