- Today, the FDA issued an update to its guidance for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. In the update, FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not in a cleanroom, when specific beyond-use dates are utilized. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
- Testing updates:
- During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
- To date, the FDA has authorized 98 tests under EUAs, which include 85 molecular tests, 12 antibody tests, and 1 antigen test.
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