[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the Drug Supply Chain Security Act; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``Enhanced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 This draft guidance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DATES: Submit either electronic or written comments on the draft
guidance by August 3, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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,
[email protected] 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]
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