- Veterinarian Survey 2020
- What is compounding?
- Facts About FDA's Guidance for Industry #256
- Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients
- Why Compounding from Finished Goods Will Increase Costs
- The Case for Office Use of Compounded Medications
- Anticipatory Compounding: An Important Part of Pharmacy Practice
- Pharmacy or Manufacturer? Size Doesn't Matter.
- The Negatives About FDA’s “Positive List.”
- The Law
Ted Yoho (R-FL), Mark Pocan (D-WI), and Donald Norcross (D-NJ), members of the U.S. House of Representatives, are the lead sponsors of a letter sent to Food and Drug Administration Commissioner, Stephen Hahn, M.D., expressing their concerns about the FDA’s draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances.
The report language for the bill that funds the Food and Drug Administration (FDA) has been released by the U.S. House of Representatives Committee on Appropriations. While this language does not have the force of law, it instructs federal agencies on actions to take as part of accepting new funding from Congress.
Here are excerpts that relate to compounding pharmacy:
The Food & Drug Administration announced today that it has extended the comment period for its draft guidance #256, “Compounding Animal Drugs from Bulk Drug Substances," by 120 days, to October 15, 2020.
The Food & Drug Administration announced today that it has extended the comment period for its draft guidance #256, “Compounding Animal Drugs from Bulk Drug Substances, by 120 days, to October 15, 2020.
Drug shortages have been a perennial issue for veterinarians.
The issue is again gaining interest because demands related to treating COVID-19, the disease caused by the Novel Coronavirus, is causing pressure on the supply of drugs for animal health. Here’s a blog post written in 2012 by a veterinary ophthalmologist on one of our sponsor’s websites that reviews the causes of drug shortages in veterinary medicine. It’s just as relevant and instructive today as it was when first published.
Breaking: Pharmacy Coalition Pushes Back on FDA Draft GFI #256
Wedgewood Pharmacy and several other pharmacies that specialize in preparing compounded medication for animal patients submitted formal comments today to FDA about its proposed guidance, Compounding Animal Drugs from Bulk Drug Substances.
UPDATE: February 14, 2020
In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.
The new deadline to receive comments will be June 17, 2020.