DEA Documentation Requirements
Special Guest: Carlos Aquino from PharmaDiversion LLC™
DEA On-Site inspections have increased over the last six (6) months. Jeff Hedges has been working with Carlos Aquino from PharmaDiversion LLC™. Carlos is a retired DEA diversion investigator and great supporter of independent pharmacies. After reviewing DEA inspections, speaking to Carlos and observing first hand in pharmacies, I have found that every pharmacy needs to follow three (3) basic steps to ensure they are in compliance with current DEA rules.
First, anyone who completes one of the following tasks must be authorized through a signed Power of Attorney for DEA Forms 222 and Electronic Orders to:
- Obtain and execute the DEA Form 222
- Process a CSOS user name and password
- Obtain a CSOS certificate for electronic order
- Digitally sign a Certification Authority (CA).
Note: The Power of Attorney for DEA Forms 222 and Electronic Orders is found on the Compliance Portal®, DEA Compliance, Item # 6c(iii).
Second, whomever is signing into CSOS to order Controlled Substances or to receive a C-II order MUST:
• Have an individual user name and password to accomplish this task o You may NOT use someone else’s user name and password
• The user must have authorization to use CSOS through a Power of Attorney. Finally, receive and complete orders of Schedule II substances correctly. The wholesaler electronic ordering system (electronic DEA 222) works very well. Simply log in, order the controlled substances and the DEA 222 is automatically generated.
When the drug order comes in, log into the wholesaler computer and in-check the order and the DEA 222 is completed. Unfortunately, you have not met the DEA regulatory requirements.
The following steps must be completed to be in compliance with DEA. They are easy to follow but there is no room for error.
The individual logging in to CSOS to order Controlled Substances must: a. Be authorized by a Power of Attorney for DEA Forms 222 and Electronic Orders b. Have an individual user name and password that is not shared with another person
When the drug order is received: a. CSOS is accessed by an authorized individual with a Power of Attorney for DEA Forms 222 and Electronic Orders with an individual user name and password that is not shared with another person b. The order of Controlled Substances is checked against the packing slip/invoice c. DEA 222 is completed through CSOS d. Print the DEA 222. Note: Most systems will state on the document, “This is not a DEA issued Form 222. This form is available for convenience.”
If this document does not print, check your Pop-up Blocker
The Pop-up Blocker may also prevent a completed DEA 222 from being printed • This document acts as the DEA 222 for DEA on-site inspection purposes • In most cases, this document prints with the fields empty. Manually complete this document by entering the following information:
o Packages Received
o Date Received o DEA requires the persons initials:
Remember this person must have a Power of Attorney
Recommend a signature over an initial e. Attach the packing slip/invoice to the acting DEA 222 f. Keep on file for two (2) years:
• DEA requires the pharmacy to produce the completed DEA 222 and invoice upon demand o DEA regulations require you to have this record to be “readily retrievable” and separate from other records o Reference: DEA Pharmacist’s Manual, Section VI – Record Keeping o You cannot print and complete the document when a DEA inspector is on-site.
Failure to comply with this requirement is a $14,000.00 fine for every DEA 222 that is not completed or available.
Technical assistance provided by:
Carlos Aquino PharmaDiversion LLC™
If a pharmacy has a DEA Compliance issue where a DEA citation is being issued, we strongly recommend you contact Carlos Aquino as quickly as possible.
Jeffrey Hedges, CDME
President & CEO
P.O. Box H, New Florence, PA 15944