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Federal Court Upholds FDA’s Interpretation of Clinical Need for Determining the Use of Bulk Substances for 503B Outsourcing Facilities

Late last week, a U.S. District Court judge in Washington, D.C., issued a decision that upheld the FDA’s interpretation of clinical need regarding bulk substances that may be used by outsourcing facilities in drug compounding. Following the ruling, the FDA released a statement calling the decision a victory and that it will continue to evaluate bulk drug substances nominated for use in compounding by 503B outsourcing facilities in accordance with its interpretation of clinical need. Given the verdict, ASCRS remains concerned that the FDA’s determination of clinical need may impact access to compounded ophthalmic drugs from outsourcing facilities. We have written comments and explained to the FDA that determinations of clinical necessity should be left to the prescribing physician’s discretion. We urge the FDA to work with the medical community when making decisions about substances to include on the 503B Bulks List for compounding.

As a reminder, ASCRS is working with AAO and ASRS to nominate bulk drug substances to the 503B Bulks List to ensure physicians and patients have access to important treatments. We will keep you updated.

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