Managing pharmaceutical waste in health care facilities and any organization which manages medications such as correctional facilities, must carefully regulate the control and disposal of pharmaceutical waste. Facilities must meet updated Drug Enforcement Administration, DEA, regulations which amend the Controlled Substances Act, as well as Environmental Protection Agency, EPA, requirements related to the proper disposal of pharmaceuticals. 21 CFR is the Code of Federal Regulations issued by the DEA which outlines the regulations for the secure disposal of controlled substances. 21 CFR 1308 addresses:
- Drug traffic control
- Recordkeeping and reporting requirements
- Administrative procedures and practices
Schedules I through V of Controlled Substances
Drugs which are considered to be controlled substances as defined under the Controlled Substances Act (CSA) are separated into five schedules. 21 CFR 1308.11 through 1308.15 provides a complete list of all controlled substances divided into Schedules I through V and is updated annually. Drugs are listed in each respective schedule based on the medical treatment use in the U.S., the potential for diversion, abuse and the likelihood of causing a drug dependence.
21 CFR 1308.11 Schedule I
Schedule I substances are considered to have no currently accepted medical use in the U.S. and have a high potential for abuse with a lack of accepted safety. Drugs in this class include heroin, LSD, Ecstasy and others.
21 CFR 1308.12 Schedule II
Schedule II substances include drugs which may lead to severe physical or psychological dependence and have a high potential for abuse. These drugs include narcotics such as Dilaudid®, Demerol®, oxycodone (Percocet®, OxyContin®), fentanyl, morphine, codeine, opium and others. Stimulants listed in Schedule II drugs include Adderall®, Ritalin® and others.
21 CFR 1308.13 Schedule III
Schedule III drugs include controlled substances which have less of a potential for abuse and may cause low to moderate physical or psychological dependence. Drugs in this category include narcotics which contain less than 15 milligrams of hydrocodone per dosage such as Vicodin® and drugs with no more than 90 milligrams of codeine such as Tylenol with Codeine® and buprenorphine (Suboxone®).
21 CFR 1308.14 Schedule IV
Schedule IV controlled substances include drugs with are considered to have a low potential for abuse such as alprazolam (Xanax®), clonazepam (Klonopin®) and others.
21 CFR 1308.15 Schedule V
Schedule V controlled substances are drugs which have a low potential for abuse and contain limited quantities of narcotics such as Phenergan with Codeine® and Robitussin AC®.
Controlled Substance Drug Disposal Compliance
C2R Global Manufacturing, Inc. provides compliance to EPA and DEA controlled substance disposal regulations including 21 CFR and key aspects regarding methods of destruction. We provide free compliance consultations to qualified customers along with education and training. Our patented* formula begins neutralizing medications on contact to render them immediately non-retrievable, which greatly reduces drug diversion while protecting the environment.
C2R Global Manufacturing, Inc. is an industry leader in pharmaceutical waste management and disposal with safe, simple and affordable products. Our drug disposal products are pharmacist approved and recommended, meeting safety, cost and efficacy considerations. Contact us for drug disposal solutions federally compliant to EPA and DEA regulations including 21 CFR 1308 and other key parts.