CSP Regulatory and Compliance Issues 2 — Questions and Answers
Question 1: Under the Drug Supply Chain Security Act (DSCSA), which data element set must accompany each change of ownership of a prescription drug product?
- Wholesale acquisition cost and invoice number only
- Lot number, NDC, and patient name
- Medication guide, package insert, and REMS form
- Transaction information, transaction history, and transaction statement (Correct answer)
Correct 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.
Question 2: A specialty pharmacy receives a product it suspects is counterfeit. Under DSCSA, what must the pharmacy do?
- Destroy it immediately without notifying anyone
- Return it to the wholesaler without documentation
- Quarantine the product and investigate it as suspect product (Correct answer)
- Dispense it if the lot number appears valid
Correct 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.
Question 3: Within how many hours must a dispenser notify FDA after determining a product is illegitimate under DSCSA?
- 72 hours
- 30 days
- 7 days
- 24 hours (Correct answer)
Correct answer: 24 hours
DSCSA requires notification to FDA (via Form 3911) and affected trading partners within 24 hours of determining a product is illegitimate.
Question 4: How long must dispensers retain DSCSA transaction documentation?
- At least 2 years
- At least 3 years
- At least 6 years (Correct answer)
- At least 10 years
Correct answer: At least 6 years
DSCSA requires trading partners to keep transaction information, history, and statements for no less than 6 years.
Question 5: Which FDA resource lists biological products, including biosimilars and interchangeable biosimilars?
- The Orange Book
- The Green Book
- The Red Book
- The Purple Book (Correct answer)
Correct answer: The Purple Book
The Purple Book lists FDA-licensed biological products along with biosimilarity and interchangeability determinations.
Question 6: Substitution of an interchangeable biosimilar for a reference product at the pharmacy level is governed primarily by which authority?
- The DEA
- The Federal Trade Commission
- CMS Conditions of Participation
- State pharmacy laws (Correct answer)
Correct answer: State pharmacy laws
Although FDA designates interchangeability, whether and how pharmacists may substitute and notify prescribers is determined by state law.
Question 7: A drug with an FDA-approved REMS that includes Elements to Assure Safe Use (ETASU) may require which of the following?
- Only a Dear Healthcare Provider letter
- Only a Medication Guide at dispensing
- Pharmacy certification and documentation of safe-use conditions before dispensing (Correct answer)
- A DEA Form 222 for every order
Correct 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.
