CFPN Pharmacy Law and Regulatory Compliance 3

Question 1

Which provision of OBRA '90 (Omnibus Budget Reconciliation Act of 1990) established a standard for pharmacist-patient interaction that remains influential today?

Accepted Answer

Requirement to offer counseling to Medicaid patients receiving new prescriptions

Answer

Drug Utilization Review (DUR) retrospective requirement

Answer

Mandate for generic substitution of all brand drugs

Answer

Mandatory pharmacist verification of all insurance claims

Question 2

The concept of 'corresponding responsibility' in pharmacy law establishes that:

Accepted Answer

A pharmacist shares legal responsibility with the prescriber for ensuring controlled substances are dispensed for legitimate medical purposes

Answer

A pharmacist must verify all insurance claims before dispensing

Answer

Prescribers must notify pharmacies of all prescriptions they write

Answer

Pharmacies are solely responsible for reporting all adverse drug events to the FDA

Question 3

Under the Combat Methamphetamine Epidemic Act (CMEA) of 2005, pseudoephedrine purchases are limited to a maximum of:

Accepted Answer

3.6 grams per day and 9 grams per 30-day period

Answer

3.6 grams per day and 7.5 grams per 30-day period

Answer

9 grams per day with no monthly limit

Answer

5 grams per month with no daily limit

Question 4

Which of the following best describes a 'black box warning' (boxed warning) on a pharmaceutical product?

Accepted Answer

The FDA's strongest required warning, indicating serious or life-threatening risks

Answer

A warning for medications with minor but common side effects

Answer

A DEA-required warning on all Schedule II controlled substances

Answer

A voluntary manufacturer safety communication

Question 5

The Ryan Haight Online Pharmacy Consumer Protection Act primarily regulates:

Accepted Answer

Internet pharmacies dispensing controlled substances without prescriptions from valid in-person evaluations

Answer

Mail-order pharmacy pricing and reimbursement rates

Answer

Online pharmacy licensure requirements across state lines

Answer

Electronic prescription format standards for controlled substances

Question 6

Which regulatory body issues and maintains the DEA registration required for healthcare providers to prescribe controlled substances?

Accepted Answer

Drug Enforcement Administration (DEA)

Answer

State Board of Pharmacy

Answer

Food and Drug Administration (FDA)

Answer

Centers for Medicare and Medicaid Services (CMS)

Question 7

Which federal statute prohibits the dispensing of prescription drugs without a valid prescription and establishes the framework distinguishing prescription from over-the-counter medications?

Accepted Answer

Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act

Answer

Controlled Substances Act of 1970

Answer

Drug Quality and Security Act of 2013

Answer

OBRA '90