Limitation of application of functional equivalence standard
(i) In general
(i)In general#
The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph.
(ii)Application#
Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after December 8, 2003 , unless—
(I) such application was being made to such drug or biological prior to December 8, 2003 ; and
(II) the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter.
(ii)(I)#
such application was being made to such drug or biological prior to December 8, 2003 ; and
(ii)(II)#
the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter.
(iii)Rule of construction#
Nothing in this subparagraph shall be construed to effect the Secretary’s authority to deem a particular drug to be identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs.