6.1 Controlled Substance Schedules (CI through CV) & Classification Criteria

6.1 Controlled Substance Schedules (CI through CV) & Classification Criteria

MPJE Core Concept: The Controlled Substances Act (CSA) of 1970 establishes a statutory framework that categorizes controlled substances into five schedules (CI through CV) based on three legislative criteria: potential for abuse, currently accepted medical use in treatment in the United States, and abuse liability leading to physical or psychological dependence.

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Overview of the Controlled Substances Act (CSA)

Enacted as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, the Controlled Substances Act (CSA) created a closed, legally enforceable system of distribution for controlled substances. The overarching statutory purpose is to prevent drug diversion and illicit trafficking while guaranteeing an adequate, uninterrupted supply of controlled medications for legitimate scientific, medical, and therapeutic use.

Under federal law, authority to schedule, reschedule, or deschedule substances is granted to the U.S. Attorney General, who has formally delegated this administrative authority to the Administrator of the Drug Enforcement Administration (DEA). However, before initiating scheduling proceedings under 21 U.S.C. § 811, the DEA must request a scientific and medical evaluation from the Department of Health and Human Services (HHS), conducted via the Food and Drug Administration (FDA). The medical and scientific findings of HHS are binding on the DEA regarding medical evaluation and scientific necessity.

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Statutory Classification Criteria (21 U.S.C. § 812)

The federal statute mandates five distinct operational schedules based on strict statutory findings:

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Schedule I Controlled Substances (CI / C-I)

Statutory Criteria

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

Regulatory Impact

Schedule I substances cannot be prescribed, administered, or dispensed in routine clinical practice. Possession and use are strictly restricted to research entities registered specifically with the DEA under a Schedule I research protocol.

Representative Examples

• Opiates & Opioids: Heroin, Acetorphine, Dihydromorphine, Normorphine.
• Hallucinogens & Psychedelics: Lysergic acid diethylamide (LSD), Mescaline, Peyote, Psilocybin, Psilocyn, 3,4-Methylenedioxymethamphetamine (MDMA / Ecstasy).
• Cannabinoids: Marijuana / Cannabis (under federal CSA statutory law, pending formal administrative rescheduling actions), Tetrahydrocannabinols (synthetic THC not otherwise exempted or scheduled elsewhere).
• Depressants & Synthetics: Methaqualone, Gamma-hydroxybutyric acid (GHB - illicit non-FDA formulations).

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Schedule II Controlled Substances (CII / C-II)

Statutory Criteria

1. High potential for abuse.
2. Currently accepted medical use in treatment in the United States or accepted medical use with severe restrictions.
3. Abuse may lead to severe psychological or physical dependence.

Critical Scheduling Actions

In October 2014, the DEA published a landmark final rule rescheduling all hydrocodone combination products (HCPs)—such as Vicodin, Norco, and Lortab—from Schedule III to Schedule II nationwide due to high abuse rates and severe addiction liability.

Representative Examples

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Schedule III Controlled Substances (CIII / C-III)

Statutory Criteria

1. Potential for abuse less than substances in Schedules I and II.
2. Currently accepted medical use in treatment in the United States.
3. Abuse may lead to moderate or low physical dependence or high psychological dependence.

Precise Narcotic Concentration Thresholds (Crucial MPJE Rules)

Federal law specifies strict mathematical concentration cutoffs for narcotic combination preparations to qualify as Schedule III. If a preparation exceeds these limits, it automatically defaults to Schedule II:

1. Codeine Combinations: Not more than 1.8 grams of codeine per 100 mL, or not more than 90 mg per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium or with one or more active non-narcotic ingredients (e.g., Tylenol with Codeine #3 [30 mg codeine / 300 mg APAP], Tylenol #4 [60 mg codeine / 300 mg APAP]).
2. Dihydrocodeine Combinations: Not more than 1.8 grams of dihydrocodeine per 100 mL, or not more than 90 mg per dosage unit, with active non-narcotic ingredients.
3. Ethylmorphine Combinations: Not more than 300 mg of ethylmorphine per 100 mL, or not more than 15 mg per dosage unit.
4. Opium Combinations: Not more than 500 mg of opium per 100 mL or per 100 grams, or not more than 25 mg per dosage unit, with active non-narcotic ingredients.
5. Morphine Combinations: Not more than 50 mg of morphine per 100 mL or per 100 grams, with active non-narcotic ingredients.

Non-Narcotic Schedule III Examples

• Anabolic Steroids: Testosterone (AndroGel, Depo-Testosterone), Oxandrolone, Nandrolone, Stanozolol (under the Anabolic Steroid Control Act).
• Opioid Partial Agonists / Maintenance: Buprenorphine (Subutex, Suboxone - used in opioid use disorder treatment).
• Anesthetic & Sedative Agents: Ketamine (Ketalar), Dronabinol oral capsules in sesame oil (Marinol - note that Syndros oral solution is CII), Sodium oxybate (Xyrem - FDA-approved formulation of GHB with restricted REMS distribution).
• Barbiturate Combinations: Butalbital combined with aspirin (Fiorinal). Note: Butalbital combined with acetaminophen (Fioricet) is federally exempted from scheduling due to ratio rules, though several state MPJE jurisdictions schedule Fioricet as CIII.

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Schedule IV Controlled Substances (CIV / C-IV)

Statutory Criteria

1. Low potential for abuse relative to substances in Schedule III.
2. Currently accepted medical use in treatment in the United States.
3. Abuse may lead to limited physical dependence or psychological dependence relative to Schedule III.

Representative Examples

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Schedule V Controlled Substances (CV / C-V)

Statutory Criteria

1. Low potential for abuse relative to substances in Schedule IV.
2. Currently accepted medical use in treatment in the United States.
3. Abuse may lead to limited physical or psychological dependence relative to Schedule IV.

Federal Concentration Thresholds (Antitussives & Antidiarrheals)

Schedule V preparations contain limited quantities of certain narcotics combined with non-narcotic active ingredients:

• Codeine: Not more than 200 mg of codeine per 100 mL or per 100 grams (e.g., Robitussin AC, Cheratussin AC - 10 mg codeine / 100 mg guaifenesin per 5 mL).
• Dihydrocodeine: Not more than 100 mg per 100 mL or per 100 grams.
• Ethylmorphine: Not more than 100 mg per 100 mL or per 100 grams.
• Diphenoxylate with Atropine: Not more than 2.5 mg diphenoxylate and not less than 25 micrograms atropine sulfate per dosage unit (Lomotil).
• Opium: Not more than 100 mg per 100 mL or per 100 grams.

Anticonvulsants & Neuropathic Pain Agents

• Pregabalin (Lyrica), Lacosamide (Vimpat), Brivaracetam (Brivaact), Ezogabine.

Federal Non-Prescription OTC Dispensing Rules

Under federal regulations (21 CFR § 1306.26), certain Schedule V controlled substances that are not prescription drugs under the FD&C Act may be dispensed by a pharmacist without a prescription at retail, provided:

1. Dispensed only by a licensed pharmacist (though non-pharmacist personnel may complete cash transaction).
2. Maximum quantity dispensed to the same purchaser within a 48-hour period does not exceed 240 mL (8 oz) or 48 dosage units of an opium-containing product, or 120 mL (4 oz) or 24 dosage units of any other controlled substance (e.g., codeine cough syrup).
3. Purchaser is at least 18 years of age and presents suitable government photo identification.
4. Bound logbook is maintained containing purchaser's name, address, signature, name/quantity of drug, date, and pharmacist's initials (logbook retained for at least 2 years).

Note for MPJE Candidates: While federal law allows OTC Schedule V dispensing, the vast majority of U.S. states prohibit OTC sales of Schedule V codeine products and require a prescription.