[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63304-63305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 guidance for industry entitled ``Incorporation of 
Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products 
for Anticounterfeiting.'' This guidance provides recommendations 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) or 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.

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

[[Page 63305]]

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: John L. Smith, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 2619, Silver Spring, MD 20993, 301-796-
1757.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Incorporation of Physical-Chemical Identifiers Into Solid 
Oral Dosage Form Drug Products for Anticounterfeiting.'' For the 
purpose of this guidance, a PCID is a substance or combination of 
substances possessing a unique physical or chemical property that 
unequivocally identifies a drug product or dosage form as authentic and 
distinguishes it from counterfeits. To thwart drug product 
counterfeiting, pharmaceutical manufacturers have been investigating 
technologies that may make drug products more difficult to duplicate, 
including the incorporation of PCIDs into SODFs. One approach that 
manufacturers appear to be considering involves adding a trace amount 
of one or more inactive ingredients to an existing section of the 
dosage form (in the guidance, section is the term used for a discrete, 
contained solid or a layer in a solid oral dosage form). Any section 
can be described by its composition, the functional characteristics 
that distinguish it from other sections in that dosage form, and its 
position relative to other sections that may be present (e.g., 
coatings, capsule shells, encapsulated particles, a layer in a bilayer 
tablet, and compressed powders). A unique physical-chemical 
characteristic of that ingredient makes it possible to detect and 
authenticate legitimate dosage forms, and to identify counterfeits. 
Examples of substances that may be incorporated into SODFs as PCIDs 
include inks, pigments, flavors, and molecular taggants. Such PCIDs may 
allow product authentication by their presence alone or may be used to 
code the product identity into or onto the SODF.
    This guidance provides recommendations to pharmaceutical 
manufacturers on the following topics: (1) Design considerations for 
PCIDs into SODFs, (2) supporting documentation to be submitted in NDAs 
or 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. Although not addressed in this 
guidance, FDA is considering whether to address the incorporation of a 
PCID into a drug's packaging or labeling in a future guidance.
    In the Federal Register of July 14, 2009 (74 FR 34021), FDA 
announced the availability of a draft guidance for industry entitled 
``Draft Guidance for Industry on Incorporation of Physical-Chemical 
Identifiers Into Solid Oral Dosage Form Drug Products for 
Anticounterfeiting.'' The notice gave interested persons an opportunity 
to comment by October 13, 2009. We have carefully considered the 
comments we received and, where appropriate, have made corrections, 
added information, or clarified the information in the guidance in 
response to the comments.
    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 use of PCIDs in SODF drug products to 
prevent counterfeiting. 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 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 has been approved under OMB control 
number 0910-0001. The recommendations for labeling would be covered 
under 21 CFR 201.57. This information collection has been approved 
under OMB control number 0910-0572.

III. 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.

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: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26296 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P