Final answer:
The Controlled Substances Act (CSA) of 1970 established a closed system for controlled substances, managed by the FDA and DEA. It aims to prevent misuse while ensuring medications are available for legitimate use, though sometimes this causes delays in new drug availability for patients.
Step-by-step explanation:
The federal statute that established a closed system for the manufacturing, distribution, and dispensing of controlled substances is the Controlled Substances Act (CSA). Passed by Congress in 1970, the CSA places all substances which were in some manner regulated under existing federal law into one of five schedules. This classification is based upon the substances’ medicinal value, harmfulness, and potential for abuse or addiction. The CSA is designed to reduce the misuse of these substances and to promote access to medications for legitimate purposes while preventing their diversion into illegal activities.
The Food and Drug Administration (FDA), along with the Drug Enforcement Administration (DEA), is responsible for enforcing the CSA. The FDA oversees the safety and efficacy of pharmaceuticals, requiring rigorous testing before allowing drugs onto the market to ensure they do not harm the public. However, some critics argue that these strict regulations can also lead to “anonymous losers” such as patients who may suffer from the unavailability of new therapies while they are tied up in the lengthy approval process.