(SUD) are strictly controlled by the federal government. The aim is to protect access to drugs with a legitimate medical purpose while preventing the detrimental ef- fects of illegal importation, manufacture, distribution, possession, and improper use. The Drug Enforcement Administration (DEA) enforces federal CS laws in all states and territories. In recent Drug Schedules The Controlled Substance Act (CSA), which took effect in 1971 regulates manufacture, distribution, and dispensing of CS with specifics laid out in the Code of Federal Regulations (CFR) Title 21, §§1300-1316. Under the CSA, illegal and prescription drugs are classified into 5 schedules according to: 18,19 ● Actual or relative potential for misuse ● Known scientific evidence of pharmacological effects ● Current scientific knowledge of the substance ● History and current pattern of misuse ● Scope, duration, and significance of misuse ● Risk to public health ● Psychic or physiological dependence liability
decades, the agency’s approach to curtailing drug misuse and diversion of pharmaceutical opioids has been to focus on traffickers and doctors who prescribe inappropriately rather than on individuals who illegally obtain opioids. 18
● Whether the substance is an immediate precursor of an already-scheduled substance Two federal agencies, the DEA and the Food and Drug Administration (FDA), determine which substances are added to or removed from Schedules I-V. 12 Each schedule is defined as shown in Table 1. Schedule I drugs have the highest risk for substance use disorder (SUD) and misuse and no accepted medical uses. Cannabis, although legal in some states, is still a Schedule I drug at the federal level. It is the only Schedule I drug that is legal at the state level for medicinal and recreational uses. The DEA does allow research to be conducted with Schedule I drugs when an investigator is deemed to be qualified and the protocol is found to have merit.
Table 1. Drug Schedules I-V Established by the Controlled Substances Act
Schedule Risk Level
Medical Use Status Prescriptions
Refills allowed Examples
I
Highest risk for SUD and misuse
No currently accepted medical use Lack of accepted safety for medical use
No
N/A
Heroin LSD Mescaline MDMA Methaqualone Marijuana
II
High potential for SUD and misuse (less than Schedule I)
Currently accepted medical use
Paper Electronically transmitted with strict requirements Phone only in emergencies with written prescription to follow within 7 days
No*
Amphetamine Opioids: Codeine Fentanyl Hydrocodone Hydromorphone Meperidine Morphine Methadone Opium Oxycodone Methylphenidate Pentobarbital ACET with codeine Anabolic steroids Buprenorphine Ketamine
III
Less potential for SUD and misuse than Schedules I or II
Currently accepted medical use
Paper Electronically transmitted Phone, fax
Up to 5 refills within 6 months
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Book Code: TN24CME
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