REMS
A REMS (Risk Evaluation and Mitigation Strategy) is an FDA-required safety program attached to certain drugs whose risks demand more than labeling — extra requirements on prescribers, pharmacies, and sometimes patients before the drug can be dispensed.
- FDA-mandated safety programs for higher-risk drugs
- ETASU tiers can require certified prescribers and pharmacies
- iPLEDGE (isotretinoin) is the best-known example
- A REMS drug imports its program requirements into your catalog
How REMS programs work
REMS requirements scale with risk. The lightest are medication guides and communication plans; the heaviest — called elements to assure safe use (ETASU) — require certified prescribers, certified pharmacies, patient enrollment, lab monitoring, or restricted distribution. Isotretinoin’s iPLEDGE program and clozapine’s monitoring requirements are the classic examples: the drug simply cannot be dispensed outside the program’s rails.
Why REMS matters to telehealth catalogs
A REMS drug in your treatment catalog imports the program’s requirements into your operation: prescriber certification, pharmacy network participation, documented patient counseling or enrollment, and auditable compliance with each element. Most DTC categories avoid heavy-ETASU drugs for exactly this reason — but dermatology programs meet iPLEDGE the moment isotretinoin is on the menu, and any expansion into specialty medications starts with a REMS check as part of catalog diligence.
Compliance handled, so you can build
Lithos runs the clinicians, pharmacies, and 50-state rules behind your care program — one API.
Frequently asked questions
How do I know if a drug has a REMS?
The FDA maintains a public REMS database listing every active program and its requirements — checking it is a standard step in catalog diligence.
Can telehealth programs prescribe REMS drugs?
Often yes, if prescribers and pharmacies meet the program requirements — some REMS integrate smoothly with telehealth, others effectively require in-person infrastructure.
Do GLP-1s have REMS programs?
The major GLP-1 weight-loss drugs do not currently carry REMS programs; their operational complexity comes from supply, coverage, and compounding rules instead.