CFPN Pharmacy Law and Regulatory Compliance

Question 1

Which federal agency is primarily responsible for enforcing the Controlled Substances Act (CSA)?

Accepted Answer

DEA

Answer

FDA

Answer

CMS

Answer

SAMHSA

Question 2

Under the Controlled Substances Act, Schedule II drugs are characterized by which of the following?

Accepted Answer

High abuse potential with accepted medical use and severe dependence risk

Answer

No accepted medical use and high abuse potential

Answer

Low to moderate abuse potential with accepted medical use

Answer

Accepted medical use with very low abuse potential

Question 3

A DEA Form 222 (or its electronic equivalent) is required for ordering which schedule of controlled substances?

Accepted Answer

Schedule I and II

Answer

Schedule III and IV only

Answer

Schedule V only

Answer

All schedules I through V

Question 4

Which law established the modern comprehensive federal drug scheduling system still in use today?

Accepted Answer

Controlled Substances Act of 1970

Answer

Pure Food and Drug Act of 1906

Answer

Harrison Narcotic Tax Act of 1914

Answer

Combat Methamphetamine Epidemic Act of 2005

Question 5

A Prescription Drug Monitoring Program (PDMP) is primarily designed to:

Accepted Answer

Identify potential drug diversion, misuse, and doctor-shopping patterns

Answer

Track Medicare prescription costs for CMS reporting

Answer

Monitor prescription drug pricing across state borders

Answer

Regulate state pharmacy licensing and renewal

Question 6

Under HIPAA, which of the following circumstances permits disclosure of patient medication records without patient authorization?

Accepted Answer

Disclosure to law enforcement pursuant to a valid court order

Answer

Sharing with family members who request the information

Answer

Providing records to a patient's employer upon written request

Answer

Releasing records to insurance companies for marketing purposes

Question 7

Which federal regulation primarily governs the handling and disposal of pharmaceutical waste, including unused hazardous medications in healthcare settings?

Accepted Answer

Resource Conservation and Recovery Act (RCRA)

Answer

OSHA Hazard Communication Standard

Answer

FDA Drug Quality and Security Act

Answer

DEA Practitioner's Manual