Final answer:
The DEA Form 225 is required for entities wishing to manufacture or distribute controlled substances. The CDER evaluates new drugs through the NDA process to ensure their safety and efficacy. Upon approval, drugs are available by prescription and considered safe when used as directed.
Step-by-step explanation:
The manufacturing and distribution of controlled substances are regulated by the Drug Enforcement Administration (DEA) through various forms, one of which is the DEA Form 225. This form is used to apply for registration as a manufacturer or distributor of controlled substances. Any company or entity that wishes to engage in the manufacturing or distribution of substances that fall under DEA control must obtain the appropriate registration before they can handle these drugs.
The Center for Drug Evaluation and Research (CDER) is responsible for evaluating new drugs and has a rigorous approval process for them, known as a New Drug Application (NDA). Upon approval, these new drugs are generally available by prescription. Drugs are deemed "safe and effective when used as directed" following this comprehensive review process.