SECTION XIII - OTHER CONTROLLED SUBSTANCE REGULATIONS

Controlled Substance Distribution by a Pharmacy – “Five Percent Rule”

A pharmacy registered to dispense controlled substances may distribute such substances (without being registered as a distributor) to another pharmacy or to a registered practitioner for the purpose of general dispensing by the practitioner to patients, provided that the following conditions are met:

1. The pharmacy or practitioner that will receive the controlled substances is registered under the CSA to dispense controlled substances;
2. The distribution is recorded by the distributing practitioner in accordance with 21 C.F.R. § 1304.22(c) and the receipt is recorded by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);
3. If the pharmacy distributes a schedule II controlled substance, it must document the transfer on an official order form (DEA Form 222) or the electronic equivalent. For instructions on completing this form, see Section VIII, Ordering Controlled Substances.
4. “Five Percent Rule” - total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor.