Notice2026-10372
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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Published
May 26, 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.
Full Text
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<title>Federal Register, Volume 91 Issue 100 (Tuesday, May 26, 2026)</title>
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[Federal Register Volume 91, Number 100 (Tuesday, May 26, 2026)]
[Notices]
[Pages 30659-30662]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10372]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-5128]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Drug Compounding Under Sections 503A and 503B of
the Federal Food, Drug, and Cosmetic Act
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, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection relating to human
drug compounding.
DATES: Either electronic or written comments on the collection of
information must be submitted by July 27, 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 July 27, 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.
FDA-2026-N-5128 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Drug Compounding Under
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.''
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.
1. 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
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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: Anne Taylor, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5683,
<a href="/cdn-cgi/l/email-protection#1f4f4d5e4c6b7e79795f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="722220332106131414321416135c1a1a015c151d04">[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, including
each proposed extension/reinstatement of an existing 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) 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.
Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act OMB Control Number 0910-0800--Revision
This information collection helps support the implementation of
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353a and 353b); Pharmacy Compounding and
Outsourcing Facilities. Compounding is generally a practice in which a
licensed pharmacist, a licensed physician, or, in the case of an
outsourcing facility, a person under the supervision of a licensed
pharmacist, combines, mixes, or alters ingredients of a drug to create
a medication tailored to the needs of an individual patient. Although
compounded drugs can serve an important medical need for certain
patients, they may also present risks. Our compounding program aims to
protect patients from unsafe, ineffective, and poor-quality compounded
drugs, while preserving access to lawfully-marketed compounded drugs
for patients who have a medical need for them.
Respondents to the information collection are those engaged in the
practice of human drug compounding. The information collection is
intended to account for burden attributable to activities pertaining to
the registration of outsourcing facilities and reporting of drugs, as
established in sections 503B(b)(1) through 503B(b)(3) of the FD&C Act.
The information collection is also intended to account for burden
attributable to certain activities associated with the submission of
adverse event reports, as required under section 503B(b)(5) of the FD&C
Act. Additionally, the information collection is intended to account
for burden attributable to certain activities associated with the
documentation of clinical need of a compounded drug product as
described in the revised draft guidance entitled ``Hospital and Health
System Compounding Under Section 503A of the Federal Food, Drug, and
Cosmetic Act''. Finally, the information collection is intended to
account for burden attributable to activities associated with States
entering into memoranda of understanding with the Secretary, as
described in section 503A(b)(3) of the FD&C Act.
To help respondents understand statutory requirements applicable to
compounding activities governed by the FD&C Act, we have developed the
following topical guidance documents:
<bullet> ``Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act'' (January 3, 2017), available on our
website at <a href="https://www.fda.gov/media/90173/download">https://www.fda.gov/media/90173/download</a>. The guidance is
intended for entities that compound human drugs and elect to register
as outsourcing facilities under section 503B of the FD&C Act. Once an
entity has elected to register as an outsourcing facility, it must
submit reports identifying the drugs compounded by the outsourcing
facility. The guidance describes who must report, the format of the
report, the content to include in each report, when to report, how
outsourcing facilities may submit reports to FDA, and the consequences
of outsourcing facilities' failure to submit reports.
<bullet> ``Adverse Event Reporting (AER) for Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act''
(October 8, 2015), available at Adverse Event Reporting for Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act [verbar] FDA. The guidance document is intended for firms that have
registered with FDA under section 503B of the FD&C Act as human drug
compounding outsourcing facilities (outsourcing facilities). Under
section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit
adverse event reports to FDA ``in accordance with 21 CFR
310.305(e)(1).'' The guidance document explains that, under 21 CFR
310.305(c)(1), manufacturers, packers, and distributors of marketed
prescription drug products that are not the subject of an approved new
drug or abbreviated new drug application must submit to FDA serious and
unexpected adverse event reports within 15 calendar days of receiving
the information and must submit follow-up reports within 15 calendar
days of receipt of new information about the serious adverse event, or
as requested by FDA. Also, under Sec. 310.305(f), entities must
maintain for 10 years the records of all adverse events required to be
reported under Sec. 310.305. The guidance document also explains that,
in accordance with regulatory requirements, adverse event reports must
be submitted in an electronic format that FDA can process, review, and
archive (collection of information is
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submitted via Form FDA 3500A (MedWatch), approved under OMB control
number 0910-0291). A copy of the current labeling of the compounded
drug product must be provided in the report.
<bullet> ``Hospital and Health System Compounding Under Section
503A of the Federal Food, Drug, and Cosmetic Act'' (October 2021,
Revision 1), available at <a href="https://www.fda.gov/media/97353/download">https://www.fda.gov/media/97353/download</a>. A
condition under section 503A(b)(2) of the FD&C Act, is a drug product
must be compounded by a licensed pharmacist or a licensed physician
that ``does not compound regularly or in inordinate amounts (as defined
by [FDA]) any drug products that are essentially copies of a
commercially available drug product. Pursuant to section 503A(b)(2) of
the FD&C Act, a compounded drug product is not essentially a copy of a
commercially available drug product if a change is made to the
commercially available drug product for an identified individual
patient, and the prescribing practitioner has determined that the
change will produce a significant difference for that patient. As
described in the FDA's 503A copies guidance, if a compounder intends to
rely on such a determination to establish that a compounded drug is not
essentially a copy, the compounder should ensure that the determination
is documented on the prescription. The guidance explains that FDA
generally would not intend to take action against a hospital or health
system pharmacy that is not an outsourcing facility for compounding a
drug product regularly or in inordinate amounts that is essentially a
copy of commercial available drug product, if the compounded drug
product is administered only to patients within the hospital or health
system and the pharmacy obtains from the prescriber a statement that:
(1) Specifies a change between the compounded drug product and the
commercially available drug product; (2) indicates that the compounded
drug product will be administered only to patients for whom a change
produces a significant difference from the commercially available drug
product; and (3) describes the intended patient population for the
compounded drug product. The guidance also specifies that the statement
would be maintained in the hospital or health system pharmacy to
address routine orders for patients whom the change produces a
significant difference, and a statement would be on file for each
prescriber that covers each drug product that is compounded.
We maintain a searchable database on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that
includes other topical guidance pertaining to human drug compounding.
Guidance documents are issued consistent with FDA's good guidance
practice regulations in 21 CFR 10.115, which provide for public comment
at any time. Please see 21 CFR 10.115(f) for instruction on how to
participate in the development and issuance of FDA guidance documents.
In the Federal Register of February 23, 2026 (91 FR 8495), we
published a 30-day notice announcing that we had submitted this
collection to OMB for review and clearance under the PRA to extend OMB
approval. With this notice we are announcing a revision to this
collection. We are revising the information collection to include
reporting activities related to a human drug compounding cross-sector
stakeholder group. As part of its efforts under FDA's Compounding
Quality Center of Excellence, FDA seeks to better understand the
challenges and barriers that compounders, outsourcing facilities, and
other stakeholders encounter related to the purchasing, production,
distribution, and use of compounded drugs, as well as opportunities for
education and growth in these areas. The Agency also seeks to gain
further insight into any issues that the compounding sector faces in
fully complying with relevant policies, laws, and regulatory oversight.
A comprehensive understanding of the compounding sector--its challenges
and successes--is essential to the growth and success of FDA's
endeavors to protect the public health.
The cross-sector stakeholder group will be comprised of up to 30
stakeholders, including entities such as outsourcing facilities with
different business models, hospitals, health systems, physician groups,
and suppliers of drug ingredients and components. The purpose of these
meetings will be to gather individual perspectives on topics such as
demand and patient need, quality, drug shortages, the current and
future roles of 503B outsourcing facilities, education, and messaging
about the 503B outsourcing facility industry, or other cross-cutting
issues germane to human drug compounding. The goals of the meetings are
to improve FDA's understanding of complex issues relevant to
compounding and to foster cross-disciplinary discussion within the
compounding sector. An existing limited iteration of the cross-sector
stakeholder group has discussed topics such as drug shortages,
educating stakeholders about the outsourcing facility industry,
compounding in outsourcing facilities, the future role of outsourcing
facilities, drug approval pathways, and drug compendia databases.
Individual perspectives shared by group members during meetings of the
existing small group have been instrumental in understanding challenges
faced by the industry as well as potential opportunities to catalyze
solutions that improve the quality of compounded drugs, safeguarding
patients. It is based on the success of this initiative that we want to
continue and expand the Cross-Sector Stakeholder group.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
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Number of
Information collection activity in sections Number of responses per Total annual Average burden per response Total hours
503A and 503B of the FD&C Act respondents respondent responses
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503B AERs.................................... 55 1 55 1.10..................................... 61
503B Recordkeeping AERs...................... 55 1 55 16....................................... 880
503A Reporting............................... 45 197.3111 8,879 0.87..................................... 7,725
503A Recordkeeping........................... 45 2 90 1........................................ 90
503A Disclosure (MOU)........................ 1 1 1 1........................................ 1
Outsourcing facility drug product reporting 75 108.1467 8,111 0.025 (1.5 mins)......................... 203
under 503B(b).
Cross-sector stakeholder group meeting 30 9 270 2........................................ 540
planning, participation, and follow up.
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Total.................................... .............. .............. 17,461 ......................................... 9,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Figures have been rounded.
As shown in Table 1, we estimate an increase in reporting burden
hours and annual responses associated with the cross-sector stakeholder
group. We have otherwise retained our currently approved reporting
burden estimates. We base our estimates on our experience with
compounding related activities. We estimate that 30 respondents will
participate in the cross-sector stakeholder group. We anticipate that
respondents will engage in approximately 9 various meeting preparation
and planning, meeting participation, and meeting follow up activities.
We anticipate that these activities will take respondents approximately
two hours per response, on average.
Our estimated reporting burden for the information collection
reflects an increase of 540 hours and a corresponding increase of 270
responses. We attribute this increase to activities associated with the
cross-sector stakeholder group.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10372 Filed 5-22-26; 8:45 am]
BILLING CODE 4164-01-P
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