21 CFR 1308 – Drug Diversion & The DEA
Feb. 23, 2022 | 21 CFR Compliance
Managing pharmaceutical waste in health care facilities and any organization which manages medications, must carefully regulate the control and disposal of pharmaceutical waste. The responsibility of safe disposal falls on the organization’s DEA Registrant. The specific role of the Registrant differs facility to facility depending on the method and volume of medications that are handled.
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. It is the responsibility of a facility’s DEA Registrant to be up to date with all pharmaceutical and controlled substance regulations. 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 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.
Schedules are determined by the DEA by the drug’s acceptable medical use and the abuse or dependency potential. For example, the DEA considers Schedule I drugs to have a high potential for abuse and the potential to create severe psychological and/or physical dependence. As the drug schedule decrease– Schedule II, Schedule III, etc., so does the abuse potential– Schedule V drugs are considered to have the least abuse potential.
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
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