US FDA 'Bulks Up' 503B Outsourcing Drug List By Proposing Four First-Time Additions
The US FDA has proposed allowing outsourcing facilities to compound from four drug substances, but not from 19 others that it says already are available in FDA-approved drug products. Compounding pharmacies also would be allowed to compound from two of the four drug substances.
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The US FDA has added hydroxychloroquine sulfate to the list of drugs outsourcing facilities can compound as pharmacy group calls for more such approvals with COVID-19 driving demand for additional prescription and over-the-counter drugs.
FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.
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