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How to submit a GFI 256 comment

A quick-start guide to making your comments count

Wedgewood Pharmacy has nominated nearly 200 medications for FDA to consider adding to their list of office stock drugs. Now FDA wants to hear from veterinarians about the compounded medications you need for office use.

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How to submit a comment

Visit the FDA docket to comment on drugs that are under review or have been reviewed and not listed.

Write your comment using the name of the bulk drug substance (BDS) about which you're commenting, and include examples of how not having the medication available for office use could impact your patient's health.

3 simple rules to make your comments count:

  1.  Always include the name the bulk drug substance. The docket does not allow you to comment on a specific preparation (ie Doxycycline 400mg Quad Tabs), so instead focus on the bulk drug substance. To make the biggest impact, focus your comments on the list of medications currently under review, and the medications that are reviewed and not listed.
  2. Focus on the "clinical difference". FDA wants to hear about how the compounded medication makes a difference in your practice. Be sure to tell them why you need the medication for office use, and provide them with a clinical rationale for using the compounded medication instead of an FDA-approved alternative. Use specific examples about allergy-friendly formulas, specific strengths, and compliance-improving flavors. Lower cost is not an acceptable reason for FDA.
  3. Follow the proper format. Be sure to select "Drug Industry" from the "what is your comment about?" menu. Clearly indicate which substance you're addressing within your comments. Example: “NAME OF BDS: I must have this medication available for office use because the FDA approved medication contains Xylitol, an artificial sweetener that is poisonous to dogs.”  You can include as many BDSs as you like within one comment.

What is GFI 256?

GFI #256, "Compounding Animal Drugs from Bulk Drug Substances," is a guidance document issued by the FDA. It gives recommendations for compounding animal drugs from bulk drug substances (BDS).

How does it affect veterinary practices?

Medications on FDA’s list of office stock drugs may be ordered for office use and prescriptions. Medications currently under review may be ordered for office use for the time-being.

Medications that have been reviewed and not listed may be prescribed for patients. You can continue to prescribe these “not listed” medications for individual patients. In some instances, you’ll be required to provide a medical rationale for prescriptions.

Submit a comment

Additional Resources

GFI 256 Resource Center

Our general counsel, Barry Siegel, is available to answer GFI related questions. Send your inquiries to hello@wedgewoodpharmacy.com

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