Sexual Health Compounding

What makes sexual health compounding different

Sexual health is an area where approved products already cover a great deal. Compounding has a narrower job here: a strength no manufacturer makes, a form for a patient who cannot swallow a tablet, a formula without an ingredient the patient reacts to, or an ingredient with no approved product at all.

Federal law restricts compounding preparations that are essentially copies of commercially available drugs, unless the prescriber determines that a change made for an identified individual patient produces a significant difference for that patient [1]. That determination belongs on the prescription.

How Mixwell supports these practices

• Troches and other oromucosal forms for patients who struggle with tablets
• Custom strengths for careful titration, including doses between commercial tablet sizes
• Vaginal creams and suppositories, including estriol, which has no FDA approved product in the United States
• Dye free, fragrance free, and paraben free versions for sensitive tissue
• Several prescribed actives consolidated into one preparation

Guidance in this field is specific, and we follow it rather than talk around it. The 2019 global consensus position statement on testosterone therapy for women concluded that the only evidence based indication is hypoactive sexual desire disorder in postmenopausal women, that no approved female testosterone product exists, and that compounded bioidentical testosterone cannot be recommended for that use unless an authorized equivalent preparation is unavailable [2]. For erectile dysfunction, the American Urological Association guideline frames evaluation and treatment, and phosphodiesterase type 5 inhibitors are contraindicated with nitrate medicines [3].

Working with our pharmacist

Our pharmacist reviews the form, the strength, and the base with the prescribing office, and asks what the preparation needs to do that an approved product cannot. Prescriptions should name each active and strength, the dosage form, the quantity, the directions, and the clinical reason for the customization. Mixwell is a non sterile pharmacy, so injectable and implantable therapies are outside what we prepare. Batch records document every preparation, and finished preparations ship across California.