Practice Test GeeksCSP - Certified Specialty Pharmacist Practice Test
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Regulatory and Compliance Issues Flashcards

7 cards from real CSP 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 and Compliance Issues flashcards as text

  1. Under the Drug Supply Chain Security Act (DSCSA), which data element set must accompany each change of ownership of a prescription drug product?

    Answer: Transaction information, transaction history, and transaction statement

    DSCSA requires trading partners to exchange transaction information (TI), transaction history (TH), and a transaction statement (TS) with ownership changes.

  2. A specialty pharmacy receives a product it suspects is counterfeit. Under DSCSA, what must the pharmacy do?

    Answer: Quarantine the product and investigate it as suspect product

    Dispensers must quarantine suspect product, investigate, and notify FDA and trading partners within 24 hours if it is determined to be illegitimate.

  3. Within how many hours must a dispenser notify FDA after determining a product is illegitimate under DSCSA?

    Answer: 24 hours

    DSCSA requires notification to FDA (via Form 3911) and affected trading partners within 24 hours of determining a product is illegitimate.

  4. How long must dispensers retain DSCSA transaction documentation?

    Answer: At least 6 years

    DSCSA requires trading partners to keep transaction information, history, and statements for no less than 6 years.

  5. Which FDA resource lists biological products, including biosimilars and interchangeable biosimilars?

    Answer: The Purple Book

    The Purple Book lists FDA-licensed biological products along with biosimilarity and interchangeability determinations.

  6. Substitution of an interchangeable biosimilar for a reference product at the pharmacy level is governed primarily by which authority?

    Answer: State pharmacy laws

    Although FDA designates interchangeability, whether and how pharmacists may substitute and notify prescribers is determined by state law.

  7. A drug with an FDA-approved REMS that includes Elements to Assure Safe Use (ETASU) may require which of the following?

    Answer: Pharmacy certification and documentation of safe-use conditions before dispensing

    ETASU can require prescriber and pharmacy certification, patient enrollment, and documented safe-use conditions such as lab results before dispensing.