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6.1 Controlled Substance Schedules (CI through CV) & Classification Criteria
NABP MPJE Multistate Pharmacy Jurisprudence Examination Exam
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1 Chapter 1: Pharmacist Licensure & Reciprocity
1.1 Initial Licensure Requirements & Examinations 1.2 License Renewal, Continuing Education (CE) & Status 1.3 Reciprocity, License Transfer & Multistate Licensure 1.4 Disciplinary Actions, Board Hearings, Sanctions & Reinstatement
2 Chapter 2: Pharmacy Personnel Roles & Supervision Ratios
2.1 Pharmacy Interns: Scope of Practice, Supervision & Preceptor Rules 2.2 Pharmacy Technicians: Registration, Certification & Permitted Duties 2.3 Technician-to-Pharmacist Ratios & Delegated Tasks 2.4 Non-Pharmacist Personnel & Automated Dispensing Technology Roles
3 Chapter 3: Prescriptive Authority & Practitioner Categories
3.1 Physicians, Dentists, Veterinarians & Podiatrists: Prescribing Scope 3.2 Mid-Level Practitioners: APNs, PAs, Optometrists & Independent Authority 3.3 Out-of-State, Foreign & Deceased Practitioner Prescriptions 3.4 Self-Prescribing & Prescribing for Family Members
4 Chapter 4: Patient Counseling & Drug Utilization Review (OBRA '90)
4.1 OBRA '90 Mandates & Prospective Drug Utilization Review (DUR) 4.2 Patient Counseling Requirements, Offer-to-Counsel & Documentation 4.3 Patient Profile Requirements & Retrospective DUR
5 Chapter 5: Advanced Pharmacist Practice & Collaborative Agreements
5.1 Collaborative Practice Agreements (CPAs) & Protocol-Based Care 5.2 Pharmacist Immunization Authority & Vaccine Administration Protocols 5.3 Medication Therapy Management (MTM) & Point-of-Care Testing (POCT) 5.4 Hormonal Contraceptive, Naloxone & Post-Exposure Prophylaxis (PEP/PrEP) Prescribing
6 Chapter 6: Federal Controlled Substances Act (CSA) & Scheduling
6.1 Controlled Substance Schedules (CI through CV) & Classification Criteria 6.2 DEA Registration: Types, Forms (224, 225, 363) & Renewal Cycles 6.3 Scheduled Listed Chemical Products (SLCPs) & Combat Methamphetamine Epidemic Act (CMEA)
7 Chapter 7: Controlled Substance Prescriptions & Legitimate Purpose
7.1 Corresponding Responsibility & Red Flags for Improper Prescribing 7.2 Required Components of Controlled Substance Prescriptions 7.3 Electronic Prescriptions for Controlled Substances (EPCS) & Security Requirements 7.4 Emergency Schedule II Prescriptions & Partial Filling Rules (CARA Act)
8 Chapter 8: Controlled Substance Ordering, Inventory & Recordkeeping
8.1 Ordering Schedule II Substances: CSOS & DEA Form 222 Execution 8.2 Controlled Substance Inventory Requirements (Initial, Biennial, Count Exactness) 8.3 Theft, Significant Loss (DEA Form 106) & Disposal/Destruction (DEA Form 41) 8.4 Prescription Transfers & Prescription Drug Monitoring Programs (PDMPs)
9 Chapter 9: Federal Pure Food, Drug & Cosmetic Act (FD&C Act) & Drug Safety
9.1 Adulteration vs. Misbranding: Statutory Definitions & Legal Violations 9.2 Prescription Labeling Requirements, Expiration Dates & Side Effect Statements 9.3 Poison Prevention Packaging Act (PPPA) & Child-Resistant Container Exemptions 9.4 Drug Recalls (Class I, II, III) & Market Withdrawals 9.5 Drug Product Selection, Generic Substitution & DAW Codes 9.6 Returning & Reusing Dispensed Drugs: Restocking, Redispensing & Repository Programs
10 Chapter 10: Drug Supply Chain Security Act (DSCSA) & Commercial Distribution
10.1 DSCSA Track-and-Trace Requirements: Transaction Information & Statements 10.2 Suspect & Illegitimate Product Verification, Quarantine & Notification 10.3 Prescription Drug Marketing Act (PDMA): Samples, Reimportation & Wholesale Distribution
11 Chapter 11: Compounding Standards: USP <795>, <797> & <800>
11.1 Section 503A vs. 503B Compounding Facilities (DQSA Architecture) 11.2 Non-Sterile Compounding (USP <795>) & Beyond-Use Dating (BUD) 11.3 Sterile Compounding (USP <797>): Air Quality, Cleanrooms & BUD 11.4 Hazardous Drug Handling (USP <800>): Engineering Controls & Personal Protective Equipment
12 Chapter 12: Pharmacy Operational Security, Records & Telepharmacy
12.1 Physical Pharmacy Security, Alarm Systems & Keyholder Rules 12.2 Mandatory Pharmacy Records Retention & Audit Inspection Readiness 12.3 Central Fill, Automated Dispensing Systems (ADS) & Telepharmacy Operations 12.4 HIPAA Privacy Rule, Patient Records & Breach Notification Protocols
6.1 Controlled Substance Schedules (CI through CV) & Classification Criteria
Key Takeaways Explain This Topic AI
Federal CSA scheduling under 21 U.S.C. § 812 categorizes controlled substances into Schedules I through V based on abuse potential, accepted medical use, and dependency liability.
Schedule I drugs (e.g., heroin, LSD, mescaline, MDMA) have high abuse potential, no currently accepted medical use in the U.S., and lack accepted safety under medical supervision.
Schedule II drugs include potent opioids (morphine, oxycodone, fentanyl, hydromorphone, hydrocodone combination products since 2014), stimulants (amphetamine, methylphenidate), and short-acting barbiturates (pentobarbital, secobarbital).
Schedule III narcotic limits stipulate that codeine combination products must contain no more than 1.8 grams of codeine per 100 mL or 90 mg per dosage unit, combined with an equal or greater quantity of an isoquinoline alkaloid or active non-narcotic ingredient.
Schedule V controlled substances include cough preparations containing not more than 200 mg of codeine per 100 mL or 100 grams (e.g., Robitussin AC) and anticonvulsants like pregabalin (Lyrica) and lacosamide (Vimpat).
Last updated: November 2026
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 .
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.
Statutory Classification Criteria (21 U.S.C. § 812)
The federal statute mandates five distinct operational schedules based on strict statutory findings:
- Schedule Abuse Potential Accepted Medical Use in U.S. Physical & Psychological Dependence Liability
- Schedule I (CI) High None Lack of accepted safety under medical supervision
- Schedule II (CII) High Yes (with severe restrictions) Severe physical and/or severe psychological dependence
- Schedule III (CIII) Less than CI or CII Yes Moderate or low physical dependence; high psychological dependence
- Schedule IV (CIV) Low relative to CIII Yes Limited physical or psychological dependence relative to CIII
- Schedule V (CV) Low relative to CIV Yes Limited physical or psychological dependence relative to CIV
- Schedule I Controlled Substances (CI / C-I)
- Statutory Criteria
High potential for abuse.
No currently accepted medical use in treatment in the United States.
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 (federally, marijuana in an FDA-approved drug product and marijuana subject to a state medical marijuana license have been Schedule III since April 28, 2026 (91 FR 22714); all other marijuana, including state adult-use cannabis, remains Schedule I), Tetrahydrocannabinols (synthetic THC not otherwise exempted or scheduled elsewhere).
Depressants & Synthetics: Methaqualone, Gamma-hydroxybutyric acid (GHB - illicit non-FDA formulations).
- Schedule II Controlled Substances (CII / C-II)
- Statutory Criteria
High potential for abuse.
Currently accepted medical use in treatment in the United States or accepted medical use with severe restrictions.
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
Pharmacologic Category Drug Examples
Narcotic Opioids (Single Entity & Combo) Morphine, Codeine (single-entity), Hydrocodone (single-entity & combinations like Vicodin, Norco), Oxycodone (OxyContin, Percocet, Roxicodone), Fentanyl (Sublimaze, Duragesic), Hydromorphone (Dilaudid), Methadone (Dolophine), Meperidine (Demerol), Tapentadol (Nucynta), Oxymorphone (Opana), Opium tincture.
Central Nervous System Stimulants Amphetamine salts (Adderall), Dextroamphetamine (Dexedrine), Methylphenidate (Ritalin, Concerta), Lisdexamfetamine (Vyvanse), Methamphetamine (Desoxyn), Cocaine (topical local anesthetic in nasal procedures).
Barbiturates & Short-Acting Depressants Amobarbital (single-entity oral/injectable), Secobarbital (Seconal single-entity), Pentobarbital (Nembutal single-entity), Phencyclidine (PCP).
- Schedule III Controlled Substances (CIII / C-III)
- Statutory Criteria
Potential for abuse less than substances in Schedules I and II.
Currently accepted medical use in treatment in the United States.
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 :
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]).
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.
Ethylmorphine Combinations: Not more than 300 mg of ethylmorphine per 100 mL , or not more than 15 mg per dosage unit .
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.
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.
- Schedule IV Controlled Substances (CIV / C-IV)
- Statutory Criteria
Low potential for abuse relative to substances in Schedule III.
Currently accepted medical use in treatment in the United States.
Abuse may lead to limited physical dependence or psychological dependence relative to Schedule III.
Representative Examples
Category Drug Examples
Benzodiazepines Alprazolam (Xanax), Diazepam (Valium), Lorazepam (Ativan), Clonazepam (Klonopin), Temazepam (Restoril), Midazolam (Versed), Triazolam (Halcion), Chlordiazepoxide (Librium), Clobazam (Onfi), Oxazepam.
Non-Benzodiazepine Sedatives ("Z-Drugs") Zolpidem (Ambien), Zaleplon (Sonata), Eszopiclone (Lunesta).
Skeletal Muscle Relaxants & Analgesics Carisoprodol (Soma - rescheduled nationally to CIV in Jan 2012), Tramadol (Ultram - rescheduled nationally to CIV in Aug 2014).
Anorexiants & Stimulant-Like Agents Phentermine (Adipex-P), Diethylpropion, Lorcaserin, Modafinil (Provigil), Armodafinil (Nuvigil).
Long-Acting Barbiturates & Hypnotics Phenobarbital, Chloral hydrate, Fospropofol, Suvorexant (Belsomra).
- Schedule V Controlled Substances (CV / C-V)
- Statutory Criteria
Low potential for abuse relative to substances in Schedule IV.
Currently accepted medical use in treatment in the United States.
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:
Dispensed only by a licensed pharmacist (though non-pharmacist personnel may complete cash transaction).
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).
Purchaser is at least 18 years of age and presents suitable government photo identification.
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.