CCP Federal and State Regulations 3

Question 1

Under the Poison Prevention Packaging Act (PPPA), which of the following is EXEMPT from child-resistant packaging requirements?

Accepted Answer

Sublingual nitroglycerin

Answer

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:

Accepted Answer

A potential violation of the pharmacist's professional duty to report

Answer

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:

Accepted Answer

3 years

Answer

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?

Accepted Answer

Schedule III–V: up to 5 refills within 6 months

Answer

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:

Accepted Answer

Finished pharmaceutical products manufactured by registered establishments

Answer

cGMP regulations (21 CFR Part 211) apply to finished pharmaceuticals manufactured by FDA-registered drug manufacturers, not to routine pharmacy compounding.

(CCP) Certified Consultant Pharmacist Practice Test

(CCP) Certified Consultant Pharmacist Practice Test

CCP Federal and State Regulations 3