FDA Eases Requirements for Repackaging of Propofol

In an emergency final guidance released yesterday, the FDA agency said it is temporarily relaxing its regulations for repackaging and combining units of propofol during the COVID-19 pandemic.

Normally, the drug must be repackaged or combined using nitrogen to eliminate degradation caused by oxygen exposure, but the FDA said it is temporarily lifting that requirement due to the increased demand of the drug for COVID-19 patients.

The guidance lists certain requirements for repackaging or combining the drug. For example, when propofol products are placed into a new container, the drug cannot be used after 12 hours from the date and time of preparation and the product must not be frozen. After 12 hours, the product should be thrown out.

The repackaged or combined drug’s labeling must also state that the drug is to be stored between 40 and 77 degrees Fahrenheit, the agency said.

Read the full guidance here: www.fdanews.com/04-23-20-RepackagingCombiningPropofol.pdf. — James Miessler