CPhT Pharmacy Law 2 — Questions and Answers
Question 1: Which DEA schedule includes drugs with high abuse potential and no currently accepted medical use in the US?
- Schedule I (Correct answer)
- Schedule II
- Schedule III
- Schedule IV
Correct answer: Schedule I
Schedule I substances (e.g., heroin, LSD) have high abuse potential and no accepted medical use, making them illegal for standard prescribing.
Question 2: Under the Combat Methamphetamine Epidemic Act (CMEA), how many grams of pseudoephedrine can an individual purchase per day?
- 3.6 grams (Correct answer)
- 7.5 grams
- 9.0 grams
- 5.0 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.
Question 3: Which federal law requires pharmacies to maintain a written policy and procedure for medication therapy management (MTM) services?
- Medicare Modernization Act (MMA) (Correct answer)
- HIPAA
- Drug Quality and Security Act
- Omnibus Budget Reconciliation Act
Correct answer: Medicare Modernization Act (MMA)
The Medicare Modernization Act of 2003 established the Part D benefit and required MTM programs for eligible beneficiaries.
Question 4: A pharmacy receives a prescription for a Schedule III controlled substance. How many total refills are permitted?
- 5 refills within 6 months (Correct answer)
- 3 refills within 6 months
- No refills allowed
- Unlimited refills within 1 year
Correct answer: 5 refills within 6 months
Schedule III and IV controlled substances may be refilled up to 5 times within 6 months of the original issue date.
Question 5: Which act established the requirement that pharmacists offer counseling to Medicaid patients receiving new prescriptions?
- OBRA-90 (Correct answer)
- Kefauver-Harris Amendment
- Durham-Humphrey Amendment
- Poison Prevention Packaging Act
Correct answer: OBRA-90
OBRA-90 (Omnibus Budget Reconciliation Act of 1990) mandated prospective drug utilization review and patient counseling offers for Medicaid patients.
Question 6: When a prescriber writes 'brand necessary' or 'dispense as written' on a prescription, what must the pharmacy do?
- Dispense only the brand-name drug (Correct answer)
- Dispense the generic equivalent
- Contact the prescriber to confirm
- Dispense whichever is cheaper
Correct answer: Dispense only the brand-name drug
A 'dispense as written' instruction legally requires the pharmacy to dispense the brand-name product without substituting a generic.
Question 7: Which organization publishes the Orange Book, which lists FDA-approved drug products and their therapeutic equivalence?
- FDA (Correct answer)
- DEA
- CMS
- USP
Correct answer: FDA
The FDA publishes the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to guide generic substitution decisions.
CPhT Pharmacy Law 2
Which DEA schedule includes drugs with high abuse potential and no currently accepted medical use in the US?