Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation; Availability, 15956-15957 [2013-05725]
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Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
sponsor may disagree with one of these
decisions, and a dispute arises. Because
these disputes often involve complex
scientific or procedural matters and also
may be precedent setting, it is critical
that there be procedures in place to
encourage open, prompt discussion of
such disputes. The procedures and
policies described in this guidance are
intended to promote rapid resolution of
scientific and procedural disputes
between sponsors and FDA. This draft
guidance is a revision of the guidance of
the same name that published in
February 2000. The procedures and
policies have been updated to reflect the
current practices.
This draft guidance is being issued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The draft guidance, when finalized, will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 the Agency’s current thinking
on formal dispute resolution regarding
appeals above the division level. 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
II. The Paperwork Reduction Act of
1995
This draft guidance refers to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of information in this draft guidance
have been approved under OMB control
number 0910–0430. This draft guidance
is a revision of an earlier version of the
guidance. The revised version contains
no additional information collections;
therefore, it continues to be covered
under OMB control number 0910–0430.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
VerDate Mar<15>2010
17:11 Mar 12, 2013
Jkt 229001
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Food and Drug Administration
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 https://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:
Russell Wesdyk, Center for Drug
Evaluation and Research (HFD–003),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm.
4182, Silver Spring, MD 20993–0002,
301–796–2400.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2011–D–0595]
I. Background
Guidance for Industry on Tablet
Scoring: Nomenclature, Labeling, and
Data for Evaluation; Availability
FDA is announcing the availability of
a guidance for industry entitled ‘‘Tablet
Scoring: Nomenclature, Labeling, and
Data for Evaluation.’’ This guidance
provides recommendations to sponsors
of NDAs and ANDAs regarding what
criteria should be met when evaluating
and labeling tablets that have been
scored. (A scoring feature facilitates
tablet splitting, which is the practice of
breaking or cutting a higher-strength
tablet into smaller portions.)
Specifically, this guidance recommends:
• Guidelines to follow, data to
provide, and criteria to meet and detail
in an application to support approval of
a scored tablet; and
• Nomenclature and labeling for
approved scored tablets.
On August 30, 2011 (76 FR 53909),
FDA announced the availability of the
draft version of this guidance. The
public comment period closed on
November 28, 2011. A number of
comments were received from the
public, all of which the Agency
considered carefully as it finalized the
guidance and made appropriate
changes. The Agency also held an
Advisory Committee for Pharmaceutical
Science and Clinical Pharmacology
meeting on August 9, 2012, to discuss
the draft guidance. Any changes to the
guidance were minor and made to
clarify statements in the draft guidance.
The Agency has previously
considered tablet scoring as an issue
when determining whether a generic
drug product is the same as the
reference listed drug (RLD). One
characteristic of a tablet dosage form is
that it may be manufactured with a
score or scores. This characteristic is
useful because the score can be used to
facilitate the splitting of the tablet into
fractions when less than a full tablet is
desired for a dose. Although there are
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05721 Filed 3–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Tablet Scoring: Nomenclature,
Labeling, and Data for Evaluation.’’ This
guidance provides recommendations to
sponsors of new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs) regarding what
criteria should be met when evaluating
and labeling tablets that have been
scored. (A scoring feature facilitates
tablet splitting, which is the practice of
breaking or cutting a higher-strength
tablet into smaller portions.)
Specifically, this guidance recommends
guidelines to follow, data to provide,
and criteria to meet and detail in an
application to support approval of a
scored tablet; and nomenclature and
labeling for approved scored tablets.
This guidance does not address
specific finished-product release testing,
where additional requirements may
apply to scored tablets. This guidance
does not describe the medical practice
conditions under which tablet splitting
is considered or recommended.
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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
SUMMARY:
PO 00000
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Notices
no standards or regulatory requirements
that specifically address scoring of
tablets, the Agency recognizes the need
for consistent scoring between a generic
product and its RLD.
Consistent scoring ensures that the
patient is able to adjust the dose, by
splitting the tablet, in the same manner
as the RLD. This enables the patient to
switch between products made by
different manufacturers without
encountering problems related to the
dose. In addition, consistent scoring
ensures that neither the generic product
nor the RLD has an advantage in the
marketplace because one is scored and
one is not.
The Center for Drug Evaluation and
Research’s Drug Safety Oversight Board
considered the practice of tablet
splitting at its October 2009 and
November 2010 meetings. During those
meetings, they discussed how insurance
companies and doctors are increasingly
recommending that patients split
tablets, either to adjust the patients’
dose or as a cost-saving measure.
Because of this, the Agency conducted
internal research on tablet splitting and
concluded that in some cases, there are
possible safety issues, especially when
tablets are not scored or evaluated for
splitting. The Agency’s concerns with
splitting a tablet included variations in
the tablet content, weight,
disintegration, or dissolution, which can
affect how much drug is present in a
split tablet and available for absorption.
In addition, there may be stability issues
with splitting tablets.
Tablet splitting also is addressed in
pharmacopeial standards. The European
Pharmacopeia currently applies
accuracy of subdivision standards for
scored tablets—and has at various times
also included standards for content
uniformity, weight variation, and loss of
mass—while the United States
Pharmacopeia published a Stimuli
article in 2009 proposing criteria for loss
of mass and accuracy of subdivision for
split tablets.
As an outgrowth of these discussions,
FDA is providing recommendations for
application content regarding the
scientific basis for functional scoring on
solid oral dosage form products to
ensure the quality of both NDA and
ANDA scored tablet products. To
accomplish this, the Agency has
developed consistent and meaningful
criteria by which scored tablets can be
evaluated and labeled by: (1) Providing
a harmonized approach to chemistry,
VerDate Mar<15>2010
17:11 Mar 12, 2013
Jkt 229001
manufacturing, and controls reviews of
scored tablets; (2) ensuring consistency
in nomenclature (e.g., score versus
bisect) and labeling; and (3) providing
information through product labeling or
other means to health care providers.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on tablet scoring:
Nomenclature, labeling, and data for
evaluation. 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. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
III. The 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
§ 201.57 (21 CFR 201.57) and 21 CFR
314.50 and 314.70 have been approved
under OMB control numbers 0910–0572
(for § 201.57) and 0910–0001 (for 21
CFR part 314).
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05725 Filed 3–12–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food and Drug Administration/Xavier
University Global Medical Device
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Cincinnati
District, in cosponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University Global Medical Device
Conference.’’ This 3-day public
conference includes presentations from
key FDA officials and industry experts
with small group breakout sessions. The
conference is intended for companies of
all sizes and employees at all levels.
Date and Time: The public conference
will be held on May 1, 2013, from 8:30
a.m. to 5 p.m.; May 2, 2013, from 8:30
a.m. to 5 p.m.; and May 3, 2013, from
8:30 a.m. to 1 p.m.
Location: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3396.
Contact Persons: For information
regarding this notice: Gina Brackett,
Food and Drug Administration, 6751
Steger Dr., Cincinnati, OH 45237, 513–
679–2700, Fax: 513–679–2771,
Gina.Brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH 45207,
513–745–3073, phillipsm4@xavier.edu.
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, and lunches for the 3 days of
the conference. Early registration ends
March 13, 2013. Standard registration
ends April 9, 2013. There will be onsite
registration. The cost of registration is as
follows:
SUMMARY:
BILLING CODE 4160–01–P
PO 00000
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]]>Agencies
[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15956-15957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05725]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0595]
Guidance for Industry on Tablet Scoring: Nomenclature, Labeling,
and Data for Evaluation; 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 ``Tablet Scoring:
Nomenclature, Labeling, and Data for Evaluation.'' This guidance
provides recommendations to sponsors of new drug applications (NDAs)
and abbreviated new drug applications (ANDAs) regarding what criteria
should be met when evaluating and labeling tablets that have been
scored. (A scoring feature facilitates tablet splitting, which is the
practice of breaking or cutting a higher-strength tablet into smaller
portions.) Specifically, this guidance recommends guidelines to follow,
data to provide, and criteria to meet and detail in an application to
support approval of a scored tablet; and nomenclature and labeling for
approved scored tablets.
This guidance does not address specific finished-product release
testing, where additional requirements may apply to scored tablets.
This guidance does not describe the medical practice conditions under
which tablet splitting is considered or recommended.
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, 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
guidance document.
Submit electronic comments on the guidance to https://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: Russell Wesdyk, Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4182, Silver Spring, MD 20993-0002,
301-796-2400.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for
Evaluation.'' This guidance provides recommendations to sponsors of
NDAs and ANDAs regarding what criteria should be met when evaluating
and labeling tablets that have been scored. (A scoring feature
facilitates tablet splitting, which is the practice of breaking or
cutting a higher-strength tablet into smaller portions.) Specifically,
this guidance recommends:
Guidelines to follow, data to provide, and criteria to
meet and detail in an application to support approval of a scored
tablet; and
Nomenclature and labeling for approved scored tablets.
On August 30, 2011 (76 FR 53909), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
November 28, 2011. A number of comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. The Agency also held an Advisory
Committee for Pharmaceutical Science and Clinical Pharmacology meeting
on August 9, 2012, to discuss the draft guidance. Any changes to the
guidance were minor and made to clarify statements in the draft
guidance.
The Agency has previously considered tablet scoring as an issue
when determining whether a generic drug product is the same as the
reference listed drug (RLD). One characteristic of a tablet dosage form
is that it may be manufactured with a score or scores. This
characteristic is useful because the score can be used to facilitate
the splitting of the tablet into fractions when less than a full tablet
is desired for a dose. Although there are
[[Page 15957]]
no standards or regulatory requirements that specifically address
scoring of tablets, the Agency recognizes the need for consistent
scoring between a generic product and its RLD.
Consistent scoring ensures that the patient is able to adjust the
dose, by splitting the tablet, in the same manner as the RLD. This
enables the patient to switch between products made by different
manufacturers without encountering problems related to the dose. In
addition, consistent scoring ensures that neither the generic product
nor the RLD has an advantage in the marketplace because one is scored
and one is not.
The Center for Drug Evaluation and Research's Drug Safety Oversight
Board considered the practice of tablet splitting at its October 2009
and November 2010 meetings. During those meetings, they discussed how
insurance companies and doctors are increasingly recommending that
patients split tablets, either to adjust the patients' dose or as a
cost-saving measure. Because of this, the Agency conducted internal
research on tablet splitting and concluded that in some cases, there
are possible safety issues, especially when tablets are not scored or
evaluated for splitting. The Agency's concerns with splitting a tablet
included variations in the tablet content, weight, disintegration, or
dissolution, which can affect how much drug is present in a split
tablet and available for absorption. In addition, there may be
stability issues with splitting tablets.
Tablet splitting also is addressed in pharmacopeial standards. The
European Pharmacopeia currently applies accuracy of subdivision
standards for scored tablets--and has at various times also included
standards for content uniformity, weight variation, and loss of mass--
while the United States Pharmacopeia published a Stimuli article in
2009 proposing criteria for loss of mass and accuracy of subdivision
for split tablets.
As an outgrowth of these discussions, FDA is providing
recommendations for application content regarding the scientific basis
for functional scoring on solid oral dosage form products to ensure the
quality of both NDA and ANDA scored tablet products. To accomplish
this, the Agency has developed consistent and meaningful criteria by
which scored tablets can be evaluated and labeled by: (1) Providing a
harmonized approach to chemistry, manufacturing, and controls reviews
of scored tablets; (2) ensuring consistency in nomenclature (e.g.,
score versus bisect) and labeling; and (3) providing information
through product labeling or other means to health care providers.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on tablet scoring: Nomenclature, labeling,
and data for evaluation. 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. Comments
Interested persons may submit either electronic comments regarding
this document to https://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 https://www.regulations.gov.
III. The 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 Sec. 201.57 (21 CFR 201.57) and 21 CFR
314.50 and 314.70 have been approved under OMB control numbers 0910-
0572 (for Sec. 201.57) and 0910-0001 (for 21 CFR part 314).
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05725 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P
