Understanding the difference between inventory and wastage is crucial in the safe and compliant disposal of controlled substances. To help you better understand the distinction between the two types of pharmaceutical waste and how they need to be disposed of according to federal regulatory requirements, Stericycle has defined each, provided examples, and outlined the proper disposal method.
What is a Controlled Substance?
A controlled substance is any drug that has been scheduled by the Drug Enforcement Agency (DEA). The DEA places controlled substances into one of five schedules. This placement is based on whether the substance has an accepted medical use, its potential for abuse, and the likelihood it may cause dependence when abused. Examples of drugs that have been scheduled by the DEA include:
- Schedule I: Heroin, LSD, Marijuana, Ecstasy
- Schedule II: Oxycodone, Fentanyl, Morphine, Hydrocodone, Dilaudid, Methadone
- Schedule III: Ketamine, Testosterone, Tylenol with Codeine (less than 90mg/dose)
- Schedule IV & *V: Xanax, Darvocet, Valium, *Robitussin AC
Under federal law, Schedule I drugs have no current federally accepted medicinal use and a higher potential for abuse or dependence, whereas Schedule II through V drugs do have a currently accepted medical use and lower potential for abuse or dependence. Prescription opioids, such as oxycodone, hydrocodone, and morphine are controlled substances, and the DEA considers them Schedule II drugs. It should be noted that certain states and local governments have enacted laws that differ from the current schedules adopted at the federal level, so you should be mindful of potential differences at the state and local level when evaluating your compliance programs.
What is Inventory?
DEA regulations define inventory as controlled substances that are acquired through the established closed system of distribution and have not been administered or dispensed and are part of a facility’s stock. Drugs remain part of the pharmacy’s inventory until the drugs are expired, recalled, or unwanted and are removed from inventory either through reverse distribution by a regulated transfer between DEA registrants or DEA authorized witnessed destruction, or they are dispensed to a patient.
Examples of inventory include:
- Expired vials of testosterone at a clinic
- Boxes of fentanyl patches in an ambulatory surgery center
- Full/unopened vials of ketamine at a veterinary clinic
- Expired vials of morphine at a hospital pharmacy
- Unopened cups of methadone at a narcotic treatment center
What is Wastage?
Wastage refers to controlled substances remaining in a vial, tube, transdermal patch, or syringe when a controlled substance has been dispensed by a practitioner for immediate administration at their institutional/registered location pursuant to an order for medication. Unlike inventory, wastage is not defined in DEA regulations. Instead, the term was first found and described in a letter from the DEA in October 2014 titled “Dear Practitioner.”
Examples of wastage include:
- A partial vial of testosterone at a clinic remaining after administration to a patient
- A fentanyl patch removed from a patient at an ambulatory surgery center
- A partial syringe of ketamine from a veterinary clinic
- A partial IV or PCA pump of morphine from a hospital surgical area
What is Waste But Not Wastage?
It's important to distinguish whether an item that a facility may consider to be a waste is not wastage. For example, some items that are often considered to be a waste but are not technically wastage include:
- Clean up from breakage or spills of controlled substances
- Expired controlled substances
- Recalled controlled substances
- Controlled substance containers/packaging (no requirements from the DEA on disposal of empty containers)
- Schedule I controlled substances obtained under their DEA registration
These items may be a waste because you can no longer use them, but they are still regulated as part of your inventory and are not considered wastage.
How to Dispose of Inventory
When disposing of inventory, the waste can only be disposed of once it is rendered non-retrievable — that is, permanently altering its physical or chemical condition or state, rendering it unavailable and unusable for all practical purposes so that it cannot be used again. The DEA does not specify a destruction method to achieve the non-retrievable standard but requires that both chemical compounds and analogs must be destroyed. The DEA has indicated that incineration is currently the only destruction method they have reviewed, which achieves the non-retrievable standard.
Disposal of inventory is possible by using a DEA-registered reverse distributor that is authorized to receive controlled substances for destruction or to return them to the manufacturer. This approach requires detailed paperwork and recordkeeping by the reverse distributor and the DEA registrant:
- When a registered practitioner distributes schedule II-controlled substances to a reverse distributor, the reverse distributor must issue an official order form (DEA Form 222) to the practitioner.
- When a practitioner delivers schedule III-V controlled substances to a reverse distributor for purposes of disposal, the registered practitioner must maintain a record that includes the date and manner of disposal, name, address, and registration number of the person to whom it was distributed, and the quantity disposed. In addition, a copy of this record must be provided to the reverse distributor of the transaction.
- The reverse distributor is then responsible for completing a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to record the destruction and provide a copy to the practitioner for their records.
How to Dispose of Wastage
The DEA does not mandate destroying wastage, meaning it does not need to be rendered non-retrievable. While the DEA requires paperwork when disposing of inventory, there are no forms required for disposing of wastage. However, any remaining substances must be properly recorded and stored, and the wastage must come from a practitioner. The DEA strongly recommends that practitioners implement security controls to prevent the diversion of wastage. Registered practitioners can utilize a trusted partner, like Stericycle, to manage pharmaceutical wastage in a sequestration device. Stericycle’s program provides deactivation of controlled substance wastage, acts as a deterrent to prevent ingestion of contents, and facilitates the solidification of waste for safe storage and transportation.
Learn more about Stericycle’s CsRx® Controlled Substance Waste Service to support your organization’s efforts to dispose of controlled substance wastage safely. Stericycle also offers services designed to help patients dispose of their controlled substance medications, including Seal&SendTM Consumer Medication Mail Envelopes and MedDropTM Medication Collection Kiosks.
