March 31, 1997
TIME EXTENDED FOR RELABELING OF CTC/OTC FEEDS
In a January 30, 1997 CVM UPDATE, the Center for Veterinary Medicine announced that the approved conditions of use for some Type A medicated articles containing chlortetracycline (CTC) and oxytetracycline (OTC) were changed as a result of the approval of several supplemental new animal drug applications (NADAs) in accordance with findings of the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness evaluations and the approval of "me-too" NADAs that were dependent upon the DESI-finalization. These changes in labeling no longer allow CTC or OTC in the rations of lactating dairy cows.
In that CVM UPDATE, the Agency stated that manufacturers of these Type A articles would have until April 1, 1997, to revise labeling to comply with the new conditions of use and to cease marketing any of these products bearing unrevised labeling. Similarly, mills manufacturing feed incorporating these Type A articles would have until April 1, 1997, to use up existing stocks of labeling, and to print and begin using revised labeling.
CVM is now extending the time for relabeling of feeds made from CTC and OTC to provide for an orderly transition in the marketplace. CVM is not changing the date the Type A medicated article manufacturer/sponsor needs to have its labeling changed. That date remains April 1, 1997.
CVM is granting an extension of time for distributors in the drug and feed industry to allow for depletion of existing stocks of the previously labeled product. They will have until October 1, 1997, to cease distribution of the old Type A product, and to begin distributing the revised labeled Type A product. After that date, distributors may not sell Type A medicated articles that are not labeled in compliance with the DESI changes.
CVM is granting an extension of time to the feed manufacturers using these Type A products to allow for development and printing of new labels and depletion of existing labeling for products made from the Type A articles. They will have until April 1, 1998, to make this change. After this date, feed manufacturers may not use Type A medicated articles that are not labeled in compliance with the DESI changes and they may not distribute feeds that are not labeled in conformance with the DESI changes.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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