[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68132-68133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27724]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1995-N-0031; (formerly Docket No. 1995N-0205) ]
Compliance Guidance for Small Business Entities on Labeling for
Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and
Antiasthmatic Drug Products for Over-the-Counter Human Use;
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 compliance guidance for small business entities
entitled ``Labeling for Bronchodilators: Cold, Cough, Allergy,
Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter
Human Use; Small Entity Compliance Guide.'' This guidance is intended
to help small businesses understand and comply with the requirements of
the final rule that provides new labeling applicable to all over-the-
counter (OTC) bronchodilator drug products marketed without an approved
application. The guidance describes the bronchodilator labeling
requirements in plain language and provides answers to common questions
on how to comply with the rule. This guidance was prepared in
accordance with the Small Business Regulatory Fairness Act.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Elaine Abraham, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 22, Rm. 5410, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a compliance guidance for
small business entities entitled ``Labeling for Bronchodilators: Cold,
Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for
Over-the-Counter Human Use; Small Entity Compliance Guide.'' This small
entity compliance guide applies to OTC bronchodilator drug products
used to treat asthma that are marketed without an approved application
(i.e., under the OTC bronchodilator monograph) (21 CFR part 341). OTC
bronchodilators are those that contain any of the ephedrine ingredients
(i.e., ephedrine, ephedrine hydrochloride, ephedrine sulfate, and
racephedrine hydrochloride) or epinephrine ingredients (i.e.,
epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride)
listed under 21 CFR 341.16.
This guidance summarizes the July 26, 2011, final rule (76 FR
44475) regarding OTC bronchodilator drug products, which makes the
following changes to the OTC regulations:
Sets forth a new use statement, warnings (including an
Asthma Alert warning), and directions that are required in the labeling
of OTC bronchodilator drug products under 21 CFR 341.76.
Revises labeling requirements for OTC bronchodilator drug
products to ensure consistency with the standardized Drug Facts content
and formatting requirements set forth in 21 CFR 201.66.
Manufacturers must be in compliance with the rule beginning on
January 23, 2012.
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 labeling for OTC bronchodilator 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 approach satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket
[[Page 68133]]
number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27724 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P