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.
Standards and Regulations
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's 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's own pharmacies following customized protocols to create individualized medications tailored to each patient.
Using Your Local Pharmacy
Winona prepares and ships your medications free of charge from our own compounding pharmacies. While you have the option to send your HRT prescription to an outside pharmacy of your choice, we do not recommend it.
Most retail pharmacies are unable to fulfill personalized, compounded medications and may also choose to reject your prescription.
If your Winona doctor prescribes patches or pills, retail pharmacies may dispense synthetic versions of these medications, which have been shown to be less effective and safe than bioidentical HRT.
If you choose to have your prescription sent to an outside pharmacy, a $50 monthly platform fee will apply in addition to the cost of your medications. This fee covers continued care with your Winona doctor.
If you're ready to start your Winona Journey, click the button below. If you're already a Winona patient, click here to access your patient portal.