The Food & Drug Administration announced today that it has extended the
comment period for its draft guidance #256, “Compounding
Animal Drugs from Bulk Drug Substances," by 120 days, to October 15, 2020.
In its
announcement, FDA said that it did so “in response to requests to extend the
comment period.” These included letters from the
Alliance for Pharmacy Compounding,
Congressional Veterinarians, and the American Veterinary Medical Association.
Wedgewood Pharmacy and the MyMedsMatter coalition of compounding pharmacies worked closely with APC
and members of Congress in making their requests to FDA. The coalition submitted
comments to FDA on February 26, 2020 outlining how FDA is overreaching and
exceeding its statutory authority. It also published “Facts
About FDA’s Guidance for Industry #256,” explaining how the guidance would
restrict access to compounded medications, reduce the quality and safety of
compounded medications, increase the cost by an average 300%, and burden
veterinarians with additional FDA regulatory oversight. Veterinarians, pet
owners, compounding pharmacy representatives and any person or organization that
would be impacted negatively by FDA’s guidance if enacted, may now submit
comments directly to FDA until the extended deadline of October 15, 2020.
To have the greatest impact, follow these best practices for
submitting
comments to FDA:
- Make your comments personal. Be sure to include your name, company name,
and contact information.
- Draw from your past experiences and clearly state how GFI #256 would
have an impact on your practice and patients, or your pet.
- Know the facts. Read more about the impacts of GFI #256 at MyMedsMatter.com.
Remember: comments are not votes. One well-written, well-supported comment is
often considered more influential than hundreds of copied letters. Submit
a comment to FDA before October 15, 2020.