[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78366-78367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Naming of Drug Products Containing 
Salt Drug Substances; 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availability of a draft guidance for industry entitled ``Naming of Drug 
Products Containing Salt Drug Substances.'' The United States 
Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy 
that changed the nomenclature for compendial drug products that contain 
a salt. Under the new policy, drug names and strengths for new 
compendial drug products will be based on the active moiety. The name 
and strength of the active ingredient (e.g., salt) will appear 
elsewhere on the drug product label and labeling. The policy became 
official on May 1, 2013. This draft guidance describes the U.S.P. 
policy, discusses the Center for Drug Evaluation and Research's 
(CDER's) application of the policy, and recommends how CDER and 
industry can implement the policy.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 26, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

[[Page 78367]]

    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Richard Lostritto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD, 20993, 301-796-1697, 
NewDrugCMC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Naming of Drug Products Containing Salt Drug Substances.'' 
This draft guidance is being published to explain how CDER is 
implementing the U.S.P.'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 
U.S.P. 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). FDA is separately considering applying the U.S.P. Salt 
Policy to nonprescription drug products, and to biological products 
licensed under the Public Health Service Act.
    The U.S.P. Salt Policy became official on May 1, 2013, and U.S.P. 
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 U.S.P. 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)(3)). 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 draft guidance describes the U.S.P. 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. More accurate naming of drug products containing a salt 
helps health care practitioners calculate equivalent doses when 
changing from one dosage form to another.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent CDER's current thinking on drug product 
naming nomenclature for new drugs that contain a salt as the active 
ingredient. 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. Paperwork Reduction Act of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (the PRA) of 1995 (44 U.S.C. 3501-
3520). The collections of information referenced in this draft 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 draft guidance that are related to the 
burden for the submission of new drug applications 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.
    In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

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: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30800 Filed 12-24-13; 8:45 am]
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