Notice2022-14342
Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs." This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance is a revision of the draft guidance for industry entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information," issued in November 2014 as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 87 Issue 128 (Wednesday, July 6, 2022)</title>
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[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40258-40260]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14342]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1981]
Drug Supply Chain Security Act Standards for the Interoperable
Exchange of Information for Tracing of Certain Human, Finished,
Prescription Drugs; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs.'' This guidance identifies
the standards necessary to facilitate adoption of secure,
interoperable, electronic data exchange among the pharmaceutical
distribution supply chain, and clarifies the trading partners,
products, and transactions subject to such standards. This guidance is
a revision of the draft guidance for industry entitled ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs: How to Exchange Product
Tracing Information,'' issued in November 2014 as required by the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance by September 6, 2022 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:
<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
[[Page 40259]]
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-2014-D-1981 for ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription
Drugs.'' 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 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: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
<a href="/cdn-cgi/l/email-protection#e185939486959380828a808f859593808284a1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="6501171002111704060e040b011117040600250301044b0d0d164b020a13">[email protected]</span></a>; 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 revised draft guidance for
industry entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription
Drugs.'' The Drug Supply Chain Security Act (DSCSA) outlines
requirements for enhanced drug distribution security, which include the
steps to achieve interoperable, electronic tracing of products at the
package level. These requirements for enhanced drug distribution
security go into effect on November 27, 2023. Section 582(g)(1) of the
FD&C Act (21 U.S.C. 360eee-1(g)(1)) sets forth enhanced drug
distribution security requirements for trading partners, including
adherence to standards established by FDA for the exchange of
transaction information and transaction statements in a secure,
interoperable, electronic manner and the verification of product at the
package level. Additionally, section 582(h)(4)(A) of the FD&C Act
specifies that FDA issue a draft guidance, and revise the draft
guidance as appropriate, to identify and make recommendations with
respect to the standards necessary for adoption in order to support the
secure, interoperable, electronic data exchange among the
pharmaceutical distribution supply chain that comply with a form and
format developed by a widely recognized international standards
development organization.
In this revised draft guidance, FDA considered the standards
established pursuant to sections 505D of the FD&C Act (21 U.S.C. 355e)
and 582(a)(2) of the FD&C Act in the November 2014 draft guidance
entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information'' (available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs</a>). The pilot projects conducted per section
582(j) of the FD&C Act also informed revisions made to this draft
guidance.
This revised draft guidance updates the policy articulated in the
November 2014 draft guidance to reflect the enhanced drug distribution
security requirements that will go into effect on November 27, 2023,
including that paper-based methods of product tracing will no longer be
permitted and verification of product at the package level will be
required, unless a waiver, exception, or exemption applies. This
revised draft guidance is intended to facilitate the creation of a
uniform methodology for product tracing while ensuring the protection
of confidential commercial information and trade secrets. FDA also
published other guidances describing recommendations for enhanced drug
distribution security, including the attributes necessary for enhanced
product tracing and verification, which should be read in conjunction
with this draft guidance (see FDA's Drug Supply Chain Security Law and
Policies web page at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies</a>).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will
[[Page 40260]]
represent the current thinking of FDA on ``DSCSA Standards for the
Interoperable Exchange of Information for Tracing of Certain Human,
Finished, Prescription Drugs.'' 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 draft 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 draft 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>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <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: June 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14342 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P
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