In short. Estradiol is an estrogen. FDA has approved drug products that contain it; a compounded estradiol preparation is not FDA-approved. In TrueRoute it is ordered as a patient prescription that the prescriber signs.
What it is
Estradiol is an estrogen. The prescribing information FDA publishes for estradiol tablets, USP describes a tablet containing micronized estradiol for oral administration.
FDA status
Because FDA has approved drug products that contain estradiol, FDA’s guidance on compounded drugs that are essentially copies applies: a 503A pharmacy may not compound, regularly or in inordinate amounts, a drug that is essentially a copy of a commercially available drug product. FDA ties the difference to a change that the prescriber determines makes a significant difference for the patient, documented on the prescription.
FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess compounded “bioidentical” hormone therapy, naming estradiol among its examples. NASEM reported to FDA on July 1, 2020 that it found a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies, and concluded that the therapy’s wide-spread use poses a public health concern.
Compounded medications are not FDA-approved, and FDA does not review them for safety, effectiveness or quality.
How it is ordered in TrueRoute
Estradiol is ordered as a patient prescription. The prescriber names the patient, chooses the product from your catalogue at your account’s price, reviews the order total and signs. Before anything is charged, TrueRoute checks what it can check, such as the prescriber’s licence in the patient’s state as attested and whether the product can be sent there, and selects the route under its written routing policy. Orders are filled by licensed pharmacies in our network.
Office-use and physician-use purchasing is a separate purchase-order flow with no patient attached, available once your account holds that program.
The forms and strengths your account can order, with their prices for your ship-to state, are shown in your catalogue once your account is set up. This page lists none, because what is carried changes.
What the prescriber decides
The prescription is the prescriber’s. They decide whether estradiol is appropriate for the patient and set the product, quantity and directions. TrueRoute is software: it does not recommend a medication, a dose or a product, it does not dispense, and it does not practice medicine.
Every medication reference page · Women’s health purchasing · How it works