
[Federal Register: November 5, 2009 (Volume 74, Number 213)]
[Notices]               
[Page 57319]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no09-60]                         


[[Page 57319]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry on Dosage Delivery Devices for Over-
The-Counter 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availability of a draft guidance for industry titled ``Dosage Delivery 
Devices for OTC Liquid Drug Products.'' 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 inconsistent or incompatible with the labeled dosage 
directions for over-the-counter (OTC) liquid drug products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by February 3, 2010.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the 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://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Spencer Salis, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 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 
titled ``Dosage Delivery Devices for OTC Liquid Drug Products.'' This 
document is intended to provide guidance to firms that are 
manufacturing, marketing, or distributing OTC liquid drug products 
packaged with dosage delivery devices (e.g., calibrated cups, droppers, 
syringes, or spoons). The Agency has determined that many 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 OTC 
drug products. FDA recommends that dosage delivery devices be included 
for all OTC drug products that are liquid formulations; they should 
bear markings that are consistent with the labeled dosage directions; 
and they should be labeled in a manner that attempts to ensure that 
they are used only with the products with which they are included.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). When finalized the 
guidance will represent the agency's current thinking on ``Dosage 
Delivery Devices for 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) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper 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. 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/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26531 Filed 11-04-09; 8:45 am]

BILLING CODE 4160-01-S
