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Ilisa Bernstein, a former FDA official and pharmacist specializing in drug and pharmacy policy, told NPR that the agency bears a "responsibility to ensure that there's some level of safety before they become widely available," while acknowledging that once compounding is authorized, "any pharmacy can compound these products." The distinction between compounding eligibility and drug approval remains critical

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The clinical trial data is specifically reassuring on this point: across six trials involving approximately 900 participants, glucose levels, insulin levels, and markers of insulin sensitivity remained unchanged from baseline