Recommended Guidelines for Using Schedule VI Drug Isoflurane in Research Laboratories

Background

Isoflurane is an inhalation anesthetic drug frequently used to induce and maintain general anesthesia in animals used for research. It is a halogenated hydrocarbon and must be used under proper engineering controls to prevent personnel and environmental exposure. These engineering controls are gas-capturing devices that include fume hoods, articulating arm local exhaust ventilation units (or snorkels), down-draft tables, or activated charcoal canisters. Isoflurane is a Schedule VI drug recognized by the Commonwealth of Massachusetts Controlled Substance Act (105 CMR 700: Implementation of M.G.L.c.94C) and separate from federal Drug Enforcement Agency (DEA) Schedules I – V. Laboratories at Boston University (BU) that plan to procure, store, use, and administer those federally controlled drugs for research or veterinary use must register and request their purchase with the office of Environmental Health and Safety (EHS). Because isoflurane has a potential for abuse and diversion as well as unintended and unsafe exposure when aerosolized, this guidance document was promulgated. Laboratories must adhere to this guidance document. Other Schedule VI drugs with similar risks for abuse or unintended and unsafe exposure may be added to this guidance if and when appropriate.

Registration

Laboratories must first register with EHS before purchasing isoflurane. Registration with EHS will authorize the Principal Investigator (PI) and their staff to handle and use the material for their laboratory research. The EHS registration form is available here. Completed registration forms must be submitted to the Controlled Substance Officer (CSO) for review and approval. Its use on research animals must also be registered and approved by the Institutional Animal Care and Use Committee (IACUC). Before any requisition of isoflurane is approved, CSP will identify an immovable and lockable cabinet in the PI’s lab space that is accessible only to the lab’s CS-authorized users. In the absence of such a cabinet, CSP will provide a safe to the lab, and identify a place for its installation in the lab. Registered laboratories will be inspected by EHS on a routine basis to ensure that this guidance is followed, drugs are secured and stored properly, and inventories are appropriately maintained.

Procurement

Purchase request of isoflurane must be submitted to the EHS. The authorized PI must complete the requisition form and submit it to EHS for review and processing. The requisition form is available at https://www.bu.edu/ehs/ehs-topics/controlled-substances/faqs/controlled-substances-operational-forms/16689-2/.

Training

All PIs and laboratory personnel must complete the online CS Training and CS Authorized User Annual Attestation form in BioRAFT® before they are approved and authorized by CSP to handle the drug. The training and the form must be completed annually thereafter. Additional information about the training is available at https://www.bu.edu/research/ethics-compliance/safety/environmental-health-and-safety-training/.

Storage

Isoflurane and other similar Schedule VI drugs must be stored in a secured storage cabinet with lock or a CSP provided safe and separate from secure storage and usage logs used for DEA Schedule I-V drugs. Access to the cabinet must only be granted to authorized PI’s and laboratory personnel. The lock/safe code must be replaced/changed whenever any authorized personnel leaves their position from the laboratory. As an alternative, labs can purchase a combination lock so that every time an authorized lab personnel leaves; the lock code can be changed. The lab must ensure that access to the key(s) is only for the CSP-authorized personnel currently working in the lab.

Inventory Record

Laboratories that are authorized to use isoflurane must maintain a complete record of the drugs received and used in the laboratory. Once the isoflurane is received, the lab must record receipt of that shipment in its CS logbook as well as the following information: complete name of the product, number and enter each bottle and date received, original bottle volumes, drug concentration, batch or lot number. When a bottle is finished or drug in that bottle has expired, it must be recorded in the same page of the logbook for that bottle.

The discovery of any missing or stolen drug must be reported to the CSO immediately at 617-358-9446 (work) or 617-372-6737 (cell). Diversion must be reported by completing the Diversion Report form and submitting to the CSO by email at csp@bu.edu. The form is available at https://www.bu.edu/research/files/2016/12/Controlled-Substances-Diversion-Report-Form.pdf. The volume of drug and its container missing or stolen must also be documented in the logbook provided by EHS.

The logbook will be reviewed by EHS during routine inspections.

The transfer of drugs to another registered laboratory at BU must be first approved by the CSO. The Controlled Substance Transfer form must be completed and submitted to the CSO at csp@bu.edu.

The form is available at https://www.bu.edu/research/files/2016/12/Controlled-Substance-Transfer-Form.pdf. Drugs may only be transferred upon approval of the CSO.

Engineering Controls

Any laboratory using isoflurane must utilize some type of engineering control to capture any potential fugitive airborne isoflurane. These engineering controls can include, but not limited to chemical fume hoods, articulating arm local exhaust ventilation unit (or snorkel), down-draft tables, or activated charcoal canisters. Biological Safety Cabinets (BSC), either types I or II, are generally insufficient as engineering controls for isoflurane. Based on the type of engineering control selected, EHS may elect to perform air monitoring for isoflurane during work activities.

Waste Disposal

Disposal of expired isoflurane or waste will follow the same procedure as other non-acutely hazardous reagents on campus. There is no need to request CSP to pick up isoflurane bottles, versus Schedule II-V containers. The empty containers should be properly defaced and disposed of in regular trash. Empty containers are defined as those containers which have less than 3% of the original volume. In the interest of sustainability, researchers should do their best to utilize all their isoflurane, emptying contents during use so that waste generation is minimized. Researchers should only rinse containers if the entire rinsate is collected as hazardous waste and should not allow it to evaporate. Containers that have more than 3% of original volume after researchers have used their isoflurane should be disposed as hazardous waste by submitting a hazardous waste pick up form through BioRAFT®.

Revised Date: June 29, 2023