Final answer:
Schedule V drugs are substances with a lower potential for abuse, have an accepted medical use for treatment, and include preparations with limited narcotic content used mainly for antitussive, antidiarrheal, and analgesic purposes. They differ from more highly-regulated prescription pain relievers and must be approved through a New Drug Application before prescribing.
Step-by-step explanation:
Schedule V drugs are defined as a category of drugs that are considered to have a lower potential for abuse relative to substances listed in Schedule IV of the Controlled Substances Act. Drugs in this schedule have accepted medical use for treatment in the United States and typically consist of preparations containing limited quantities of certain narcotics. They are generally used for antitussive, antidiarrheal, and analgesic purposes. For example, cough preparations with less than 200 milligrams of codeine per 100 milliliters, such as those with a small amount of opium, are Schedule V drugs.
It's important to distinguish Schedule V drugs from other prescription pain relievers like Heroin, Fentanyl, Morphine, Oxycodone, and Vicodin which are categorized in more restrictive schedules due to their higher potential for abuse and addiction. Schedule V drugs are considered to have the least potential for abuse among the schedules that are subject to the Controlled Substances Act.
New drugs, including potential Schedule V candidates, undergo a rigorous evaluation process through a New Drug Application (NDA), as required by the Center for Drug Evaluation and Research. Upon approval, a drug may be considered 'safe and effective when used as directed' and can be prescribed by healthcare professionals.