Compounded Medications: What They Are and Why Selvara Uses Them
Compounded medications are made by state-licensed pharmacies for individual patients. Here's the regulatory and safety picture.
What compounded means
A compounded medication is prepared by a state-licensed pharmacy for a specific patient based on a prescription from a licensed practitioner. It is not mass-manufactured; each batch is individualized.
503A vs 503B
503A pharmacies serve individual patients. 503B outsourcing facilities serve healthcare providers and are FDA-registered with stricter manufacturing standards. Selvara works with both depending on the medication.
Safety standards
All Selvara compounding pharmacies meet USP <797> (sterile) and USP <795> (non-sterile) standards. Sterility, potency, and stability are tested for every batch.
Why not brand-name only?
Many of the medications Selvara prescribes. Enclomiphene, Tri-Mix, PT-141, custom-dose TRT, are not available as branded finished products. Compounding is the legal and clinical pathway for individualized care.
Frequently asked questions
Are compounded meds FDA approved?
No, compounded medications are individualized and therefore not eligible for FDA finished-product approval. The pharmacies themselves are regulated.
Are they safe?
USP standards govern preparation. Practitioner oversight gates prescribing.
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