Winona owns and operates two licensed pharmacies that create customized and compounded hormone therapies for patients.

Compounding provides a flexible, individualized approach to treatment, unlike the standard one-size-fits-all dose of HRT. It also offers the added advantage of allowing medication adjustments to address fluctuating symptoms as needed.

Compounding pharmacies, including those owned by Winona, must employ specially trained and licensed pharmacists to oversee the production of compounded medications. They must also adhere to the United States Pharmacopeia (USP) 795 and 800 guidelines.

The USP is a nonprofit organization that sets standards for the quality, purity, strength, and identity of healthcare products, including compounded medications. These standards are enforced by the FDA, the Federal Food, Drug, and Cosmetic Act (FDCA), and by laws and regulations set forth by the state boards of pharmacy. Additionally, compounding pharmacies must be licensed as either a 503A or 503B pharmacy.

Winona pharmacies are designated as 503A pharmacies, which allows them to prepare patient-specific medications authorized by a specific provider and at a specific time. Alternatively, 503B pharmacies produce medications in bulk without being tied to a specific prescription or timeline.

Furthermore, 503A pharmacies are only permitted to use wholesale ingredients sourced from FDA-inspected, regulated, and registered facilities. These regulations ensure that compounded medications are prepared in a safe, clean, and quality-controlled environment to avoid the risk of contamination or errors during production and dispensing.

Winona's compounded medications are not mass-manufactured. Instead, they are made in Winona pharmacies following customized protocols to create individualized medications tailored to each patient.