Thalidomide REMS includes which of the following?

• A. Maximum 60 DS, auto refills allowed
• B. Maximum 12 DS, auto refills allowed
• C. Maximum 28 DS, no auto refills
• D. Maximum 28 DS, auto refills allowed

Answer: (C)

Thalidomide REMS is designed to minimize teratogenic risk by strict dispensing controls. The program specifies a maximum 28 days’ supply and prohibits auto-refills, so every refill triggers the REMS requirements—re‑enrollment, counseling, and, for women of childbearing potential, pregnancy testing where applicable. This arrangement ensures ongoing risk management rather than letting patients automatically receive more medication without review. The option that combines a 28-day supply with no auto-refills best matches these safety controls. Longer supplies or allowing auto-refills would reduce the frequency of safety checks and monitoring.