The FDA updated its temporary drug compounding guidance to include a weekly data reporting system as well as guidance on adverse event reporting, according to Regulatory Focus.
The FDA has created several temporary drug compounding policies in response to the COVID-19 pandemic, including allowing outsourcing facilities to supply hospitals with drugs to treat COVID-19 patients without receiving patient-specific prescriptions.
The agency May 22 added a requirement for weekly reporting to allow hospitals to identify which compounders are making what quantities of drugs in shortage during the pandemic, according to Regulatory Focus.
Beginning June 1, drug products compounded under the temporary guidance should be included in weekly reports from outsourcing facilities. The FDA will post the information on its website to help determine which facilities are compounding drugs for hospitalized COVID-19 patients.
The FDA also included directions for adverse event reporting. Pharmacies should report adverse events associated with drugs covered by the temporary guidance "as soon as possible but no later than 15 days after receipt of such information to FDA's MedWatch Adverse Event Reporting program," the guidance says, according to Regulatory Focus.
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