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doi: 10.1126/scitranslmed.3001108 170 HegyiZZwickerSBureikDPericMKoglinSBatycka-BaranAet al

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Treatment with progesterone attenuates proliferation of endometrial polyps via regulation of expression of miR-320b and its target gene MCL1

Legal Basis for Compounding FDA Regulations: 503A Compounding Pharmacies: Traditional compounding under state law Can compound when patient-specific prescription exists Must be licensed pharmacy Subject to state board oversight 503B Outsourcing Facilities: Federally registered with FDA Can produce larger batches Subject to FDA inspection Can distribute across state lines more easily Drug Shortage List: Tirzepatide on FDA shortage list periodically Allows compounding of commercially available drugs Permits legitimate compounding when supply limited Legal basis for current compounding market Compounding is legal, regulated, and appropriate for addressing drug shortages and patient access

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Food and Drug Administration (FDA) for any indication