[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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