Regulatory Compliance Flashcards
7 cards from real CCP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance flashcards as text
Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which activity is REQUIRED of pharmacists when dispensing Medicaid prescriptions?
Answer: Prospective drug utilization review and patient counseling
OBRA '90 mandates prospective DUR and an offer to counsel Medicaid patients at the point of dispensing.
A long-term care facility asks the consultant pharmacist to review medication regimens. Which federal regulation specifically requires this review for nursing facility residents?
Answer: OBRA '87 (NHRA)
OBRA '87, also known as the Nursing Home Reform Act, requires monthly pharmacist medication regimen reviews for nursing facility residents.
Which agency is responsible for enforcing the Controlled Substances Act at the federal level?
Answer: DEA
The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the Controlled Substances Act.
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?
Answer: MedWatch Form 3500A
MedWatch Form 3500A is the FDA's mandatory reporting form for serious adverse drug events and medication errors.
Under 21 CFR Part 211, which type of facility must comply with Current Good Manufacturing Practice regulations?
Answer: Outsourcing facilities registered under Section 503B
Section 503B outsourcing facilities must comply with FDA's cGMP regulations under 21 CFR Part 211.
Which Schedule of controlled substances has no currently accepted medical use in the United States and a high potential for abuse?
Answer: Schedule I
Schedule I controlled substances have no accepted medical use and the highest potential for abuse.
A consultant pharmacist reviewing LTC records finds a resident was given a benzodiazepine without a documented clinical indication. This most directly violates which regulatory standard?
Answer: F-tag 758 unnecessary drug use in nursing facilities
F-tag 758 (formerly F329) requires that nursing facility residents receive only necessary medications with documented clinical indications.