What additional identifiers are required on labels for controlled substances according to the DEA?

The requirement for controlled substances labels to include a capital "C" followed by a Roman numeral is crucial for identifying the schedule of the controlled substance. This labeling is mandated by the Drug Enforcement Administration (DEA) to ensure proper classification and identification in accordance with the Controlled Substances Act.

Controlled substances are categorized into schedules (I through V) based on their potential for abuse, accepted medical use, and potential for dependence. The use of a capital "C" along with the Roman numeral denotes the specific schedule to which the substance belongs, making it easy for pharmacists, healthcare providers, and law enforcement to quickly assess the substance’s classification and any associated regulations. This, in turn, helps in preventing misuse and ensuring that these medications are handled with the necessary caution.

Other labeling requirements do exist, such as usage instructions, warnings, and details about expiration dates and storage, but they do not fulfill the specific DEA regulatory requirements concerning the classification of controlled substances. Therefore, the inclusion of the capital "C" and Roman numeral is a distinctive and essential aspect of controlled substance labeling that safeguards both the public and healthcare professionals.