FDA updates hand sanitizer, hydroxychloroquine sulfate, ventilator and LDT policies

March 26, 2020

The U.S. Food and Drug Administration (FDA) announced several actions and guidance around healthcare supplies, treatment and policies 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 healthcare 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 [email protected].

·        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.

FDA has the round-up.

More COVID-19 coverage HERE.