• Hero Banner
  • ACVCACVC
  • DVM 360
  • Fetch DVM 360Fetch DVM 360
DVM 360
dvm360 | Veterinary News, Veterinarian Insights, Medicine, Pet Care
dvm360 | Veterinary News, Veterinarian Insights, Medicine, Pet Care
By Role
AssociatesOwnersPractice ManagerStudentsTechnicians
Subscriptions
dvm360 Newsletterdvm360 Magazine
News
All News
Association
Breaking News
Education
Equine
FDA
Law & Ethics
Market Trends
Medical
Products
Recalls
Regulatory
Digital Media
dvm360 LIVE!™
Expert Interviews
The Vet Blast Podcast
Medical World News
Pet Connections
The Dilemma Live
Vet Perspectives™
Weekly Newscast
dvm360 Insights™
Publications
All Publications
dvm360
Firstline
Supplements
Top Recommended Veterinary Products
Vetted
Clinical
All Clinical
Anesthesia
Animal Welfare
Behavior
Cardiology
CBD in Pets
Dentistry
Dermatology
Diabetes
Emergency & Critical Care
Endocrinology
Equine Medicine
Exotic Animal Medicine
Feline Medicine
Gastroenterology
Imaging
Infectious Diseases
Integrative Medicine
Nutrition
Oncology
Ophthalmology
Orthopedics
Pain Management
Parasitology
Pharmacy
Surgery
Toxicology
Urology & Nephrology
Virtual Care
Business
All Business
Business & Personal Finance
Buying or Selling a Practice
Hospital Design
Leadership & Personal Growth
Personnel Management
Practice Finances
Practice Operations
Technology
Wellbeing & Lifestyle
Continuing Education
Conferences
Live Conferences
Conference News
Conference Proceedings
Resources
CBD in Pets
Contests
Veterinary Heroes
Partners
Spotlight Series
Team Meeting in a Box
Toolkit
Top Recommended Veterinary Products
Vet to Vet
  • Contact Us
  • Fetch DVM360 Conference
  • Terms and Conditions
  • Privacy
  • Do Not Sell My Information
  • About Us

© 2023 MJH Life Sciences and dvm360 | Veterinary News, Veterinarian Insights, Medicine, Pet Care. All rights reserved.

Advertisement
By Role
  • Associates
  • Owners
  • Practice Manager
  • Students
  • Technicians
Subscriptions
  • dvm360 Newsletter
  • dvm360 Magazine
  • Contact Us
  • Fetch DVM360 Conference
  • Terms and Conditions
  • Privacy
  • Do Not Sell My Information
  • About Us
  • MJHLS Brand Logo

© 2023 MJH Life Sciences™ and dvm360 | Veterinary News, Veterinarian Insights, Medicine, Pet Care. All rights reserved.

FDA appeals compounding ruling

January 1, 2007

New Orleans - Federal regulators want the U.S. Court of Appeals for the Fifth Circuit to overturn a trial court's ruling that limits the Food and Drug Administration's (FDA) jurisdiction over the production of some compounded drugs.

NEW ORLEANS — Federal regulators want the U.S. Court of Appeals for the Fifth Circuit to overturn a trial court's ruling that limits the Food and Drug Administration's (FDA) jurisdiction over the production of some compounded drugs.

The appeal, filed Dec. 1, is the latest move by FDA, which has sent warning letters to two animal-health and seven human-health compounding companies since a U.S. District Court ruled Aug. 30 that compounding from bulk ingredients does not violate the Federal Food, Drug and Cosmetic Act (FDCA), as asserted by the regulatory agency.

FDA has long maintained that compounding from bulk substances constitutes manufacturing and is subject to the agency's oversight. Yet the 26-page decision exempts compounding drugs in "reasonable quantities" with receipt of a valid prescription from a licensed practitioner.

Advertisement

The trial court decision is valid only in the Western Texas district. The appeals ruling will cover Louisiana, Texas and Mississippi. Any challenge would go to the U.S. Supreme Court.

Detailed warnings

In the meantime, Wedgewood Pharmacy and Pharmacy Creations, both animal-health compounders in New Jersey, received letters from FDA Oct. 31 that were not scheduled to post on the agency's Web site until Dec. 19 due to "resource issues" within the Freedom of Information Office.

A six-page letter to Wedgewood notes a month-long inspection in October 2005 uncovered "serious" FDCA violations. It accuses Wedgewood of manufacturing new animal drugs that are not recognized by "qualified experts as safe and effective" for their labeled uses. The letter references its Compounding Policy Guide (CPG), which acts as internal document that directs inspectors, and alleges Wedgewood makes "copies of commercially available products," including enrofloxacin, pyimethamine/sulfadiazine, cyclosporine ophthalmic, altrenogest, flunixin meglumine and ketoprofen, among others.

The lawsuit asks Wedgewood to respond to the letter and correct the alleged violations. FDA officials did not return DVM Newsmagazine's comment requests. Linda Grassie, director of FDA's Center for Veterinary Medicine communications staff, says she has "serious doubts" about agency officials speaking publicly on the issue.

Wedgewood President George Malmberg contends the company operates within legal limits. Last month, the agency granted Wedgewood an extension to respond to its warning letter.

"This is a disagreement FDA has with our entire profession. This is the first warning letter we've received in the 26 years we've been doing business, and its allegations are unproven," he says.

Related Content:

Regulatory
Feed control officials reassert copper concentration guidelines
Feed control officials reassert copper concentration guidelines
What's going on with xylazine becoming a street drug?
What's going on with xylazine becoming a street drug?
USDA aims to strengthen handling regulations for exotic animals in exhibition
USDA aims to strengthen handling regulations for exotic animals in exhibition

Advertisement

Latest News

Can our Pride panel answer these LGBTQ+ trivia questions?

Creating inclusive spaces for the LGBTQ+ community in vet med

Happy Pride Month, Hill's launches Prescription Diet ONC Care, and more

CityVet Celina opens in Prosper, Texas

View More Latest News
Advertisement