Lets unpack what that means (without the jargon)
[6] This means they are prepared for an individual patient based on a prescription, using pharmaceutical-grade ingredients, but they have not undergone FDA evaluation for safety or efficacy as a manufactured product
(Ethics batch number: 2021-61, S-BPM-5-002-01)
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Since then, it has gained attention for its low prices compared to traditional pharmacies, where drugs can cost considerably more for those who are uninsured or have a high-deductible plan