The FDA has issued an update to its Temporary Policy Regarding Non-Standard PPE Practices for Pharmacy Compounders During the COVID-19 Pandemic. In the update, the FDA has clarified that drugs can be compounded under the policy in a segregated compounding area that is not a cleanroom when the following BUD’s are utilized:
- Up to 12-hours for products stored at room temperature
- Up to 24-hours for products stored refrigerated
You can find the new version of the guidance document by following the link below:
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