Notice2026-18368
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability
Primary source
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Published
September 9, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.
Full Text
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<title>Federal Register, Volume 91 Issue 173 (Wednesday, September 9, 2026)</title>
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[Federal Register Volume 91, Number 173 (Wednesday, September 9, 2026)]
[Notices]
[Pages 57358-57359]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18368]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-D-9571]
Temporary Policies for Compounding Certain Starter Parenteral
Nutrition Drug Products for Neonates; 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, Agency, or we) is
announcing the availability of a guidance for industry titled
``Temporary Policies for Compounding Certain Starter Parenteral
Nutrition Drug Products for Neonates.'' This guidance describes the
FDA's regulatory and enforcement priorities regarding the compounding
of certain starter parenteral nutrition drug products for neonates by
outsourcing facilities and by State-licensed pharmacies and Federal
facilities that are not registered with FDA as outsourcing facilities.
This guidance is being published for immediate implementation due to
the expected market exit of the predominant source of certain starter
parenteral nutrition drug products for neonates in the United States.
DATES: The announcement of the guidance is published in the Federal
Register on September 9, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 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-D-9571 for ``Temporary Policies for Compounding Certain
Starter Parenteral Nutrition Products for Neonates.'' 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 the 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. Send two self-
addressed adhesive labels to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Heather Messick, Center for Drug
Evaluation and Research, Food and
[[Page 57359]]
Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20903,
240-402-4641.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry,
titled ``Temporary Policies for Compounding Certain Starter Parenteral
Nutrition Drug Products for Neonates.'' We are issuing this guidance
consistent with our good guidance practices (GGP) regulation (Sec.
10.115 (21 CFR 10.115)). We are implementing this guidance without
prior public comment because we have determined that prior public
participation is not feasible or appropriate (Sec. 10.115(g)(2)). This
guidance document is being implemented immediately to help ensure
patient access to certain starter parenteral nutrition products for
neonates, which are essential to the care of this vulnerable patient
population. Although this guidance document is immediately in effect,
it remains subject to comment in accordance with FDA's GGP regulation.
FDA has determined that temporary enforcement policies for both
pharmacy compounders operating under Section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) and for outsourcing
facilities registered under Section 503B of the FD&C Act (21 U.S.C.
353b) are needed to help ensure that treatment options for neonates
remain available to hospitals and health systems.
The guidance represents the current thinking of FDA on the
``Temporary Policies for Compounding Certain Starter Parenteral
Nutrition Drug Products for Neonates.'' 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 guidance contains no collections of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
for current good manufacturing practice requirements have been approved
under OMB control number 0910-0139. The collections of information for
registration of human drug compounding outsourcing facilities under
section 503B of the FD&C Act and associated fees under section 744K of
the FD&C Act (21 U.S.C. 379j-62) have been approved under OMB control
number 0910-0776. The collections of information for human drug
compounding and adverse event reporting under sections 503A and 503B
(21 U.S.C. 353a and 353b) of the FD&C Act have been approved under OMB
control number 0910-0800. The collections of information for adverse
product experience reporting under the MedWatch System has been
approved under OMB control number 0910-0291.
In addition, the guidance mentions certain records, including
records regarding information about which patients received specific
compounded products, that FDA expects generally exist as a result of
recordkeeping requirements imposed by Federal and State regulatory
authorities independent from FDA, including the Centers for Medicare
and Medicaid Services and individual State pharmacy licensing
authorities. FDA does not believe the guidance includes conducting or
sponsoring a collection of information regarding those records.
III. Electronic Access
Persons with access to the internet may obtain the document at
<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>. Use the FDA website listed
in the previous sentence to find the most current version of the
guidance.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18368 Filed 9-4-26; 4:15 pm]
BILLING CODE 4164-01-P
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