How to Survive a DEA Inspection Series: DEA Forms 222 and e222
Carlos Aquino
Senior Associate DEA
Every day pharmacists are confronted with the issues pertaining to the record keeping of DEA Forms 222 or DEA Forms e222. Here’s my recommendations or if you want to wait for a DEA Diversion inspection which requires your pharmacy DEA records to be complete and accurate and are required to be “readily retrievable” from all other records.
CSOS Generated DEA Forms e222
Let’s start with the CSOS generated DEA Forms e222. First, our recommendation is to confirm all DEA CSOS orders and print out a PDF copy of the DEA Form e222. Staple them to your invoice you keep or file the PDF copy by itself in a three-ring binder by the year and month the order was received by the pharmacy. Remember, the invoice is a secondary record! The DEA Form 222 or e222 is the primary record.
Second, you should save the CSOS generated PDF copy of the DEA Form e222 in a subfolder in the computer by the year and month received by the pharmacy. Why? Because if your Schedule II controlled substance supplier closes your account, you won’t have access to them and your supplier is not obligated to provide them to you.
Doing both methods will give the DEA Diversion personnel an opportunity to accept an electronic file of the confirmed DEA Forms e222 or take the paper copy of the order forms. Therefore, the records would be “readily retrievable” from all other records.
Don’t want to accept my recommendation, call me when you get cited for failure to make the DEA order forms “readily retrievable” and “available” for inspection.
Reverse Distributor Documentation Requirements
All DEA registered reverse distributor will provide the pharmacy with the original paper DEA Form 222 for all Schedule II controlled substances to be shipped to them for destruction purposes. They will also provide an invoice for all Schedules III to V controlled and non-controlled substances shipped to them for destruction purposes.
Therefore, your pharmacy MUST maintain these two DEA required records for every shipment of controlled substances shipped to the reverse distributor for destruction.
If a laminated folder is provided by the reverse distributor, we recommend that the laminated folder should maintain the original DEA Form 222 and the invoices for Schedules III to V controlled substance that notes the quantities and date that the controlled substances were shipped to the reverse distributor with the date listed on the outside of the folder. If the reverse distributor did not provide a laminated folder, we recommend that the pharmacy should use a binder or manila envelope to store such records.
With the laminated folder, place the executed DEA Forms 222 on the left side of the folder and the Schedules III to V invoices on the right side of the folder with any other additional record provided by the reverse distributor.
Emailing Executed DEA Form 222
A copy of the executed original DEA Form 222 must be emailed to the DEA Diversion email address noted on the back of the original DEA Form 222. Although a reverse distributor will tell a customer that they will email it to DEA Diversion email address, it is not possible for the form to be complete since the quantities shipped, and date shipped would not be noted on the copy of the order form.
Therefore, the DEA Form 222 will be incomplete without such information noted on the order form and your pharmacy may be cited for such DEA regulation violation as noted on the back of the original DEA Form 222.
DEA Civil Fines
Remember, the DEA civil fine for DEA required records and inventory is $19,246.00 per violation and for controlled substance prescription issues it is $82,950 per violation. Can you afford the DEA civil fine?
Carlos M. Aquino
Sr. Associate
Gates Healthcare Associates, Inc.