FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies


On December 19, 2012, the U.S. Food and Drug Administration (FDA) and officials from all 50 states' boards of pharmacy met to discuss their views on state and federal roles in regulating compounding pharmacies. The meeting was prompted by the recent fungal meningitis outbreak, which has been linked to injections produced by a compounding pharmacy, New England Compounding Center. FDA Commissioner Dr. Margaret Hamburg called the meeting to address what she described as gaps in oversight of compounding pharmacies, which FDA believes contributed to this meningitis outbreak.

FDA took the opportunity to reinforce its push for authority from Congress to regulate compounding pharmacies. The FDA has proposed Congress give it authority over "nontraditional" compounders, leaving the state boards of pharmacy to regulate the "traditional" compounders. FDA Commissioner Hamburg views FDA authority under the current law as contested and unclear. Under the FDA's proposed framework, "nontraditional" compounding pharmacies would be required to register with the FDA, label their drugs according to FDA standard, and meet FDA’s good manufacturing practices.

The FDA defines traditional compounding as the creation of a drug to meet the needs of an individual patient. The definition of a "nontraditional" compounding pharmacy is not as clear. During the meeting, the factors discussed that would be included in this definition were the risk of the medication compounded, the volume of the compounded medications dispensed and whether the medications travel across state lines. The FDA did not present a formal and definitive definition of "nontraditional" compounding.

State boards of pharmacy responded to FDA's proposal by reinforcing their capability to regulate all pharmacy practices, including compounding pharmacies, under the existing state statutes. The only clarity state boards of pharmacy sought from federal regulations was more precise definitions of "traditional" and "nontraditional" compounding, contrasted with definitions of "manufacturing."

Although state boards of pharmacy representatives did not call for federal legislation to broaden the authority of the FDA, they were frank about their need for federal cooperation in overseeing compounding pharmacies, beginning with better communication between the FDA and the state authorities. Both the states and the FDA agreed they need to keep the lines of communication open, especially when it comes to sharing inspection data. State board representatives also agreed that information must be shared among states to address the medications sent interstate.

This meeting was heralded as historic; it was the FDA's first effort to solicit feedback from the state boards of pharmacy regarding its proposal to gain congressional authority to regulate compounding pharmacies, a practice that has traditionally been regulated exclusively by the states. It remains to be seen if Congress will grant the FDA the authority it seeks.

For Further Information

If you have any questions about this Alert, please contact Rachael G. Pontikes, any member of the Pharmaceutical, Medical Device, Pharmacy & Food industry group or the attorney in the firm with whom you are in regular contact.

Topics:  Drug Compounding, FDA, Pharmacies

Published In: Administrative Agency Updates, General Business Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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