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Controlled Substances Exemption

The Hazardous Waste Pharmaceuticals Rule, 40 CFR § 266 Subpart P, contains a conditional exemption from the Resource Conservation and Recovery Act (RCRA) regulations 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 are found at 40 CFR § 266.506. 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 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, as defined in 40 CFR § 261.2, and exhibits one or more characteristics identified in 40 CFR Part 261 Subpart C or is listed in 40 CFR Part 261 Subpart D.

Household Waste Pharmaceutical: A pharmaceutical that is a solid waste, as defined in 40 CFR § 261.2, but is excluded from being a hazardous waste under 40 CFR § 261.4(b)(1.)

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.)

All specific definitions related to the Pharmaceuticals Rule requirements are provided on the Definitions web page and 40 CFR § 266.500.

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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

Notes:
*  No longer commonly in use.
** No longer considered hazardous waste because it is in salt form.
RCRA: Resource Conservation and Recovery Act
RCRA Hazardous Waste Codes: 40 CFR § 261.24 and 40 CFR § 261 Subpart D
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 in Title 21 Code of Federal Regulations (CFR) §§ 1308.11 through 1308.15. 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 (https://www.deadiversion.usdoj.gov/schedules/.)

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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:

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Virginia Department of
Environmental Quality
P.O. Box 1105
Richmond, VA 23218
(804) 698-4000


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