DEA Controlled Substance Record Keeping for ASCs

DEA Record Keeping Obligations for ASCs

The Drug Enforcement Administration (DEA) requires all registered entities, including ambulatory surgery centers, to maintain complete and accurate records of controlled substance transactions. These records must be maintained for a minimum of two years from the date of the transaction and must be readily retrievable for DEA inspection.

For ASCs in Texas, TSBP Rule 291.76 imposes additional requirements that supplement federal DEA regulations. Facilities must comply with both federal and state requirements.

Registration and Scheduling

DEA Registration

Every ASC that handles controlled substances must maintain a current DEA registration. Key points:

• The registration must be specific to the facility's physical address
• Registration must cover all schedules of controlled substances the facility uses
• Registration must be renewed before expiration (typically every three years)
• A copy of the current registration should be posted in the pharmacy or medication storage area
• Any change in address, name, or responsible individual requires notification to DEA

Understanding Schedules

DEA schedules determine the level of record keeping required:

• Schedule II: Highest level of control. Separate records required. Includes fentanyl, morphine, oxycodone, hydromorphone, and methamphetamine.
• Schedule III: Includes ketamine, testosterone, buprenorphine, and combination products with limited quantities of certain narcotics.
• Schedule IV: Includes benzodiazepines (midazolam, diazepam), propofol (in some states), tramadol, and zolpidem.
• Schedule V: Lowest level of control. Includes pregabalin and certain cough preparations.

Ordering and Receiving

Schedule II Ordering

Schedule II controlled substances must be ordered using DEA Form 222 or through the DEA's Controlled Substance Ordering System (CSOS):

• Paper 222 forms must be executed by an authorized individual
• CSOS electronic orders require a digital certificate from DEA
• Orders must be documented upon receipt with the date, quantity received, and receiving individual's signature
• Discrepancies between ordered and received quantities must be investigated and documented

Schedule III-V Ordering

These may be ordered through standard purchase orders but must still be documented:

• Maintain copies of all invoices
• Verify quantities received against the order
• Document the date of receipt and individual receiving

Perpetual Inventory

A perpetual inventory is a running record of every controlled substance transaction. For each medication, the record must show:

• Opening balance: The count at the start of each day or period
• Receipts: Every addition to inventory, with source, date, and quantity
• Administrations: Patient name, date, time, dose administered, and administering individual
• Waste: Amount wasted, reason, witnessing individual, and signatures of both the waster and witness
• Disposals: Method of disposal, date, witnessing individuals, and any reverse distributor documentation
• Running balance: The current count after each transaction

Biennial Inventory

DEA requires a complete physical inventory of all controlled substances at least every two years (biennially). This inventory:

• Must be conducted on a specific date
• Must include exact counts for all Schedule II substances
• May use estimated counts for Schedule III-V (if the container holds more than 1,000 units and has not been opened)
• Must be signed, dated, and retained for at least two years
• Must indicate whether it was taken at the opening or close of business

Administration Records

When a controlled substance is administered to a patient:

• Record the patient name and identifier
• Date and time of administration
• Medication name, strength, and route
• Dose administered
• Name and signature of the administering individual
• Update the perpetual inventory immediately

Waste Documentation

Controlled substance waste is a high-risk area for diversion. Proper documentation includes:

• The medication name, strength, and quantity wasted
• The reason for waste (partial dose, canceled procedure, etc.)
• The method of waste (sink, sharps container, pharmaceutical waste system)
• Signatures of two individuals: the person performing the waste and a witness
• Date and time of waste
• Update to the perpetual inventory

Disposal of Expired or Unwanted CS

Controlled substances that are expired, damaged, or otherwise unwanted must be disposed of through an authorized method:

• Reverse distributor: A DEA-registered reverse distributor can accept controlled substances for destruction. This is the most common method for ASCs.
• DEA-authorized collection: Some pharmacies and law enforcement agencies accept controlled substances for disposal.
• On-site destruction: Requires DEA authorization and specific documentation. Not commonly used by ASCs.

In all cases, document the substances disposed of, the quantities, the method, the date, and the individuals involved.

Audit and Inspection Readiness

DEA may conduct unannounced inspections. Ensure:

• All records are organized and readily accessible
• The perpetual inventory is current and accurate
• The biennial inventory is completed and on file
• 222 forms or CSOS records are maintained in order
• Waste logs are complete with dual signatures
• Any discrepancies have been investigated and documented

Staff should know what to expect during a DEA inspection and who is authorized to provide access to records.