[Federal Register Volume 63, Number 49 (Friday, March 13, 1998)]
[Notices]
[Pages 12473-12474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


FDA Modernization Act of 1997: Guidance for Industry on 
Implementation of Section 126, Elimination of Certain Labeling 
Requirements; Availability

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 guidance for industry entitled ``Implementation of 
Section 126, Elimination of Certain Labeling Requirements, of the Food 
and Drug Administration Modernization Act of 1997.'' The Food and Drug 
Administration Modernization Act of 1997 (FDAMA) amends the Federal 
Food, Drug, and Cosmetic Act (the act) to require, at a minimum, that 
before dispensing, the labels 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statement ``Warning--May be habit forming'' has been repealed. This 
guidance is intended to clarify FDA policy with respect to 
implementation of these amendments that became effective February 19, 
1998. The agency requested comments on this guidance.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance may be obtained on the Internet at 
http://www.fda.gov/cder/guidance/index.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. 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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Implementation of Section 126, 
Elimination of Certain Labeling Requirements, of the Food and Drug 
Administration Modernization Act of 1997.'' 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.'' In addition, section 502(d) of the act (21 U.S.C. 352(d)) is 
repealed. This section required the labels of certain habit-forming 
drugs to bear the statement ``Warning--May be habit forming.'' The 
amendments to section 503(b)(4) of the act and the repeal of section 
502(d) of the act became effective February 19, 1998.
    This guidance for industry is intended to: (1) Describe the new 
prescription drug labeling requirements of the act as amended by FDAMA 
and (2) advise manufacturers, packers, and distributors of the policy 
the agency will follow in implementing the requirements of section 126. 
The guidance advises that, for a limited period of time, FDA does not 
intend to object if manufacturers, packers, or distributors of already 
approved products implement section 126 of FDAMA at the time of next 
printing of its labels, but that such entities should implement the

[[Page 12474]]

amendments no later than August 18, 1998, which is 180 days from the 
effective date of FDAMA. For full or abbreviated applications approved 
between February 19, 1998, and August 18, 1998, manufacturers, packers, 
and distributors have until August 18, 1998, to comply with the 
amendments. The guidance also advises that full or abbreviated 
applications submitted after February 19, 1998, should provide labels 
in compliance with the amendments.
    This guidance document represents the agency's current thinking on 
implementation of 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 requirement 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: March 3, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-6572 Filed 3-13-98; 8:45 am]
BILLING CODE 4160-01-F