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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Requests Comments on a Professional Flexible Labeling Draft Guidance Document

January 27, 1998

This CVM Update was revised April 23, 2009 to indicate that Guidance for Industry #66 was withdrawn on January 30, 2002.

Food and Drug Administration (FDA) is announcing the availability for comment of a draft Guidance for Industry on "Professional Flexible Labeling of Antimicrobial Drugs (#66)." This draft is intended to provide specific guidance on the development of Professional Flexible Labeling (PFL) for therapeutic veterinary prescription and veterinary feed directive (VFD) antimicrobial drugs. This draft guidance is being made available for the purpose of receiving comments only. This guidance cannot be implemented until the comments are received and analyzed by the Agency, and a final document is published.

Copies of this document may be obtained from CVM's Internet Home Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.

For many years, CVM has approved veterinary prescription antimicrobial products labeled with single fixed dosages for a narrow range of specific diseases and organisms. The very narrow label indications often failed to address the fact that, while some specific bacteria produce a repeatable, recognized disease, many organisms are either opportunistic or are known to produce a variety of clinical manifestations. In addition, with the approval of single fixed dosages, the efficacy of some products could become suboptimal as bacterial susceptibility patterns change with time.

The basic concept of Professional Flexible Labeling (PFL) is to approve prescription veterinary products that carry useful prescribing information for the range of clinical situations within the labeled conditions of use. Implementation of PFL is based on the recognition that, as a function of their medical training, veterinarians possess the knowledge, skills, and abilities to interpret medical diagnostic and prescribing information. Accordingly, they are able to develop these data into appropriate therapeutic regimens. In the course of their professional studies, veterinarians are trained in microbiology, the interpretation of bacterial culture and sensitivity determinative procedures, and pharmacokinetics. This knowledge gives them the ability to determine the appropriateness of a particular drug for use in a specific case.

This draft guidance is intended to describe how the PFL concept can be applied to prescription antimicrobial products to enable veterinary practitioners to apply their expertise to appropriately, effectively, and safely use antimicrobials for specific clinical cases. The draft document provides specific guidance for drug sponsors on the development of PFL labeling for therapeutic veterinary prescription and VFD antimicrobial drugs. Ultimately, the labeling of products such as described in this draft guidance will better accommodate the needs of veterinary practitioners in utilizing animal drugs to treat animals in the course of their professional practices.

Interested parties are encouraged to submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, room 1-23, 12420 Parklawn Dr., Rockville, MD 20857. Comments, which should be submitted by April 22, 1998, should be identified with the full title of the draft guidance and docket number 98D-0016.

Comments received on the draft guidance may be seen at the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. After review of these comments, FDA will finalize the guidance document with any appropriate changes.

Further information about this draft guidance document is contained in a January 22, 1998, Federal Register notice, and is also available from Dr. John D. Baker, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0130.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855