[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34677-34678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1566]


Naming of Drug Products Containing Salt Drug Substances; 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 ``Naming of Drug 
Products Containing Salt Drug Substances'' which replaces the draft 
guidance of the same title that published on December 26, 2013. This 
guidance describes the United States Pharmacopeia's (USP's) ``Monograph 
Naming Policy for Salt Drug Substances in Drug Products and Compounded 
Preparations,'' which became official on May 1, 2013, and how the 
Center for Drug Evaluation and Research (CDER) is implementing it.

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 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. 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: Mamta Gautam-Basak, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-0712.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Naming of Drug Products Containing Salt Drug Substances'' 
that replaces the draft of the same title that published on December 
26, 2013 (78 FR 78366). This guidance is being published to explain how 
CDER is implementing the USP's policy entitled ``Monograph Naming 
Policy for Salt Drug Substances in Drug Products and Compounded 
Preparations.'' It is a naming and labeling policy applicable to drug 
products that contain an active ingredient that is a salt. The policy 
stipulates that USP will use the name of the active moiety, instead of 
the name of the salt, when creating a drug product monograph title and 
the strength will be expressed in terms of the active moiety. The 
policy allows for exceptions under specified circumstances. CDER is now 
applying this policy to new prescription drug products under 
development under section 505 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 355).
    The USP Salt Policy became official on May 1, 2013, and USP is now 
applying it to all new drug product monographs for products that 
contain an active ingredient that is a salt. It affects the development 
of new drug products because a USP monograph title for a new drug 
product, in most instances, serves as the nonproprietary or 
``established'' name of the related drug product (section 502(e)(3) of 
the FD&C Act) (21 U.S.C. 352(e)). If a drug product's label or labeling 
contains a name that is inconsistent with the applicable monograph 
title, it risks being misbranded (section 502(e)(1)(A)(i) of the FD&C 
Act).
    This guidance describes the USP policy and discusses how CDER and 
industry can implement the policy. Following the policy will help 
reduce medication errors caused by a mismatch between the established 
name and strength on the label of drug products that contain a salt. In 
addition, we anticipate that this policy will help health care 
practitioners calculate equivalent doses when changing from one dosage 
form to another, even if the products contain active ingredients that 
are different salts, because the strengths and names will both be based 
on the active moiety.
    In the Federal Register of December 26, 2013 (78 FR 78366), this 
guidance was published as a draft guidance. 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. This guidance represents CDER's 
current

[[Page 34678]]

thinking on drug product naming nomenclature for new drugs that contain 
a salt as the active ingredient. 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 includes information collection provisions 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 referenced in this guidance that are related 
to the burden for the submission of investigational new drug 
applications are covered under 21 CFR 312 and have been approved under 
OMB control number 0910-0014. The collections of information referenced 
in this guidance that are related to the burden for the submission of 
new drug applications that are covered under 21 CFR 314 have been 
approved under OMB control number 0910-0001. The submission of 
prescription drug product labeling under 21 CFR 201.56 and 201.57 is 
approved under OMB control number 0910-0572.
    The guidance also references 21 CFR 201.10 ``Drugs; Statement of 
Ingredients.'' In the Federal Register of December 18, 2014 (79 FR 
75506), FDA published its proposed rule on the electronic distribution 
of prescribing information for human prescription drugs, including 
biological products. In Section VII, ``Paperwork Reduction Act of 
1995,'' FDA estimated the burden to design, test, and produce the label 
for a drug product's immediate container and outer container or 
package, as set forth in 21 CFR part 201, including Sec. Sec.  201.10, 
201.100(b), and other sections in subpart A and subpart B.

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 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14884 Filed 6-16-15; 8:45 am]
 BILLING CODE 4164-01-P