Hormone Replacement Therapy (HRT) Compounding

What makes hormone compounding different

Hormone compounding has a narrow, well defined place. National reviews point to two situations where a prescriber orders a compounded hormone preparation instead of an approved one: a documented allergy to an ingredient in an FDA approved product, and a documented need for a dosage form or strength that approved products do not offer [1][2].

Outside those situations, guidance favors approved products, which carry uniform labeling and standard warnings. Compounded preparations are not reviewed by the FDA, and preference alone is not a reason to use one [2].

How Mixwell supports these practices

• Capsules, creams, gels, troches, and vaginal suppositories, depending on the order
• Custom strengths, including doses between commercial tablet sizes
• Estriol preparations, which have no FDA approved product in the United States
• Versions without a dye, preservative, or excipient a patient reacts to
• More than one hormone combined in a single preparation when the prescriber specifies it

Two practical notes for prescribing offices. Testosterone is a Schedule III controlled substance, which affects how the prescription is written and refilled. Mixwell is a non sterile pharmacy, so injectable hormones and implantable pellets are outside what we prepare.

Working with our pharmacist

Our pharmacist reviews the hormone, the strength, the base, and the dosage form with the prescribing office, and asks what the preparation needs to do that an approved product cannot. That reason belongs on the prescription, along with each active and strength, the quantity, and the directions.

Estradiol and testosterone are handled as hazardous drugs, so these preparations are compounded in our negative pressure containment room rather than on an open bench [3]. Batch records document every preparation, and finished preparations ship across California.