Guidance for Industry on Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting; Availability, 63304-63305 [2011-26296]

Download as PDF 63304 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices Submit electronic comments on the guidance to https://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: Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3244, Silver Spring, MD 20993–0002, 301– 796–3516; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: jlentini on DSK4TPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ The guidance provides recommendations on how to determine which adverse reactions are significant enough to warrant inclusion in the ‘‘Warnings And Precautions’’ section; how to decide what situations warrant a ‘‘Contraindication’’; and when to include a ‘‘Boxed Warning.’’ The guidance also provides recommendations on how to organize each section and what information to include when describing warnings and precautions, in situations when the use of the product is contraindicated, and in a boxed warning. This guidance is one of a series of guidances FDA is developing, or has developed, to assist applicants and reviewers with the content and format of certain sections of the labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3999), FDA issued final guidances on the content and format of the ‘‘Adverse Reactions’’ and ‘‘Clinical Studies’’ sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA issued a final guidance on determining established pharmacologic class for use in the highlights of prescribing information. In the Federal Register of March 23, 2010 (75 FR 13766), FDA issued a final guidance on the content and format of the ‘‘Dosage and Administration’’ section of labeling and in the Federal Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the content and format of VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 the ‘‘Clinical Pharmacology’’ section of labeling. The new labeling requirements (final rule, January 24, 2006, 71 FR 3922) and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use. On January 18, 2006, FDA issued a draft of this guidance on the ‘‘Warnings and Precautions, Contraindications, and Boxed Warning’’ sections of the labeling to obtain public comment (71 FR 3998). FDA received a number of comments, most of which focused on clarifications and further illustrations of issues discussed in individual sections and subsections of the guidance. FDA reviewed all received comments carefully during the finalization of the guidance. Other than clarifying edits, no changes of significance were made to the final version of the guidance. 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 content and format of the ‘‘Warnings and Precautions, Contraindications, and Boxed Warning’’ sections of labeling for human prescription drug and biological products. 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. Paperwork Reduction Act of 1995 This 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 and 201.56 have been approved under OMB control number 0910–0572. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm, https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm or https://www.regulations.gov. Dated: October 6, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–26297 Filed 10–11–11; 8:45 am] BILLING CODE 4160–01–P 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. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Incorporation of PhysicalChemical 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 SUMMARY: E:\FR\FM\12OCN1.SGM 12OCN1 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: INFORMATION jlentini on DSK4TPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 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 PhysicalChemical 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. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 63305 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/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0400] DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2011–0014] Approaches To Reducing Sodium Consumption; Public Meeting Food and Drug Administration, HHS; Food Safety and Inspection Service, USDA. ACTION: Notice of public meeting; request for comments. AGENCY: The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Food Safety and Inspection Service (FSIS), the Agricultural Research Service (ARS) and the Center for Nutrition Policy and Promotion (CNPP) are announcing a public meeting entitled ‘‘Approaches to Reducing Sodium Consumption.’’ FDA and FSIS recently published a Federal Register notice that announced the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. The purpose of the public meeting is to provide interested persons an opportunity to SUMMARY: E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63304-63305]
From the Federal Register Online via the Government Printing 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.

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

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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
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