[Federal Register: January 13, 2005 (Volume 70, Number 9)]
[Notices]
[Page 2415-2416]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja05-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0549]
Draft Guidance for Industry on Labeling Over-the-Counter Human
Drug Products; Questions and Answers; 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availability of a draft guidance for industry entitled ``Labeling OTC
Human Drug Products--Questions and Answers.'' This guidance is intended
to assist manufacturers, packers, and distributors of over-the-counter
(OTC) drug products to implement the agency's regulation on
standardized content and format requirements for the labeling of OTC
drug products. This draft guidance discusses labeling questions that
have been frequently asked by manufacturers, packers, and distributors
in implementing the new requirements. The labeling examples in this
draft guidance show various format and content features and suggest how
OTC drug monograph labeling information finalized before the new
[[Page 2416]]
requirements can be converted to the new format.
DATES: Submit written or electronic comments on the draft guidance for
industry by March 14, 2005. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Cazemiro R. Martin or Gerald M.
Rachanow, 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 draft guidance for industry
entitled ``Labeling OTC Human Drug Products--Questions and Answers.''
This is one of several draft guidances the agency is developing to help
manufacturers, packers, and distributors implement the regulation
establishing standardized content and format requirements for the
labeling of all OTC drug products. Once finalized, these draft
guidances will supersede all other statements, feedback, and
correspondence provided by the agency on these matters since the
issuance of the final rule.
In the Federal Register of March 17, 1999 (64 FR 13254), FDA
published a final rule establishing standardized content and format
requirements for the labeling of OTC drug products (21 CFR 201.66).
This regulation 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 for this standardized labeling requires
manufacturers to present OTC drug labeling information in a prescribed
order and format. The standardized format will require revision of all
labeling in use before the compliance date of the final rule. The final
rule covers all OTC drug and drug-cosmetic products, whether marketed
under a new drug marketing application, abbreviated new drug
application, or OTC drug monograph (or product not yet the subject of a
final OTC drug monograph).
Following issuance of the final rule, the agency received a number
of inquires from manufacturers seeking guidance on how to present the
labeling information for their OTC drug products using the standardized
content and format requirements. This draft guidance discusses those
inquiries and provides labeling examples to show various format and
content features of the labeling requirements and suggest how OTC drug
monograph labeling finalized before the new regulation was issued can
be converted to the new format. This draft guidance also discusses how
to list inactive ingredients that may or may not be contained in the
OTC drug product.
This level I draft guidance is being issued consistent with FDA's
good guidance practices (21 CFR 10.115). The draft guidance includes
labeling examples that are consistent with the new OTC drug products
standardized labeling content and format. The draft guidance represents
the agency's current thinking on how OTC drug monograph labeling can be
converted to the new OTC ``Drug Facts'' format labeling. 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 submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two copies of any mailed
comments except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. The draft guidance and received comments are
available for public examination in the Division of Dockets Management
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
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: December 28, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-696 Filed 1-12-05; 8:45 am]
BILLING CODE 4160-01-S