[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
