Federal and State Regulations 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 Federal and State Regulations flashcards as text
Under the Poison Prevention Packaging Act (PPPA), which of the following is EXEMPT from child-resistant packaging requirements?
Answer: Sublingual nitroglycerin
Sublingual nitroglycerin is specifically exempted from PPPA child-resistant packaging requirements by federal regulation.
A CCP conducting an MRR in a skilled nursing facility documents a medication error but does not report it to the Director of Nursing. Under federal nursing home regulations, this failure is best characterized as:
Answer: A potential violation of the pharmacist's professional duty to report
Federal regulations (42 CFR 483.45) require the consultant pharmacist to report irregularities, including medication errors, to the attending physician, director of nursing, and administrator.
The Drug Supply Chain Security Act (DSCSA) requires pharmacies to maintain transaction records for drug product tracing for at least:
Answer: 3 years
DSCSA requires pharmacies to maintain transaction information, transaction history, and transaction statements for at least 3 years.
Under federal law, which Schedule III–V controlled substances may be prescribed via oral authorization to a pharmacy, with the prescription being valid for how many refills?
Answer: Schedule III–V: up to 5 refills within 6 months
Federal law allows Schedule III and IV drugs to be refilled up to 5 times within 6 months of the original date; Schedule V may also be refilled up to 5 times in 6 months.
Under 21 CFR Part 211, current Good Manufacturing Practice (cGMP) regulations apply to:
Answer: Finished pharmaceutical products manufactured by registered establishments
cGMP regulations (21 CFR Part 211) apply to finished pharmaceuticals manufactured by FDA-registered drug manufacturers, not to routine pharmacy compounding.
A state law requires pharmacists to offer counseling to all new prescription patients. Under OBRA '90, Medicaid pharmacies must offer counseling to all Medicaid outpatients. Which statement correctly describes the interaction between these laws?
Answer: The pharmacist must comply with whichever law is MORE stringent
When federal and state laws both regulate an activity, pharmacists must comply with the more stringent requirement; state law here expands OBRA '90 to all patients.
The Safe Harbor provisions under the Anti-Kickback Statute (AKS) allow pharmaceutical manufacturers to provide pharmacies with:
Answer: Discounts that are disclosed and reflected in the cost to the beneficiary
The discount safe harbor permits manufacturers to offer discounts to pharmacies provided the discount is properly disclosed and reflected in cost reporting.