Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry; Availability, 60217-60218 [2023-18831]
Download as PDF
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2023–18841 Filed 8–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2024]
Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act.’’ This
guidance clarifies the enhanced drug
distribution security requirements listed
in the Federal Food, Drug, and Cosmetic
Act (FD&C Act). In addition, this
guidance outlines and makes
recommendations on the system
attributes necessary to enable secure
tracing of product at the package level,
including allowing for the use of
verification, inference, and aggregation,
as necessary. This guidance finalizes the
draft guidance of the same title issued
on June 4, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on August 31, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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
VerDate Sep<11>2014
18:04 Aug 30, 2023
Jkt 259001
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–
2020–D–2024 for ‘‘Enhanced Drug
Distribution Security at the Package
Level 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.
• 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
60217
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Abha Kundi, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov; or Anne Taylor, 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 guidance for industry entitled
‘‘Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act.’’ The Drug
Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113–54) was signed
into law on November 27, 2013.
The DSCSA outlines critical steps to
achieve electronic pharmaceutical
supply chain interoperability by
November 27, 2023, that will enhance
E:\FR\FM\31AUN1.SGM
31AUN1
ddrumheller on DSK120RN23PROD with NOTICES1
60218
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
the identification and tracing of certain
prescription drugs as they are
distributed within the United States.
Section 202 of the DSCSA added section
582 to the FD&C Act (21 U.S.C. 360eee1), which established product tracing,
product identifier, authorized trading
partner, and verification requirements
for manufacturers, repackagers,
wholesale distributors, and dispensers
to facilitate the tracing of products
through the pharmaceutical distribution
supply chain. Section 582 of the FD&C
Act also imposed requirements for
enhanced drug distribution security that
go into effect on November 27, 2023.
Trading partners, along with Federal
and State authorities, have an important
role in ensuring the quality of
prescription drugs and protecting the
integrity of the pharmaceutical
distribution supply chain. The DSCSA
requirements, which have been phased
in since 2013, improve supply chain
security activities by trading partners
involved in prescription drug
manufacturing, repackaging, wholesale
distribution, warehousing or related
logistical activities, and dispensing. The
gradual implementation of the DSCSA
requirements for product tracing,
product identification, authorized
trading partners, and verification
facilitates the development of electronic
interoperability to enhance the security
of the pharmaceutical distribution
supply chain.
Section 582(g)(1) of the FD&C Act sets
forth the requirements for enhanced
drug distribution security as of
November 27, 2023, including (as
described in that provision and
generally summarized here):
• The exchange of transaction
information and transaction statements
in a secure, interoperable, electronic
manner.
• Transaction information that
includes the product identifier at the
package level for each package included
in the transaction.
• Systems and processes for
verification of product at the package
level.
• Systems and processes needed to
promptly respond to requests from FDA
(or other appropriate Federal or State
officials) for product transaction
information in the event of a recall or
to investigate suspect and illegitimate
products.
This guidance clarifies the enhanced
drug distribution security requirements
VerDate Sep<11>2014
18:04 Aug 30, 2023
Jkt 259001
and pursuant to section 582(h)(3) of the
FD&C Act describes recommendations
for system attributes necessary for
enhanced product tracing and enhanced
verification, including when the use of
aggregation and inference may be
appropriate.
This guidance finalizes the draft
guidance entitled ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act’’ issued on June 4, 2021 (86
FR 30053). FDA considered comments
received on the draft guidance as the
guidance was finalized. Changes from
the draft to the final guidance include
removal of the term ‘‘enhanced system’’
when referring to the requirements in
section 582(g) of the FD&C Act to avoid
confusion and clarification of
recommendations addressing (1)
reconciliation of transaction
information, (2) aggregation and
inference, and (3) verification of
saleable returns, including a brief
discussion of the sunset provisions of
section 582(k) of the FD&C Act. Changes
also include clarification of
requirements for provision of certain
information in response to requests
stemming from investigation of suspect
or illegitimate product. In addition,
editorial changes were made to improve
clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Enhanced Drug
Distribution Security at the Package
Level 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.
II. Paperwork Reduction Act of 1995
This guidance includes information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this guidance that are
new or that would represent substantive
or material modifications to those
previously approved collections of
information found in FDA regulations or
guidance.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–18831 Filed 8–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Supporting Healthy Start Performance
Project
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
Announcing period of
performance supplement for the
Supporting Healthy Start Performance
Project (SHSPP) recipient.
ACTION:
HRSA will provide
supplemental award funds to the
current SHSPP recipient, in fiscal year
2023 to provide new and continued
support to Healthy Start grant
recipients.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rochelle Logan, Healthy Start Team
lead, Division of Healthy Start and
Perinatal Services, Maternal and Child
Health Bureau, Health Resources and
Services Administration, at rlogan@
hrsa.gov or (301) 443–0543.
SUPPLEMENTARY INFORMATION:
Amount of Non-Competitive
Award(s): One award for $1,900,000.
Project Period: June 1, 2023, to May
31, 2024.
Assistance Listing (CFDA) Number:
93.926.
Award Instrument: Supplement.
Authority: 42 U.S.C. 254c–8 (title III,
section 330H of the Public Health
Service Act).
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60217-60218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18831]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2024]
Enhanced Drug Distribution Security at the Package Level Under
the Drug Supply Chain Security Act; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act.'' This guidance clarifies the enhanced drug
distribution security requirements listed in the Federal Food, Drug,
and Cosmetic Act (FD&C Act). In addition, this guidance outlines and
makes recommendations on the system attributes necessary to enable
secure tracing of product at the package level, including allowing for
the use of verification, inference, and aggregation, as necessary. This
guidance finalizes the draft guidance of the same title issued on June
4, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on August 31, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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'').
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-2020-D-2024 for ``Enhanced Drug Distribution Security at the
Package Level 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.
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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Abha Kundi, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-3130,
[email protected]; or Anne Taylor, 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 guidance for industry
entitled ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act.'' The Drug Supply Chain
Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law
on November 27, 2013.
The DSCSA outlines critical steps to achieve electronic
pharmaceutical supply chain interoperability by November 27, 2023, that
will enhance
[[Page 60218]]
the identification and tracing of certain prescription drugs as they
are distributed within the United States. Section 202 of the DSCSA
added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which
established product tracing, product identifier, authorized trading
partner, and verification requirements for manufacturers, repackagers,
wholesale distributors, and dispensers to facilitate the tracing of
products through the pharmaceutical distribution supply chain. Section
582 of the FD&C Act also imposed requirements for enhanced drug
distribution security that go into effect on November 27, 2023.
Trading partners, along with Federal and State authorities, have an
important role in ensuring the quality of prescription drugs and
protecting the integrity of the pharmaceutical distribution supply
chain. The DSCSA requirements, which have been phased in since 2013,
improve supply chain security activities by trading partners involved
in prescription drug manufacturing, repackaging, wholesale
distribution, warehousing or related logistical activities, and
dispensing. The gradual implementation of the DSCSA requirements for
product tracing, product identification, authorized trading partners,
and verification facilitates the development of electronic
interoperability to enhance the security of the pharmaceutical
distribution supply chain.
Section 582(g)(1) of the FD&C Act sets forth the requirements for
enhanced drug distribution security as of November 27, 2023, including
(as described in that provision and generally summarized here):
The exchange of transaction information and transaction
statements in a secure, interoperable, electronic manner.
Transaction information that includes the product
identifier at the package level for each package included in the
transaction.
Systems and processes for verification of product at the
package level.
Systems and processes needed to promptly respond to
requests from FDA (or other appropriate Federal or State officials) for
product transaction information in the event of a recall or to
investigate suspect and illegitimate products.
This guidance clarifies the enhanced drug distribution security
requirements and pursuant to section 582(h)(3) of the FD&C Act
describes recommendations for system attributes necessary for enhanced
product tracing and enhanced verification, including when the use of
aggregation and inference may be appropriate.
This guidance finalizes the draft guidance entitled ``Enhanced Drug
Distribution Security at the Package Level Under the Drug Supply Chain
Security Act'' issued on June 4, 2021 (86 FR 30053). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include removal of the
term ``enhanced system'' when referring to the requirements in section
582(g) of the FD&C Act to avoid confusion and clarification of
recommendations addressing (1) reconciliation of transaction
information, (2) aggregation and inference, and (3) verification of
saleable returns, including a brief discussion of the sunset provisions
of section 582(k) of the FD&C Act. Changes also include clarification
of requirements for provision of certain information in response to
requests stemming from investigation of suspect or illegitimate
product. In addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Enhanced Drug Distribution Security at the
Package Level 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.
II. Paperwork Reduction Act of 1995
This guidance includes information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). FDA intends
to solicit public comment and obtain OMB approval for any information
collections recommended in this guidance that are new or that would
represent substantive or material modifications to those previously
approved collections of information found in FDA regulations or
guidance.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18831 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P