
[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 [www.gpo.gov]
[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:
     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-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 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.

[[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: [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 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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/

[[Page 58500]]

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 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


