Warning Letters Continue for Compounding Pharmacies – FDA Cites Five in 2014 So Far

The FDA has stepped up its surveillance of compounding pharmacies and has issued at least 5 Warning Letters to such establishment so far this year.  The beat goes on, and now the FDA must begin to integrate with the State Boards of Pharmacy and State Drug Inspectors to determine the evolving definition of what is a compounding pharmacy and what is an “outsourcing” compounding pharmacy.

The Warning Letters referred to above can be found here.  It is clear that FDA is very active in this area and who can blame them after the criticism they received from the New England Compounding Center debacle.  We are likely going to see additional enforcement actions and new warning letters as the FDA exercises its “new” authority under the Drug Quality and Security Act, signed into law on November 27, 2013.  DQSA added a new section 503B to the Food, Drug and Cosmetic Act (FDCA), under which a compounder can become an “outsourcing facility.” The law defines an outsourcing facility as “a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.”   What about those facilities that do not register as an outsourcing facility, but continue to operate as one?  What about those facilities that operate in the gray area?

The FDA will be busy because of this new legislation, and busy because of another new piece of legislation, which allows FDA to ferret out and resolve these gray area issues and identify those firms that fail to properly indemnify their facility and register.  With some of the findings such as:

  • Continued failure to obtain patient specific prescriptions for compounded products
  • Use of drugs for compounding that do not appear on the available for compounding list or that do not have a USP or NF monograph
  • Failure to hold sterile drug products under sanitary conditions
  • Failure to follow appropriate documentation practices and cGMP requirements
  • Failure to observe particulate matter in sterile product
  • Failure to ensure that proper sterile techniques are used in the preparation of products intended for parenteral administration.
  • Use of non-sterilized equipment in the production of products purported to be sterile
  • Products are misbranded because their labeling was false or misleading

The Agency efforts and actions are certainly warranted; however, they get no additional funds to carry out the additional obligations under the new Act.  Not a new problem for FDA, as Congress is good at giving the FDA more responsibilities through the passage of new legislation, but usually does not provide for increased funding to support the new requirements the Agency must undertake.  The result of this is often something else has to be put on the back burner, but rest assured, if one of the pots on the back burner boils over from lack of attention, Congress will be the first group to call FDA on the carpet.

Back to the compounding issue!  Pharmacy compounding, when conducted under the rules of the road, meets an important public health need.  The FDA and the States must now define the new boundaries for oversight and enforcement when a pharmacy steps outside of the lines.  The authorities must assure the public health mission is being met and met in an acceptable manner consistent with federal and state law and the respective regulations.