Notice2021-11733
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance issued on September 20, 2018.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 106 (Friday, June 4, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30058-30059]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-11733]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
</pre></body>
</html>Indexed from Federal Register on June 4, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.