Final answer:
For a dangerous drug to be prescribed, it must undergo FDA approval via the NDA process, ensuring it is safe and effective when used as directed. Licensed healthcare professionals can prescribe these drugs, and regulations protect the public but may lead to delayed access to new treatments.
Step-by-step explanation:
The requirements for signing a prescription drug order for a dangerous drug (not a controlled substance) include various checks and balances to ensure the safety and efficacy of the drug. Such drugs, unlike over-the-counter medicines, must be prescribed by a licensed healthcare professional. This includes verifying the legitimacy of the drug through the New Drug Application (NDA) process overseen by the Food and Drug Administration (FDA). A drug is considered 'new' if substantial changes are made regarding its composition, manufacturing, or intended use, and it must undergo rigorous testing before it can be approved. Once approved, these drugs can only be prescribed and are monitored to ensure they are used safely. Understanding the FDA's strict regulation is important because, while it protects the public from the potential dangers of untested drugs, there can be delayed access to new therapies as a result of the lengthy approval process. Critics argue this can adversely affect patients who may have benefited from earlier access to new medicinal treatments.