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It does not appear on the bulks list at 21 CFR 216.23(a), it is no longer in any category of FDA’s interim compounding policy because the nominator withdrew the nomination, and FDA continues to publish the safety concern it identified, stating that “FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment.” Unauthorized is not the same as prohibited: TB-500 is not among the finished drug products withdrawn from the market at 21 CFR 216.24, so the accurate description is unauthorized rather than banned, and unauthorized is not a green light either
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