PTCE Pharmacy Law and Regulations 2 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act (CMEA), how many grams of pseudoephedrine may an individual purchase per day?
- 3.6 grams (Correct answer)
- 7.5 grams
- 9.0 grams
- 12.0 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.
Question 2: Which DEA form is used to report theft or significant loss of controlled substances?
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 222
- DEA Form 224
Correct answer: DEA Form 106
DEA Form 106 must be completed and submitted to report theft or significant loss of controlled substances.
Question 3: The Orange Book published by the FDA is used to identify:
- Drug interactions and contraindications
- Approved drug products with therapeutic equivalence evaluations (Correct answer)
- Maximum allowable costs for generic drugs
- Schedule classifications for controlled substances
Correct answer: Approved drug products with therapeutic equivalence evaluations
The FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) lists approved drugs and their therapeutic equivalence ratings.
Question 4: A pharmacy technician discovers a forged prescription. What is the FIRST action they should take?
- Fill the prescription and alert the pharmacist afterward
- Refuse to fill and notify the pharmacist immediately (Correct answer)
- Call the prescriber listed on the prescription
- Confiscate the prescription and call the police
Correct answer: Refuse to fill and notify the pharmacist immediately
The technician must immediately notify the pharmacist, who is responsible for all final dispensing decisions and handling of fraudulent prescriptions.
Question 5: Under HIPAA, which of the following is considered Protected Health Information (PHI)?
- De-identified patient data used in research
- A patient's name combined with their diagnosis (Correct answer)
- Aggregate statistics with no individual identifiers
- Anonymized prescription volume reports
Correct answer: A patient's name combined with their diagnosis
PHI includes any individually identifiable health information, such as a patient's name linked to a medical condition or treatment.
Question 6: Which act requires childproof packaging for most prescription medications?
- Durham-Humphrey Amendment
- Kefauver-Harris Amendment
- Poison Prevention Packaging Act (PPPA) (Correct answer)
- Drug Quality and Security Act
Correct answer: Poison Prevention Packaging Act (PPPA)
The Poison Prevention Packaging Act of 1970 mandates child-resistant packaging for most prescription and certain OTC medications.
Question 7: A Schedule II prescription may be transferred between pharmacies:
- Once, if both pharmacies share a real-time database
- Twice, with pharmacist authorization
- Never — Schedule II cannot be transferred (Correct answer)
- Up to three times within 6 months
Correct answer: Never — Schedule II cannot be transferred
Schedule II prescriptions cannot be transferred between pharmacies; a new prescription from the prescriber is required.
PTCE Pharmacy Law and Regulations 2
Under the Combat Methamphetamine Epidemic Act (CMEA), how many grams of pseudoephedrine may an individual purchase per day?