[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Notices]
[Page 64402-64403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc02-94]
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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