[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]


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

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Draft Guidance for Industry on Tablet Scoring: Nomenclature, 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.

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

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availability of a draft guidance for industry entitled ``Tablet 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 This draft 
guidance provides recommendations to sponsors of new drug applications 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 Specifically, this draft 
guidance recommends guidelines to follow, data to provide, and criteria 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 28, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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\
---------------------------------------------------------------------------

    \1\ Geoff Green et al., November-December 2009, 35(6), 
``Pharmacopeial Standards for the Subdivision Characteristics of 
Scored Tablets,'' Pharmacopeial Forum.
---------------------------------------------------------------------------

    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