CFPN Pharmacy Law and Regulatory Compliance 1 — Questions and Answers
Question 1: Which federal agency is primarily responsible for enforcing the Controlled Substances Act (CSA)?
- FDA
- DEA (Correct answer)
- CMS
- SAMHSA
Correct answer: DEA
The Drug Enforcement Administration (DEA) is the primary federal agency responsible for enforcing the Controlled Substances Act and regulating controlled substance distribution.
Question 2: Under the Controlled Substances Act, Schedule II drugs are characterized by which of the following?
- No accepted medical use and high abuse potential
- High abuse potential with accepted medical use and severe dependence risk (Correct answer)
- Low to moderate abuse potential with accepted medical use
- Accepted medical use with very low abuse potential
Correct answer: High abuse potential with accepted medical use and severe dependence risk
Schedule II drugs have a high potential for abuse, currently accepted medical use, and may lead to severe psychological or physical dependence.
Question 3: A DEA Form 222 (or its electronic equivalent) is required for ordering which schedule of controlled substances?
- Schedule III and IV only
- Schedule V only
- Schedule I and II (Correct answer)
- All schedules I through V
Correct answer: Schedule I and II
DEA Form 222 or CSOS electronic equivalent is required specifically for ordering Schedule I and Schedule II controlled substances.
Question 4: Which law established the modern comprehensive federal drug scheduling system still in use today?
- Pure Food and Drug Act of 1906
- Harrison Narcotic Tax Act of 1914
- Controlled Substances Act of 1970 (Correct answer)
- Combat Methamphetamine Epidemic Act of 2005
Correct answer: Controlled Substances Act of 1970
The Controlled Substances Act of 1970 created the five-schedule classification system and established comprehensive federal drug policy including record-keeping requirements.
Question 5: A Prescription Drug Monitoring Program (PDMP) is primarily designed to:
- Track Medicare prescription costs for CMS reporting
- Monitor prescription drug pricing across state borders
- Identify potential drug diversion, misuse, and doctor-shopping patterns (Correct answer)
- Regulate state pharmacy licensing and renewal
Correct answer: Identify potential drug diversion, misuse, and doctor-shopping patterns
PDMPs are state-run electronic databases that track controlled substance prescriptions to identify potential drug diversion, misuse, and 'doctor shopping' behavior.
Question 6: Under HIPAA, which of the following circumstances permits disclosure of patient medication records without patient authorization?
- Sharing with family members who request the information
- Disclosure to law enforcement pursuant to a valid court order (Correct answer)
- Providing records to a patient's employer upon written request
- Releasing records to insurance companies for marketing purposes
Correct answer: Disclosure to law enforcement pursuant to a valid court order
HIPAA permits disclosure of protected health information to law enforcement without patient authorization when required by a valid court order, warrant, or subpoena.
Question 7: Which federal regulation primarily governs the handling and disposal of pharmaceutical waste, including unused hazardous medications in healthcare settings?
- Resource Conservation and Recovery Act (RCRA) (Correct answer)
- OSHA Hazard Communication Standard
- FDA Drug Quality and Security Act
- DEA Practitioner's Manual
Correct answer: Resource Conservation and Recovery Act (RCRA)
The Resource Conservation and Recovery Act (RCRA) governs pharmaceutical waste disposal, classifying certain drugs as hazardous waste that requires special handling and disposal procedures.
CFPN Pharmacy Law and Regulatory Compliance 1
Which federal agency is primarily responsible for enforcing the Controlled Substances Act (CSA)?