[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36547-36548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0248]


Allowable Excess Volume and Labeled Vial Fill Size in Injectable 
Drug and Biological Products; Guidance for Industry; 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 ``Allowable Excess 
Volume and Labeled Vial Fill Size in Injectable Drug and Biological 
Products.'' It replaces the draft of the same name that was published 
on March 14, 2014. This guidance clarifies FDA requirements and 
regulations pertaining to allowable excess volume in injectable vials 
and reinforces the importance of appropriate fill volumes and labeled 
vial fill sizes for injectable drug and biological 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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911. Send one self-addressed adhesive label to assist 
that office in processing your requests. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. 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: Pallavi Nithyanandan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD

[[Page 36548]]

20993-0002, 301-796-7546; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Allowable Excess Volume and Labeled Vial Fill Size in 
Injectable Drug and Biological Products.'' This guidance replaces the 
draft guidance of the same name that published in the Federal Register 
of March 14, 2014 (79 FR 14517). FDA is concerned that injectable vial 
misuse, including unsafe handling and injection techniques, has led to 
an increase in vial contamination and an increased risk of bloodborne 
illness transmission between patients. This guidance clarifies the FDA 
requirements and regulations pertaining to allowable excess volume in 
injectable vials and describes when justification is needed for a 
proposed excess volume in an injectable drug or biological product. 
This guidance also discusses the importance of appropriate fill volume 
and recommends that labeled vial fill sizes be appropriate for the use 
and dosing of the drug and biological product.
    In the Federal Register of March 14, 2014 (79 FR 14517), a draft 
guidance was published entitled ``Draft Guidance for Industry on 
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug 
and Biological Products; Availability.'' We have carefully reviewed and 
considered the comments that were received on the draft guidance and 
have made changes for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on allowable excess fill volume and labeled 
vial fill size for injectable drug and biological products packaged in 
vials and ampules. It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15637 Filed 6-24-15; 8:45 am]
 BILLING CODE 4164-01-P