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CVM Announces New Assistance for Registering Medicated Feed Mills; Refuses to Grant Waiver for MGA Changes

Medicated Feed Mill Annual Registration

The FDA Center for Veterinary Medicine has issued new registration procedures for licensed medicated feed mills required to register annually under the drug establishment registration procedures, or DERs. These procedures apply only to those medicated feed mills that hold an approved Medicated Feed Mill License.

According the CVM Director of Animal Feed Dr. Sharon Benz, medicated feed mills that have not registered since January 2012 should do so now. A new law enacted in 2012 requires registration every year between October and December. Here is a link to the CVM Medicated Feed webpage. On that page is a section entitled “Resources for Registering.” Please read the Registration User Manual, which lays out the process step-by-step. If followed, it will instruct firms to save a copy of their registration information on their computer and the next year the firm can link to that information and not need to re-enter their information (they can update anything that is changed).

With regard to the “Submit to FDA” button, the instructions do not specifically indicate this, but the button will not appear until all key information is entered. The instructions do however address what you will see step-by-step, with screen shots. 

CVM understands there have been problems in the past when firms try to register, however, Dr. Benz said they have worked to make the process easier and would like to ensure that all firms that are required to register do become registered. 

 

Melengestrol Acetate (MGA) Changes

Recently, the drug sponsor for melengestrol acetate (MGA), an approved animal drug, announced that changes made in 2011 have been added to the Code of Federal Regulations and subject to enforcement. Some of these changes will eliminate some Type B MGA combinations allowed previously. The drug sponsor has assured that it is filing the necessary applications to address the issues involved, but it will take several weeks to file, and the Food and Drug Administration will take many months to review. 

In the interim, a waiver of the changes has been requested until the new ones were adopted to allow for feed firms to make the necessary transitions, and FDA officials denied the request indicating that the drug sponsor needs to file the applications required to make the changes.  

For a copy of the changes involved, please contact the drug sponsor’s at http://www.zoetis.com/.

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