FDA temporarily expands hospitals’ access to compounded drugs, authorizes non-patient-specific orders

Apr 21, 2020 - 03:54 PM
FDA-guidance

The Food and Drug Administration yesterday said that it will temporarily forgo action against 503A compounding pharmacies that provide to hospitals certain compounded drugs without patient-specific prescriptions.

The agency’s temporary policy outlines specific criteria that pharmacies and hospitals must meet in addition to some conditions established in section 503A of the Federal Food, Drug, and Cosmetic Act.

While the agency recently provided additional guidance for 503B outsourcing facilities, it acknowledged that the flexibilities provided might not be sufficient to meet urgent needs. FDA says this new policy is intended to remain in effect for no longer than the duration of the COVID-19 public health emergency and will be modified as circumstances evolve.

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