What labeling requirement must be met according to FDA part C?

The requirement for a label to indicate the drug schedule is crucial because it provides essential information regarding the control status of a medication. This is particularly relevant for substances that fall under the Controlled Drugs and Substances Act (CDSA) in Canada, as well as under FDA regulations in the United States. The schedule indicates the level of regulation for the drug, which includes specifics about prescription requirements, refills, and potential for abuse.

Indicating the drug schedule on the label promotes safe use by healthcare providers and patients. It helps in identifying drugs that may have a higher potential for misuse or dependency. Therefore, ensuring that the label contains this information helps maintain adherence to laws and provides transparency and safety in pharmaceutical practice.

The other options, which include misleading labels, sizing of trade names relative to generic names, and suggestions that lot numbers are optional, do not align with the requirements set forth by regulatory authorities. Labels must always be clear and not misleading, the generic name should generally be prominent to avoid confusion, and lot numbers are essential for ensuring traceability in the event of a recall or quality issue.