80 FR 18239 - Residual Solvents in Animal Drug Products; Questions and Answers; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 64 (April 3, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers.'' The questions and answers guidance addresses the United States Pharmacopeia (USP) General Chapter <467> Residual Solvents that applies to both human and veterinary drugs and to compendial and non-compendial drug products. This document answers questions regarding the Center for Veterinary Medicine's (CVM) implementation of USP <467> Residual Solvents.

[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18239-18240]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0566]


Residual Solvents in Animal Drug Products; Questions and Answers; 
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 #211 entitled ``Residual 
Solvents in Animal Drug Products; Questions and Answers.'' The 
questions and answers guidance addresses the United States Pharmacopeia 
(USP) General Chapter <467> Residual Solvents that applies to both 
human and veterinary drugs and to compendial and non-compendial drug 
products. This document answers questions regarding the Center for 
Veterinary Medicine's (CVM) implementation of USP <467> Residual 
Solvents.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your request. 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: Heather Longstaff, Center for 
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0651, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 3, 2010 (75 FR 75482), FDA 
published the notice of availability for a draft guidance entitled 
``Residual Solvents in Animal Drug Products; Questions and Answers'' 
giving interested persons until February

[[Page 18240]]

1, 2011, to comment on the draft guidance. FDA received one comment on 
the draft guidance and that comment was considered as the guidance was 
finalized. Two of the questions and answers were revised, in addition 
to a few editorial changes made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated December 2, 
2010.
    On July 1, 2008, the USP implemented a requirement for the control 
of residual solvents in drug products marketed in the United States. 
Once implemented, the requirement, USP General Chapter <467> Residual 
Solvents, became a statutory requirement under section 501(b) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(b)). 
This document answers questions regarding CVM's implementation of USP 
<467> Residual Solvents.

II. Significance of Guidance

    This level 1 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 ``Residual Solvents in Animal Drug 
Products; Questions and Answers.'' 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 part 514 have been approved under 
OMB control number 0910-0032; the collections of information in section 
512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB 
control number 0910-0669.

IV. 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.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07632 Filed 4-2-15; 8:45 am]
 BILLING CODE 4164-01-P