2.2 Controlled Substance Scheduling & Criteria

Controlled Substance Scheduling System

The Controlled Substances Act categorizes drugs into five distinct schedules (I through V). The scheduling of a substance is determined by three main criteria: its potential for abuse, whether it has a currently accepted medical use in treatment in the United States, and the degree to which it may cause physical or psychological dependence. The DEA, operating under the authority of the U.S. Attorney General, is responsible for scheduling decisions, though they must request a scientific and medical evaluation from the Department of Health and Human Services (HHS), specifically the FDA.

Understanding the nuanced differences between the schedules and memorizing key examples within each is heavily tested on the MPJE.

Schedule I (C-I)

Criteria:

• High potential for abuse.
• No currently accepted medical use in treatment in the United States.
• Lack of accepted safety for use of the drug under medical supervision.

Schedule I substances cannot be prescribed, administered, or dispensed for medical use. They are strictly regulated and can only be used for research purposes by individuals or institutions with a specific Schedule I DEA registration (Form 225 for researchers).

Key Examples:

• Heroin (diacetylmorphine)
• Marijuana (Cannabis) - Note: While many states have legalized medical or recreational marijuana, it remains a Schedule I controlled substance under federal law. Pharmacies cannot dispense it under a standard DEA registration.
• LSD (Lysergic acid diethylamide)
• MDMA (Ecstasy, 3,4-methylenedioxymethamphetamine)
• Peyote (Mescaline)
• Psilocybin (Magic mushrooms)
• Methaqualone (Quaalude)
• GHB (Gamma-hydroxybutyric acid) - Note: When GHB is formulated as an FDA-approved drug (sodium oxybate, brand name Xyrem/Xywav), it is a Schedule III substance, but illicit GHB is Schedule I.

Schedule II (C-II)

Criteria:

• High potential for abuse.
• Has a currently accepted medical use in treatment in the U.S., or a currently accepted medical use with severe restrictions.
• Abuse of the drug may lead to severe psychological or physical dependence.

Schedule II represents the most tightly controlled legally prescribable medications. They require strict inventory controls, specialized ordering procedures, and have stringent prescription requirements (e.g., generally no refills, no verbal orders except in emergencies).

Key Examples - Opioids/Narcotics:

• Morphine (MS Contin, Roxanol)
• Fentanyl (Duragesic, Actiq, Sublimaze)
• Oxycodone (OxyContin, Roxicodone, Percocet - all oxycodone combination products are C-II)
• Hydrocodone (Vicodin, Lortab, Norco, Hysingla) - Note: All hydrocodone products were rescheduled from C-III to C-II in 2014.
• Methadone (Dolophine)
• Hydromorphone (Dilaudid)
• Oxymorphone (Opana)
• Codeine (when used alone/single-ingredient)
• Meperidine (Demerol)
• Tapentadol (Nucynta)
• Cocaine (Used medically as a topical anesthetic)

Key Examples - Stimulants:

• Amphetamine (Adderall, Dexedrine)
• Methylphenidate (Ritalin, Concerta, Daytrana)
• Lisdexamfetamine (Vyvanse)
• Methamphetamine (Desoxyn)

Key Examples - Depressants/Others:

• Pentobarbital (Nembutal) - Oral/injectable formats are C-II; suppository forms are C-III.
• Secobarbital (Seconal)
• Amobarbital (Amytal)
• Phencyclidine (PCP)

Schedule III (C-III)

Criteria:

• Potential for abuse less than the substances in Schedules I and II.
• Has a currently accepted medical use in treatment in the U.S.
• Abuse may lead to moderate or low physical dependence or high psychological dependence.

Key Examples:

• Buprenorphine (Subutex) and Buprenorphine/Naloxone (Suboxone) - Used for opioid use disorder and pain.
• Codeine combinations: Products containing not more than 90 mg of codeine per dosage unit (e.g., Tylenol with Codeine #3, #4).
• Ketamine (Ketalar)
• Anabolic Steroids: (e.g., Testosterone, Oxandrolone, Stanozolol).
• Dronabinol capsules (Marinol) - Synthetic THC in sesame oil. Note: Dronabinol oral solution (Syndros) is C-II.
• Sodium Oxybate (Xyrem) - The FDA-approved formulation of GHB.
• Fiorinal (Butalbital/Aspirin/Caffeine) - Note: Fioricet (Butalbital/Acetaminophen/Caffeine) is federally exempt from scheduling, but some states schedule it. Always check state law.
• Suppository forms of amobarbital, secobarbital, and pentobarbital.

Schedule IV (C-IV)

Criteria:

• Low potential for abuse relative to the substances in Schedule III.
• Has a currently accepted medical use in treatment in the U.S.
• Abuse may lead to limited physical or psychological dependence relative to the substances in Schedule III.

Key Examples - Benzodiazepines (Most end in -lam or -pam):

• Alprazolam (Xanax)
• Clonazepam (Klonopin)
• Diazepam (Valium)
• Lorazepam (Ativan)
• Temazepam (Restoril)
• Midazolam (Versed)

Key Examples - Z-Drugs (Hypnotics):

• Zolpidem (Ambien)
• Zaleplon (Sonata)
• Eszopiclone (Lunesta)

Key Examples - Others:

• Phentermine (Adipex-P)
• Tramadol (Ultram, Ultracet)
• Carisoprodol (Soma) - Muscle relaxant.
• Modafinil (Provigil)
• Phenobarbital
• Suvorexant (Belsomra)
• Lorcaserin (Belviq)

Schedule V (C-V)

Criteria:

• Low potential for abuse relative to the substances in Schedule IV.
• Has a currently accepted medical use in treatment in the U.S.
• Abuse may lead to limited physical or psychological dependence relative to the substances in Schedule IV.

Schedule V drugs generally consist of preparations containing limited quantities of certain narcotics, often formulated for antitussive, antidiarrheal, or analgesic purposes.

Key Examples:

• Promethazine with Codeine cough syrup (Must contain not more than 200 mg of codeine per 100 mL or per 100 grams).
• Guaifenesin with Codeine (Robitussin AC, Cheratussin AC).
• Diphenoxylate with Atropine (Lomotil) - Contains not more than 2.5 mg diphenoxylate and not less than 25 mcg atropine sulfate per dosage unit.
• Pregabalin (Lyrica).
• Brivaracetam (Briviact).
• Lacosamide (Vimpat).
• Ezogabine (Potiga).

The "Rule of Threes" for Codeine

Codeine is a classic example of how concentration determines the schedule of a drug:

• Schedule II: Pure codeine or any product with more than 90 mg of codeine per dosage unit, or more than 1.8 grams of codeine per 100 mL.
• Schedule III: Combination products containing not more than 90 mg of codeine per dosage unit, or not more than 1.8 grams per 100 mL (e.g., Tylenol #3).
• Schedule V: Combination liquid products containing not more than 200 mg of codeine per 100 mL or per 100 grams (e.g., Promethazine with Codeine cough syrup).

Rescheduling Authority

The Attorney General has the ultimate authority to schedule, reschedule, or remove a substance from the schedules. Before doing so, the Attorney General must request a scientific and medical evaluation from the Secretary of the Department of Health and Human Services (HHS), which delegates this to the FDA. The FDA's scientific recommendation regarding scientific and medical matters is binding on the DEA. If the FDA recommends that a drug not be controlled, the DEA cannot schedule it.

However, there is an exception for emergency scheduling. The Attorney General may place a substance into Schedule I temporarily (for up to 2 years, with a possible 1-year extension) to avoid an imminent hazard to public safety without having to consult HHS/FDA first.