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Multiple Choice

A pharmacy can sell controlled substances to other pharmacies or prescribers without being registered as a distributor if the total dosage units does not exceed what percent of the total dosage units dispensed per calendar year?

Distributors exemptions allow a pharmacy to transfer controlled substances to other registrants without becoming a distributor, as long as the amount distributed does not exceed five percent of the pharmacy’s total dosage units dispensed in a calendar year. This threshold exists to prevent triggering the full distributor registration for small, incidental transfers between registrants while still keeping control of larger, more systematic distributions. So, if a pharmacy dispenses 100,000 dosage units in a year, it can legally distribute up to 5,000 dosage units to other registrants without needing distributor registration. If the amount exceeds five percent, the pharmacy would need to register as a distributor and comply with applicable distributor obligations.

Distributors exemptions allow a pharmacy to transfer controlled substances to other registrants without becoming a distributor, as long as the amount distributed does not exceed five percent of the pharmacy’s total dosage units dispensed in a calendar year. This threshold exists to prevent triggering the full distributor registration for small, incidental transfers between registrants while still keeping control of larger, more systematic distributions.

So, if a pharmacy dispenses 100,000 dosage units in a year, it can legally distribute up to 5,000 dosage units to other registrants without needing distributor registration. If the amount exceeds five percent, the pharmacy would need to register as a distributor and comply with applicable distributor obligations.