[Federal Register Volume 63, Number 14 (Thursday, January 22, 1998)]
[Notices]
[Pages 3328-3329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0016]


Draft Guidance on Professional Flexible Labeling of Antimicrobial 
Drugs; Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft level 1 Guidance 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draft guidance is intended to provide specific guidance on the 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comments on this draft guidance.

DATES: Submit written comments by April 22, 1998.
ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. Comments should be identified 
with the full title of the draft guidance and the docket number found 
in brackets in the heading of this document.
    Submit written requests for single copies of this draft guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests.
    Copies of this draft guidance document may also be obtained from 
the CVM Home Page (http://www.cvm.fda.gov) on the Internet.
FOR FURTHER INFORMATION CONTACT: John D. Baker, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0130. E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    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 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. 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.
    Under section 502 (f)(1) of the Federal Food, Drug, and Cosmetic 
Act (the act), a drug is deemed to be misbranded unless its labeling 
bears adequate directions for use (21 U.S.C. 352(f)(1)). The 
regulations regarding veterinary drugs at 21 CFR 201.105 exempt a drug 
from this provision of the act if it is in the possession of a licensed 
veterinarian for use in the course of professional practice, is 
dispensed in accordance with section 503(f) of the act (21 U.S.C. 
353(f)), and its label bears certain stipulated information. Section 
504 of the act (21 U.S.C. 354) stipulates that a veterinary feed 
directive drug, a drug intended for use in or on animal feed which is 
limited to use under the supervision of a licensed veterinarian, is 
exempt from section 502(f) when labeled, distributed, held, and used in 
accordance with the conditions set forth in section 504.
    Drugs labeled 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, use of PFL on nonprescription or nonveterinary 
feed directive drugs would cause the drugs to be misbranded under 
section 502 (f)(1) of the act, PFL-labeled drugs must be classified as 
prescription animal drugs or veterinary feed directive drugs. 
Accordingly, the PFL concept discussed in this document may apply to 
either veterinary

[[Page 3329]]

prescription or veterinary feed directive antimicrobial drugs.
    The PFL concept has been a topic of discussion for many years. 
Recent workshops on PFL were held in April and December 1995 under the 
cosponsorship of the Center for Veterinary Medicine, the American 
Academy of Veterinary Pharmacology and Therapeutics, the Animal Health 
Institute, and the American Veterinary Medical Association.
    A summary of the discussions and opinions expressed in the April, 
1995 workshop were published in the Journal of the American Veterinary 
Medical Association (JAVMA), October 1, 1995. At the conclusion of the 
December, 1995 workshop, a task force prepared a report on the PFL 
concept. The task force report, which included a model drug label, was 
published in the JAVMA on July 1, 1996.
    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 
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.
    Approaches to PFL may not be equally applicable to all classes of 
therapeutic prescription products (e.g., antimicrobials, 
antiparasitics, physiologics). Therefore, CVM intends to develop PFL 
guidances that are specific to the various classes of drugs. This draft 
guidance document specifically addresses the application of the PFL 
concept to prescription therapeutic antimicrobial products.
    A sponsor may follow the guidance provided in this draft document, 
or a sponsor may choose to follow alternate procedures or practices. If 
a sponsor elects to use alternate procedures or practices, that sponsor 
may wish to discuss the matter a priori with the agency to prevent an 
expenditure of money and effort on activities that may later be 
determined to be unacceptable to FDA.
    This draft document represents current FDA thinking on PFL for 
antimicrobial drugs. This draft guidance document does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternate approach may be used if such an approach 
satisfies the requirements of the applicable statute, regulations, or 
both. FDA may amend this draft guidance document based upon comments 
submitted by interested persons.

Request for Comments

    Interested persons may, on or before April 22, 1998, submit to the 
Dockets Management Branch (address above) written comments on the draft 
guidance document. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document, and with the full title of the guidance document.
    The draft guidance and received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday. An electronic 
version of this guidance is available on the Internet at http://
www.fda.gov. After review of these comments, FDA will finalize the 
guidance document with any appropriate changes. Thereafter, interested 
persons may submit written comment on the guidance document directly to 
the CVM Communications Staff (address above).

    Dated: January 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1417 Filed 1-15-98; 3:51 pm]
BILLING CODE 4160-01-F