[Federal Register Volume 63, Number 139 (Tuesday, July 21, 1998)]
[Notices]
[Pages 39100-39101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0133]


Revised Guidance for Industry on Implementation of Section 126 of 
the Food and Drug Administration Modernization Act of 1997--Elimination 
of Certain Labeling Requirements

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 revised guidance for industry entitled 
``Implementation of Section 126 of the Food and Drug Administration 
Modernization Act of 1997-- Elimination of Certain Labeling 
Requirements.'' Section 126 of the Food and Drug Administration 
Modernization Act of 1997 (Modernization Act) amends the Federal Food, 
Drug, and Cosmetic Act (the act) to require, at a minimum, that prior 
to dispensing, the label of prescription products contain the symbol 
``Rx only'' instead of the ``Caution: Federal law prohibits dispensing 
without prescription'' statement. In addition, the requirement that the 
labels of certain habit-forming drugs bear the statement ``Warning-May 
be habit forming'' has been repealed. The revised guidance changes the 
implementation schedule provided in the original guidance dated 
February 1998, and answers certain questions concerning implementation 
of these amendments.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance for industry can be obtained on the 
Internet at http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/cber/guidelines.htm. Submit written requests for single 
copies of this guidance to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857 or to the Office of 
Communication, Training and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests. Submit written comments on the 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
     Jerry Phillips, Center for Drug Evaluation and Research (HFD-610), 
Food and Drug Administration, Office of Generic Drugs, 7500 Standish 
Pl., Rockville, MD 20855, 301-827-5846, or
     Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
revised guidance for industry entitled ``Implementation of Section 126 
of the Food and Drug Administration Modernization Act of 1997--
Elimination of Certain Labeling Requirements.'' Section 126 of Title I 
of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 
105-115), signed into law by President Clinton on November 21, 1997, 
amends section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 353(b)(4)) to require, at a minimum, that prior to 
dispensing, the label of prescription products contain the symbol ``Rx 
only'' instead of the ``Caution: Federal law prohibits dispensing 
without prescription'' statement. In addition, section 502(d) of the 
act (21 U.S.C. 352(d)), that required the labels of certain habit-
forming drugs to bear the statement ``Warning-May be habit forming'' is 
repealed. The amendments to section 503(b)(4) and the repeal of section 
502(d) of the act became effective February 19, 1998.
     FDA published a notice in the Federal Register of March 13, 1998, 
announcing the availability of the original guidance (63 FR 12473) and 
soliciting comments. Three comments on the guidance were submitted to 
the docket. In response to the comments, and to questions that were 
asked concerning the implementation of section 126 of the Modernization 
Act, FDA is issuing a revised guidance.
    The revised guidance: (1) Describes the new prescription drug 
labeling requirements of the act as amended by the Modernization Act, 
(2) changes the implementation schedule previously described in the 
February 1998 guidance, and (3) answers certain frequently asked 
questions about the provision. The revised guidance advises that FDA 
does not intend to object if a sponsor of a currently approved product 
implements section 126 of the Modernization Act at the time of the next 
revision of its labels, or by February 19, 2003, whichever comes first, 
and reports these minor changes in the next annual report. For pending

[[Page 39101]]

(unapproved) full or abbreviated applications received by the agency 
prior to February 19, 1998, sponsors have until the time of next 
revision of their labels or by February 19, 2003, whichever comes 
first, to comply with the amendments and they must report these minor 
changes in their next annual report. The guidance also advises that 
full or abbreviated applications received by FDA after February 19, 
1998, should provide labels and labeling in compliance with the 
amendments.
    This revised guidance document represents the agency's current 
thinking on implementation of the elimination of certain labeling 
requirements. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). 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. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 10, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19317 7-20-98; 8:45 am]
BILLING CODE 4160-01-F