Code of Federal Regulations, Title 21, Food and Drugs, Parts 300-499 — PDF
The federal government has compiled the new clinical trial-related Title 21 CFR volumes for 2019, with all of the FDA rules for drugs, devices and biologics revised through April 1, 2019.
Title 21 CFR, Parts 300-499, includes rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and Health and Human Services (drugs for human use), investigational new drug applications, diagnostic radiopharmaceuticals, orphan drugs, bioavailability and bioequivalence requirements, over-the-counter (OTC) drug products indtended for oral ingestion that contain alcohol, OTC human drugs generally recognized as safe and effective and not misbranded, OTC digestion-related drugs, OTC antimicrobials, OTC sleep aid drugs, OTC stimulant drugs, OTC skin protectant drugs, OTC antipersperants, OTC miscellaneaous internal and external drug products, and more.
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