[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