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 stock.

Under FDA Guidance for Industry #256, many compounded medications can no longer be used for office stock and are only available through patient-specific prescriptions.

The FDA is actively seeking feedback from veterinarians. If they don’t hear from the profession, these restrictions will remain—and could expand. By sharing your experiences, you can help them to understand why timely access to compounded office stock is critical for patient care.

Every comment makes a difference. Your input helps protect treatment flexibility for your practice and for the entire veterinary community.

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 stock could impact your patient's health.

1.  Always include the name of 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 stock, 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.

• A significant percentage of my patients reject the commercial product.
• Animals often refuse commercial liquid medications or cannot be accurately dosed with liquids due to refusal of a syringe, spitting, drooling, and/or the inability to gauge how much of the medication has been ingested.
• Only a very restricted range of low-concentration oral suspensions are currently permitted for office use. This range of drugs is insufficient to meet the needs of animals who may require other dosage forms or strengths.
• Tablet sizes of the commercial product are too large for many feline and small canine patients, resulting in compliance failure. Additionally, commercial tablet products cannot be split accurately into appropriate weight-based doses.
• Animals left untreated while waiting 1-2 weeks for a patient-specific prescription may experience unresolved diarrhea containing blood and mucous, vomiting, lethargy, anorexia, and even death. Giardia infections, which are commonly treated with Metronidazole, have zoonotic potential and must be treated immediately to prevent human infection.

GFI 256 Resource Center

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