Overview Of DEA Audits

The Drug Enforcement Agency’s (DEA) Diversion Control Division is responsible for overseeing registrants that manage controlled substances to ensure compliance with all federal laws and regulations pertaining to controlled substances. The Controlled Substance Act (CSA) outlines federal policies for regulating all aspects of manufacturing, distributing, importing, exporting, and use of controlled substances to help prevent diversion into the illicit market.   

Controlled substances should be available for legitimate medical and scientific purposes; however, their use must be regulated to prevent misuse, abuse, and diversion. Pharmacies play a critical role in preventing abuse and diversion. All pharmacy staff members are essential in maintaining compliance with the CSA and protecting their communities from misuse of prescription drugs.  

DEA pharmacy audits can happen randomly; therefore, it is best to be prepared and know what to expect.  

Common Inspection Items During a DEA Audit:  

DEA & state licenses  

Pharmacist and technician licenses  

Employee pre-employment screening procedures  

Safety and security of pharmacy  

Storage and security of controlled substances 

Power of attorneys and appropriate revocations  

CMEA training and self-certificate  

Ordering controlled substances 

DEA paper 222 forms  

Electronic 222 forms  

Inventory Requirements   

Initial inventory  

Biennial inventory  

Perpetual inventories  

Change of PIC inventories if applicable  

Change in drug schedule inventories if applicable  

Record Keeping  

Receiving records (222s, invoices, purchase orders, packing slips, CSOS records) 

Dispensing and distribution records  

Records of returns  

Records of destruction (DEA Form 41, waste records, reverse distributor records)  

Prescription records  

Physical counts of inventory  

DEA Form 106 suspected loss or theft of controlled substances  

List of suppliers (name, address, DEA #)