Disposal of Controlled Substances

Reverse Distributor Disposal

Proper disposal of controlled substances is important to reduce the risk of diversion and ensure safety and security within the laboratory or registered storage location.

For expired/unwanted controlled substances

Controlled substances that are expired, unwanted, or damaged (i.e., unused vials, expired dilutions, or broken/damaged containers with recoverable contents) must be transferred to a reverse distributor for destruction. Roswell Park contracts with Inmar for reverse distribution. See Policy 1101 for Disposal of Controlled Substances.

Laboratory Self-Disposal

For Waste of "Non-recoverable" contents

Residual amounts of non-recoverable waste may remain in the used (empty) syringes or vials after the administration or use of a controlled substance. If this waste amount cannot be drawn out with a syringe (i.e., is non-recoverable), you may discard the empty controlled substance container in a biohazardous sharps container. There is no need to record the disposal of the non-recoverable waste separately on the usage log if the container balance is zeroed out on the usage log upon disposal of that container.

For Waste of "recoverable" contents

Using controlled substances in a laboratory procedure may result in recoverable waste amounts from unused doses in a syringe (e.g., 5 ml was drawn out of a vial or dilution, but only 4 ml was administered) or from container spillage. The use of Rx Destroyer™ is the only method of laboratory self-wasting, in conjunction with a witness, and using the applicable log.

If recoverable waste remains from unused volume in a syringe:

A witness must be present to observe the waste and to document the waste (via initials) on the applicable use log.

1. Record the waste amount on corresponding use log (e.g., Multiple Dose Log) and on DEA Form 41.
2. Waste the contents into the Rx Destroyer™ bottle, then shake the bottle several times to activate the ingredients.
3. When the content in the bottle has reached the fill line, use the hardener pellet to solidify the contents.
4. Once the contents have reached the fill line or one year has passed from opening date, discard the bottle into the regular trash.

If recoverable waste remains from container spillage (e.g., puddle on the bench top)

Two authorized personnel (one being the Registrant or an Authorized Agent) must perform the waste and witness the waste on the use log and the DEA Form 41:

1. Place cleanup refuse (e.g., paper towels) from a spilled container into a secure biohazard or biohazard sharps container.
2. Record spillage amount on the usage log and DEA Form 41.

References and resources

• Reverse Distributor Inventory List: Inventory template to use when disposing of controlled substances through EHS - Hazardous Materials using U-M's contracted reverse distributor (Drug, & Laboratory, Inc. or DLD.) Also known as the DLD Controlled Substance Inventory List.
• Reverse Distributor Inventory Instructions: Instructions to complete the Reverse Distributor Inventory List, also known as the DLD Controlled Substance Inventory List.

Relevant Laws and Regulations

Title 21, Part 1300-1308 of the Code of Federal Regulations (CFR) and Article 33 of the New York State Public Health Law. Applicable laws and regulations governing the use of controlled substances in research include the Controlled Substances Act (21 U.S.C. Chapter 13 § 801 et. seq.); DEA regulations 21 C.F.R. § 1300 et. Seq; Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances, Public Health Law, Sections 338, 3300, 3305, 3307, 3308, 3309, 3381, 3701(1), (6), art. 33.

Questions?

Occupational and Environmental Services
Phone: 716-845-5998
Email: OES@RoswellPark.org
For more information about RX Destroyer™ bottles, visit rxdestroyer.com