(1998; 18 pages)
Professional Flexible Labelling of Antimicrobial Drugs - draft guidance available
United States of America. The Food and Drug Administration has announced the availability of a draft guidance document for industry entitled "Professional Flexible Labeling of Antimicrobial Drugs (#66)". This draft guidance is intended to provide specific guidance on the development of Professional Flexible Labeling (PFL) for therapeutic veterinary prescription antimicrobial drugs. The agency is requesting comments on this draft guidance.
For many years the Center for Veterinary Medicine has approved veterinary prescription antimicrobial products labelled 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 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 provide prescription veterinary products that carry useful prescribing information for the range of clinical situations included within their approved 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, and thus have the ability to determine the appropriateness of a particular drug for use in a specific case.
Drugs labelled in accordance with the PFL concept require the training of licensed veterinarians to help ensure appropriate clinical usage. Such labels would not provide adequate directions for use by the lay person. Therefore, PFL-labelled drugs must be classified as prescription animal drugs or veterinary feed directive drugs and the PFL concept discussed in the guidance document applies only to these prescription products.
Copies of the guidance may be obtained from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville MD 20855, USA (with two self-addressed adhesive labels) or from the Internet at: http://www.cvm.fda.gov.
[See also Pharmaceuticals Newsletter No. 7, July 1996]
Reference: Federal Register 63(14): 3328-9 (1998).