ALERT: FDA Draft Compounding Guidance

IMMEDIATE ACTION NEEDED: Compounded medications at risk!

The FVMA has recently learned of a concerning development that, if enacted, will significantly restrict veterinarians’ ability to treat their patients. This is in regards to the FDA’s Draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (“GFI #256″): https://www.fda.gov/media/132567/download

  1. Veterinarians’ access to compounded medications would be severely restricted. A leading compounder has informed us that 36 of the 38 most-frequently prescribed medications, that are compounded from bulk ingredients, would no longer be available.
  2. The cost of compounded medications would increase an average of 300% and by as much as 3,000%. Why? FDA is proposing a scientifically unsound method for compounding from manufactured tablets and capsules instead of bulk pharmaceutical ingredients purchased from FDA-registered suppliers.
  3. Veterinarians would be burdened with new requirements to justify why they have prescribed a compounded medication. Human-health physicians have no such requirement.
  4. The FDA has no legal authority and no reason to issue this Guidance. The last time the agency issued similar guidance, it was withdrawn altogether after an outpouring of opposition, including a demand from Congress.

This is such an important matter that 9 congressmen have already signed onto a Congressional Letter expressing their concern that GFI #256 will negatively impact veterinarians’ ability to treat their patients, and are requesting the FDA to modify or withdraw the guidance so that it is: in compliance with existing laws, does not increase the cost of animal health care or restrict the safe pharmaceutical options available to veterinarians for treating their animal patients. Read the letter here.


How can you help?

The FVMA calls on all Florida licensed veterinarians to contact their Congressional Representative!

  1. Engage as much as possible with your legislators in Congress.
      • Make a phone call or send an email. The FVMA has created a template to make it as easy as possible to reach out to your congressional representatives.
        • Share your perspective on the unworkability of GFI #256, encourage your employees and teams to do the same.
        • This issue will also affect pet owners, so share this issue on social media and mention it to clients!
        • You can contact your House Representative, organized alphabetically by state, here: https://www.house.gov/representatives
  2. Prepare your unique and thoughtful comments to FDA and submit them before October 15. Submit your comments here.

 

Learn more at MyMedsMatter.com, which includes detailed information about the potentially devastating impact of this proposed Guidance.

 

The veterinary profession needs your voice to fight this!

Contact the FVMA regarding any questions you may have:
Telephone: 407-851-3862 | Email: info@fvma.org