[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34021-34022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0212]


Draft Guidance for Industry on ``Incorporation of Physical-
Chemical Identifiers into Solid Oral Dosage Form Drug Products for 
Anticounterfeiting,'' 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availability of a draft guidance for industry entitled ``Incorporation 
of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug 
Products for Anticounterfeiting.'' This draft guidance provides 
recommendations to pharmaceutical manufacturers on design 
considerations for incorporating physical-chemical identifiers (PCIDs) 
into solid oral dosage forms (SODFs), supporting documentation to be 
submitted in new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) to address the proposed incorporation of PCIDs in 
SODFs, supporting documentation to be submitted in postapproval 
submissions to report or request approval to incorporate PCIDs into 
SODFs, and procedures for reporting or requesting approval to 
incorporate PCIDs into SODFs as a postapproval change. This draft 
guidance also provides our recommendations regarding evaluation of 
toxicological and other concerns for PCIDs that are incorporated into 
packaging and labeling and procedures for reporting or requesting 
approval to add PCIDs to packaging and containers as a postapproval 
change.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 13, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

[[Page 34022]]


FOR FURTHER INFORMATION CONTACT:  John L. Smith, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10993 New 
Hampshire Ave., Building 21, rm. 2619, Rockville, MD 20857, 301-796-
1757.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Incorporation of Physical-Chemical Identifiers into Solid 
Oral Dosage Form Drug Products for Anticounterfeiting.'' Pharmaceutical 
manufacturers aiming to thwart drug product counterfeiting have been 
investigating readily available technologies to make drug products more 
difficult to duplicate. One approach that pharmaceutical manufacturers 
appear to be considering involves adding a trace amount of an inactive 
ingredient(s) to an existing section of the dosage form. A unique 
physical-chemical characteristic of that ingredient makes it possible 
to detect and authenticate legitimate dosage forms and identify 
counterfeits.
    This draft guidance provides recommendations to pharmaceutical 
manufacturers on the following topics: (1) Design considerations for 
incorporating PCIDS into SODFs, (2) supporting documentation to be 
submitted with NDAs and ANDAs to address the proposed incorporation of 
PCIDs in SODFs, (3) supporting documentation to be submitted in 
postapproval submissions to report or request approval to incorporate 
PCIDs into SODFs, and (4) procedures for reporting or requesting 
approval to incorporate PCIDs into SODFs as a postapproval change. This 
draft guidance also provides our recommendations regarding: (1) 
Evaluation of toxicological and other concerns for PCIDs that are 
incorporated into packaging and labeling and (2) procedures for 
reporting or requesting approval to add PCIDs to packaging and 
containers as a postapproval change.
    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 
``Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage 
Form Drug Products for Anticounterfeiting.'' 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information 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 documentation in premarketing regulatory submissions 
recommended for applicants incorporating PCIDs into SODFs would be 
covered under 21 CFR 314.50 and 314.94, and the documentation in 
postapproval regulatory submissions would be covered under 21 CFR 
314.70. This information collection is approved by OMB under OMB 
control number 0910-0001.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: July 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16612 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S