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According to FDA inspection data, only 72 outsourcing facilities maintained active registration as of December 2025, compared to thousands of 503A pharmacies. This concentration reflects the significant investment required for 503B compliance

However, they must carefully source materials to avoid quality issues that could invalidate studies

Regulators see untested drugs requiring restriction until proven safe

Enhanced State-Federal Coordination : The FDA and state pharmacy boards are developing information-sharing protocols to coordinate enforcement

Most likely, both trends continue simultaneouslytighter restrictions on some fronts, liberalization on others

Alternatively, patient advocacy and congressional pressure might create new access pathways