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, 80726-80728 [2023-25609]
Download as PDF
<![CDATA[
80726
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
Head Start’s participation in or use of
coordinated funding, defined as the
piecing together or combining of
multiple funding sources. The data
collection effort will consist of two
surveys: (1) a census survey of Head
Start program directors (of any grant
recipient with a Head Start grant, Early
Head Start grant, or both, or one of their
delegate programs), and (2) a census
survey of three state government
administrative positions in each of the
50 states and Washington, DC (the Head
Start Collaboration Office Director, the
administrator of state pre-kindergarten
funds, and the administrator of the
federal Child Care and Development
Fund [CCDF]). The surveys will identify
the most common approaches to
coordinated funding; examine how
these approaches relate to the provision
of high-quality, comprehensive ECE
services in Head Start programs;
understand policy levers and conditions
that influence Head Start programs’
decisions around and ability to
coordinate funding; and document how
participation in coordinated funding
relates to Head Start’s engagement with
other ECE programs and system efforts.
The resulting insights will inform ACF
about the prevalence of coordinated
funding in Head Start, facilitators and
challenges of coordinated funding for
Head Start programs, and potential
associations with program quality. They
will also inform future case studies.
Respondents: Head Start Program
Directors, state-based Head Start
Collaboration Office Directors, state
administrators of state pre-kindergarten
funds, and state-based administrators of
federal CCDF.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
Program Director Survey (Head Start Program Directors or financial administrators) .......................................................................................................
ECE State Administrator Survey (State-based Head Start Collaboration Office Directors, administrators of state pre-kindergarten funds, state-based
administrators of federal CCDF) ..................................................................
Estimated Total Annual Burden
Hours: 1,456.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 9835; 42 U.S.C.
9844.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–25607 Filed 11–17–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4184–22–P
.83
1,363
138
1
.67
93
[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
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
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).
SUMMARY:
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.
VerDate Sep<11>2014
17:42 Nov 17, 2023
Jkt 262001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Total/annual
burden
(in hours)
1
Food and Drug Administration
DATES:
Avg. burden
per response
(in hours)
1,642
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
(total over
request
period)
You may submit
information and comments at any time
as follows:
ADDRESSES:
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’’).
E:\FR\FM\20NON1.SGM
20NON1
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
VerDate Sep<11>2014
17:42 Nov 17, 2023
Jkt 262001
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,
drugtrackandtrace@fda.hhs.gov.
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/
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
80727
search-fda-guidance-documents/
enhanced-drug-distribution-securityrequirements-under-section-582g1federal-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
E:\FR\FM\20NON1.SGM
20NON1
80728
Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4718]
Advancing the Development of
Therapeutics Through Rare Disease
Patient Community Engagement
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Advancing the
Development of Therapeutics Through
Rare Disease Patient Community
Engagement.’’ Convened by the DukeRobert J. Margolis, MD Center for Health
Policy (Duke-Margolis) in collaboration
with FDA and supported by a
cooperative agreement between FDA
and Duke-Margolis, the workshop will
focus on how best to understand
patients’ experiences living with a rare
disease and how to incorporate those
experiences, as well as patients’
priorities for treatment goals,
throughout the drug development
process.
DATES: The public meeting will be held
virtually on December 14, 2023, from 12
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:42 Nov 17, 2023
Jkt 262001
p.m. to 5 p.m. Eastern Time. Either
electronic or written comments on this
public meeting must be submitted by
February 12, 2024. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held virtually using the Zoom platform.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 12, 2024.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
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’’).
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.’’
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–4718 for ‘‘Advancing the
Development of Therapeutics Through
Rare Disease Patient Community
Engagement.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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-201509-18/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:
Stuti Ganatra, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Silver Spring, MD
20993, 301–796–8112, PatientFocused@
fda.hhs.gov.
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
