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 catalog. A practice standardizing 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 milliliter 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 labeled with the quantity per capsule and a cream with the concentration per milliliter, 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. Pricing is released once the practice has been verified and reviewed.

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 labeling 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.

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)