Health Law & Business News

Small Facilities Making Virus Drugs Get New Reporting Procedures

May 22, 2020, 4:42 PM

Drug manufacturers that make small batches of Covid-19 drugs for hospitals that can’t find them elsewhere will have to update the FDA more frequently about their operations under a policy change announced Friday.

Drugs like muscle relaxers and painkillers have been in short supply for hospitals across the country because of increased demand due to the pandemic. To ease supply chains, the Food and Drug Administration temporarily relaxed rules in mid-April for small facilities to make those drugs and sell them to hospitals.

Now those facilities have to send weekly reports to the FDA about the drugs they sell to hospitals, including how many individual units of a drug they made. Typically they would only have to send reports to the FDA twice a year.

The information will be posted on the agency’s website where hospitals can use it to track which facilities are making drugs for Covid-19 patients.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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