The Federal Drug Administration
The FDA regulates pharmacutical companies and testing on new drugs for the treatment of diseases. Federal law requires that the drug has to go through testing in the lab and then on animals to determine if it does prevent or treat the intended disease. If the drug passes these rounds of testing, then it moves forward to human test trails. Only after it passes all trials and the benefits outweigh the side-effects or risks from actually having the disease does a drug go out on the market.
Over the counter drugs are also regulated. OTC drugs are "drugs that are safe and effective for use by the general public without seeking treatment by a health professional." OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval.
Prescription vs. Over-the-Counter (OTC) Medicine
So what is the difference between prescription drugs and over-the-counter drugs?
| Prescription Medication | OTC Medication |
| Prescribed by a doctor; under a doctor's care |
Does not require a doctor’s prescription |
| Bought at a pharmacy |
Bought off-the-shelf in stores |
| Prescribed for and intended to be used by one person |
Okay for most people to use |
| Regulated by FDA |
Regulated by FDA through OTC Drug monographs |
