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[2] Estradiol cypionate injection is compounded on an individualized basis by 503A pharmacies pursuant to a patient-specific prescription and may also be produced in cGMP-compliant batches by 503B outsourcing facilities for office use, allowing clinicians flexible access to bioidentical estrogen preparations while maintaining regulatory oversight of quality and sterility

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If compounding access is restored for these substances, they will still not be FDA-approved drugs