[Home]FDA Regulatory Activities 2004

Contents | (Visit Preferences to set your user name.) | Related To FDA Regulatory Activities 2004 | RecentChanges | Preferences | Index | Login | Logout

Featured: Featured Stories | Picture Gallery

Matthias - The Apostle Chosen By Lot | Why Well Disposed Wives Fail
Google
Chat11.com Web Bible11.com MyBibleCenter.com
Cover of ISBN 0834003465 Cover of ISBN 0785201688
Cover of ISBN 081297476X The Bush Survival Guide - 250 Ways to Make It Through The NExt Four Years Without Misunderestimating the Dangers Ahead, and Other Subliminable Stategeries
Links:

United States Food And Drug Administration

Subjects > World (Search) > Countries?Create|Search > United States (Search) > United States Government Agencies > U.S. Food And Drug Administration > FDA And Animals (Search)

Regulatory Activities
by Linda A. Grassie, Director, Communications Staff

The following firms/individuals re-ceived Warning Letters for offering animals for slaughter that contained illegal residues:

The above violations involved sulfadimethoxine in cows, penicillin in cows, flunixin in cows, gentamicin in cows and ivermectin in a bull.

Warning Letters were sent to the following individuals and firms for significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds.

Warning Letters were sent to the following individuals/firms because they compounded and distributed veterinary drug products that were considered adulterated under the Federal Food, Drug, and Cosmetic Act (the Act). A new animal drug is deemed unsafe unless an approved New Animal Drug Application (NADA) is in effect for the specific product in question. None of the animal drugs compounded and distributed by these firms were the subject of an approved NADA. The only legal compounding of animal drugs is provided under the Animal Medicinal Drug Use Clarification Act and its implementing regulations at Title 21 of the Code of Federal Regulations (CFR) Part 530, Extralabel Drug Use in Animals.

A Warning Letter was issued to Robert H. Douglas, Ph.D., BET Pharm LLC, Lexington, KY, because, while the firm purports to be a compounding pharmacy for veterinary drugs, FDA investigation determined that the firm exceeds the scope of the regular course of the practice of pharmacy. The firm's activities go beyond that of a pharmacy and into the activities of a drug manufacturer. The only legal compounding of animal drugs is provided under the Animal Medicinal Drug Use Clarification Act and its implementing regulations at Title 21 of the Code of Federal Regulations (CFR) Part 530, Extralabel Drug Use in Animals.

A Warning Letter was issued to ­Kenneth L. Collier, DVM, Co-owner, Friendship Valley, LLC, Clintonville, WI, because an investigation into an illegal tissue residue in a dairy cow sold for slaughter as human food by the firm revealed serious deviations from the regulations for Extralabel Drug Use in Animals. These deviations caused an animal drug to be used in a manner that was unsafe and adulterated under the Act.

A Warning Letter was issued to ­Timothy J. Dennis, DVM, Partner, Eastview Veterinary Clinic P.C., Penn Yan, NY, because an investigation revealed serious deviations from Extralabel Drug Use in Animals. The extralabel use of approved animal drugs by veterinarians is allowed under the Act provided that the regulations contained in 21 CFR Part 530 are followed. Extralabel use of an approved animal drug that is not in compliance with the regulations contained in 21 CFR Part 530 renders the drug unsafe under Section 512 and thus adulterated under Section 501 (a)(5) of the Act.

A Warning Letter was issued to Mr. ­Richard Chapman, President, North Country Dairy Supply, Inc., West Rutland, VT, for significant deviations from FDA's regulations establishing cGMPs for finished pharmaceuticals.

See also FDA And Animals (Search for FDA And Animals) and other animal related topics:


Check out [Facts About Trees]


Contents | (Visit Preferences to set your user name.) | Related To FDA Regulatory Activities 2004 | RecentChanges | Preferences | Index | Login | Logout
Edit this www.chat11.com page | View other versions
Last edited March 21, 2008 7:30 pm (diff)
Search:
Sign up for PayPal and start accepting credit card payments
instantly.
Bobsgear - Get A Free Enterrpise Wiki Space!
Review: The Bobsgear Project was started to develop a variety of Confluence plugins. This installation of the Confluence Enterprise wiki includes flexible attachments, many Confluence plugins, personal blogs, interesting articles, and more. Bobsgear already has spaces related to politics, art and photography wiki, technical issues wiki, ediscovery wiki, health, Christian theology and Sabbath School wiki, the bible, book reviews, and quotations. Bobsgear allows free signup, and invites anyone to create a free hosted Confluence wiki space.


NEW USERS CLICK HERE! for a quick introduction to Wiki.

 

 Interested in Freeze Dried Beef Stew?
1120 total hits since 10/2007
Recently accessed pages: All The Apostles Of The Bible Antenna Departure Angle Celebrities Comments On Civil Jury Instructions On Initial Interest Confusion Contents Copywriting DOT NET Framework Garnets Thoughts On Gas Boycotts How To Improve Basic Management Skills Questia Affiliate Program Agreement Remove Wma Copy Protection Short History Of Computer Compression Sprint IP-830W Worldphone By Samsung Stretching FAQ Part 1 Trust Deed Investments

Elapsed:0