Notice2022-14345
Identifying Trading Partners Under the Drug Supply Chain Security Act; Revised Draft Guidance for Industry; Availability
Primary source
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Published
July 6, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act." FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). The revised draft guidance explains how to determine when certain statutory requirements will apply to entities that are considered trading partners in the drug supply chain. It also discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers. Additionally, the revised draft guidance discusses the distribution of drugs for emergency medical reasons, office use, non-human research purposes, and research purposes in humans under an investigational new drug application. This guidance revises the August 2017 draft guidance entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act."
Full Text
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<title>Federal Register, Volume 87 Issue 128 (Wednesday, July 6, 2022)</title>
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[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40254-40256]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14345]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-1956]
Identifying Trading Partners Under the Drug Supply Chain Security
Act; Revised Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled
``Identifying Trading Partners Under the Drug Supply Chain Security
Act.'' FDA is issuing this guidance to assist industry and State and
local governments in understanding how to categorize the entities in
the drug supply chain in accordance with the Drug Supply Chain Security
Act (DSCSA). The revised draft guidance explains how to determine when
certain statutory requirements will apply to entities that are
considered trading partners in the drug supply chain. It also discusses
the activities of private-label distributors, salvagers, and returns
processors and reverse logistics providers. Additionally, the revised
draft guidance discusses the distribution of drugs for emergency
medical reasons, office use, non-human research purposes, and research
purposes in humans under an investigational new drug application. This
guidance revises the August 2017 draft guidance entitled ``Identifying
Trading Partners Under the Drug Supply Chain Security Act.''
DATES: Submit either electronic or written comments on the draft
guidance by September 6, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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'').
[[Page 40255]]
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-2017-D-1956 for ``Identifying Trading Partners Under the Drug
Supply Chain Security Act.'' 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 draft 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; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Aaron Weisbuch, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
<a href="/cdn-cgi/l/email-protection#357454475a5b1b62505c465740565d755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="6928081b0607473e0c001a0b1c0a01290f0d084701011a470e061f">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#acc8ded9cbd8decdcfc7cdc2c8d8decdcfc9eccac8cd82c4c4df82cbc3da"><span class="__cf_email__" data-cfemail="4f2b3d3a283b3d2e2c242e212b3b3d2e2c2a0f292b2e6127273c61282039">[email protected]</span></a>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Identifying Trading Partners Under the Drug Supply
Chain Security Act.'' The DSCSA (Title II of Pub. L. 113-54)
establishes new requirements to develop and enhance drug distribution
security by 2023. It does this, in part, by defining different types of
entities in the drug supply chain as trading partners (manufacturers,
repackagers, wholesale distributors, third-party logistics providers,
and dispensers). Among other things, the DSCSA requires that trading
partners of manufacturers, wholesale distributors, dispensers, and
repackagers meet the applicable requirements for being ``authorized
trading partners.''
In addition, the DSCSA outlines requirements for specific trading
partners, including drug product tracing, verification, and licensure
requirements (where applicable). This revised draft guidance describes
the activities and requirements for entities that are considered to be
a manufacturer, repackager, wholesale drug distributor, third-party
logistics provider, and/or dispenser and therefore considered a trading
partner under the DSCSA. This guidance revises the draft guidance
entitled ``Identifying Trading Partners Under the Drug Supply Chain
Security Act'' that was published on August 24, 2017 (82 FR 40159).
In response to public comments received and policy considerations,
FDA has added or revised its current thinking on the status of some
entities as trading partners, including private-label distributors,
salvagers, and returns processors and reverse logistics providers. The
Agency has also provided clarification on certain drug distribution
scenarios, including distribution for emergency medical use, office
use, non-human research purposes, and research in humans under an
investigational new drug application. FDA also addresses the
interpretation of section 582(a)(7) of the Federal Food, Drug, and
Cosmetic Act, which discusses third-party logistics providers licensure
status prior to the effective date of the forthcoming regulations
establishing licensure standards.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Identifying Trading Partners Under the Drug Supply Chain Security
Act.'' 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.
This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this revised draft 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 draft guidance
at <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/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, https://www.fda.gov/
vaccines-blood-biologics/guidance-compliance-regulatory-
[[Page 40256]]
information-biologics/biologics-guidances, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14345 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P
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