Storage of Controlled Substances and Accessibility

Storage of controlled substances must provide effective prevention of theft. Proper storage of both material and usage logs is the responsibility of the Principal Investigator.

Minimum security standards for practitioners are set forth in Title 21 CFR 1301.71 and are used in evaluating security. Full requirements are covered in Title 21 CFR 1301.71 - 1301.76. The regulations only provide minimum standards and each storage location is individually approved for effective controls and operating procedures to prevent diversion or theft of controlled substances.

There are several items that are considered when evaluating a storage unit and areas. Some are locations the of unit within the lab, accessibility of storage unit, number of individuals that have access, key access procedures, type of material being stored, and quantity.

Storage Guidelines

Storage locations are limited to one location per CSUA or Individual Registrations. The approved storage is only for associated controlled substances.

Any other items are not permitted such as saline, needles, pharmaceuticals, or files. Schedule I and II material must be segregated and clearly labeled with its corresponding schedule, if stored in the same storage unit.

DEA inspectors will check that cabinets are bolted or affixed to a permanent structure (i.e. wall or floor) and that keys allowing access to the main cabinet are secure.

To get your storage location approved and verified or to develop a storage plan schedule a consultation with us.

Book a Service Appointment

Please review hand out for detailed information.

All primary storage units must be anchored or affixed to a permanent structure if their weight is under 750 lbs.

Schedule I: Store in a safe or in a substantially constructed steel cabinet equivalent with a double lock system and with burglary prevention rating. Required burglary ratings may vary based on additional security provisions provided

Schedule II: Store in a safe or in a substantially constructed steel cabinet equivalent with a double lock system. (e.g. Narcotics cabinets or a steel lockbox within a lockable desk drawer or cabinet.)

Schedule III - V: Store in a locked drawer or cabinet that is inaccessible from above or below.

The following substance must be stored in a safe:

“Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container. “

For more information see 21 CFR 1301.75

Drawers: Must be inaccessible from the upper or lower drawers in the stack. Top drawers of a stack can be assigned to use as the storage facility.

Other Storage units: Must be secure enough to show forced entry and affixed to the floor or wall. Secondary containment (security locked box) is primarily required for schedule II material to provide a double-lock system and separate materials from other items.

Padlocks and hinges: Mounting screws or bolts of the hasp-lock so they are inaccessible when the door is closed and the lock is fastened.
Examples of acceptable locks:
- Hasp lock(link is external) and carriage bolts (link is external)
- Hasp Lock Installation Information

Refrigerators: Controlled substances requiring refrigeration may be stored in a locked container securely fastened within a locked refrigeration unit.

Safes and steel cabinet equivalents: Must be cemented or bolted to the floor or wall or weigh more than 750 pounds.

Controlled substances must be stored securely in a manner adequate for safeguarding. It is highly recommended that access be limited to one or two individuals when possible.

General requirements:

Only store controlled substances in your storage unit.
Store usage log in a separate area without labeling.
Restricted Access- grant access only to authorized personnel on associated CSUA
Keep storage key(s) in the physical custody of authorized personnel at all times or in a secured a lockbox. ( If there are multiple key copies assigned to authorized personnel, ensure lock combinations are changed and/or retrieve keys when there is a change in personnel.)
Notify the Controlled Substance Program as soon as possible of any personnel changes to update your CSUA.

Storage restrictions:

Storage Units cannot be shared between CSUAs.
Material should not be transferred from its original container for storage unless it is diluted.
No other chemicals or supplies can be stored in the storage unit.
Portable safety boxes are NOT adequate for storage of controlled substances.
Corridor storage of controlled substances is prohibited.

Dilutions and mixtures of controlled substance are handled the same as the stock material. These materials should never be left unattended on the countertops and/or lab benches. Proper labeling is also essential. Label containers with name of the drug, ID number, expiration date, and the date when the drugs are diluted or opened. Controlled substances must never be used after their expiration date in animal research.

Any of the following must be approved prior to use:

New Location - Any new storage location or the addition of a new storage unit to an existing location must be document by the CSP and approved by the DEA.

Additional Unit - A CSUA can have one approved location to store controlled substances. At time this my not be possible as material may require different temperature for storage. In this situation and request for exemption is submitted to the DEA and a justification is provided for the second storage unit.

Moving (with UCLA) - If you are moving to a different lab space or are planning to please notify us immediately so we can start the new location process.

Closing- If you are leaving UCLA you must contact us immediately so that we can collect any remaining material and usage logs. Material can not be moved to any other location without notification.

Lab are responsible for ensuring materials are secured. Any locks or combinations must be changed when there is staff turnover.