FDA Hears Comments from AVMA, Key Stakeholders on Pharmacy Compounding Changes

By: Dr. Ashley Morgan, assistant director, Governmental Relations Division

In response to the recent fungal meningitis outbreak, the Food and Drug Administration (FDA) held meetings with stakeholder groups last month to hear comments on its proposed framework to change pharmacy compounding regulations.

“Compounding” is any manipulation of a drug beyond that which is stipulated on the drug label and might include mixing, diluting, concentrating, flavoring or changing a drug’s dosage form.

Since veterinarians are major users of compounded medications, the FDA commissioner’s office invited the AVMA to participate in a roundtable discussion with other health care professionals on Dec. 12, 2012.  Having a seat at the table during these discussions gave AVMA the opportunity to explain how the impending changes to pharmacy compounding regulations might impact veterinary medicine and to stress the need for the FDA to continue approving new animal drugs.

“Compounding is necessary in some cases for veterinarians because there are, and always will be, a limited number of FDA-approved drugs for the many species and conditions that we treat,” said Dr. Morgan, who attended the roundtable discussion on behalf of the association. “In addition, intermittent drug shortages and commercial unavailability of FDA-approved drugs drive the need for compounded medications in various situations within veterinary medicine.”

Though compounding is a necessity for veterinary medicine, the AVMA contends that the approval of new animal drugs should remain a high priority for the FDA “as it would curtail the need for compounded preparations in veterinary medicine,” said a follow-up letter to the agency from Dr. Ron DeHaven, AVMA’s executive vice president and chief executive officer.

The agency also hosted representatives from all 50 states for an intergovernmental meeting on Dec. 19, 2012.  This meeting created a venue for the states to discuss their role and the role that the FDA has in the oversight of compounding.  The FDA and the states presented their perspectives and a summary of the discussion during a public meeting.

The FDA continues to seek public comments in response to the issues that were discussed during the December meetings and questions that have been posed in the Federal Register Notice.  The deadline for submitting comments is Jan. 18, 2013.  For information, contact Patricia Kuntze at patricia.kuntze@fda.hhs.gov or at:

Patricia Kuntze
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 32, Rm. 5322
Silver Spring, MD 20993

To read the FDA’s proposed framework on pharmacy compounding, see the commissioner’s testimony given at the U.S. House of Representatives and U.S. Senate hearings held in November 2012.

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