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FDA Publishes Design Recommendations for Residue Studies in Honey

FDA Publishes Design Recommendations for Residue Studies in Honey

January 4, 2017

The U.S. Food and Drug Administration today published a draft guidance for industry (GFI) #243 entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods.”

GFI #243 supports the FDA’s work with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), an international program aimed at harmonizing technical requirements for veterinary product regulation.

This VICH draft guidance (VICH GL56) provides study design recommendations that will facilitate the acceptance of the generated residue depletion data to establish appropriate Maximum Residue Limits (MRLs) or other safety limits in honey following the treatment of honeybees with veterinary drug products, or justify withdrawal periods in honey when an MRL already exists.

The comment period on this draft guidance for industry is 60 days and will close on March 6, 2017. To submit comments to the docket electronically, visit http://www.regulations.gov and type FDA-2016-D-4461 in the search box.

To submit comments to the docket by mail, use the following address. Please be sure to include docket number FDA-2016-D-4461 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Additional Information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.