[Federal Register Volume 89, Number 201 (Thursday, October 17, 2024)]
[Notices]
[Pages 83691-83692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-4774]


Temporary Policies for Compounding Certain Parenteral Drug 
Products; 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 we) is announcing the 
availability of a final guidance for industry entitled ``Temporary 
Policies for Compounding Certain Parenteral Drug Products.'' As of 
October 10, 2024, pursuant to the Public Health Service Act (PHS Act), 
Department of Health and Human Services (HHS) Secretary Becerra has 
determined that public health emergencies (PHEs) exist as a result of 
the consequences of Hurricane Helene in the States of North Carolina, 
Florida, Georgia, Tennessee, and South Carolina, and as a result of the 
consequences of Hurricane Milton in the State of Florida. In late 
September 2024, Hurricane Helene had a devastating impact on one of the 
largest manufacturers of certain intravenous and peritoneal dialysis 
solutions in the United States. This guidance describes the FDA's 
regulatory and enforcement priorities regarding the compounding of 
certain parenteral drug products by outsourcing facilities and by 
State-licensed pharmacies and Federal facilities that are not 
registered with FDA as outsourcing facilities.

DATES: The announcement of the guidance is published in the Federal 
Register on October 17, 2024.

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: 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.
    <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-2024-D-4774 for ``Temporary Policies for Compounding Certain 
Parenteral Drug Products.'' 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.
    <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 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)).

[[Page 83692]]

    Submit written requests for single copies of the guidance to the 
Office of Communications, Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Bldg., 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: Gabrielle Cosel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100.

SUPPLEMENTARY INFORMATION:

I. Background

    As of October 10, 2024, pursuant to section 319(a) of the Public 
Health Service Act (42 U.S.C. 247d) (PHS Act), HHS Secretary Becerra 
has determined that public health emergencies (PHEs) exist as a result 
of the consequences of Hurricane Helene in the States of North 
Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a 
result of the consequences of Hurricane Milton in the State of Florida. 
FDA is aware of reports from hospitals, health systems, and State-
licensed pharmacies that they have experienced difficulties obtaining 
certain intravenous solutions. FDA is closely monitoring this situation 
and using all of its applicable authorities to work with the 
manufacturers of intravenous solutions to increase supply. For example, 
FDA has facilitated the temporary importation of intravenous solution 
products from certain foreign facilities, detailed at: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina.
    However, we recognize that hospitals, health systems, State-
licensed pharmacies, and applicable Federal facilities have concerns 
about assuring access to intravenous solutions as the impacts of the 
hurricanes continue. Therefore, FDA is issuing this policy to describe 
the FDA's regulatory and enforcement priorities regarding the 
compounding of certain parenteral drug products for hospitals by 
outsourcing facilities and by State-licensed pharmacies and Federal 
facilities that are not registered with FDA as outsourcing facilities.
    We are announcing the availability of a guidance for industry 
entitled ``Temporary Policies for Compounding Certain Parenteral Drug 
Products.'' 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 
parenteral drug products, such as intravenous fluids, which are 
essential in the care of patients, including those who are critically 
ill and those undergoing surgery. Although this guidance document is 
immediately in effect, it remains subject to comment in accordance with 
FDA's GGP regulation.
    The guidance represents the current thinking of FDA on ``Temporary 
Policies for Compounding Certain Large Volume Parenteral Drug Products 
for Hospitals.'' 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 collection 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 
event and product experience reporting under the MedWatch System has 
been approved under OMB control number 0910-0291.
    To the extent this guidance also contains a new collection of 
information not approved under a current collection, a PHE waiver from 
the PRA has been granted by HHS on October 11, 2024, under section 
319(f) of the Public Health Service Act. Information concerning the PHE 
PRA waiver can be found on the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Use the FDA website listed in 
the previous sentence to find the most current version of the guidance.

    Dated: October 11, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23954 Filed 10-16-24; 8:45 am]
BILLING CODE 4164-01-P