CCP Regulatory Compliance 2

Question 1

Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which activity is REQUIRED of pharmacists when dispensing Medicaid prescriptions?

Accepted Answer

Prospective drug utilization review and patient counseling

Answer

OBRA '90 mandates prospective DUR and an offer to counsel Medicaid patients at the point of dispensing.

Question 2

A long-term care facility asks the consultant pharmacist to review medication regimens. Which federal regulation specifically requires this review for nursing facility residents?

Accepted Answer

OBRA '87 (NHRA)

Answer

OBRA '87, also known as the Nursing Home Reform Act, requires monthly pharmacist medication regimen reviews for nursing facility residents.

Question 3

Which agency is responsible for enforcing the Controlled Substances Act at the federal level?

Accepted Answer

DEA

Answer

The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the Controlled Substances Act.

Question 4

A pharmacist discovers a significant medication error that caused patient harm at a nursing facility. Under federal guidelines, which document should be completed to report this to the FDA?

Accepted Answer

MedWatch Form 3500A

Answer

MedWatch Form 3500A is the FDA's mandatory reporting form for serious adverse drug events and medication errors.

Question 5

Under 21 CFR Part 211, which type of facility must comply with Current Good Manufacturing Practice regulations?

Accepted Answer

Outsourcing facilities registered under Section 503B

Answer

Section 503B outsourcing facilities must comply with FDA's cGMP regulations under 21 CFR Part 211.

(CCP) Certified Consultant Pharmacist Practice Test

(CCP) Certified Consultant Pharmacist Practice Test

CCP Regulatory Compliance 2