SILVER SPRING, Md.,
March 25, 2020 /PRNewswire/
-- The U.S. Food and Drug Administration today announced the
following actions taken in its ongoing response effort to the
COVID-19 pandemic:
- In response to the demand for alcohol-based hand sanitizers and
their active ingredient, alcohol, certain entities that are not
currently regulated by the FDA as drug manufacturers have requested
guidance on the preparation and distribution of alcohol for
incorporation into hand sanitizer products for the public's use.
The FDA issued another guidance for industry about hand sanitizers,
Temporary Policy for Manufacture of Alcohol for Incorporation Into
Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency (COVID-19) Guidance for Industry. The guidance is for
firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for
use as the active pharmaceutical ingredient (API) in alcohol-based
hand sanitizers for consumer use and for use as health care
personnel hand rubs for the duration of the public health
emergency.
- The FDA added hydroxychloroquine sulfate to category 1 under
the Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act. The FDA does not intend to object to
registered outsourcing facilities using hydroxychloroquine (or
chloroquine phosphate, which was already on category 1), to
compound human drugs provided the drugs meet other conditions and
requirements in the FD&C Act. Compounding is generally a
practice in which a licensed pharmacist, a licensed physician, or,
in the case of an outsourcing facility, a person under the
supervision of a licensed pharmacist, combines, mixes, or alters
ingredients of a drug to create a medication tailored to the needs
of an individual patient. The FDA is placing hydroxychloroquine
sulfate on category 1 after it reviewed the nomination and
determined there was sufficient information for the agency to
evaluate the substance for outsourcing facilities to use in
compounding. When FDA categorized hydroxychloroquine sulfate it did
not change its approach, but we prioritized this substance due to
the COVID-19 pandemic. There are currently no FDA approved
therapeutics or drugs to treat, cure or prevent COVID-19; however,
there are FDA-approved treatments that may help ease the symptoms
of COVID-19. Additionally, state-licensed pharmacies and federal
facilities that compound drugs under section 503A of the FD&C
Act may compound drugs using hydroxychloroquine sulfate or
chloroquine phosphate bulk drug substances because they are
components of an FDA-approved drug, provide other requirements in
the Act are met.
- The FDA issued an emergency use authorization for ventilators,
anesthesia gas machines modified for use as ventilators, and
positive pressure breathing devices modified for use as ventilators
(collectively referred to as "ventilators"), ventilator tubing
connectors, and ventilator accessories. Manufacturers and other
stakeholders may submit a request to FDA under the process outlined
in the EUA to have their device(s) added to the EUA. If you have
questions, please email
CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
- Diagnostics update to date: During the COVID-19 pandemic, the
FDA has worked with more than 190 test developers who have said
they will be submitting applications to make tests that detect the
virus. To date, 16 emergency use authorizations have been issued
for nation-wide use. Additionally, under our COVID-19 laboratory
developed test policy, the FDA has been notified by more than 100
laboratories. The FDA also added additional updates to its COVID-19
Diagnostics FAQ.
Additional Resources:
- Coronavirus Disease 2019 (COVID-19)
Media Contact: Stephanie
Caccomo, 301-348-1956
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration