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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

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

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