80 FR 34677 - Naming of Drug Products Containing Salt Drug Substances; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range		34677-34678
FR Document		2015-14884

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of a guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances'' which replaces the draft guidance of the same title that published on December 26, 2013.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.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34677-34678]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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Products Containing Salt Drug Substances'' which replaces the draft
guidance of the same title that published on December 26, 2013.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

34678 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices

thinking on drug product naming http://www.fda.gov/Drugs/Guidance addressed adhesive label to assist that
nomenclature for new drugs that ComplianceRegulatoryInformation/ office in processing your request.
contain a salt as the active ingredient. It Guidances/default.htm or http:// Submit electronic comments on the
does not establish any rights for any www.regulations.gov. guidance to http://www.regulations.gov.
person and is not binding on FDA or the Dated: June 10, 2015. Submit written comments to the
public. You can use an alternative Leslie Kux,
Division of Dockets Management (HFA–
approach if it satisfies the requirements 305), Food and Drug Administration,
Associate Commissioner for Policy.
of the applicable statutes and 5630 Fishers Lane, Rm. 1061, Rockville,
regulations. [FR Doc. 2015–14884 Filed 6–16–15; 8:45 am]
MD 20852. Identify comments with the
BILLING CODE 4164–01–P docket number found in brackets in the
II. Paperwork Reduction Act of 1995
heading of this document.
This guidance includes information
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
collection provisions that are subject to
HUMAN SERVICES Shyam Kalavar, Center for Devices and
review by the Office of Management and
Radiological Health, Food and Drug
Budget (OMB) under the Paperwork
Food and Drug Administration Administration, 10903 New Hampshire
Reduction Act of 1995 (44 U.S.C. 3501–
Ave., Bldg. 66, Rm. 5568, Silver Spring,
3520). The collections of information
[Docket No. FDA–2014–D–1242] MD 20993–0002, 301–796–6807.
referenced in this guidance that are
related to the burden for the submission SUPPLEMENTARY INFORMATION:
of investigational new drug applications Content and Format of Abbreviated
510(k)s for Early Growth Response 1 I. Background
are covered under 21 CFR 312 and have
been approved under OMB control Gene Fluorescence In-Situ This guidance document was
number 0910–0014. The collections of Hybridization Test System for developed to provide industry and
information referenced in this guidance Specimen Characterization Devices; Agency staff with recommendations for
that are related to the burden for the Guidance for Industry and Food and the suggested format and content of an
submission of new drug applications Drug Administration Staff; Availability abbreviated 510(k) submission for EGR1
that are covered under 21 CFR 314 have gene FISH test system for specimen
AGENCY: Food and Drug Administration, characterization devices and
been approved under OMB control HHS.
number 0910–0001. The submission of recommendations for addressing certain
ACTION: Notice. labeling issues relevant to the review
prescription drug product labeling
under 21 CFR 201.56 and 201.57 is process specific to these devices. An
SUMMARY: The Food and Drug
approved under OMB control number EGR1 gene FISH test system for
Administration (FDA) is announcing the
0910–0572. specimen characterization is a device
availability of the guidance entitled
The guidance also references 21 CFR intended to detect the EGR1 probe target
‘‘Content and Format for Abbreviated
201.10 ‘‘Drugs; Statement of on chromosome 5q in bone marrow
510(k)s for Early Growth Response 1
Ingredients.’’ In the Federal Register of specimens from patients with acute
(EGR1) Gene Fluorescence In-Situ
December 18, 2014 (79 FR 75506), FDA myeloid leukemia or myelodysplastic
Hybridization (FISH) Test System for
published its proposed rule on the syndrome. The assay results are
Specimen Characterization Devices.’’
electronic distribution of prescribing intended to be interpreted only by a
This guidance provides industry and
information for human prescription qualified pathologist or cytogeneticist.
Agency staff with recommendations for
drugs, including biological products. In These devices do not include automated
the suggested format and content of an
Section VII, ‘‘Paperwork Reduction Act systems that directly report results
abbreviated 510(k) submission for EGR1
of 1995,’’ FDA estimated the burden to without review and interpretation by a
gene FISH test system for specimen
design, test, and produce the label for a qualified pathologist or cytogeneticist.
characterization devices.
drug product’s immediate container and These devices also do not include any
DATES: Submit either electronic or device intended for use to select patient
outer container or package, as set forth written comments on this guidance at
in 21 CFR part 201, including §§ 201.10, therapy, predict patient response to
any time. General comments on Agency therapy, or to screen for disease as well
201.100(b), and other sections in guidance documents are welcome at any
subpart A and subpart B. as any device with a claim for a
time. particular diagnosis, prognosis, and
III. Comments ADDRESSES: An electronic copy of the monitoring or risk assessment.
Interested persons may submit either guidance document is available for In the Federal Register of September
electronic comments regarding this download from the Internet. See the 26, 2014 (79 FR 57939), the Agency
document to http://www.regulations.gov SUPPLEMENTARY INFORMATION section for issued the draft guidance entitled
or written comments to the Division of information on electronic access to the ‘‘Content and Format for Abbreviated
Dockets Management (see ADDRESSES). It guidance. Submit written requests for a 510(k)s for Early Growth Response 1
is only necessary to send one set of single hard copy of the guidance (EGR1) Gene Fluorescence In-Situ
comments. Identify comments with the document entitled ‘‘Content and Format Hybridization (FISH) Test System for
docket number found in brackets in the for Abbreviated 510(k)s for Early Specimen Characterization Devices.’’
heading of this document. Received Growth Response 1 (EGR1) Gene The Agency received no comments on
Fluorescence In-Situ Hybridization
asabaliauskas on DSK5VPTVN1PROD with NOTICES

comments may be seen in the Division the draft guidance dated September 26,
of Dockets Management between 9 a.m. (FISH) Test System for Specimen 2014.
and 4 p.m., Monday through Friday, and Characterization Devices’’ to the Office
of the Center Director, Guidance and II. Significance of Guidance
will be posted to the docket at http://
www.regulations.gov. Policy Development, Center for Devices This guidance is being issued
and Radiological Health, Food and Drug consistent with FDA’s good guidance
IV. Electronic Access Administration, 10903 New Hampshire practices regulation (21 CFR 10.115).
Persons with access to the Internet Ave., Bldg. 66, Rm. 5431, Silver Spring, The guidance represents the current
may obtain the document at either MD 20993–0002. Send one self- thinking of FDA on ‘‘Content and

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Document Created: 2015-12-15 14:22:55
Document Modified: 2015-12-15 14:22:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on Agency guidances at any time.
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.
FR Citation		80 FR 34677

80 FR 34677 - Naming of Drug Products Containing Salt Drug Substances; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration