[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40254-40256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Act; Revised Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 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 The revised draft guidance explains how to determine when 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draft guidance discusses the distribution of drugs for emergency 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guidance revises the August 2017 draft guidance entitled ``Identifying 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DATES: Submit either electronic or written comments on the draft 
guidance by September 6, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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'').

[[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 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 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/
vaccines-blood-biologics/guidance-compliance-regulatory-

[[Page 40256]]

information-biologics/biologics-guidances, or https://www.regulations.gov.

    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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