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Product that was USP-compliant when it left the original manufacturer may no longer be compliant after repackaging, and the repackager typically does not perform the release testing that would detect the degradation

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Comment: Several commenters requested clarification on how to document that a practice meets the 24/7 access to care requirement if a patient receiving APCM services does not use after-hours care in a given month, and asked if they would need to document in each patient's medical record that the practice has 24/7 access to care