Winona operates its own pharmacies in order to provide high-quality, effective menopause care. Winona’s pharmacies are classified with 503A status because they develop individual prescriptions for each patient.
These patient-specific prescriptions must be produced in 503A-regulated pharmacies, also known as compounding pharmacies. By owning compounding pharmacies, Winona has the ability to create personalized formulas tailored to each patient’s unique needs and symptoms.
There are two main pharmacy classifications in the US: 503A, or compounding pharmacies, and 503B, or outsourcing pharmacies. These pharmacies have different production styles and are regulated by different organizations.
503A-classified pharmacies are patient-specific, meaning prescriptions are ordered by one medical provider and made for only one patient.
503A pharmacies like Winona’s are regulated at the state level, overseen by the State Boards of Pharmacy where they operate. The State Boards of Pharmacy require all 503A pharmacies to follow United States Pharmacopeial Convention (USP) Compounding Standards.
The USP is a nonprofit organization that sets standards for the quality, purity, strength, and identity of healthcare products. 503A pharmacies must also follow additional state-specific reporting requirements and production standards.
503B-classified pharmacies operate more like manufacturers. They mass-produce prescriptions without customization to be used by many patients.
503B pharmacies are regulated at the federal level by the U.S. Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety and quality of all prescriptions and ingredients produced by 503B pharmacies.
Feature | 503A Pharmacies | 503B Pharmacies |
|---|---|---|
Definition | Compounding pharmacies that prepare medications based on individual patient prescriptions | Outsourcing facilities that can produce compounded medications in bulk, with or without specific prescriptions |
Regulation | Regulated by State Boards of Pharmacy | Regulated by the FDA, subject to Current Good Manufacturing Practices (CGMP) |
Production Scale | Patient-specific, cannot produce large batches | Can produce large batches for distribution to healthcare facilities |
FDA Approval | Not FDA regulated, therefore not subject to FDA-approval; operate under state regulations instead | Must comply with FDA regulations and undergo inspections |
Patient- Specific Prescriptions | Required for each compounded medication | Can compound for both patient-specific and office-use without prescriptions |
Quality Standards | Must comply with USP standards and state regulations | Must adhere to CGMP, including rigorous testing and validation of processes |
Labeling Requirements | Limited labeling requirements, primarily for individual use | Requires specific labeling, but not pre-approved by the FDA |
Reporting Requirements | Minimal reporting to state boards | Must report compounded drugs to the FDA biannually |
Examples of Use | Custom medications for patients, such as hormone replacement therapies | Bulk sterile preparations for hospitals, such as anesthetics or IV solutions |
As 503A compounding pharmacies, Winona pharmacies are not directly regulated by the FDA and therefore are not subject to FDA-approval. However, all of Winona’s treatments are made using ingredients from FDA-regulated facilities.
The State Boards of Pharmacy require all 503A pharmacies to use products from FDA-registered wholesalers and manufacturers, and Winona adheres to these safety and quality standards to develop all our bioidentical treatments.
Patient safety comes first at Winona. Although Winona's bioidentical HRT is not regulated by the FDA for approval, Winona strictly uses ingredients from FDA-regulated facilities to produce all prescriptions.
Winona’s bioidentical hormone replacement therapy (HRT) uses natural, plant-derived hormones. Bioidentical HRT is molecularly identical to the hormones the body produces. As such, the body can more readily absorb bioidentical HRT. Since it’s functionally indistinguishable from the body's natural hormones, it tends to come with fewer side effects and risks than synthetic HRT.
Patient safety comes first at Winona. Although Winona's bioidentical HRT is not regulated by the FDA for approval, Winona strictly uses ingredients from FDA-regulated facilities to produce all prescriptions.
Winona adheres to USP Compounding Standards and State Boards of Pharmacy regulations to ensure every patient receives safe, quality treatment.
Winona’s bioidentical hormone replacement therapy (HRT) uses natural, plant-derived hormones. Bioidentical HRT is molecularly identical to the hormones the body produces. As such, the body can more readily absorb bioidentical HRT. Since it’s functionally indistinguishable from the body's natural hormones, it tends to come with fewer side effects and risks than synthetic HRT.
Winona provides patient-specific prescriptions to promote the best possible results. Personalized treatment accounts for each patient's symptoms, medical history, and lifestyle.
With custom-formulated treatment, patients often notice results sooner and find more effective relief. Menopause is different for each woman, so personalized treatment best meets these unique needs.
Winona is thoroughly committed to patient-focused care. By following high quality standards and offering personalized treatments, Winona provides every patient with safe, quality menopause treatment for optimal results.
Are you ready to say goodbye to your symptoms and experience the benefits of personalized care?
Start your treatment journey with Winona today!
