Federal Pharmacy Law Flashcards
6 cards from real PTCB practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Federal Pharmacy Law flashcards as text
Which agency is responsible for approving new drugs before they can be marketed in the US?
Answer: FDA
The FDA (Food and Drug Administration) reviews and approves all new drug applications before a drug can be sold in the US.
The Orange Book is used to identify:
Answer: Therapeutic equivalents
The FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) identifies drugs rated as therapeutically equivalent to innovator products.
A pharmacist can dispense a Schedule II drug in an emergency without a written prescription for up to how many days' supply?
Answer: 72-hour supply
In a bona fide emergency, a pharmacist may dispense a Schedule II drug based on an oral prescription sufficient to treat the patient for 72 hours.
What does NDA stand for in the drug approval process?
Answer: New Drug Application
An NDA (New Drug Application) is submitted to the FDA to request approval for a new drug product for sale in the US.
The Poison Prevention Packaging Act requires child-resistant packaging for most:
Answer: Both prescription and most OTC drugs
The Poison Prevention Packaging Act (PPPA) requires child-resistant containers for most prescription drugs and many OTC products.
Which federal agency oversees the Medicare and Medicaid programs?
Answer: CMS
CMS (Centers for Medicare & Medicaid Services) administers the Medicare and Medicaid programs in the US.