[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30058-30059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3175]


Product Identifiers Under the Drug Supply Chain Security Act: 
Questions and Answers; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Product Identifiers 
Under the Drug Supply Chain Security Act: Questions and Answers.'' The 
guidance is intended to address questions regarding product identifiers 
that, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as 
amended by the Drug Supply Chain Security Act (DSCSA), are required to 
be affixed to, or imprinted on, packages and homogenous cases of 
certain drug products intended to be introduced in a transaction into 
commerce. This guidance is intended to clarify FDA's interpretation of 
these requirements, including as they relate to the linear barcode 
requirements under the Code of Federal Regulations. This guidance 
finalizes the draft guidance issued on September 20, 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on June 4, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3175 for ``Product Identifiers Under the Drug Supply Chain 
Security Act: Questions and Answers.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the 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 the office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tia Harper-Velazquez, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4262, Silver Spring, MD 20993-0002, 301-
796-3130.

SUPPLEMENTARY INFORMATION:

[[Page 30059]]

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Product Identifiers Under the Drug Supply Chain Security 
Act: Questions and Answers.'' The DSCSA (Title II of Pub. L. 113-54) 
was signed into law on November 27, 2013. Section 202 of the DSCSA, 
which added sections 581 and 582 to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360eee and 360eee-1), set forth new 
definitions and requirements for manufacturers, repackagers, wholesale 
distributors, and dispensers to facilitate the tracing of product 
through the pharmaceutical distribution supply chain.
    A product identifier is defined under section 581(14) of the FD&C 
Act as a standardized graphic that includes the product's standardized 
numerical identifier (composed of the National Drug Code and a unique 
alphanumeric serial number), lot number, and expiration date, in both 
human- and machine-readable formats. Under sections 582(b)(2)(A) and 
582(e)(2) of the FD&C Act, respectively, manufacturers and repackagers 
are required to ``affix or imprint a product identifier to each package 
and homogenous case of a product intended to be introduced in a 
transaction into commerce.''
    In the Federal Register of September 20, 2018 (83 FR 47626), FDA 
announced the availability of the draft guidance of the same title 
dated September 20, 2018. FDA received several comments on the draft 
guidance and considered those comments as we finalized the guidance. 
Among the key substantive changes, we revised the recommendations 
regarding the expiration date format--specifically, we no longer 
recommend using a space between the day, month, and year; we now 
recommend using a hyphen or forward slash between the expiration date 
elements. In addition, we also modified our statements regarding use of 
the human-readable GS1 Global Trade Identification Number to explain 
the importance of the three segment NDC format for patient safety. We 
also clarified how to affix or imprint multiple barcodes on the label 
with sufficient space to avoid confusion in reading or scanning. We 
made additional, editorial changes to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated September 
20, 2018.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Product Identifiers Under the Supply Chain 
Security Act: Questions and Answers.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11733 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P