Pharmacy Law Flashcards

Which DEA schedule includes drugs with high abuse potential and no currently accepted medical use in the US?

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.

Under the Combat Methamphetamine Epidemic Act (CMEA), how many grams of pseudoephedrine can an individual purchase per day?

Answer: 3.6 grams

CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.

Which federal law requires pharmacies to maintain a written policy and procedure for medication therapy management (MTM) services?

Answer: Medicare Modernization Act (MMA)

The Medicare Modernization Act of 2003 established the Part D benefit and required MTM programs for eligible beneficiaries.

A pharmacy receives a prescription for a Schedule III controlled substance. How many total refills are permitted?

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.

Which act established the requirement that pharmacists offer counseling to Medicaid patients receiving new prescriptions?

Answer: OBRA-90

OBRA-90 (Omnibus Budget Reconciliation Act of 1990) mandated prospective drug utilization review and patient counseling offers for Medicaid patients.

When a prescriber writes 'brand necessary' or 'dispense as written' on a prescription, what must the pharmacy do?

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.

Which organization publishes the Orange Book, which lists FDA-approved drug products and their therapeutic equivalence?

Answer: FDA

The FDA publishes the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to guide generic substitution decisions.