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10.1111/j.1463-1326.2010.01214.x 106 LimK
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The effect was functionally similar to a coverage removal, as the barriers to approval became high enough that many patients could not navigate the process successfully
The issue is, is that the law doesn't sort of draw a line between the scale for compounding versus when it becomes commercial manufacturing
doi: 10.1016/j.celrep.2013.05.005 153
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