Ordering, Receiving and Inventory of Controlled Substances

Ordering Controlled Substances and Authorized Roles

In a pharmacy setting, the handling of controlled substances is governed by strict federal regulations to prevent diversion and maintain accountability. Pharmacy technicians may assist with controlled substance ordering under pharmacist supervision, subject to state law and pharmacy policy. However, clinical judgment and prescription evaluation regarding controlled substances are strictly the pharmacist's legal responsibilities. A pharmacy technician may never make independent clinical choices, nor may they sign an official controlled substance order unless specific legal authority has been granted. Specifically, a pharmacy technician may sign a DEA Form 222 or submit orders through the Controlled Substance Ordering System (CSOS) only if they have been granted formal Power of Attorney by the DEA registrant.

The process for ordering depends directly on the schedule of the medication. Orders and transfers of Schedule I and II controlled substances require a DEA Form 222 or a valid electronic order placed through CSOS. The Controlled Substance Ordering System allows pharmacies to order Schedule I through V controlled substances electronically. To validate the purchaser's electronic signature, CSOS orders require digital certificates issued by the DEA. In contrast, Schedule III, IV, and V controlled substances do not require DEA Form 222. Instead, these lower-schedule medications may be ordered using ordinary purchase orders, and invoices or equivalent records document their receipt.

When paper ordering is used for Schedule I or Schedule II substances on the single-sheet DEA Form 222, exact procedural rules apply. The purchaser must make and retain a legible copy of the single-sheet DEA Form 222 before sending the original form to the supplier. If an error is made while filling out the form, it cannot simply be crossed out. A supplier must not fill a DEA Form 222 that contains an alteration or erasure or is improperly completed; when this happens, a new, properly completed form is needed. A supplier is permitted to partially fill a DEA Form 222 order, provided that the remaining balance of the order is shipped within 60 days of the execution date. The pharmacy must immediately report lost or stolen unused DEA Forms 222 to the local DEA Diversion Field Office; if an executed but unfilled form is lost, the purchaser must follow the replacement-order procedures, but immediate DEA reporting is not required solely because that form was lost. Furthermore, if a pharmacy's DEA registration terminates, its unused DEA Forms 222 must be returned to the DEA as directed by federal regulations.