The Negatives About FDA’s “Positive List.”

The FDA’s proposed list of bulk ingredients that may be used in compounding medications for office use with animals (“positive list”) is positively certain to fail veterinarians, pet owners, and animals.

Facts About FDA's Guidance for Industry #256

Background

FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that Guidance in 2017.

Why Compounding from Finished Goods Will Increase Costs

Why Forcing Compounding Pharmacies to Compound from Finished Pharmaceutical Goods Instead of Bulk Active Pharmaceutical Ingredients Will Cause a Dramatic Increase in the Cost of Vital Compounded Medications.

Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients

Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients from FDA-Registered Suppliers to Make Custom Medications—and Why That’s Best

Alert

Speak up for your patients who can't speak for themselves. There are two active campaigns that you can support today:

Pharmacy or Manufacturer? Size Doesn't Matter.

Proposed regulations intended to improve the safety of compounded medications often use quantity measurements as a “marker” for safety.

The more compounds prepared, these laws reason, the less safe the compounds. So, by this rationale, the quantity of compounds made by a compounder ought to be part of a formula that distinguishes between a “traditional compounder” and a “compounding manufacturer.”

Anticipatory Compounding: An Important Part of Pharmacy Practice

The Case for Office Use of Compounded Medications

The prohibition of dispensing medication for office use, or the requirement that any pharmacy doing so must be regulated by the FDA against manufacturer-like standards, is most likely the result of misunderstanding this much needed—and in many states explicitly permitted—healthcare practice.

What is compounding?

Compounding is the Art and Science of Creating Personalized Medications.

2013 Veterinarian Survey

How Veterinarians Use Compounding Pharmacies.

This information is taken from a May 2013 survey of the customers of one of the largest veterinary compounding pharmacies in the U.S.