Classes of drugs
For purposes of this paragraph:
(i) 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 ).
(ii) Innovator multiple source drugs The term “innovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(ii) of this title .
(iii) Noninnovator multiple source drugs The term “noninnovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(iii) of this title .
(i)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 ).
(i)(I)#
a biological product (as defined under section 1395x(t)(1) of this title ); or
(i)(II)#
a single source drug (as defined in section 1396r–8(k)(7)(A)(iv) of this title ).
(ii)Innovator multiple source drugs#
The term “innovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(ii) of this title .
(iii)Noninnovator multiple source drugs#
The term “noninnovator multiple source drug” has the meaning given such term in section 1396r–8(k)(7)(A)(iii) of this title .