US FDA Allows Outsourcers To Compound Hydroxychloroquine As COVID-19 Drives Demand
Pharmacies Say More Additions Needed
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.
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The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.
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.
If Drug Distributors Can Coordinate Without Anti-Trust Concerns During The Coronavirus Pandemic, What About Generic Manufacturers?
Experts and stakeholders suggest it may help avoid drug shortages, but also indicate the interaction, which in normal times would raise anti-trust concerns, may not be needed, even to fight coronavirus.