[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be habit forming'' has been repealed.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
