Sole source drugs
The term “sole source drug” means—
(I)#
a biological product (as defined under section 1395x(t)(1) of this title ); or
(II)#
a single source drug (as defined in section 1396r–8(k)(7)(A)(iv) of this title ).
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The term “sole source drug” means—
a biological product (as defined under section 1395x(t)(1) of this title ); or
a single source drug (as defined in section 1396r–8(k)(7)(A)(iv) of this title ).