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Deficiencies in these can be linked

A: The product is available in 30ml and 100ml volumes

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For this final rule, we are adding 427.301(c) to describe how CMS will apportion the Part B rebate amount when there are multiple NDCs in a grouped billing and payment code and when manufacturer-reported ASP units for such NDCs lack manufacturer-reported ASP units during the applicable calendar quarter, have negative manufacturer-reported ASP units during the applicable calendar quarter, or have manufacturer-reported ASP units equal to zero during the applicable calendar quarter

How is batch quality verified