80 FR 35366 - Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 118 (June 19, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35366-35367]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15076]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1434]


Size, Shape, and Other Physical Attributes of Generic Tablets and 
Capsules; 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 ``Size, Shape, and 
Other Physical Attributes of Generic Tablets and Capsules.'' This 
guidance discusses FDA recommendations for the size, shape, and other 
physical attributes of generic tablets and capsules intended to be 
swallowed intact. FDA is concerned that differences in these physical 
characteristics between generic drugs and the originator drug could 
affect patient outcomes.

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, 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: Debra Catterson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-3861; or Vilayat 
Sayeed, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
240-402-9077.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Size, Shape, and Other Physical Attributes of Generic 
Tablets and Capsules.'' FDA is concerned that the differences in size, 
shape, and other physical characteristics between a generic drug and 
the originator drug may affect patient compliance and acceptability of 
medication regimens or could lead to medication errors. For example, 
studies show that tablet size and shape can affect ease of swallowing; 
generic tablets that are significantly larger than their corresponding 
reference drug product may be more difficult to swallow, leading to 
potential adverse events as well as noncompliance with treatment 
regimens. FDA is recommending that generic manufacturers consider the 
size, shape, and other physical characteristics of the originator drug 
when developing a generic version.
    In the Federal Register of December 10, 2013 (78 FR 74154), 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 editorial changes primarily for clarification.
    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 the size, shape, and other physical 
attributes of generic tablets and capsules. 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.

[[Page 35367]]

II. Paperwork Reduction Act of 1995

    This guidance contains 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 
collection of information requested in the guidance is covered under 
FDA regulations at 21 CFR part 314 and approved under OMB control 
number 0910-0001.

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 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15076 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P