Veterinarians Voice Concerns About Proposed FDA Compounding Guidelines

by | 01.23.2020 | 4:02pm

Veterinary practices and their ability to compound medications for animals could be significantly impacted by a proposed FDA guideline, reports Pharmacy Times.

The draft guidance produced by the FDA, though not binding, would advise vets on times when the FDA doesn't plan on taking action for violations of the Food, Drug and Cosmetic Act, which is when animal drugs are compounded from bulk drug substances. Over 90 percent of respondents to the survey, which was commissioned by a coalition of pharmacies that serve animal patients, noted that access to compounded medications is important to their practice and patients.

Wedgewood Pharmacy stated that compounded medications are regularly prescribed by 99 percent of veterinarians for patients whose medical needs cannot be met by off-the-shelf alternatives. The main concerns cited by poll respondents included:

  • Cost. If vets or compounding pharmacies were banned from using bulk ingredients, the average price for compounded ingredients would increase 300 percent.
  • Reduction in number of approved bulk ingredients. Currently, there are 450 bulk active pharmaceutical ingredients that are approved; the guidelines would reduce the number of approved ingredients to seven.
  • Documentation. Vets would be required to document why their patient has a need for the compounded drug in every prescription and in every medical record.
  • Prohibition of specific prescriptions. Vets would be prohibited from prescribing a compounded medication if a manufactured drug is available that has the same active ingredient.

Read more at Pharmacy Times.

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