Outpatient prescription labels must include cautions for controlled substances; true or false?

• A. Yes
• B. No
• C. Only for non-controlled substances
• D. Only if prescriber requests

Answer: (A)

Labeling for outpatient prescriptions of controlled substances includes cautions to enhance safety. These warnings help ensure patients understand the risks of abuse, dependence, and impairment, and they remind them to use the medication exactly as prescribed. Because controlled substances have higher potential for misuse, they often carry mandatory or strongly recommended cautions on the label, such as binding legal warnings about dispensing, along with usage cautions tailored to the drug (like avoiding driving if drowsy, avoiding alcohol, or storing securely). This isn’t optional; it’s standard practice driven by regulatory requirements to promote safe use and to deter misuse.

That’s why the statement is true. It would be inconsistent with safety and regulatory goals to omit cautions from controlled-substance labels, and the other options imply this safety practice is optional or limited to specific requests, which does not align with how outpatient labeling is generally handled.