Food, Drug, and Cosmetic Act (FDCA): Primary federal law governing pharmaceutical products, including clinical supplies, their manufacturing, and distribution in the United States.
Code of Federal Regulations Title 21: Comprehensive regulations specific to food and drugs, including detailed requirements for clinical trials, manufacturing, and quality control.
Good Manufacturing Practice (GMP): Standards for pharmaceutical manufacturing, ensuring product quality and consistency in production.
Public Health Service Act: Federal legislation governing biological products and public health services, including clinical research.
HIPAA: Regulations protecting patient privacy and security of health information in clinical trials.
21 CFR Part 312: Regulations specific to Investigational New Drug Applications and clinical trial conduct.
21 CFR Part 50: Requirements for protection of human subjects in clinical trials.
21 CFR Part 54: Financial disclosure requirements for clinical investigators.
21 CFR Part 11: Standards for electronic records and signatures in clinical trials and pharmaceutical operations.
Drug Supply Chain Security Act: Requirements for tracking and tracing pharmaceutical products through the supply chain.
21 CFR Part 210 & 211: Specific requirements for manufacturing, processing, packing, and holding of pharmaceutical products.
Uniform Commercial Code: State-adopted regulations governing commercial transactions, including contracts for goods.
Export Administration Regulations: Federal regulations governing the export of pharmaceutical products and clinical supplies.
Environmental Protection Agency Requirements: Environmental regulations affecting pharmaceutical manufacturing and waste disposal.
Patent Laws: Federal laws protecting intellectual property rights in pharmaceutical development and manufacturing.
