Is your specialty at risk?
Frequently Asked Questions
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Aesthetics practices and medical directors face significant exposure under both federal DSCSA requirements and state board enforcement. If your practice purchases, stores, or administers any Rx product — neurotoxins, fillers, GLP-1s, peptides — you are in scope. State boards in New York, Ohio, and California are actively co-enforcing with shared FDA inspection data.
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Biologics, injectables, and specialty Rx products are fully in scope. Missing lot tracking and vendor documentation are the most common findings.
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Chemotherapy, immunotherapy, and biologic infusions carry the highest DSCSA exposure. Complete transaction documentation required at every custody transfer.
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Anti-VEGF injections and in-office administered agents require full serialized transaction documentation.
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In-office biologic infusions are a primary enforcement target. Specialty pharmacy sourcing creates documentation inconsistencies inspectors flag immediately.
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Vaccines, injectables, and any in-office Rx product are in scope. Most primary care operators assume DSCSA applies only to pharmacies. That assumption is now demonstrably wrong.
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High-value products administered at volume without hospital compliance infrastructure creates significant exposure.
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Buy-and-bill purchasing creates specific traceability requirements. Luteinizing hormone agents and in-office oncology treatments require full transaction documentation.
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MS infusion agents, therapeutic botulinum toxin, and CGRP antagonists administered in-office all require complete authorized distributor documentation.