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In addition, section 1833(t)(1)(B)(v) of the Act does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after January 1, 2017, by an off-campus outpatient department of a provider (as defined in subparagraph (B) of paragraph (21))

reconstituted stable 46 weeks at 28C (avoid repeated freeze-thaw) All batches undergo third-party analytical testing for purity, identity, and contaminants