Pharmacist’s Corner: Common DEA Violations—and How to Avoid Them

Incomplete/Inferior Recordkeeping

• Schedule I and II controlled substances must be kept separately from all other records
• Schedule III-V controlled substances must be kept separately from all other records and be readily retrievable
• Separate DEA 222 forms, CSOS forms, and all supporting documents
• A DEA 222 form must be filled out appro­priately upon receipt (e.g., a copy should be made and part 5 for the purchaser must be filled out)
• Invoices for controlled substances should be signed and dated upon receipt

Lack of Security

• All controlled substances must be stored behind at least two differently keyed locks, at all times
• Schedule I and II controlled substances must be stored in a safe or steel cabinet made of substantial construction
• Schedule III-V controlled substances must be stored using one of the follow­ing methods
  • Wall mountable controlled substance lockbox with two doors and two keys
  • Single-lock lockbox that is stored in a drawer or cabinet that is secured at all times with a hasp and padlock
  • If not accessible to the public, then a single-lock lockbox stored in a drawer or cabinet in a room that is kept lock  
• If you have triplicate DEA 222 forms, write VOID on each one and store them in a locked file cabinet (you must use the DEA’s new single form sheet)

Failing to Prevent Drug Theft/Diversion

• There must be separation of duties (e.g., different person who orders vs. who receives the controlled substances)
• Dispose of controlled substances using an appropriate pharmaceutical waste disposal product (e.g., RxDestroyer, Cactus) using a log sheet that requires two witnesses
• Maintain administration and dispensing reconciliation logs
• Controlled substances that are drawn up and not used should be recorded on your controlled substance reconcilia­tion log as wasted and/or a controlled substance waste log with two witnesses and a reason
• Controlled substance reconciliation logs should be reconciled once a day or at every shift change
• Report any theft/loss within one day to the DEA and report using a DEA 106 form

Reporting of Unresolved Discrepancies and Significant Losses

• Maintain administration and dispensing reconciliation logs that are kept current, complete, and accurate
• Two witnesses and a reason for the dis­crepancy is always required
• If you break a bottle or spill a bottle, it is not reported as a loss; it is noted as a discrepancy and a DEA 41 form is filled out

DEA Registration and Licensing Issues

• A DEA certificate is address specific and must align with your address of practice
• If you are ordering controlled substanc­es for administration, they must be sent directly to the location they will be used, and that location must correspond to the address listed on your DEA registra­tion

Prescribing Outside the Scope of Practice

• If you are prescribing controlled sub­stances under an exemption, the person with the DEA number must be on site
• Schedule II prescriptions cannot be refilled
• Schedule III-V prescriptions cannot be filled for more than 6 months or refilled more than five times unless renewed by the prescriber
• If you do not have a DEA number, you cannot prescribe controlled substances

Failing to Maintain Required Documents

• All invoices, packing slips, and DEA 222 forms should be kept in a locked file cab­inet by schedule

Failing to Dispose of Controlled Substances According to Regulations

• Use a reverse distributor OR a DEA 41 form when disposing of controlled sub­stances that have not been designated for a patient (e.g., expired drugs)
• Dispose of controlled substances using an appropriate pharmaceutical waste disposal product (e.g., RxDestroyer, Cactus)
• Non-controlled substances cannot be mixed in with controlled substance waste

Failing to Maintain Inventory Records According to State and Federal Regula­tions

• Federal law requires keeping controlled substance records for 2 years; Illinois law requires keeping controlled sub­stance records for 5 years – Must follow most stringent law
• DEA requires a complete inventory bien­nially (every 2 years)
• An annual reconciliation inventory of all your scheduled drugs (I-IV) should be taken on or about December 31 of each calendar year
• The date the reconciliation inventory was taken should be written on your annual inventory documents and state if it was taken at the beginning or ending of the workday
• Any time a primary registrant changes, logbooks and records must be closed, and inventory form must be completed, and new logbooks must be opened

Prescribing Without a Documented and Established Veterinarian-Client-Patient Relationship (VCPR)

• There must be a documented doctor of record who has a documented VCPR as it relates to that diagnosis
• Protect access to prescription pads
• Keep your DEA number confidential, unless disclosure is required by state law (e.g., when prescribing a controlled substance)

By Alex Gochenauer, PharmD, DICVP, FSVHP, FACA