FDA targets products on market without agency approval

The Food and Drug Administration is soliciting comments on strategies to address categories of animal drug products that are on the market without FDA approval or other legal marketing status—such as injectable vitamins; various topical solutions, shampoos, and liniments; electrolyte and glucose solutions; antidotes; and a variety of anti-infective products.

According to a Dec. 20 notice in the Federal Register, the FDA "is concerned that the safety and effectiveness of these marketed products has not been demonstrated."

The agency is looking for approaches to decrease the number of animal drug products that are on the market without FDA approval or other legal marketing status. The FDA is exploring additional mechanisms for these products to achieve legal marketing status, rather than revising the process for approving new animal drugs.

Some human drugs have achieved legal marketing status through alternative pathways such as compliance with monographs, for certain over-the-counter drugs, or through an FDA review of publicly available information, for particular prescription drugs such as pancreatic enzymes.

Parties may view the FDA notice and submit comments at www.regulations.gov by searching for the docket number, FDA-2010-N-0528. Parties may submit comments by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The deadline for comments is Feb. 18.