[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Page 25696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0322]


Guidance for Industry on Dosage Delivery Devices for Orally 
Ingested OTC Liquid Drug Products; 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 ``Dosage Delivery 
Devices for Orally Ingested OTC Liquid Drug Products.'' This document 
is intended to provide guidance to firms that are manufacturing, 
marketing, or distributing orally ingested over-the-counter (OTC) 
liquid drug products packaged with dosage delivery devices (e.g., 
calibrated cups, droppers, syringes, or spoons). FDA is issuing this 
guidance because of ongoing concerns about potentially serious 
accidental drug overdoses that can result from the use of dosage 
delivery devices with markings that are inconsistent or incompatible 
with the labeled dosage directions for orally ingested OTC liquid drug 
products.

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: Spencer Salis, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Building 51, rm. 5216, Silver Spring, MD 20993-0002, 
301-796-3327.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug 
Products.'' The Agency has determined that many orally ingested OTC 
liquid drug products in the marketplace are packaged with dosage 
delivery devices that bear markings that are inconsistent with the 
labeled dosage directions, contain superfluous markings, or are missing 
necessary markings. FDA is issuing this guidance because of ongoing 
concerns about potentially serious accidental drug overdoses that can 
result from the use of dosage delivery devices with markings that are 
inconsistent or incompatible with the labeled dosage directions for 
orally ingested OTC drug products. FDA recommends that dosage delivery 
devices be included for all orally ingested OTC drug products that are 
liquid formulations, that they should bear markings that are consistent 
with the labeled dosage directions, and that they should be labeled in 
a manner that attempts to ensure that they are used only with the 
products with which they are included.
    In the Federal Register of November 5, 2009 (74 FR 57319), FDA 
announced the availability of a draft guidance for industry entitled 
``Dosage Delivery Devices for Over-the-Counter Liquid Drug Products.'' 
The notice gave interested persons an opportunity to comment by 
February 2, 2010. We received a number of comments from individuals, 
firms, and consumer groups. We have carefully considered the comments 
and, where appropriate, have made corrections, added information, or 
clarified the information in the guidance in response to the comments 
or on our own initiative.
    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 dosage delivery devices for orally 
ingested OTC liquid 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket 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.

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: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10965 Filed 5-4-11; 8:45 am]
BILLING CODE 4160-01-P