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The FDA's compounding framework — established under the Drug Quality and Security Act (DQSA) of 2013 — allows licensed pharmacies to compound drugs for individual patients (503A) or in larger quantities for healthcare facilities (503B), but only under specific conditions.[3] One of those conditions is that the active ingredient must either be an FDA-approved drug or appear on the FDA's bulk drug substance list — a list of substances that have been nominated, evaluated, and designated as appropriate for compounding

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the safest option is an approved medicine selected and monitored by a qualified healthcare professional