Controlled Substances 

The Hazardous Waste Pharmaceuticals regulations, contain a conditional exemption from Resource Conservation and Recovery Act (RCRA) requirements for Hazardous Waste Pharmaceuticals (HWP), that are regulated as Controlled Substances (CS) under the Drug Enforcement Administration (DEA) including household HWPs that are managed through a DEA collection or "take-back" program. Previously, HWPs were regulated under both the RCRA hazardous waste regulations and the DEA regulatory for controlled substances. This regulation overlap is now eliminated through the Subpart P requirements for hazardous waste pharmaceuticals that are also controlled substances.

Overview of Regulatory Provision

The conditional exemptions for Hazardous Waste Pharmaceuticals (HWPs) that are also Controlled Substances (CS) including those CS collected as part of a DEA take-back program. Controlled substances that are also hazardous waste pharmaceuticals are exempted from management under RCRA. These HWPs include those listed on a schedule of controlled substances by the Drug Enforcement Administration (DEA) or are household HWPs that are collected in take back events or programs by an authorized collector registered with the DEA. Provided that the CS or household HWPs are managed in compliance with the Sewer Prohibition, the collection, storage, transportation and disposal, including destruction method, is in compliance with all applicable DEA regulations for CS.

Definitions

Hazardous Waste Pharmaceutical (HWP) A pharmaceutical that is a solid waste, and exhibits one or more characteristics or is listed.

Household Waste Pharmaceutical: A pharmaceutical that is a solid waste, but is excluded from being a hazardous waste.

Pharmaceutical Any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system (e.g., electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials.)

A full list of definitions related to the Pharmaceuticals Rule requirements can be found here.

Controlled Substances and Hazardous Waste Pharmaceuticals Overlap 

Not all controlled substances meet the definition of hazardous waste pharmaceuticals, and not all hazardous waste pharmaceuticals are controlled substances. The prescription drugs that may fall into this overlapping regulatory category are found in the table below. This list in not meant to be all-inclusive. The HWP generator is responsible for making hazardous waste determinations.

Table: Prescription Drugs with Overlapping Regulatory Categories

NAME OF DRUG

OTHER NAMES

MEDICAL USE

RCRA HAZARDOUS WASTE CODE

DEA CONTROLLED SUBSTANCE SCHEDULES

Chloral; Chloral Hydrate

Acetaldehyde, trichloro; Aquachloral, Noctec, Somnote, Supprettes

Sedative

U034, toxic

IV

Fentanyl Sublingual Spray

Subsys

Analgesic

D001, Ignitable

II

Phenobarbital

Bellargal-S, Donnatal, Luminal

Anticonvulsant

D001, Ignitable

IV

Testosterone Gels

Androgel, Axiron, Fortesta, Testim

Hormone

D001, Ignitable

III

Valium Injectable

Diazepam, Diastat

Anti-anxiety

D001, Ignitable

IV

Paraldehyde*

1,3,5-trioxane, 2,4,6-trimethyl; Paral

Anticonvulsant

U182, Toxic

IV

Paregoric*

Camphorated tincture of opium

Analgesic, Expectorant, Antidiarrheal

D001, Ignitable

III

Opium Tincture*

Laudanum

Analgesic, Antidiarrheal

D001, Ignitable

II

Phentermine**

Alpha, alpha-dimethylphenthyl amine; benzeneethanamine, alpha, alpha-dimethyl-; Adipex-P; Atti Plex P; Fastin; Ionamin; Kraftobese; Panshape M; Obe-Nix; Pentercot; Phentride; Pro-Fast; Raphtre; Supramine; Tara-8; Termene; Termine; Zantryl

Appetite Suppressant

P046, Acutely Toxic

IV

*  No longer commonly in use.
** No longer considered hazardous waste because it is in salt form.

RCRA Hazardous Waste Codes: Characteristic hazardous waste codes and listed hazardous waste codes.

DEA: Drug Enforcement Administration

DEA Controlled Substance Schedules: Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.

Disposal - Destruction & Combustion 

Controlled Substances must be destroyed by a method that DEA has publicly deemed in writing to meet their non-retrievable standard of destruction, or combusted at one of the following: