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Notice

Guidance for Industry on Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 “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 Start Printed Page 63305INFORMATION 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.

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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.

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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.

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Dated: October 6, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-26296 Filed 10-11-11; 8:45 am]

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