MPJE Cheat Sheet 2026

The 30 highest-yield MPJE facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily purchase limit for pseudoephedrine products sold behind the counter? → 3.6 grams
2. Which drug requires enrollment in the iPLEDGE REMS program due to severe teratogenicity risks? → Isotretinoin
3. Under the FD&C Act, the 'substantial evidence' standard for drug approval requires: → One well-controlled clinical investigation plus confirmatory evidence
4. Which FD&C Act provision requires manufacturers to report serious and unexpected adverse drug experiences to the FDA? → Postmarket safety reporting requirements (21 CFR Part 314)
5. The following conditions must be met, except one, for a medicine to be declared pharmaceutically equivalent. → Same exipients
6. Which amendment to the Food, Drug, and Cosmetic Act first required manufacturers to prove both safety AND efficacy before marketing a new drug? → Kefauver-Harris Amendment of 1962
7. When can items from Schedule 1 be used? → Medically under an investigational protocol
8. A pharmacy technician trainee is working at a pharmacy. Which statement is MOST accurate regarding their scope of practice? → They must work under direct supervision until licensed or registered
9. Under federal law, which of the following is an acceptable method for a DEA-registered pharmacy to destroy expired controlled substances? → Placing in a DEA-authorized collector or using a DEA-authorized reverse distributor
10. Which of the following scenarios would MOST likely trigger a mandatory report to the state board of pharmacy? → A pharmacist is convicted of a drug-related felony
11. Which FDA form is used by healthcare professionals to voluntarily report adverse drug events through the MedWatch program? → MedWatch Form 3500
12. When dispensing a new prescription for warfarin, federal law under OBRA '90 requires the pharmacist to offer which service to Medicaid patients? → Patient counseling
13. Under federal law, who bears primary responsibility for initiating a drug recall when a product is found to be adulterated or misbranded? → The manufacturer or distributor bears primary responsibility for initiating the recall
14. Which of the following actions requires a pharmacist's professional judgment and CANNOT be delegated to a pharmacy technician? → Performing the final verification of a dispensed prescription
15. How long may a technician work there before getting their license? → 60 Days
16. What is the purpose of a 'black box warning' (boxed warning) on a drug's labeling under FDA regulations implementing the FD&C Act? → To highlight serious or life-threatening adverse reactions or restrictions
17. Act on controlled substances. → This law gave the FDA authority to determine schedule of controlled substances
18. Under a Risk Evaluation and Mitigation Strategy (REMS), which element imposes the most restrictive requirements on dispensing? → Elements to Assure Safe Use (ETASU)
19. When is a pharmacist generally NOT permitted to substitute a generic drug product? → When the prescriber has written 'Dispense as Written' or equivalent restrictive language
20. Under the FD&C Act, which of the following best describes a 'new drug application' (NDA)? → A formal submission to the FDA seeking approval to market a new drug in the US
21. Under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), a generic manufacturer must demonstrate: → Bioequivalence to the reference listed drug
22. Which DEA form is required when a pharmacy discovers a theft or significant loss of controlled substances? → DEA Form 106
23. Which DEA form is required for a pharmacy to order Schedule II controlled substances like fentanyl and methylphenidate from a distributor? → DEA Form 222
24. A pharmacist receives a verbal order for a Schedule III controlled substance. How many days does the prescriber have to provide a written follow-up? → 7 days
25. Advertising for over-the-counter (OTC) medications is controlled by: → Federal Trade Commission
26. What is the primary goal of a new drug's Phase 3 clinical trial? → To determine the drug's effectiveness versus the effectiveness of a placebo
27. Which of the following tasks is generally considered outside the scope of practice for a registered or certified pharmacy technician? → Recommending an over-the-counter (OTC) medication for a patient's allergy symptoms.
28. When a pharmacist-in-charge (PIC) resigns, which action must typically occur under state law? → A new PIC must be designated and reported to the board within a specified timeframe
29. Manufacturers must substantiate both safety AND effectiveness under this law. → Kefauver harris amendment
30. Who is the legitimate owner of a prescription once it has been filled and administered? → The pharmacy