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503A pharmacies (traditional compounding): State-licensed and state-inspected Compound medications in response to individual prescriptions Not subject to FDA inspection Can compound any FDA-approved drug (including during shortages) Sterility testing is state-mandated but standards vary Most telehealth platforms use 503A pharmacies 503B pharmacies (outsourcing facilities): State-licensed AND FDA-registered Undergo FDA inspection on a regular schedule Can compound in larger batches before receiving individual prescriptions Must follow current good manufacturing practice (CGMP) standards Sterility testing follows FDA protocols Cannot compound drugs on the FDA's "difficult to compound" list The practical difference: 503B facilities have a documented safety advantage
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