True or False: The total number of dosage units of all controlled substances distributed may not exceed 5% of all controlled substances dispensed in a calendar year.

The statement is true. According to federal regulations, specifically under the provisions governing the distribution of controlled substances, a registrant is allowed to distribute a limited quantity of controlled substances without registering as a distributor. This limit is set at 5% of the total number of dosage units of controlled substances dispensed in a calendar year. This rule helps ensure that those who are primarily practitioners and dispensers are not classified as distributors unless they exceed this threshold.

While some might consider the variations in state laws, the federal limit is a general guideline that must be adhered to unless state laws are more stringent. The regulation ensures that distribution remains tightly controlled and monitored to prevent potential misuse or diversion of controlled substances. The option referring specifically to Schedule II substances is incorrect as the 5% rule applies to all controlled substances, not just those in a specific schedule.