Realistic timeline summary Best case scenario: FDA approval Q4 2027, commercial launch Q2 2028, widespread pharmacy availability Q3-Q4 2028, insurance coverage decisions finalized Q4 2028
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Given the relatively lower risk of these kinds of small-batch and temporary operations, it isnt legally necessary for compounders to jump through all the regulatory hoops that are required of commercial drug manufacturers to market a product, nor would it be feasible, Michael Ganio, PharmD, senior director of pharmacy practice and quality at American Society of Health-System Pharmacists, tells SELF
This gives athletes and support personnel sufficient time to make themselves aware of the changes, review any medications they use on Global DRO, and apply for a Therapeutic Use Exemption (TUE) if required before the updated List comes into effect on 1 January 2025