[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30053-30054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11734]


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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the Drug Supply Chain Security Act; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Enhanced 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) 
outlines critical enhanced drug distribution security requirements for 
building an electronic, interoperable system by November 27, 2023, that 
will identify and trace certain prescription drugs at the package level 
as they are distributed within the United States. This draft guidance 
clarifies these requirements and provides recommendations on the system 
attributes necessary to enable the secure tracing of product at the 
package level, including allowing for the use of verification, 
inference, and aggregation, as necessary.

DATES: Submit either electronic or written comments on the draft 
guidance by August 3, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 draft 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 draft 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 Stephen Ripley, 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 draft guidance for industry 
entitled ``Enhanced Drug Distribution Security at the Package Level 
Under the Drug Supply Chain Security Act.''

[[Page 30054]]

    The DSCSA (Title II of Pub. L. 113-54) was signed into law on 
November 27, 2013. The DSCSA 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. 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 a 
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 the 
oversight of trading partners in the supply chain that are involved in 
the manufacturing, repackaging, wholesale distribution, warehousing or 
logistical activities, or dispensing of prescription drugs. The gradual 
implementation of the DSCSA requirements for product tracing, product 
identification, authorized trading partners, and verification 
facilitates the development of an electronic, interoperable system to 
enhance the security of the pharmaceutical distribution supply chain.
    Section 582(g)(1) of the FD&C Act sets forth the general 
requirements for enhanced drug distribution security, including:
     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; and
     systems and processes needed to promptly respond in the 
event of a recall or to investigate suspect and illegitimate products.
    This draft guidance clarifies the enhanced drug distribution 
requirements and 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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance, 
when finalized, will represent the current thinking of FDA on enhanced 
drug distribution security at the package level under the DSCSA. 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

    While this draft guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR 211.132 for tamper-evident packaging of a drug 
product have been approved under OMB control number 0910-0139. The 
collections of information in 21 CFR 201.57 for establishing 
anticounterfeiting technologies, such as physical-chemical identifiers, 
have been approved under 0910-0572. The collections of information for 
identifying suspect drug product have been approved under OMB control 
number 0910-0806. The collections of information for establishing: (1) 
An electronic, interoperable system and (2) system attributes necessary 
for enabling the secure tracing of drug product have been approved 
under OMB control number 0910-0859.

III. Electronic Access

    Persons with access to the internet may obtain the draft 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, or 
https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11734 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P


