[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Page 17429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0149]


Guidance for Industry on National Uniformity for Nonprescription 
Drugs--Ingredient Listing for OTC Drugs; 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 ``National Uniformity 
for Nonprescription Drugs--Ingredient Listing for OTC Drugs.'' This 
guidance is intended to clarify the administrative processes that will 
be followed in implementing the Food and Drug Administration 
Modernization Act of 1997 (FDAMA).

DATES: Written comments on the guidance may be submitted at any time.

ADDRESSES: Copies of this guidance for industry may be obtained on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of the guidance entitled ``National 
Uniformity for Nonprescription Drugs--Ingredient Listing for OTC 
Drugs'' 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: Thomas C. Kuchenberg, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``National Uniformity for 
Nonprescription Drugs--Ingredient Listing for OTC Drugs.'' Section 412 
of Title IV of FDAMA, signed into law by President Clinton on November 
21, 1997, amended section 502(e)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 352(e)(1)) to add as a requirement 
that the established name and quantity or, if determined to be 
appropriate, the proportion of each active ingredient appear on the 
label of all over-the-counter (OTC) drug products intended for human 
use. FDAMA amended section 502(e)(1) of the act to require the listing 
of inactive ingredients on drug product labels, including the labels of 
OTC drug products intended for human use.
    In addition, in the Federal Register of February 27, 1997 (62 FR 
9024), FDA issued a proposed rule that would establish a standardized 
format for the labeling of OTC drug products. The rule, which is being 
finalized, is intended to make labeling for OTC drug products easier to 
read and understand. This guidance for industry advises manufacturers, 
packers, and distributors of the agency's current thinking on 
implementing these provisions of FDAMA, as they apply to OTC drug 
products, in coordination with the forthcoming finalization of the 
proposed OTC labeling rule.
    This guidance 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: March 12, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9350 Filed 4-8-98; 8:45 am]
BILLING CODE 4160-01-F