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
Which accreditation body provides specific pharmacy practice standards for long-term care and specialty pharmacy settings?
Answer: All of the above
URAC, TJC, and ACHC all offer accreditation programs applicable to LTC and specialty pharmacy settings.
A pharmacist discovers that a nursing facility has been using verbal orders from physicians to administer Schedule II medications routinely. Under the CSA, this practice is:
Answer: Permitted only in emergency situations with prompt written follow-up
Emergency verbal orders for Schedule II drugs are allowed under the CSA but must be followed by a written prescription within 7 days.
Which regulatory body sets standards for sterile compounding in pharmacy practice through USP chapters?
Answer: United States Pharmacopeial Convention (USP)
The USP publishes chapters such as and that set compounding quality standards adopted by many state boards.
Under the Drug Quality and Security Act (DQSA), Section 503A pharmacies that compound for individual patients are primarily regulated by:
Answer: State boards of pharmacy
Section 503A compounding pharmacies that compound for identified patients are primarily regulated by state boards of pharmacy.
A consultant pharmacist identifies that a facility is using a medication with a REMS program without the required pharmacy certification. The MOST immediate action should be:
Answer: Cease dispensing until certification is obtained and notify the prescriber
Dispensing REMS medications without required certification is illegal; dispensing must stop until certification is completed.
Which federal regulation governs the labeling of over-the-counter drug products, including the 'Drug Facts' box?
Answer: 21 CFR Part 330
21 CFR Part 330 covers OTC drug products for human use, including the Drug Facts labeling requirements.
A consultant pharmacist is reviewing antibiotic prescribing in a nursing facility as part of an antimicrobial stewardship program. Which CMS regulation requires nursing facilities to have an antibiotic stewardship program?
Answer: F-tag 881
F-tag 881 requires nursing facilities to have an antibiotic stewardship program that includes policies and procedures for antibiotic use.