- Medications 35%
- Federal Requirements 18.75%
- Patient Safety and Quality Assurance 23.75%
- Order Entry and Processing 22.5%
Free · 2026 · 18.75% of the PTCE PTCB Federal Requirements practice questions
Federal Requirements is 18.75% of the PTCE. Answer 10 questions (6 on Federal Requirements) and see your score by domain, with every answer explained. Free, no sign-up.
A patient's zolpidem prescription was first filled at Pharmacy A, and its remaining refills were later transferred to Pharmacy B, an unrelated pharmacy. The two pharmacies do not share a real-time online database. The patient now asks Pharmacy C to transfer the remaining refills from Pharmacy B. What does federal law allow?
Tap an answer, or press A to D
DEA schedules and controlled-substance rules, hazardous waste, restricted drug programs (CMEA, REMS), FDA recalls and DSCSA.
What the PTCE tests in Federal Requirements
- Federal rules for storing, handling and disposing of non-hazardous, hazardous (e.g. P-listed) and pharmacological substances and waste
- Federal rules for controlled substance prescriptions (new, refill, transfer) and DEA schedules (calculation-based)
- Federal rules for receiving, storing, ordering, labeling, dispensing, returning, take-back, loss/theft and destruction of controlled substances
- Federal restricted drug programs and their processing rules, e.g. pseudoephedrine (CMEA) and REMS (calculation-based)
- FDA medication recall requirements
- FDA product serialization, tracing, handling and quarantine rules under the Drug Supply Chain Security Act (DSCSA)
High-yield federal requirements facts
- Emergency oral C-II: dispense only the amount needed for the emergency period. The prescriber must deliver a written or electronic follow-up within 7 days.
- A prescriber may issue multiple C-II prescriptions totaling up to a 90-day supply, each with a 'do not fill before' date.
- C-III/C-IV expiration math: the 6-month limit runs from the date written, and the limit is 5 refills or 6 months, whichever comes first. Example: written Mar 15, no fills after Sep 15.
- C-II partial-fill math: written Jun 1 and partially filled at the patient's request → the balance can be dispensed through Jul 1 (30 days). If the pharmacy was short instead, the balance is due within 72 h.
- DEA number check (example BR2413514): add digits 1+3+5 (2+1+5 = 8); add digits 2+4+6 (4+3+1 = 8) and double it (16); total 24. The last digit (4) must equal the 7th digit (4).
- DEA number letters: first letter = registrant type (A, B, F, G for practitioners; M for mid-level practitioners). Second letter = first letter of the prescriber's last name.
| Schedule | Meaning | Examples |
|---|---|---|
| C-I | No accepted US medical use | heroin, LSD, MDMA, psilocybin |
| C-II | High abuse potential, accepted medical use | oxycodone, hydrocodone products, morphine, fentanyl, methadone, hydromorphone, amphetamine salts, lisdexamfetamine, methylphenidate, cocaine |
| C-III | Moderate abuse potential | APAP/codeine, buprenorphine, ketamine, anabolic steroids, testosterone |
| C-IV | Lower abuse potential | benzodiazepines, zolpidem, eszopiclone, tramadol, carisoprodol, phenobarbital, phentermine |
| C-V | Lowest abuse potential | pregabalin, lacosamide, codeine cough syrups, diphenoxylate/atropine (Lomotil) |
The full PTCB High-Yield Cram Sheet comes with full prep.
Common federal requirements traps
- Form 222 is only for C-I and C-II; C-III to C-V are ordered by invoice.
- The 5-refill/6-month limit applies to C-III and C-IV, not C-V.
- Form 106 = loss/theft; Form 41 = destruction; Form 224 = registration.
- DEA records are kept 2 years; DSCSA records 6 years; the pseudoephedrine log 2 years.
- Outdated claims: Vicodin is C-III, Form 222 is triplicate, C-II cannot be partially filled at patient request, controlled prescriptions can never be transferred before the first fill.
- Pseudoephedrine limits are grams of base, not grams of salt.
- A technician may not destroy controlled substances without the required witness and Form 41.
- Class I is the most serious recall; numbering runs the opposite way from DEA schedules, where C-V is the least restricted.
Free PTCB federal requirements practice questions
Question 1
During a routine count, a technician finds that 100 tablets of hydrocodone/acetaminophen are missing. The pharmacist investigates and concludes the tablets were stolen. According to federal law, what must the pharmacy do?
- ARecord the shortage and report it to the DEA with the next biennial inventory
- BDocument the stolen tablets on DEA Form 41 and keep the form on file for 2 years
- CNotify the DEA field office within 7 days, then file DEA Form 106 within 30 days
- DNotify the DEA field office in writing within 1 business day, then file DEA Form 106 within 45 days
Show answer and explanation
Answer: D. DEA rules require written notice to the field division office within 1 business day of discovering a theft or significant loss, followed by a completed Form 106 within 45 days.
Why not A: A theft must be reported promptly after discovery, not held until the next biennial inventory.
Why not B: Form 41 records destruction of controlled substances; theft or significant loss is reported on Form 106.
Why not C: Seven days is the deadline for a prescriber's follow-up to an emergency oral C-II prescription, not for theft reporting, and the Form 106 deadline is 45 days.
Remember: For theft or significant loss, give the DEA written notice within 1 business day and file Form 106 within 45 days.
Question 2
A valid, hand-signed prescription for hydrocodone/acetaminophen 5/325 mg, #20, includes "Refills: 2." Which statement describes how federal law treats this prescription?
- AThe original quantity may be filled, but the refills are not valid because the drug is C-II
- BThe refills may be converted into partial fills dispensed within 30 days of the date written
- CThe refills may be dispensed if they are filled within 90 days of the date written
- DUp to 5 refills are allowed within 6 months, because hydrocodone combinations are C-III
Show answer and explanation
Answer: A. Hydrocodone combinations are C-II, and C-II prescriptions cannot be refilled. A new prescription is needed for more medication.
Why not B: A partial fill divides the original prescribed quantity. It cannot add the extra quantity a refill would supply.
Why not C: The 90-day figure refers to multiple C-II prescriptions with do-not-fill-before dates. It does not make refills valid.
Why not D: This is outdated information. Hydrocodone combination products moved to C-II in October 2014.
Remember: Hydrocodone combination products have been C-II since 2014, so they can never be refilled.
Question 3
A prescriber writes a prescription for lorazepam 1 mg, #30, on March 1, 2026, and marks "refills: 11." Under federal law, what may the pharmacy dispense on this prescription?
- AAll 11 refills, as long as they are filled within one year of March 1, 2026
- BNo refills, because a new prescription is needed for each fill
- CUp to 5 refills, as long as they are filled within one year of March 1, 2026
- DUp to 5 refills, with none dispensed more than 6 months after March 1, 2026
Show answer and explanation
Answer: D. Federal law limits C-III and C-IV prescriptions to 5 refills within 6 months of the date written, whichever limit is reached first.
Why not A: The one-year, prescriber-directed refill pattern describes many non-controlled prescriptions under state law. Lorazepam is C-IV and has a federal cap.
Why not B: The no-refill rule applies to Schedule II prescriptions, not to C-IV drugs such as lorazepam.
Why not C: The count is right but the time limit is wrong; C-III and C-IV refills expire 6 months after the date written.
Remember: C-III and C-IV prescriptions allow at most 5 refills within 6 months of the date written, whichever comes first.
Question 4
A pharmacy is registered with the DEA as an authorized collector and has a controlled substance collection receptacle. A patient hands a technician a bag of leftover oxycodone tablets and asks the pharmacy to dispose of them. What should the technician do?
- AAccept the tablets and send them to a reverse distributor using a DEA Form 222
- BAccept the tablets, count them, and document their destruction on DEA Form 41
- CDirect the patient to place the tablets into the collection receptacle personally
- DAccept the tablets, verify the lot and expiration, and return them to pharmacy stock
Show answer and explanation
Answer: C. In DEA collection, the patient (ultimate user) deposits the drugs, and pharmacy staff may not handle, count or sort them.
Why not A: Patient-owned drugs cannot be added to the pharmacy's inventory for reverse distribution. Form 222 transfers apply only to the registrant's own C-II stock.
Why not B: Staff may not take possession of or count patient-returned controlled substances. Form 41 applies to the registrant's own inventory, not to drugs deposited by patients.
Why not D: Federal law does not allow drugs returned by patients to be put back into inventory. Doing so would also risk dispensing compromised product.
Remember: Patients deposit their own unwanted controlled substances into a DEA collection receptacle, and pharmacy staff never handle or count them.
Question 5
A technician is labeling four prescriptions. Federal law requires the warning "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" on which one?
- APregabalin 75 mg capsules
- BLacosamide 100 mg tablets
- CGabapentin 300 mg capsules
- DLorazepam 1 mg tablets
Show answer and explanation
Answer: D. Lorazepam is Schedule IV, and federal rules require the transfer warning on dispensed C-II, C-III and C-IV prescriptions.
Why not A: Pregabalin is Schedule V. The federal transfer warning applies only to Schedules II through IV.
Why not B: Lacosamide is Schedule V. C-V products are not federally required to carry the transfer warning.
Why not C: Gabapentin is not federally controlled, although some states schedule it. The federal warning does not apply.
Remember: The federal 'Caution: Federal law prohibits the transfer' label is required for C-II through C-IV prescriptions but not for C-V.
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