[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Pages 64402-64403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0005]


Guidance for Industry on Labeling Over-the-Counter Human Drug 
Products--Updating Labeling in Reference Listed Drugs and Abbreviated 
New Drug Applications; 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 ``Labeling OTC Human 
Drug

[[Page 64403]]

Products--Updating Labeling in RLDs and ANDAs.'' The guidance is 
intended to assist manufacturers of over-the-counter (OTC) reference 
listed drugs (RLDs) and manufacturers, packers, and distributors of OTC 
drug products marketed under abbreviated new drug applications (ANDAs) 
to implement the agency's regulation on standardized content and format 
requirements for the labeling of these products.

DATES: The guidance for industry is effective October 18, 2002. Submit 
written or electronic comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments on the guidance to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow or Cazemiro R. 
Martin, Center for Drug Evaluation and Research (HFD-560), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Labeling OTC Human Drug Products--Updating Labeling in RLDs 
and ANDAs.'' This is one of several guidances the agency is developing 
to help manufacturers, packers, and distributors implement the final 
regulation establishing standardized content and format requirements 
for the labeling of all OTC drug products. When finalized, these 
guidances will supersede all other statements, feedback, and 
correspondence provided by the agency on these matters since the 
issuance of the final regulation.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final regulation establishing standardized content and 
format requirements for the labeling of OTC drug products. The 
regulation is codified at Sec.  201.66 (21 CFR 201.66). It is intended 
to standardize labeling for all OTC drug products so consumers can 
easily read and understand OTC drug product labeling and use these 
products safely and effectively. The regulation requires manufacturers 
to present OTC drug product labeling information in a prescribed order 
and format. This new format will require revision of all existing 
labeling.
    Following issuance of the final regulation, the agency received 
several inquiries from manufacturers of generic OTC drug products 
seeking guidance on whether they should convert products to the new 
labeling format before the manufacturers of the applicable innovator 
(or RLD) products revise their labeling. To address those inquiries, in 
the Federal Register of February 22, 2001 (66 FR 11174), FDA published 
a notice announcing the availability of a draft guidance entitled 
``Labeling Over-the-Counter Human Drug Products; Updating Labeling in 
ANDAs,'' which included draft recommendations about how manufacturers 
of OTC drug products marketed under ANDAs and manufacturers of the RLD 
products could implement the agency's new regulations for the labeling 
of OTC drug products. The draft guidance contained a series of labeling 
examples that manufacturers could use when revising their product 
labeling to the new format. The notice invited interested persons to 
submit comments on the draft guidance by April 23, 2001.
    FDA received several comments regarding the February 22, 2001, 
draft guidance and, in response, the agency has made some clarifying 
changes in the final version of the guidance. Specifically, the agency 
is providing guidance on its general implementation expectations, the 
use of agency recommended labeling examples (manufacturers of RLDs who 
use these do not need agency preapproval), submission of new labeling 
in an annual report or preapproval supplement, and deferral requests. 
The agency is also announcing that it intends to exercise its 
enforcement discretion by giving manufacturers of generic OTC drug 
products a grace period to comply with the new format requirements of 
Sec.  201.66. This grace period commenced on May 16, 2002, for most OTC 
ANDAs and shall continue until the agency posts on the Internet the 
approved, updated labeling for an ANDA holder's applicable RLD. At that 
time, the ANDA holder should revise its labeling. (See the agency's May 
2000 guidance for industry entitled ``Revising ANDA Labeling Following 
Revision of the RLD Labeling.'')
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on updating labeling in ANDAs consistent with 
the new standardized labeling content and format required for OTC drug 
products. 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 an approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (see 
ADDRESSES). 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm and http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26622 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S