7.1 CSA Schedules and Definitions
Key Takeaways
- The federal Controlled Substances Act (21 U.S.C. § 812; 21 CFR Part 1308) places drugs in Schedules I–V by accepted medical use, abuse potential, and dependence risk. Schedule I has no currently accepted medical use; Schedules II–V may be prescribed.
- High-yield Schedule II examples include oxycodone, hydrocodone combination products, methylphenidate, fentanyl, and cocaine. Hydrocodone combinations have been Schedule II since 2014 — they are not Schedule III.
- Tylenol #3 (codeine/acetaminophen) and many testosterone products are Schedule III. Alprazolam, zolpidem, and tramadol are Schedule IV. Codeine cough syrups at CV concentrations and pregabalin are Schedule V.
- Connecticut may designate additional substances under CGS § 21a-243. Gabapentin is reported to CPMRS (effective January 1, 2021) but DCP has stated it is not a controlled substance and is not subject to mandatory PDMP look-up.
- 21 CFR 1306.04(a) puts corresponding responsibility on the pharmacist who fills a controlled-substance prescription. The full test of that duty is Chapter 12; this chapter only flags that a correct schedule does not make an illegitimate order valid.
Why the CSA still decides a Connecticut fill
Quick Answer: The Controlled Substances Act (CSA) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970; 21 U.S.C. §§ 801–971) and 21 CFR Parts 1300–1308 classify drugs into Schedules I–V. Schedule I has no currently accepted medical use in the United States. Schedule II has accepted use and high abuse potential (oxycodone, hydrocodone combinations, methylphenidate, fentanyl, cocaine). III–V step down. Connecticut may add substances (CGS § 21a-243). Gabapentin is uploaded to CPMRS but is not scheduled. A correct schedule still does not save an illegitimate prescription — corresponding responsibility (21 CFR 1306.04(a)) is Chapter 12.
NABP Areas 2.1.4, 4.1, and 4.2.5 assume you can name the schedule before you name the Connecticut overlay. A New Haven pharmacist who treats hydrocodone/acetaminophen as “the old Schedule III combo,” who files gabapentin as a Schedule V, or who thinks cocaine has no medical use will miss items that the Competency Statements still score. Federal scheduling is the floor. When Connecticut is stricter, the more-restrictive rule wins — the same heuristic Chapter 2 already drilled.
This section is definitions and placement. Ordering, Form 222, prescription mechanics, inventories, and theft reports come in 7.2–7.4. Electronic prescribing, who may prescribe in Connecticut, opioid day-supply caps, CPMRS query mechanics, and the full corresponding-responsibility analysis are later chapters. Do not dump those rules here.
How the five schedules are built
21 U.S.C. § 812 and 21 CFR Part 1308 use three questions: Is there a currently accepted medical use in treatment in the United States? What is the potential for abuse? What is the dependence risk if abused? DEA — not DCP and not the Commission of Pharmacy — places a substance in a federal schedule or moves it. States may parallel or add; they may not unschedule a federal controlled substance for a pharmacy that still holds a DEA registration.
Memorize the verbs with the Roman numeral:
- Schedule I — high potential for abuse; no currently accepted medical use; lack of accepted safety for use under medical supervision. No prescriptions. Classic names: heroin, LSD, MDMA (ecstasy), peyote, and marijuana (still Schedule I federally, whatever Connecticut’s adult-use or medical-cannabis statutes do on a separate track). Do not write a “medical marijuana prescription” on a DEA 222 or treat a cannabis product as a CII opioid analog on this exam.
- Schedule II — high potential for abuse; currently accepted medical use (with severe restrictions for some); abuse may lead to severe psychological or physical dependence. These are everyday Connecticut fast-movers: oxycodone (OxyContin, Percocet), hydrocodone combination products (Norco, Vicodin — rescheduled to CII in 2014), methylphenidate (Ritalin, Concerta), fentanyl, morphine, hydromorphone, methadone, amphetamine (Adderall), and cocaine (still CII because it has accepted medical use as a topical anesthetic). Cocaine is the classic trap for candidates who think “street drug = Schedule I.”
- Schedule III — potential for abuse less than I or II; accepted medical use; moderate or low physical dependence or high psychological dependence. High-yield bottles: acetaminophen with codeine 30 mg (Tylenol #3), ketamine, buprenorphine products, and anabolic steroids / some testosterone esters. Codeine combination products sit in III or V depending on concentration — a 30 mg codeine tablet with APAP is III; a low-concentration cough syrup can be V.
- Schedule IV — lower abuse potential than III; accepted use; limited dependence. Bench drugs: alprazolam (Xanax), zolpidem (Ambien), tramadol, diazepam, clonazepam, lorazepam, phentermine.
- Schedule V — lower than IV; accepted use; limited dependence. Bench drugs: codeine cough syrups at CV concentrations (for example guaifenesin with codeine not exceeding 200 mg of codeine per 100 mL), pregabalin (Lyrica), diphenoxylate/atropine (Lomotil) at the listed CV strength, lacosamide.
Federal placement at a Connecticut counter
| Schedule | CSA core (21 U.S.C. § 812) | High-yield examples | Prescription snapshot (detail in 7.3) |
|---|---|---|---|
| I | High abuse; no currently accepted medical use; lack of accepted safety | Heroin, LSD, MDMA, peyote; marijuana remains CI federally | No prescriptions |
| II | High abuse; accepted use (sometimes with severe restrictions); severe dependence | Oxycodone; hydrocodone combinations; methylphenidate; fentanyl; cocaine; morphine; methadone; amphetamine | Written or EPCS; emergency oral exception; no refills |
| III | Abuse less than I/II; accepted use; moderate/low physical or high psychological dependence | Tylenol #3; ketamine; many testosterone / anabolic steroid products; buprenorphine | Written, oral, fax, or electronic; federal 5 refills / 6 months |
| IV | Lower abuse than III; limited dependence | Alprazolam; zolpidem; tramadol; diazepam; clonazepam | Same federal 5 / 6 rule as III |
| V | Lower than IV; limited dependence | Codeine cough syrups at CV concentrations; pregabalin; Lomotil at CV strength | Federally as authorized; Connecticut statute versus DCP FAQ is section 7.3 |
Three placement errors that cost items:
- Treating hydrocodone/acetaminophen as Schedule III because “it used to be.” DEA moved hydrocodone combination products to Schedule II effective October 6, 2014. In 2026 they order like oxycodone: Form 222 or CSOS, no refills.
- Treating tramadol as unscheduled or as CII. Tramadol is Schedule IV.
- Treating cocaine as Schedule I. Cocaine is Schedule II because it has accepted medical use.
Codeine is concentration-dependent. Pure codeine is CII. A Tylenol #3 tablet is CIII. A qualifying codeine cough syrup is CV. Do not assign every “codeine” bottle to the same schedule.
Connecticut may add substances — and gabapentin is the distinction the exam loves
CGS § 21a-243 authorizes Connecticut to designate controlled substances by regulation. A drug can therefore be state-controlled even when DEA has not scheduled it, or it can sit in a higher Connecticut schedule than the federal schedule. When that happens, the stricter rule controls the Connecticut pharmacy. Do not assume the federal orange-book schedule is the last word for a DCP inspection.
Gabapentin is the current trap, and it is not a scheduling decision. Effective January 1, 2021, DCP required pharmacies to upload gabapentin (and naloxone) dispensations into the Connecticut Prescription Monitoring and Reporting System (CPMRS). Authority for adding products to the PDMP is CGS § 21a-254(j)(2) — the Commissioner may identify other products or substances to include. DCP’s published notice is explicit: the addition does not change gabapentin to a controlled substance, gabapentin is not a scheduled medication, and mandatory CPMRS look-up prior to prescribing does not apply to it. Pharmacists still report the fill. Pharmacists do not treat the bottle as CII–V for DEA 222, for federal refill caps, for perpetual CII inventory, or for CS prescription-form rules.
Naloxone reporting is even narrower: DCP collects it for aggregate policy use and masks naloxone from ordinary CPMRS user reports. Neither gabapentin nor naloxone became a schedule by being uploaded.
Full CPMRS query timing (72-hour supply, 90-day CII–IV, annual CV) is Chapter 14. Here, only the distinction matters: reported ≠ scheduled.
Corresponding responsibility — teaser only
21 CFR 1306.04(a) states that a controlled-substance prescription is effective only if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The prescriber is responsible, but a corresponding responsibility rests with the pharmacist who fills it. Knowingly filling a purported prescription that is not a valid order is a CSA violation for the pharmacist as well as the prescriber.
That sentence is the entire teaser. How you document red flags, when you refuse, how DUR intersects, and Connecticut’s conditions that prohibit dispensing are Chapter 12. Do not turn this chapter into a corresponding-responsibility essay. Do remember that correct scheduling never rehabilitates an illegitimate order. A perfectly coded oxycodone CII written for a cash-pay stranger with no diagnosis and three out-of-area pharmacies in a week is still the pharmacist’s problem.
Scenario: two bottles, two wrong labels
A Waterbury intern sticks a Schedule III sticker on a manufacturer bottle of hydrocodone/acetaminophen 10/325 because “combos are III,” and files gabapentin 300 mg in the CII perpetual log “because we report it to CPMRS.” Both labels are wrong. Hydrocodone combinations are Schedule II — they belong on a 222/CSOS order, in the CII file, and in Connecticut’s perpetual CII inventory (Chapter 15). Gabapentin is unscheduled; CPMRS reporting does not create a DEA schedule, a 222 duty, or a CII count. The pharmacist who releases those bottles has a scheduling error and a corresponding-responsibility problem if the hydrocodone prescription itself is not a legitimate medical order.
CT may be stricter; more-restrictive wins.
Official anchors
- 21 U.S.C. § 812 — federal schedules.
- 21 CFR Part 1308 — listing and placement.
- DEA Diversion Control schedules — current alphabetical list (orange book of controlled substances).
- DCP gabapentin/naloxone CPMRS notice — reported, not scheduled.
- CGS Chapter 420b — §§ 21a-243, 21a-249, 21a-254.
DCP requires Connecticut pharmacies to upload gabapentin dispensations into CPMRS. Which statement correctly describes gabapentin’s legal status for a community pharmacy?
Which grouping is correctly scheduled under the federal CSA as applied in a Connecticut pharmacy?
A Hartford pharmacist fills a technically complete oxycodone prescription that the pharmacist believes was not issued for a legitimate medical purpose. Which federal rule is the starting point, and where is the full analysis taught?