How Winona’s Pharmacies and Treatments Are Regulated
The United States regulates pharmacies under two classifications, based on how prescriptions are made.
503A: Compounding pharmacies produce prescriptions individually per patient. These pharmacies are regulated at the state level by state pharmacy boards.
503B: Outsourcing pharmacies mass-produce prescriptions. These pharmacies are regulated at the Federal level by the FDA.
In order to offer personalized prescriptions, Winona owns and operates two 503A compounding pharmacies. Since these pharmacies aren’t regulated by the FDA, Winona’s treatments are not FDA approved.
However, all 503A compounding pharmacies, including Winona’s, are required to produce prescriptions with FDA-approved ingredients.
How Winona Ensures Safety and Quality
By owning 503A compounding pharmacies, Winona has the ability to create personalized formulas tailored to each patient’s unique needs and symptoms.
The State Boards of Pharmacy require all 503A pharmacies to adhere to the United States Pharmacopeial Convention (USP) Compounding Standards for quality, purity, strength, and identity of healthcare products. 503A pharmacies must also follow additional state-specific reporting requirements and production standards.
Learn more about compounding pharmacy regulations.
To learn more about the differences between 503A and 503B pharmacies and how Winona’s compounding pharmacies are regulated, visit this page.
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.