Rule2023-18359
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability
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Published
August 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies." This guidance describes FDA's compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.
Full Text
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<title>Federal Register, Volume 88 Issue 165 (Monday, August 28, 2023)</title>
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[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Rules and Regulations]
[Pages 58498-58500]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2023-D-1909]
Enhanced Drug Distribution Security Requirements Under Section
582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance
Policies; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Enhanced Drug Distribution Security Requirements Under Section
582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance
Policies.'' This guidance describes FDA's compliance policies regarding
enforcement of requirements for the interoperable, electronic, package
level product tracing (referred to as enhanced drug distribution
security requirements) under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) that will go into effect on November 27, 2023. FDA believes
the compliance policies outlined in this guidance will help supply
chain stakeholders, particularly trading partners, by accommodating the
additional time that may be needed to continue to develop and refine
appropriate systems and processes to conduct interoperable, electronic
tracing at the package level, to achieve robust supply chain security
under the Drug Supply Chain Security Act (DSCSA) while helping ensure
continued patient access to prescription drugs.
DATES: The announcement of the guidance is published in the Federal
Register on August 28, 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:
<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'').
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-D-1909 for ``Enhanced Drug Distribution Security Requirements
Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies.'' 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.
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.
[[Page 58499]]
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: Elizabeth Pepinsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993-0002, 301-
796-3130, email: <a href="/cdn-cgi/l/email-protection#52362027352620333139333c362620333137123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="8febfdfae8fbfdeeece4eee1ebfbfdeeeceacfe9ebeea1e7e7fca1e8e0f9">[email protected]</span></a>; 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 Requirements Under
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies.'' This guidance describes FDA's compliance
policies regarding enforcement of requirements for the interoperable,
electronic, package level product tracing (referred to as enhanced drug
distribution security requirements) under section 582(g)(1) of the FD&C
Act (21 U.S.C. 360eee-1(g)(1)) that will go into effect on November 27,
2023. FDA believes that these compliance policies will facilitate the
continued use of product tracing and verification methods currently
being used while accommodating the additional time that may be needed
by trading partners to continue to develop and refine the systems and
processes for such activities required under section 582(g)(1) of the
FD&C Act.
We are issuing this guidance consistent with our good guidance
practices (GGP) regulation (21 CFR 10.115). We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (21 CFR
10.115(g)(2)). The Agency made this determination because the Agency
needs to communicate its compliance policy in a timely manner and
provide stakeholders notice of the compliance policy ahead of the
effective date of the enhanced distribution security requirements.
Although this guidance document is being implemented immediately, it
remains subject to comment in accordance with FDA's GGP regulation and
the Agency will consider all comments received and determine whether
revisions to the guidance document are appropriate.
The DSCSA, enacted on November 27, 2013, outlines critical steps
for building an electronic, interoperable system by November 27, 2023,
that will identify and trace certain prescription drugs as they are
distributed within the United States. Since the enactment of DSCSA, FDA
and trading partners have been preparing for the implementation of the
enhanced drug distribution security requirements imposed by section
582(g)(1) of the FD&C Act. Trading partners are continuing to work to
have the necessary systems and processes in place in anticipation of
the November 27, 2023, effective date for these requirements. While
trading partners have the obligation to comply with section 582
requirements, including for enhanced drug distribution security, there
are other stakeholders involved and affected, including but not limited
to: solution providers, standards organizations, trade and professional
organizations, state authorities, and other Federal authorities.
FDA understands that collaboration and alignment among trading
partners and other stakeholders throughout the supply chain are
critical for achieving interoperability under the DSCSA. FDA has heard
from stakeholders, including a broad representation of trading
partners, about concerns regarding trading partner readiness and the
need for clarity and flexibility to ensure trading partners can
continue to move product through the supply chain when the enhanced
drug distribution security requirements under section 582(g)(1) of the
FD&C Act take effect. Most recently, at a virtual public meeting on
DSCSA Implementation and Readiness Efforts for 2023 held on December 7
and 8, 2022 (87 FR 67047, November 7, 2022), stakeholders indicated
that trading partners throughout the supply chain are at different
stages of readiness, with some trading partners being further behind
not only in terms of understanding their obligations under section
582(g)(1) of the FD&C Act, but also being aware of the time and
resources necessary to meet those obligations. Stakeholders also
expressed a need for clarity with respect to treatment of product that
is already in the supply chain on November 27, 2023, and the need for
flexibility when the requirements under section 582(g)(1) take effect,
to minimize potential disruptions in the supply chain. In addition,
stakeholders are experiencing challenges with predicting and planning
for the possible volume of requests for product tracing information
from Federal and State authorities and other trading partners, and the
resources needed to respond to such requests, in accordance with
section 582(g)(1) of the FD&C Act.
While FDA generally expects trading partners to have the systems
and processes in place to meet the enhanced drug distribution security
requirements of section 582(g)(1) as of November 27, 2023, we recognize
that some technical and operational issues, including issues involving
trading partners and other affected stakeholders, may not be fully
resolved by that time. The Agency also understands that additional time
beyond November 27, 2023, may be needed for systems to stabilize and be
fully interoperable for accurate, secure, and timely electronic data
exchange. This guidance is 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
interoperable, electronic product tracing at the package level under
the DSCSA. The compliance policies in this guidance can help trading
partners throughout the supply chain implement the requirements under
section 582(g)(1) of the FD&C Act by accommodating the additional time
that may be needed to implement, troubleshoot, and mature their systems
and processes while supporting the continued availability of products
to patients.
The guidance represents the current thinking of FDA on ``Enhanced
Drug Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic Act--Compliance Policies.'' 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.\1\
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\1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to
its interpretation of 1 CFR 5.9(b). We note that the categorization
as such for purposes of publication in the Federal Register does not
affect the content or intent of the document. See 1 CFR 5.1(c).
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II. Paperwork Reduction Act
FDA concludes that this 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 guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, https://www.fda.gov/
[[Page 58500]]
vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18359 Filed 8-25-23; 8:45 am]
BILLING CODE 4164-01-P
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