About this test
Federal Requirements is Domain 2 of the PTCE, and its weight grew in the 2026 content outline: from 12.5% to 18.75% of the exam. That makes pharmacy law one of the smartest places to invest study time this year: many candidates still prepare from outdated guides that under-weight it.
This quiz covers exactly what the outline lists: federal rules for storage, handling and disposal of hazardous substances; controlled-substance prescriptions, refills, and transfers; DEA schedules; ordering, labeling, take-back and destruction requirements; restricted drug programs like REMS and pseudoephedrine limits; FDA recall classes; and Drug Supply Chain Security Act (DSCSA) serialization and tracing.
Remember: the PTCE tests federal law only. Where your state is stricter, the real-world answer may differ, but on the exam, answer by federal rules.
New to the material? Work through our 2026 PTCB study guide first, then reinforce it with the PTCB Federal Requirements domain guide and DEA controlled substance schedules.
What's in the question bank
| Topic | Questions in bank |
|---|---|
| Csa Dispensing | 7 |
| Dea Schedules | 5 |
| Dea Forms | 5 |
| Hipaa | 4 |
| Prescription Requirements | 3 |
| Fda Recalls | 3 |
| Rems | 3 |
| Cmea | 3 |
Sample questions with answers
These 8 questions come straight from the 35-question bank the timed test above draws from. Work each one before you open the answer: recalling it cold is what moves it into long-term memory.
1. Two pharmacies that do not share an electronic database want to transfer a Schedule IV prescription with remaining refills. How many times does federal law allow the original prescription information to be transferred for refill purposes?
- A.Unlimited times, as long as refills remain
- B.One time only
- C.Twice, if the prescriber approves each transfer
- D.Transfers of controlled substance prescriptions are prohibited
Show answer and explanation
Correct answer: B. One time only
Under 21 CFR 1306.25, the transfer of original prescription information for a Schedule III, IV, or V controlled substance for refill dispensing is permitted on a one-time basis only. The transfer must also be communicated directly between two licensed pharmacists.
2. Two pharmacies in the same chain electronically share a real-time, online database. How does this affect transfers of Schedule III-V prescription refill information between them under federal law?
- A.Transfers remain limited to one time only
- B.Transfers are prohibited between commonly owned pharmacies
- C.Each transfer requires a new hard-copy prescription
- D.They may transfer the prescription up to the maximum refills permitted by law and the prescriber's authorization
Show answer and explanation
Correct answer: D. They may transfer the prescription up to the maximum refills permitted by law and the prescriber's authorization
21 CFR 1306.25(a) creates an exception to the one-time transfer limit: pharmacies electronically sharing a real-time, online database may transfer a Schedule III-V prescription up to the maximum number of refills permitted by law and the prescriber's authorization. All documentation requirements for transfers still apply.
3. A pharmacist can supply only 40 of the 90 oxycodone tablets written on a valid Schedule II prescription because of a stock shortage. Under federal law, within what period must the remaining tablets be dispensed?
- A.Within 72 hours of the first partial filling
- B.Within 7 days of the first partial filling
- C.Within 30 days of the first partial filling
- D.Within 6 months of the issue date
Show answer and explanation
Correct answer: A. Within 72 hours of the first partial filling
When a pharmacist is unable to supply the full quantity of a Schedule II prescription, 21 CFR 1306.13(a) allows a partial fill with the remainder dispensed within 72 hours of the first partial filling. If the balance cannot be supplied within 72 hours, the pharmacist must notify the prescriber, and no further quantity may be dispensed without a new prescription.
4. When a patient voluntarily requests a partial fill of a Schedule II prescription (and state law does not prohibit it), federal law requires any remaining portions to be filled no later than what deadline?
- A.72 hours after the first partial fill
- B.6 months after the date the prescription was written
- C.30 days after the date the prescription was written
- D.14 days after the first partial fill
Show answer and explanation
Correct answer: C. 30 days after the date the prescription was written
Under 21 CFR 1306.13(b), a Schedule II prescription may be partially filled at the request of the patient or prescriber if state law permits, and remaining portions must be filled no later than 30 days after the date the prescription was written. The total quantity dispensed across all partial fills may not exceed the total quantity prescribed, and for emergency oral prescriptions the limit is 72 hours instead.
5. A hospice pharmacy receives a Schedule II morphine prescription dated June 1 for a patient with a documented terminal illness, and the pharmacist annotates it 'terminally ill.' Under federal law, this prescription may be partially filled in individual dosage units for how long?
- A.Up to 6 months from the issue date
- B.Up to 60 days from the issue date, unless the medication is discontinued sooner
- C.Up to 30 days from the issue date with no exceptions
- D.Up to 72 hours from the first partial fill
Show answer and explanation
Correct answer: B. Up to 60 days from the issue date, unless the medication is discontinued sooner
Under 21 CFR 1306.13(c), Schedule II prescriptions for patients in a long-term care facility or with a medical diagnosis documenting a terminal illness may be filled in partial quantities, and the prescription is valid for up to 60 days from the issue date unless terminated earlier by discontinuance of the medication. The pharmacist must record 'terminally ill' or 'LTCF patient' on the prescription, and each partial fill must be documented.
6. A pharmacy needs to order hydromorphone tablets from its wholesaler. Which DEA form (or its electronic equivalent) must be used for this order?
- A.DEA Form 224
- B.DEA Form 222
- C.DEA Form 106
- D.DEA Form 41
Show answer and explanation
Correct answer: B. DEA Form 222
Under 21 CFR 1305.03, a DEA Form 222 or its electronic CSOS equivalent is required for each distribution of a Schedule I or II controlled substance, which includes a pharmacy ordering hydromorphone from a distributor. Schedule III-V substances may be ordered with ordinary invoices instead.
7. Which DEA form does a new retail pharmacy submit to register to dispense controlled substances, and how often must that registration be renewed?
- A.DEA Form 224, renewed every 3 years
- B.DEA Form 222, renewed every 2 years
- C.DEA Form 363, renewed every year
- D.DEA Form 225, renewed every 3 years
Show answer and explanation
Correct answer: A. DEA Form 224, renewed every 3 years
Under 21 CFR 1301.13(e), a retail pharmacy registers to dispense Schedule II-V controlled substances using DEA Form 224, and the registration period is 3 years. Renewal is completed with DEA Form 224a; Form 225 is for manufacturers and distributors and Form 363 is for narcotic treatment programs.
8. A pharmacy technician opening the store discovers a break-in overnight, and a significant quantity of oxycodone is missing. What does federal law require the pharmacy to do?
- A.File DEA Form 41 within 30 days and notify the state board
- B.Notify DEA only if the loss exceeds 100 dosage units
- C.Complete DEA Form 222 to document the missing stock
- D.Notify the local DEA Field Division Office in writing within one business day and file DEA Form 106 within 45 days of discovery
Show answer and explanation
Correct answer: D. Notify the local DEA Field Division Office in writing within one business day and file DEA Form 106 within 45 days of discovery
Under 21 CFR 1301.76(b), a registrant must notify the DEA Field Division Office in writing within one business day of discovering a theft or significant loss of controlled substances, and must then file a complete and accurate DEA Form 106 through DEA's secure network application within 45 days of discovery. Form 41 documents destruction, not theft.
Ready for the full timed run? Scroll back up and start the Federal Requirements Quiz, or browse every free PTCB quiz by exam domain.
Key concepts to know
DEA schedules cold
Schedule I: no accepted medical use (heroin, LSD). Schedule II: high abuse potential, no refills (oxycodone, Adderall). Schedules III-V step down in abuse potential; III-V prescriptions may be refilled up to 5 times within 6 months of issue.
Recall classes
Class I: reasonable probability of serious harm or death. Class II: temporary or reversible harm. Class III: unlikely to cause harm but violates regulations. Technicians must know which class demands the most urgent response.
REMS and restricted programs
Risk Evaluation and Mitigation Strategies apply to drugs like isotretinoin (iPLEDGE), clozapine, and thalidomide. Know what extra steps (enrollment, counseling, monitoring) a REMS drug can require before dispensing.
Federal Requirements Quiz: FAQ
How much pharmacy law is on the PTCE?
Federal Requirements is 18.75% of the exam under the 2026 outline: about 17 of 90 questions. This is an increase from 12.5% in the previous outline, so don't rely on older guides that call it the smallest domain.
Does the PTCE test my state's pharmacy laws?
No. The PTCE tests federal requirements only, because it's a national exam. State rules are handled by your State Board of Pharmacy, not the PTCE.
Official sources checked
This quiz's content and explanations are built from and cross-checked against primary sources. Verify current exam facts directly with PTCB.