[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15956-15957]
From the Federal Register Online via the Government Publishing 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 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: 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 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.
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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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