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Safety, Product Integrity, and the Problem of Unregulated Supply The primary clinical concern is not simply uncertainty regarding biologic effects, but uncertainty regarding product composition, sterility, and manufacturing quality

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In addition, as the commenter suggested a need for smoothing, we note that a smoothing function is already incorporated in the calculation of ASP payment limits by section 1847A(c)(5)(A) of the Act and codified at 414.804(a)(3), which requires manufacturers to factor a 12-month rolling average to estimate the costs attributable to rebates and chargebacks