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Because alpha-lipoic acid injection is not an FDA-approved drug product, compounded formulations cannot make therapeutic claims, and all preparation and distribution must occur within the regulatory framework governing 503B outsourcing facilities
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Products are not intended to diagnose, treat, cure, mitigate, or prevent any disease
Therefore, there is an urgent need to develop AIE probes with stronger targeting, more stability, and more convenient drug delivery for clinical applications
Sterile water lacks a preservative and should only be used for single-use reconstitution
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