Federal law & regulations quiz
Updated
Federal Requirements is 18.75% of the 2026 PTCE — about 15 of the 80 scored questions. Every rationale teaches the act it tests — miss a question, learn the law.
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Which DEA form does a NEW retail pharmacy submit to register to handle controlled substances?
The law tables worth memorizing
The cheat tables behind the questions — open what you missed, then drill again.
DEA schedules I–V
| Schedule | Definition | Examples |
|---|---|---|
| C-I | No accepted medical use in the US; highest abuse potential — not dispensed by pharmacies | heroin, LSD, marijuana (federal) |
| C-II | Accepted medical use, high abuse potential; no refills, written/electronic Rx rules | oxycodone, hydrocodone, fentanyl, morphine, amphetamine salts |
| C-III | Moderate physical / high psychological dependence risk; ≤5 refills in 6 months | buprenorphine, ketamine, acetaminophen with codeine, anabolic steroids |
| C-IV | Lower abuse potential than III; ≤5 refills in 6 months | alprazolam, lorazepam, zolpidem, tramadol, carisoprodol |
| C-V | Lowest abuse potential of the scheduled drugs; some sold with restrictions | pregabalin, diphenoxylate/atropine, some codeine cough preparations |
Source: 21 CFR 1308 (schedules) · verified 2026-08-03
DEA forms — 222 · 224 · 41 · 106
| Form | Purpose | Exam angle |
|---|---|---|
| DEA Form 222 | Ordering Schedule I–II substances (paper or CSOS electronic equivalent) | 222 = C-II ordering; C-III–V need only an invoice |
| DEA Form 224 | Pharmacy application to register with DEA to dispense controlled substances | 224 = the pharmacy's registration itself |
| DEA Form 41 | Recording destruction of controlled substances | 41 = destruction record (reverse distributors, 21 CFR 1317) |
| DEA Form 106 | Reporting theft or significant loss of controlled substances | 106 = theft/loss, filed after notifying the DEA within one business day |
Source: 21 CFR 1305 (Form 222/CSOS) · verified 2026-08-03
Key legislation by year
| Year | Act | What it did | Exam angle |
|---|---|---|---|
| 1906 | Pure Food and Drug Act | Prohibited interstate commerce in adulterated or misbranded food and drugs | Adulteration vs misbranding starts here |
| 1938 | Food, Drug, and Cosmetic Act | Required drugs to be proven SAFE before marketing; created the modern FDA framework | Safety first — efficacy came later (1962) |
| 1951 | Durham-Humphrey Amendment | Defined prescription (legend) vs over-the-counter drugs; restricted Rx drugs to prescriber orders | "Rx only" legend; verbal Rx + refills recognized |
| 1962 | Kefauver-Harris Amendments | Required proof of EFFECTIVENESS before marketing (post-thalidomide) | Efficacy + safety; retroactive drug review |
| 1970 | Controlled Substances Act | Categorized drugs into schedules by abuse potential vs therapeutic value | The five schedules; DEA enforcement |
| 1970 | Poison Prevention Packaging Act | Required child-resistant packaging for most oral prescription drugs | Know the common exemptions (e.g., nitroglycerin) and waiver rules |
| 1988 | Prescription Drug Marketing Act | Banned diversion, sample sale/trade, and required state wholesaler licensing | Samples can never be sold |
| 1990 | OBRA-90 | Required DUR programs and an OFFER to counsel Medicaid patients (states extended it broadly) | The counseling offer — techs relay, pharmacists counsel |
| 1996 | HIPAA | Protected identifiable health information (PHI) privacy and security | Minimum necessary; PHI disposal |
| 2005 | Combat Methamphetamine Epidemic Act | Put daily/30-day limits, logbooks, and behind-the-counter rules on pseudoephedrine sales | 3.6 g/day · 9 g/30 days · logbook 2 years |
| 2013 | DSCSA (Drug Quality and Security Act, Title II) | Built the electronic, interoperable package-level track-and-trace system | NEW on the 2026 outline: product identifiers, transaction data, quarantine of suspect product |
Source: FDA — Milestones in US food and drug law · verified 2026-08-03
Common questions
What laws do I need to know for the PTCB exam?
More than twenty acts and amendments are examinable, but a core set carries most questions: the 1938 FDCA, Durham-Humphrey, Kefauver-Harris, the Controlled Substances Act, PPPA, OBRA-90, HIPAA, the Combat Meth Act, and — new on the 2026 outline — DSCSA track-and-trace. The table below maps each to its exam angle.
How many Federal Requirements questions are on the PTCE?
Federal Requirements is 18.75% of the exam — about 15 of the 80scored questions. It’s the smallest domain, but its questions are the most black-and-white: a memorized schedule or form number is a guaranteed point.
What are the DEA controlled-substance schedules?
Five schedules ranked by abuse potential against medical use: Schedule I has no accepted US medical use, Schedule II is high-potential with the strictest prescription rules (no refills), and Schedules III–V step down in risk, allowing up to five refills within six months. The cheat table below lists definitions and example drugs.
Is HIPAA on the PTCB exam?
Yes — HIPAA appears inside Federal Requirements as protected health information (PHI) handling: what counts as PHI, the minimum-necessary rule, and proper disposal of labeled materials. You won’t be asked to cite the statute, only to apply it to pharmacy scenarios like trash handling and pickup verification.
What's the difference between DEA Forms 222, 224, and 106?
Form 224 registers the pharmacy to dispense controlled substances; Form 222 orders Schedule I–II drugs (CSOS is its electronic equivalent); Form 106 reports theft or significant loss; and Form 41 records destruction. The mnemonic: 224 = permission, 222 = purchase, 106 = missing, 41 = destroyed.