Veterinarians Concerned About Negative Impact of Proposed FDA Compounding Guidance

A proposed FDA guidance could significantly impact veterinary practices and their ability to compound medicines for animal patients, according to a national survey.¹ The research was commissioned by a coalition of pharmacies serving veterinarians and animal patients in the United States.¹

According to the FDA's request for public comment, the draft guidance would advise veterinarians on circumstances under which the FDA does not plan to take action for certain violations of the Federal Food, Drug, and Costmetic Act when pharmacists and veterinarians compound animal drugs from bulk drug substances.² Although the guidance is not a law and would not be binding for FDA, compounding pharmacies, or veterinarians, the FDA uses non-binding guidance as the basis for its enforcement actions.¹

The survey, which is still ongoing, has so far reported the responses of 1849 veterinary professionals in the United States, 78% of whom practice in a small business with 4 or fewer veterinarians. Furthermore, over 90% said that maintaining access to compounded medications when they are necessary in their medical judgment is important.³

Respondents were asked a variety of questions about their use of compounded medications. Notably, 55.5% said they "frequently" order compounded medications for office stock, compared with 17.4% who answered "always," 20.2% who said "occasionally," and 6.6% who said "rarely" or "never."³

The drafted guidance would change the way medications are prepared for difficult-to-treat patients, defined as those whose needs cannot be met with "off the shelf" alternatives. Compounded medications are regularly prescribed by 99% of veterinarians according to a statement by Wedgewood Pharmacy, which specializes in veterinary medicine.¹

The poll found significant concerns from veterinarians on the proposed changes:

• If veterinarians or compounding pharmacies were required to compound from finished pharmaceutical goods instead of bulk active pharmaceutical ingredients (APIs), the average price of compounded medications would increased by 300%. According to the survey, 98% of respondents said this would have a negative impact.¹
• Instead of the current 450 APIs that can be used for compounding, the proposed guidelines would limit approval APIs to 7 items.³ Of those surveyed, 96% said this would have a negative impact.¹
• The guidelines would also prohibit veterinarians from prescribing a compounded medication from APIs if there is a manufactured drug that contains the same active ingredient.³ This provision would have a negative impact, according to 96% of those surveyed.¹
• Compounding from bulk APIs using the 11 APIs currently listed on the FDA's proposed "negative list" would be prohibited.³ 94% of survey respondents said this would be negative.¹
• Veterinarians would be required to document why there is a clinical need for a compounded medication on every prescription and in every medical record.³ In the survey, 90% said this would have a negative impact.¹

According to the release by Wedgewood Pharmacy, the draft guidance is very similar to an FDA guidance issued in 2015,¹ which was withdrawn following significant pushback.² The new proposed guidance is intended to replace the original, withdrawn guidelines.²

REFERENCES

• In New National Poll, Veterinarians Report That FDA's Proposed Guidance Will Have a Significant Negative Impact on Animal Patients [news release]. Swedesboro, NJ; Jan 8, 2020. BusinessWire. https://www.businesswire.com/news/home/20200108005168/en/New-National-Poll-Veterinarians-Report-FDA%E2%80%99s-Proposed. Accessed Jan 10, 2020.
• FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances [news release]. FDA website; Nov 19, 2019. https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-revised-draft-guidance-compounding-animal-drugs-bulk-drug-substances. Accessed Jan 10, 2020.
• How Veterinarians Use Compounding Pharmacy: 2019/2020 [survey]. https://www.mymedsmatter.com/sites/default/files/Veterinarian_Survey_2019_Results_010620.pdf. Accessed Jan 10, 2020.