Polsinelli - FDA Regulatory


March 2014


FDA Issuing Referral Letters to State Boards of Pharmacy Against Traditional Pharmacies







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Melissa Gilmore






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FDA has recently issued several "referral letters" (RLs) to state boards of pharmacy based on year-old pre-Compounding Quality Act Form 483 Inspectional Observations. FDA counts RLs as new instruments of oversight designed to strengthen their power over both state boards of pharmacies and state-regulated pharmacies. The RLs, issued to the Oklahoma, Florida, New Jersey, and Missouri boards, "turned in" the pharmacies for "deviations from appropriate sterile practices," but did not specify whether those practices are state USP or federal GMP.

RL Key Action Points

  1. FDA believes it has the power to:
    1. inspect state-licensed non-outsourcing facilities,
    2. determine whether a state board of pharmacy is capable of properly overseeing corrections
    3. "take further action" should it feel the Board is not doing its job.
  2. All of the RLs are predicated on 483s issued on pre-CQA inspections. Now, however, the CQA delineates that state boards – and not FDA – have jurisdiction over 503A pharmacies.

It is important for pharmacies that dispense for individually-identified patients to maintain a strict jurisdictional line. The CQA specifies that the states alone may regulate 503A traditional pharmacies that have voluntarily chosen not to register as outsourcing facilities. This distinction was explicitly called out at last week's Senate HELP Committee hearing, where Senator Lamar Alexander (R-TN) questioned FDA Commissioner Margaret Hamburg on overbroad exercise of authority over non-outsourcing facilities.

Should FDA attempt to enter and inspect any 503A facility going forward, pharmacists should be aware of which regulatory bodies they need, and need not, permit access to.

For More Information

This story is still developing. For further information, please contact the author or the Coalition for Responsible Compounding:











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