[Federal Register Volume 88, Number 222 (Monday, November 20, 2023)]
[Notices]
[Pages 80726-80728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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.

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, [email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic.) 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