FDA Relaxes Rules Around Drugs Needed for COVID-19 Ventilator Patients

In light of a shortage of drugs needed for COVID-19 ventilator patients, the Food and Drug Administration (FDA) is not taking action against compounding pharmacies that make copies of approved drugs, use bulk ingredients that are unapproved, or fail to meet manufacturing requirements for stability. The primary reason for relaxing these regulations is to make treatment options available to hospitals that can not obtain FDA-approved drugs.

The new rules apply only to outsourcing facilities, and not to smaller compounders that are responsible for filling individual prescriptions. Outsourcing facilities are able to make and sell large batches of drugs without needing prescriptions. These facilities are currently only able to meet the hospital’s demands for drugs 53% of the time, down from 72% of the time in March of 2020.  

Although there is hope that this may help the situation, without substantive economic or regulatory relief the shortages will continue and patients will still be at risk. 

 

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