CCP Federal and State Regulations 3 — Questions and Answers
Question 1: Under the Poison Prevention Packaging Act (PPPA), which of the following is EXEMPT from child-resistant packaging requirements?
- Warfarin tablets in quantities ≤ 10 mg per dose
- Sublingual nitroglycerin (Correct answer)
- Oral iron supplements for adults
- Oral contraceptives in blister packs
Correct answer: Sublingual nitroglycerin
Sublingual nitroglycerin is specifically exempted from PPPA child-resistant packaging requirements by federal regulation.
Question 2: 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:
- A minor administrative oversight with no regulatory consequence
- A potential violation of the pharmacist's professional duty to report (Correct answer)
- Only reportable to the state board of pharmacy, not the facility
- Protected under peer review privilege
Correct 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.
Question 3: The Drug Supply Chain Security Act (DSCSA) requires pharmacies to maintain transaction records for drug product tracing for at least:
- 1 year
- 2 years
- 3 years (Correct answer)
- 5 years
Correct answer: 3 years
DSCSA requires pharmacies to maintain transaction information, transaction history, and transaction statements for at least 3 years.
Question 4: 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?
- Schedule III–V: up to 5 refills within 6 months (Correct answer)
- Schedule III–V: up to 6 refills within 12 months
- Schedule IV only: up to 5 refills within 6 months
- Schedule III–V: up to 3 refills within 3 months
Correct 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.
Question 5: Under 21 CFR Part 211, current Good Manufacturing Practice (cGMP) regulations apply to:
- All compounded preparations in LTC facilities
- Finished pharmaceutical products manufactured by registered establishments (Correct answer)
- Only over-the-counter drug products
- Dietary supplements sold in pharmacies
Correct 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.
Question 6: 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?
- Federal OBRA '90 preempts the state law entirely
- The pharmacist must comply with whichever law is MORE stringent (Correct answer)
- The state law applies only to non-Medicaid patients
- OBRA '90 applies only in states that have not enacted their own counseling laws
Correct 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.
Question 7: The Safe Harbor provisions under the Anti-Kickback Statute (AKS) allow pharmaceutical manufacturers to provide pharmacies with:
- Cash payments for formulary placement
- Discounts that are disclosed and reflected in the cost to the beneficiary (Correct answer)
- Free samples with no restrictions
- Rebates tied to prescribing volume for Medicare patients
Correct 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.
CCP Federal and State Regulations 3
Under the Poison Prevention Packaging Act (PPPA), which of the following is EXEMPT from child-resistant packaging requirements?