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The process of reconstitution, turning that stable powder back into a usable liquid solution, is far more than just adding water

It is not approved for human or animal use and must not be administered outside controlled in-vitro research environments

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(2015) 33:abstract 8574

therefore, CMS believes that the revised regulatory text of 427.303(b)(1) more accurately reflects our policies described in the Medicare Part B Drug Inflation Rebate Revised Guidance

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