Notice2023-25609
Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments
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
November 20, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is publishing this request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 88 Issue 222 (Monday, November 20, 2023)</title>
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[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80726-80728]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4806]
Implementing Interoperable Systems and Processes for Enhanced
Drug Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket;
Request for Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
publishing this request for information to better understand the status
of trading partners' interoperable systems and processes for enhanced
drug distribution security as required by the Food, Drug and Cosmetic
Act (FD&C Act).
DATES: Although you can comment at any time, submit either electronic
or written information and comments by February 20, 2024 to ensure that
the Agency considers your comments for potential future actions.
ADDRESSES: You may submit information and comments 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 80727]]
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-2023-N-4806 for ``Implementing Interoperable Systems and Processes
for Enhanced Drug Distribution Security Requirements Under Section
582(g)(1) of the Federal Food, Drug, and Cosmetic 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.
FOR FURTHER INFORMATION CONTACT: Sarah Venti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993, 301-796-
3130, <a href="/cdn-cgi/l/email-protection#9df9efe8fae9effcfef6fcf3f9e9effcfef8ddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="680c1a1d0f1c1a090b0309060c1c1a090b0d280e0c094600001b460f071e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Supply Chain Security Act (DSCSA) (Pub. L. 113-54),
enacted in 2013, requires trading partners--primarily manufacturers,
wholesale distributors, dispensers, and repackagers--to provide,
receive and maintain documentation about prescription drugs and their
chain of ownership from manufacturer to dispenser as the drugs are
distributed in the U.S. supply chain. Before November 27, 2023, trading
partners could choose to provide and maintain such information either
electronically or in paper format. However, beginning November 27,
2023, the DSCSA requirements changed to include requiring trading
partners to provide, receive and maintain documentation about products
and ownership only electronically using interoperable systems and
processes. Under enhanced drug distribution security requirements in
section 582(g)(1) of the FD&C Act (21 U.S.C. 360eee-1(g)(1)), amongst
other requirements, trading partners are required to: (1) exchange
transaction information and transaction statements in a secure,
interoperable, electronic manner for each package; (2) implement
systems and processes for package-level verification, including the
standardized numerical identifier; and (3) implement systems and
processes to facilitate gathering the information necessary to produce
the transaction information and statement for each transaction going
back to the manufacturer if FDA or a trading partner requests an
investigation in the event of a recall or a suspect or illegitimate
product.
In August 2023, the Agency published the ``Enhanced Drug
Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic Act--Compliance Policies (Enhanced
Drug Distribution Security Compliance Policies). (See <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic</a>.) This guidance establishes a 1-year
``stabilization period'' to accommodate the additional time trading
partners need to implement, troubleshoot, and mature their secure,
interoperable, electronic systems and processes while supporting the
continued availability of products to patients. Specifically, the
guidance describes that, until November 27, 2024, FDA does not intend
to take action to enforce requirements for the interoperable,
electronic, package level product tracing under section 582(g)(1) of
the FD&C Act that went into effect on November 27, 2023. In addition,
FDA does not intend to take action to enforce section 582(g)(1)(B) of
the FD&C Act with respect to drug product that is introduced in a
transaction into commerce by the product's manufacturer or repackager
before November 27, 2024, and for subsequent transactions of such
product through the product's expiry.
The Enhanced Drug Distribution Security Compliance Policies are
intended to provide clarity and flexibility to trading partners to help
ensure continued patient access to prescription drugs as the supply
chain transitions to the secure, interoperable, electronic product
tracing at the package level. The guidance does not provide, and should
not be viewed as providing, a justification in delaying efforts by
trading partners to implement the enhanced drug distribution security
requirements under section 582(g)(1) of the FD&C Act.
Because FDA expects trading partners to use this stabilization
period to continue to build and validate secure, interoperable,
electronic systems and processes, we are seeking information to confirm
trading partners' commitment to and progress on implementing DSCSA
requirements for enhanced drug distribution security.
II. Request for Information and Comments
Interested persons are invited to provide detailed information and
comments on the progress of their enhanced drug distribution security
implementation. This information is intended to facilitate knowledge
sharing among trading partners in order to help support successful
implementation of secure, interoperable, electronic product tracing at
the package level by November 27, 2024. FDA is particularly interested
in information related to how your current and planned implementation
ensures supply chain
[[Page 80728]]
readiness and a stronger and safer drug supply chain including the
following:
1. How are you using the stabilization period to:
a. Troubleshoot and mature secure, electronic, interoperable
systems and processes for enhanced drug distribution security with
upstream trading partners?
b. Troubleshoot and mature secure, electronic, interoperable
systems and processes for enhanced drug distribution security with
downstream trading partners?
2. What are the most significant challenges you have overcome? What
strategies did you employ to overcome those challenges?
3. What aspects of your systems and processes have you successfully
operationalized?
4. What are the next steps in your strategy to ensure successful
implementation of the enhanced drug distribution security requirements
by November 27, 2024?
Dated: November 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25609 Filed 11-17-23; 8:45 am]
BILLING CODE 4164-01-P
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