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Campbell JE, Drucker DJ

An authorized generic is different from a generic drug, according to the FDA, because its the exact same drug product as a branded drug, just without the brand name on the label

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How to read mg, mL, and units When a label says 0.6 mg, its describing the amount of drug

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The Federal Register notice states that the agency found "no clinical need for outsourcing facilities to compound these drugs from bulk substances." This proposal specifically targets Section 503B outsourcing facilities FDA-registered compounding operations that can produce and distribute drugs at scale without individual patient prescriptions