- Veterinarian Survey 2020
- What is compounding?
- Facts About FDA's Guidance for Industry #256
- Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients
- Why Compounding from Finished Goods Will Increase Costs
- The Case for Office Use of Compounded Medications
- Anticipatory Compounding: An Important Part of Pharmacy Practice
- Pharmacy or Manufacturer? Size Doesn't Matter.
- The Negatives About FDA’s “Positive List.”
- The Law
CVM GFI #256 Compounding Animal Drugs from Bulk Drug Substances
The report language for the bill that funds the Food and Drug Administration (FDA) has been released by the U.S. House of Representatives Committee on Appropriations. While this language does not have the force of law, it instructs federal agencies on actions to take as part of accepting new funding from Congress.
Here are excerpts that relate to compounding pharmacy:
The Food & Drug Administration announced today that it has extended the comment period for its draft guidance #256, “Compounding Animal Drugs from Bulk Drug Substances, by 120 days, to October 15, 2020.
The Food & Drug Administration announced today that it has extended the comment period for its draft guidance #256, “Compounding Animal Drugs from Bulk Drug Substances," by 120 days, to October 15, 2020.
On May 5, 2020, Scott Brunner, CEO of the Alliance for Pharmacy Compounding (formerly the International Academy of Compounding Pharmacists) wrote to Dr. Steven Solomon, DVM, Director of the Center for Veterinary Medicine of the Food and Drug Administration, and requested a further 180-day extension of the comment period for FDA’s draft GI #256, Compounding Animal Drugs from Bulk Drug Substances.
Breaking: Pharmacy Coalition Pushes Back on FDA Draft GFI #256
Wedgewood Pharmacy and several other pharmacies that specialize in preparing compounded medication for animal patients submitted formal comments today to FDA about its proposed guidance, Compounding Animal Drugs from Bulk Drug Substances.
The FDA’s proposed list of bulk ingredients that may be used in compounding medications for office use with animals (“positive list”) is positively certain to fail veterinarians, pet owners, and animals.
UPDATE: February 14, 2020
In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.
The new deadline to receive comments will be June 17, 2020.
FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that Guidance in 2017.