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Since then, several clinical studies have shown its safe and effective use - but the pharmacuetical companies have decided not to (yet) pursue FDA-Approval (likely because each new FDA-Approval costs several million dollars to go through the process, and because there are a good deal of drugs used off-label in the way tranexamic acid is for melasma, especially when the drug has a long history of safety and efficacy, as is in this case)

Likewise, Oracle Peptides is not an outsourcing facility under Section 503B of the same Act

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