[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:
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.
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:
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.
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.
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