Medication disposal can be confusing. The practice is regulated by many government agencies, and there are a number of rules to follow to ensure you are correctly disposing of any unused medications. Sharps Compliance’s MedSafe is a collection receptacle for ultimate user medication disposal. This blog will clarify the rules and regulations of disposing of medications in MedSafe and other similar containers.
Federal Hazardous Waste regulations for generators of hazardous waste are found in 40 CFR §262.11. These regulations require that any generator who produces or generates a waste must determine if that waste is hazardous. If the waste is determined to be hazardous, the waste must be managed according the regulations in 40 CFR 262 (et al).
The RCRA regulations also exempt households from these regulations in CFR 261.4(b)(1) — The Household Hazardous Waste (HHW) Exclusion. The EPA’s Household Hazardous Waste exemption is the EPA rule for consumers/households that exclude the items they possess from having to follow RCRA rules for disposal. Once the item is in the possession of the household, the exclusion carries through for the ultimate disposal.
So, if a business entity is generating hazardous waste through their everyday business practices, the waste needs to be managed as a hazardous waste by Federal and State regulations — including profiling the waste to a hazardous waste treatment facility and managing the waste by a licensed EPA and DOT transporter to the treatment facility, including the completion of a Uniform Hazardous Waste manifest.
But once an item (in this case, a pharmaceutical) has been offered and accepted by a consumer (ultimate user), and the consumer takes possession of the item, the item is now exempt from the RCRA regulations regardless of its constituents, the same constituents/ingredients that may have made the item a hazardous waste previously.
The DEA has also implemented the Final Rule on Disposal of Controlled Substances, which allow for collection of controlled substances in a receptacle at authorized locations — per the guidance in the rule. MedSafe adheres to the stipulations in the DEA Final Rule for collection receptacles.
The EPA’s stance is that pharmaceuticals that are considered HHW may be collected along with the DEA Controlled Substances in a receptacle — as long as the DEA rules are followed. The liner in the receptacle will be shipped per DOT regulations, under the classification of ORM-D Consumer Commodities in Limited Quantities.
MedSafe accepts controlled and non-controlled medications for disposal because the patient is the ultimate user per DEA Controlled Substances Rule and the medications will be HHW exempt. It is not necessary to maintain an inventory list of what medications are in MedSafe. This rule only applies to a “generator” of hazardous waste but not to waste that is excluded from the RCRA regulations as HHW would be. It is safe to put all types of waste pharmaceuticals (except aerosols) in MedSafe because they are consumer packaged commodities that will not interact and react. Flammable pharmaceuticals, such as liquids, creams and lotions, are in an outer plastic packaging prior to being placed in MedSafe. Any pills considered toxic have an outer protective coating on the pill and are also in a consumer package (vial) for placement into MedSafe.