[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53909-53910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22146]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0595]
Draft Guidance for Industry on Tablet Scoring: Nomenclature,
Labeling, and Data for Evaluation; 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availability of a draft guidance for industry entitled ``Tablet
Scoring: Nomenclature, Labeling, and Data for Evaluation.'' This draft
guidance provides recommendations to sponsors of new drug applications
(NDAs) and abbreviated new drug applications (ANDAs) regarding what
criteria should be met to facilitate the evaluation and labeling of
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 Specifically, this draft
guidance recommends guidelines to follow, data to provide, and criteria
to meet and detail in an application to approve 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 be appropriate for scored
tablets.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 28, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Russell Wesdyk, Center for Drug
Evaluation and Research, 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 draft guidance for industry
entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for
Evaluation.'' This draft guidance provides recommendations to sponsors
of NDAs and ANDAs regarding what criteria should be met to facilitate
the evaluation and labeling of 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 draft guidance recommends:
Guidelines to follow, data to provide, and criteria to
meet and detail in an application to approve a scored tablet.
Nomenclature and labeling for approved scored tablets.
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 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.
CDER'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.
[[Page 53910]]
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.\1\
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\1\ Geoff Green et al., November-December 2009, 35(6),
``Pharmacopeial Standards for the Subdivision Characteristics of
Scored Tablets,'' Pharmacopeial Forum.
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As an outgrowth of these discussions and developments, FDA is
providing recommendations for application content regarding the
scientific basis for functional scores 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. The criteria are as follows: (1) Provide a harmonized approach
to chemistry, manufacturing, and controls reviews of scored tablets;
(2) ensure consistency in nomenclature (e.g., score versus bisect) and
labeling; and (3) provide information through product labeling or other
means to healthcare providers.
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 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 to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
III. 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 21 CFR 201.57, 314.50, and 314.70 have
been approved under OMB control numbers 0910-0572 (for section 201.57)
and 0910-0001 (for 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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22146 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P