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The label describes the regulatory pathway

In Vivo Biodistribution and Pharmacokinetics CQDs demonstrate organ-specific accumulation influenced by particle size, surface charge, and administration route

Commenters asserted that the proposals are not authorized by and conflict with CMS's statutory authority, are arbitrary and capricious, and require new unsupported expansive interpretations of the statute

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Providers need reliable sourcing, pharmacy coordination, clear clinical guidance, and confidence in when newer compounds actually make sense for the patient sitting in front of them