Order & Receive Controlled Substances for Research

Ordering and receiving controlled substances requires strong internal controls as well as strict adherence to Roswell Park, state, and federal policies. This procedure contains information about the controls required for the ordering and receiving process.

Ordering

All orders must include the DEA registrant’s information (i.e., name, address of the registered storage location, research registration number, expiration date).

To order controlled substances for research purposes:

• Contact Purchasing to establish a purchasing contract or to identify an existing contract to use with a commercial supplier.
• Orders must be submitted on a Workday requisition or sent directly to the wholesaler using DEA Form 222 and a copy of the DEA registration must accompany the requisition for Schedule I-II.

Receiving

Vendors must ship orders within 60 days of the date on the DEA Form 222. Best practices for receiving a controlled substance order in your laboratory, regardless of substance schedule, include:

• Ensuring invoice contains the following data:
  • Name, address, and DEA Registration number of registrant
  • Controlled substance name, concentration, dosage form, and quantity
  • Signature of authorized personnel who picked up or received the drug order
  • Date of pickup or receipt
  • Having the DEA registrant or an authorized agent receive, verify, log, and securely store the substances into the registered storage location.
  • Maintaining invoices and packing slips with your controlled substance records, separated by schedule I-II, and schedule III-V.
• If there are any discrepancies, immediately notify the supplier to rectify. If discrepancies cannot be rectified, the Office of Research Subject Protection and the DEA and NYS relevant enforcement bureau should be contacted by the registrant.
  • From the time a controlled substance is accepted on campus until it is administered, wasted or disposed of, a disposition record of the chain of custody must be kept at each point where the substance changes hands or is used.

Additional process information

Rejected orders

A supplier may void all or any part of an order on a DEA Form 222, without an explanation other than “insufficient order.” The supplier will return copies 1 and 2 to the DEA registrant (purchaser). The rejected DEA 222 form copies 1-3 must be kept on file and maintained for at least two years.

Lost/delayed order forms

If a supplier does not receive a DEA 222 form for a particular order (i.e., lost) the DEA registrant, as the purchaser, must:

1. Submit in writing a notice to the supplier indicating the original DEA Form 222 serial number, the date on the form, and the controlled substances listed on the form.
2. Attach a copy of that written notice to copy 3 (blue) of the original DEA 222 form and maintain that as a record of a voided order.
3. Complete and send a new DEA 222 form to the supplier.
4. Report the voided form’s serial number to the DEA field office.

If the vendor subsequently receives the original (i.e. voided) order form, the vendor will not accept the order and will return the form to the DEA registrant for their records. If the lost DEA 222 form is found after notification to the Buffalo DEA field office, re-notify the DEA of the discovery.