Category Archives: FDA

On June 2, the U.S. Food and Drug Administration (FDA) issued the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes. The final rule becomes effective October 1, 2015. [Source: FDA, CVM News and Events]

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances. [Source: FDA Press Release, May 18, 2015]

The U.S. Food and Drug Administration is proposing revisions to its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales by major food-producing species (cattle, swine, chickens, and turkeys). The additional data would improve understanding about how antimicrobials are sold or distributed for use in major food-producing species and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials. [Source: FDA, May 19, 2015]

Congresswoman Louise Slaughter (D-NY) has reintroduced the “Preservation of Antibiotics for Medical Treatment Act,” which would ban non-therapeutic uses of medically important antibiotics in food animal production. This is legislation she has introduced over a number of years. [Source: National Hog Farmer, Apr 13, 2015 By P. Scott Shearer, Bockorny Group, Washington, D.C.]

The AVMA is elated to announce that President Barack Obama has signed into law the long-awaited Veterinary Medicine Mobility Act (H.R. 1528), making it legal for veterinarians to provide complete medical care to their animal patients beyond their clinics and across state lines. The AVMA’s Government Relations Division made passage of this legislation a top priority and is to be congratulated on their successful effort.

Since our article discussing this topic appeared in e-Letter (Pain Mitigation, March 26), there have been a couple of significant events that I wanted to bring to your attention.

The U.S. Food and Drug Administration (FDA) is announcing the availability of a new website for the public to report problems related to livestock animal food. [FDA-CVM]

In an effort to improve transparency about the amount of antimicrobials sold or distributed for use in food-producing animals, the U.S. Food and Drug Administration is announcing a proposal to provide additional data tables in its annual summary report of this information. The proposal is available for public comment until November 25, 2013.

In an effort to improve transparency about the amount of antimicrobials sold or distributed for use in food-producing animals, the U.S. Food and Drug Administration is announcing a proposal to provide additional data tables in its annual summary report of this information. The proposal is available for public comment until November 25, 2013.

In an effort to improve transparency about the amount of antimicrobials sold or distributed for use in food-producing animals, the U.S. Food and Drug Administration is announcing a proposal to provide additional data tables in its annual summary report of this information. The proposal is available for public comment until November 25, 2013.