Compounded Hormone Formulations

Why strength range is the whole point

Commercially manufactured hormone products come in a small set of fixed strengths. Compounding exists so a prescriber can specify a strength and a dosage form that the manufactured range does not cover, and hormone formulations are where practices use that latitude most.

That is why this category carries more formulations than any other in the catalogue. A practice standardising on compounded hormones is usually doing so because it wants a strength ladder fine enough to follow a prescriber protocol, and a single dosage form family across the whole ladder.

Dosage forms available

• Immediate-release capsules, across the full strength ladder for most compounds.
• Sustained-release capsules, where the prescriber specifies extended delivery.
• Topical creams, prepared per millilitre rather than per unit, so the strength is stated as a concentration.
• Tablets, for the compounds where the pharmacy prepares them.

Capsule and cream strengths are not interchangeable figures. A capsule is labelled with the quantity per capsule and a cream with the concentration per millilitre, so comparing the two numbers directly is a category error. The table separates them.

Beyond-use dating differs by dosage form

Creams in this category carry a fixed beyond-use date. Capsules are dated per prescription instead, because the dating follows the prescribed directions and the quantity prepared rather than a standing shelf figure. Both are assigned at compounding under USP General Chapter 795 and printed on the container label.

For the per-prescription entries the pharmacy sets dating at preparation. Your account manager can confirm how that lines up with your ordering cadence before you place a first order.

Selection of compound, strength and dosage form is a prescriber decision made for a named patient. This page states what the pharmacy is able to prepare. It offers no view on which formulation suits any patient, and nothing on it should be read as clinical direction. Wholesale pricing is released once an account is verified.

Section 503A of the Federal Food, Drug, and Cosmetic Act exempts a compounded drug from new drug approval, current good manufacturing practice and adequate-directions labelling requirements when it is compounded for an identified individual patient on receipt of a valid prescription. ^[1]

The safety and effectiveness of compounded hormone preparations has been studied by the National Academies at FDA request, and the resulting 2020 report describes the available evidence as limited and drawn largely from low quality data. ^[2]

That finding is worth stating plainly on a supplier page rather than leaving a prescriber to discover it elsewhere. It does not bear on whether a preparation can be compounded to a specified strength, which is what this page describes, and it is squarely a prescriber consideration.

Ordering

Accounts are opened to NPI-verified licensed practitioners. Each preparation is dispensed against a prescription for an individual patient, so ordering runs through the pharmacy rather than as stock purchasing, and quantity per fill is bounded by the limits shown for each entry. Wholesale pricing is released once an account is verified.

Sources

1. FDA, Section 503A of the Federal Food, Drug, and Cosmetic Act (accessed 2026-08-09)
2. FDA, NASEM Study on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Therapy (accessed 2026-08-09)

Frequently asked questions

Can a strength outside the listed ladder be prepared?

Often, yes. The ladder shown is what the pharmacy prepares routinely, and strengths outside it are assessed per compound and dosage form. Send the specification to your account manager and we will confirm what can be prepared and documented.

Why are some entries dated per prescription rather than in days?

Because the dating follows the prescribed directions and the quantity prepared. A cream made to a standing formulation carries a fixed beyond-use date; a capsule prepared against one prescription is dated at compounding for that preparation.

Do you supply pellets or injectable hormone preparations?

This category covers capsule, sustained-release capsule, tablet and cream. If you need pellets or an injectable hormone preparation, tell your account manager which one and we will confirm the sourcing route.

How is this different from the hormone optimization clinic page?

That page is about supplying a clinic running a hormone service line, including devices and adjacent categories. This one is the formulary: which compounds, which strengths, which dosage forms, and how they are dated and documented.

What is the regulatory status of these formulations?

Compounded medications are not FDA-approved finished drug products. They are prepared under section 503A of the Federal Food, Drug, and Cosmetic Act against a prescription for an individual patient, which is a separate regulatory pathway rather than a lesser version of the same one.

What documentation ships with an order?

Lot identification on the container label, with a Certificate of Analysis available on request. Practices with their own documentation requirements should raise them at account setup so the pharmacy can confirm what it is able to supply.

Who can open an account?

NPI-verified licensed practitioners. Verification happens before pricing is released, and licensure is confirmed for the destination state before a first order ships.