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Per the telehealth consent published by OpenLoop Healthcare Partners, PC: "The FDA does not approve nor review compounded products for safety, effectiveness, or quality." Compounding pharmacies are licensed and subject to state pharmacy board regulations and federal law under the Drug Quality and Security Act, but the oversight framework is meaningfully different from the pre-market approval process that governs brand-name drugs - and buyers who understand that distinction can ask better questions before their first shipment arrives
However, some patients switch from brand-name pens to compounded vials for cost reasons
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