[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Pages 8872-8873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02809]


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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.

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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,'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/repackaging-certain-human-drug-products-pharmacies-and-outsourcing-facilities), 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.
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    \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.
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    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


