Notice2026-03333
Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers
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Published
February 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on approved organizations involved in the licensure and inspection process for wholesale drug distributors ("wholesale distributors") and third-party logistics providers ("3PLs"), as directed by the Drug Supply Chain Security Act (DSCSA).
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8247-8249]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03333]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0684]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Approved Organizations for Wholesale Drug Distributors
and Third-Party Logistics Providers
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on approved organizations involved in the licensure
and inspection process for wholesale drug distributors (``wholesale
distributors'') and third-party logistics providers (``3PLs''), as
directed by the Drug Supply Chain Security Act (DSCSA).
DATES: Either electronic or written comments on the collection of
information must be submitted by April 21, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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.
for ``Approved Organizations for Wholesale Drug Distributors and Third-
Party Logistics Providers.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-1244,
<a href="/cdn-cgi/l/email-protection#9dcdcfdccee9fcfbfbddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4)
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ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Approved Organization for Wholesale Drug Distributors and Third-Party
Logistics Providers--21 CFR Part 205
OMB Control Number--NEW
Approved Organizations for Wholesale Distributors
This information collection supports Food and Drug Administration
(FDA) regulations. Section 583(c) of the Federal Food, Drug, and
Cosmetics Act FD&C Act states that to satisfy the statutory inspection
requirement for wholesale distributors, ``the Federal or State
licensing authority may conduct the inspection or may accept an
inspection by the State in which the facility is located, or by a
third-party accreditation or inspection service (AOs) approved by the
Secretary or the State licensing such wholesale distributor.'' Subpart
D of the proposed rules defines the scope of work these AOs would be
tasked with performing, as well as the standards an AO must meet to
become approved by FDA. Additionally, this subpart will explain the
circumstances in which an inspection conducted by an AO may be used,
what activities the AOs have the authority to conduct and are expected
to conduct, and the qualifications that each third-party organization
must possess to become approved by FDA.
Approved Organizations for Third-Party Logistics Providers (3PLs)
Section 584(d)(2)(A) of the FD&C Act, states that such regulations
shall ``establish a process by which a third-party accreditation
program approved by the Secretary shall, upon request by a third-party
logistics provider (3PL), issue a license to each third-party logistics
provider that meets the requirements set forth in this section.''
Accordingly, FDA interprets the language of 584(d)(2)(A) of the FD&C
Act to mean that a third-party organization approved by FDA--an
approved organization (AO)--will conduct a review of the 3PL's
qualifications for licensure and issue a report to FDA regarding
whether the 3PL ``demonstrates that all applicable requirements for
licensure . . . are met,'' which FDA can rely on when issuing a license
per section 584(e) of the FD&C Act.
A licensure review consists of performing a review of all documents
submitted to the licensing authority in support of an application for
3PL licensure and conducting an inspection of the facility as directed
by the licensing authority. If a review of documentation supports
licensure of the 3PL facility, the facility will then be inspected by
an AO, as directed by FDA. Upon completion of the inspection, the AO
would then provide FDA with a report based on the inspection within 7
days. Using the report submitted by the AO, FDA makes the final
determination as to whether a wholesale distributor or a 3PL facility
should be issued a license.
It is important that FDA can verify an AO's continued compliance
with the approval requirements. Therefore, to keep its approval, FDA is
proposing to require that an AO maintain certain records for a period
of at least 5 years and these records must be readily available to FDA
upon request. On February 4, 2022, FDA published the proposed rule
``National Standards for the Licensure of Wholesale Drug Distributors
and Third-Party Logistics Providers'' (87 FR 6708) to codify
regulations in 21 CFR part 205. Proposed Sec. Sec. 205.17, 205.18, and
205.19 contain the process that FDA will use to approve organizations
and the qualifications to become an AO for 3PLs and proposed Sec. Sec.
205.31, 205.32, and 205.33 contain the process that FDA will use to
approve organizations and qualifications to become an AO for wholesale
drug distributors (wholesale distributors).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Proposed 21 CFR part 205 Number of responses per Total annual Average burden Total hours
section; IC activity respondents respondent responses per response
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SUBPART B (Approved 6 15 90 5 450
Organizations for 3PLs) Sec.
205.17; licensure review and
inspection reports of 3PL
facilities.....................
Sec. 205.19; applications, 3 1 3 2 6
denials, revocations,
suspensions, renewals,
reinstatements for AO status...
SUBPART D (Approved 6 31 186 5 930
Organizations for WDDs) Sec.
Sec. 205.32 and 205.33;
documentation of qualifications
and disclosures to FDA.........
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Total....................... 15 .............. 279 .............. 1,386
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Proposed 21 CFR part 205 Number of records per per Average burden Total hours
section; IC activity recordkeepers recordkeeper recordkeeping per response
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SUBPART B (Approved 6 15 90 2 180
Organizations for 3PLs) 205.17;
licensure review and inspection
records........................
205.19; written procedures, 6 1 6 3 18
policies, training records.....
SUBPART D (Approved 6 1 6 1 6
Organizations for WDDs) 205.31;
records demonstrating
qualification status...........
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Total....................... 18 .............. 102 .............. 204
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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FDA therefore request OMB approval of Approved Organizations for
Wholesale Drug Distributors and Third-Party Logistics Providers
pursuant to Sections 584(d)(2)(A) and Section 583(c) of the FD&C Act
and codified regulations in 21 CFR parts 205.17-19, and 205.31-33 as
discussed in this notice.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03333 Filed 2-19-26; 8:45 am]
BILLING CODE 4164-01-P
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