<P> Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code . Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others . In many cases these responsibilities are shared with other federal agencies . </P> <Table> <Tr> <Th> Regulation of therapeutic goods in the United States </Th> </Tr> <Tr> <Td> </Td> </Tr> <Tr> <Td> Prescription drugs Over-the - counter drugs </Td> </Tr> <Tr> <Td> Law (show) Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch - Waxman exemption Marihuana Tax Act </Td> </Tr> <Tr> <Td> Government agencies (show) Department of Health and Human Services Food and Drug Administration Department of Justice Drug Enforcement Administration </Td> </Tr> <Tr> <Td> Process (show) Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off - label use </Td> </Tr> <Tr> <Td> International coordination (show) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs </Td> </Tr> <Tr> <Td> Non-governmental organizations (show) Institute of Medicine Research on Adverse Drug events And Reports NORML </Td> </Tr> <Tr> <Td> <Ul> <Li> </Li> <Li> </Li> <Li> </Li> </Ul> </Td> </Tr> </Table> <Tr> <Th> Regulation of therapeutic goods in the United States </Th> </Tr> <Tr> <Td> Prescription drugs Over-the - counter drugs </Td> </Tr>

What are some duties and responsibilities of the fda