Federal Requirements is 18.75% of the scored PTCE (the PTCB exam). Answer 10 exam style questions on pseudoephedrine limits and REMS programs and see exactly which concepts would cost you points on test day.
Start the 10 questions →Under the Combat Methamphetamine Epidemic Act, how long must a pharmacy keep each entry in its pseudoephedrine sales logbook?
These questions cover CMEA: logbook retention, CMEA: purchaser requirements, CMEA: storage, CMEA: covered ingredients and REMS: definition. Each one shows the correct answer and why every other option is wrong, so a miss tells you exactly what to review before the PTCE.
Prefer to read first? Every question from the practice set above, with the correct answer and why each wrong option is wrong.
Answer: D. The CMEA requires the seller to keep each logbook entry for at least 2 years after the date the entry is made.
Why not A: 6 months is the refill window for C-III to C-V prescriptions, not the logbook retention period.
Why not B: 30 days is the period used for the 9 g purchase limit, not for record keeping.
Why not C: 7 years is longer than the federal CMEA requirement of 2 years.
Exam tactic: CMEA logbook = keep 2 years.
Answer: B. The CMEA requires the purchaser to present a photo identification issued by a state or the federal government and to sign the logbook, which records the name, address, date and time, product and quantity.
Why not A: Pseudoephedrine is sold without a prescription under federal law. ID and a logbook entry are required.
Why not C: Federal law does not require counseling for pseudoephedrine sales.
Why not D: Proof of residence is not a federal requirement. A government-issued photo ID is.
Exam tactic: Pseudoephedrine sale: photo ID + logbook signature.
Answer: A. The CMEA requires these products to be kept behind the counter or, if on the sales floor, in a locked cabinet, so customers have no direct access without help from staff.
Why not B: Pseudoephedrine products are scheduled listed chemicals, not controlled substances. They do not go in the C-II safe.
Why not C: Open-shelf placement gives customers direct access, which the CMEA prohibits.
Why not D: Refrigeration has nothing to do with the CMEA. The rule is about access, not temperature.
Exam tactic: CMEA products: behind the counter or locked up.
Answer: B. The CMEA covers OTC products containing ephedrine, pseudoephedrine and phenylpropanolamine, because they can be used to make methamphetamine.
Why not A: Phenylephrine is an OTC decongestant that is not covered by the CMEA.
Why not C: Dextromethorphan is a cough suppressant that is not a CMEA chemical.
Why not D: Guaifenesin is an expectorant with no CMEA restrictions.
Exam tactic: CMEA = ephedrine, pseudoephedrine, phenylpropanolamine. Not phenylephrine.
Answer: B. A REMS is a drug safety program the FDA can require for certain medications with serious safety concerns, to help ensure the benefits outweigh the risks. It goes beyond standard labeling.
Why not A: Tracking controlled substance orders is done through DEA forms and reporting systems, not a REMS.
Why not C: A state database of dispensed controlled substances is a PDMP, not a REMS.
Why not D: Prior authorization is a payer process. A REMS is an FDA safety requirement.
Exam tactic: REMS = FDA safety program for risky drugs.
Answer: D. Isotretinoin is dispensed only by pharmacies certified in iPLEDGE. Before each fill, the pharmacy must obtain authorization through the iPLEDGE system confirming the patient and prescriber have met program requirements.
Why not A: Isotretinoin is not a controlled substance, so no Form 222 is involved.
Why not B: The CMEA logbook is for pseudoephedrine, not isotretinoin.
Why not C: Insurance approval does not replace the iPLEDGE authorization required by the REMS.
Exam tactic: Isotretinoin = iPLEDGE authorization before every fill.
Answer: A. When the FDA requires a Medication Guide, it must be provided to the patient each time the drug is dispensed in the outpatient setting, including refills, and whenever the patient asks for one.
Why not B: Medication Guides are required with refills too, not only the first fill.
Why not C: A request is one trigger, but the guide must also be given at every dispensing.
Why not D: Medication Guides are tied to FDA safety concerns, not to DEA schedules.
Exam tactic: Medication Guide = every fill, every refill.
Answer: D. The federal retail limit is 9 g of pseudoephedrine base per purchaser in a 30-day period. The customer has bought 3.6 g + 3.6 g = 7.2 g, so only 9 - 7.2 = 1.8 g more may be sold within that period.
Why not A: 3.6 g is the daily limit, but selling it would bring the 30-day total to 10.8 g, above the 9 g cap.
Why not B: 5.4 g exceeds both the daily limit of 3.6 g and the remaining 30-day allowance.
Why not C: The customer has bought 7.2 g, not 9 g, so 1.8 g is still allowed.
Exam tactic: CMEA: daily 3.6 g, 30-day 9 g. Subtract what was already bought from 9 g.
Answer: C. The CMEA requires non-liquid forms to be sold in blister packs with no more than 2 dosage units per blister, or in unit-dose packets or pouches when blister packs are not technically feasible.
Why not A: Bottle packaging with up to 100 tablets is not the CMEA standard for non-liquid forms.
Why not B: A sealed bag does not meet the federal blister-pack requirement.
Why not D: There is no 10-tablet carton rule. The rule is 2 dosage units per blister.
Exam tactic: CMEA tablets = blister packs, max 2 per blister.
Answer: C. iPLEDGE limits each isotretinoin dispensing to a maximum 30-day supply with no refills. A new authorization is needed for every fill.
Why not A: 90-day supplies and refills are not allowed for isotretinoin under iPLEDGE.
Why not B: 5 refills is the Schedule III to V rule. iPLEDGE allows no refills.
Why not D: There is no 7-day limit for isotretinoin, and refills are not allowed.
Exam tactic: iPLEDGE: max 30 days, zero refills.
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