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Compounding Update: FDA’s Draft Guidance on Veterinary Compounding

2 MIN READ|
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by PCCA|
April 7, 2020 |
Pharmacy Legislation/Regulation, Veterinary Compounding

By Amy Shank, PCCA Director of Government Relations

This article was updated: September 1, 2020

In November 2019, the FDA released the draft guidance Compounding Animal Drugs from Bulk Drug Substances: Guidance for Industry (GFI) #256. This guidance would severely limit access to compounded medications for animal patients, and it is similar to agency guidance issued in 2015 that the FDA later withdrew.

The FDA does not have the statutory authority to regulate animal compounding from bulk ingredients, and Congress had previously cautioned the agency that any new guidance document should be grounded in statute. As written, the draft proposal:

Requires compounds made for individual animal patients to be made from FDA-approved products unless a clinical need demonstrates why it has to be made from the bulk drug substance. The FDA has not demonstrated that the active ingredients from approved products are of higher quality or that final compounds prepared from FDA-approved products are of higher quality. Pharmacies also do not generally have access to FDA-approved animal drug products to compound with them if they were required to do so
Would create a positive list and negative list of bulk drug ingredients for medications compounded for office use, which would limit treatment options for animal patients
Singles out veterinarians as the only practitioners required to demonstrate a clinical need for a patient to receive a compounded medication
Requires that formulations that have a USP compounded finished product monograph must follow that monograph, which would expose some animals to inappropriate ingredients and remove the option for customization to the animal patient
Establishes a significantly more restrictive framework for compounding medications for animal patients than for humans, since the Drug Quality and Security Act authorizes compounding from bulk drug substances for human patients

The public comment period for the FDA draft guidance on veterinary compounding was originally set to end on February 18, 2020, but in response to feedback from numerous stakeholder organizations, the FDA has extended the comment period to October 15, 2020. This gives compounders more time to voice their concerns about this issue.

How You Can Stand up for Veterinary Compounding
It is important for you to provide your feedback to the FDA by October 15, 2020, in order to protect your veterinary patients’ access to compounded medications. To help with this, we have prepared a customizable GFI #256 letter template that you can download. You can share it with your local veterinarians, too.

Want to Learn More?
PCCA members can watch our informational webinar on GFI #256 in PCCA Play, our educational media library. It features Matt Martin, PharmD, PCCA Clinical Services Manager, and Chris Simmons, RPh, PCCA Vice President of Creative Development. They can also visit the PCCA Public Affairs page on our Members-Only Website or email us at publicaffairs@pccarx.com.

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group (CHCG), where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip Office as a policy advisor.