rems program requirements

PTCB PTCE
Federal Requirements
Matrix
Difficulty 3 of 5

Question

A pharmacy technician is comparing statements about different REMS programs. Classify each statement as consistent or inconsistent with FDA guidance.

Row	Consistent	Inconsistent
Some programs require pharmacy certification.	✓ Correct	Not correct
Every program has identical dispensing requirements.	Not correct	✓ Correct
Some programs require patient enrollment.	✓ Correct	Not correct
Every Medication Guide is part of a REMS.	Not correct	✓ Correct

Answer

Some programs require pharmacy certification.: Consistent · Every program has identical dispensing requirements.: Inconsistent · Some programs require patient enrollment.: Consistent · Every Medication Guide is part of a REMS.: Inconsistent

Rationale

Certification and patient enrollment are requirements in some programs. Requirements vary, and only a small proportion of Medication Guides are included in REMS.

RememberREMS requirements vary by program.

Sources

Roles of Different Participants in REMS U.S. Food and Drug Administration · License: US government work (public domain) · Retrieved November 4, 2026 · What Pharmacies and/or Health Care Settings that Dispense Medications with REMS Need to Know · page updated Tue, 05/07

Last verified: November 5, 2026 2 independent automated checks Question ptcb-fr-00174, version 1

Checks are automated. No licensed clinician has reviewed this question. Check the sources and your program’s materials.

Report an error in this question. For education only; not medical advice. See all sources and licenses.