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