Safety
Compounded medications: what "not FDA-approved" means
Why compounded medications exist, how they differ from FDA-approved drugs, who oversees compounding pharmacies, and questions worth asking.
Every program on Awesentials uses compounded medications. That makes it worth understanding exactly what compounding is.
What compounding is
Compounding is when a licensed pharmacist combines, mixes or alters ingredients to create a medication for an individual patient, based on a prescription. Compounding has a long history in pharmacy and can meet needs that mass-produced drugs do not.
How it differs from an FDA-approved drug
FDA-approved drugs go through a review of safety, effectiveness and manufacturing quality before they can be sold. Compounded medications do not go through that premarket review. That is why every Awesentials program page states plainly that compounded medications are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness or quality.
Who oversees compounding pharmacies
Compounding pharmacies are licensed and inspected by state boards of pharmacy. Federal law also sets rules for which ingredients may be used and how. Those rules can change, which is one reason Awesentials only offers programs the dispensing pharmacy confirms it can prepare.
Why a provider is always involved
A compounded medication requires a prescription for a specific patient. On Awesentials, a licensed provider reviews your online visit and decides whether any program is appropriate. If it is not, no medication ships.
Questions worth asking
- Which pharmacy prepares my medication, and is it licensed to ship to my state?
- How should I store it, and when does it expire?
- Are there FDA-approved alternatives I should consider?
Your provider can answer these in the patient portal.
Sources
This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
