Notice2023-02809
Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency; Withdrawal of Guidance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the guidance for industry entitled "Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency," which was issued in April 2020 to communicate a temporary policy regarding the repackaging or combining of propofol drug products. FDA is withdrawing this guidance document because the conditions that created the need for this policy described in the document have evolved and the policy is no longer needed.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 28 (Friday, February 10, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8872-8873]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1136]
Temporary Policy on Repackaging or Combining Propofol Drug
Products During the COVID-19 Public Health Emergency; Withdrawal of
Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of the guidance for industry entitled ``Temporary Policy
on Repackaging or Combining Propofol Drug Products During the COVID-19
Public Health Emergency,'' which was issued in April 2020 to
communicate a temporary policy regarding the repackaging or combining
of propofol drug products. FDA is withdrawing this guidance document
because the conditions that created the need for this policy described
in the document have evolved and the policy is no longer needed.
DATES: The withdrawal date is March 13, 2023.
FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Office of Regulatory
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-2357.
SUPPLEMENTARY INFORMATION:
I. Background
As part of FDA's commitment to providing timely guidance to support
response efforts to the Coronavirus Disease 2019 (COVID-19) \1\
pandemic, in April 2020, the Agency published the guidance for industry
entitled ``Temporary Policy on Repackaging or Combining Propofol Drug
Products During the COVID-19 Public Health Emergency.'' This guidance
communicated the Agency's temporary policy regarding the repackaging or
combining of propofol drug products by licensed pharmacists in State
licensed pharmacies, Federal facilities, and outsourcing facilities
registered pursuant to section 503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353b).\2\ FDA had received reports
from some hospitals that they were having difficulty obtaining adequate
supplies of FDA-approved propofol injectable emulsion (propofol)
products, 10 milligrams (mg) per milliliter (mL), in the presentations
used to support COVID-19 patients who had been sedated and intubated,
or for other procedures involved in the care of such patients. At the
time the guidance was published, propofol was on FDA's drug shortage
list, with several presentations on backorder or on allocation. FDA
recognized that pharmacies and outsourcing facilities that had access
to certain presentations of propofol drug products wanted to repackage
or combine units of a finished, FDA-approved drug product to provide
hospitals with presentations needed for patients with COVID-19. The
guidance stated that as a temporary measure during the public health
emergency related to COVID-19, or for such shorter time as FDA may
announce by updating or withdrawing the guidance based on evolving
needs and circumstances, FDA intended to extend, under certain
circumstances described in the guidance, its existing enforcement
discretion policy described in the
[[Page 8873]]
guidance for industry entitled ``Repackaging of Certain Human Drug
Products by Pharmacies and Outsourcing Facilities,'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/repackaging-certain-human-drug-products-pharmacies-and-outsourcing-facilities">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/repackaging-certain-human-drug-products-pharmacies-and-outsourcing-facilities</a>), when a State-licensed pharmacy, Federal facility, or
outsourcing facility repackaged an FDA-approved propofol injectable
emulsion, 10 mg/mL product, or combined different FDA-approved propofol
injectable emulsion, 10 mg/mL products in the same container.
---------------------------------------------------------------------------
\1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
\2\ As explained in the guidance, provided that circumstances
described in the guidance were present, FDA did not intend to take
action for violations of section 505 (concerning new drug
applications), section 502(f)(1) (concerning labeling with adequate
directions for use), and section 582 (concerning drug supply chain
security) of the FD&C Act (21 U.S.C. 355, 352(f)(1), and 360eee-1)
if a State-licensed pharmacy, a Federal facility, or an outsourcing
facility prepared drug products as described in this guidance and
met other applicable requirements. Applicable requirements included,
for example, the requirement that manufacturers not adulterate a
drug product by preparing, packing, or holding the drug product
under insanitary conditions. See section 501(a)(2)(A) of the FD&C
Act (21 U.S.C. 351(a)(2)(A)). In addition, FDA did not intend to
take action for violations of section 501(a)(2)(B) of the FD&C Act
if the drug product was repackaged by a State-licensed pharmacy or a
Federal facility in accordance with the conditions described in the
guidance, and any applicable requirements. Finally, with respect to
entities that did not qualify for the exemptions from registration
under section 510 of the FD&C Act (21 U.S.C. 360), FDA did not
intend to take action for violations of section 502(o) of the FD&C
Act.
---------------------------------------------------------------------------
As stated above, propofol had been on FDA's drug shortage list when
FDA issued the guidance document. Based on our review of currently
available data, we have determined that the shortage of propofol drug
products has been resolved, with manufacturers reporting having an
adequate supply of the drug products. Further, hospitals have not been
reporting to FDA that they are having difficulty obtaining adequate
supplies of propofol drug products. Accordingly, we have determined
that the circumstances related to this temporary policy have evolved
such that the temporary policy is no longer needed, and the guidance
document should be withdrawn.
II. Withdrawal Date
The withdrawal date for the guidance document discussed in this
document is March 13, 2023. The COVID-19 pandemic is a constantly
evolving situation. FDA continues to assess these circumstances and
should the current data change to indicate that the demand of propofol
drug product has again outstripped supply before March 13, 2023, FDA
may revise this date.
Dated: February 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02809 Filed 2-9-23; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on February 10, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.