H.L.C.
(B) Strike ‘‘(b) SECTION 505(j).—’’ and
all that follows through ‘‘‘(3)(A) The Secretary
shall’’ and insert the following:
‘‘(b) SECTION 505(j).—Section 505(j) (21 U.S.C.
355(j)) is amended by adding at the end the following
paragraph:
‘‘‘(9)(A) The Secretary shall’’.
(2) In section 123 of the bill, strike subsection
(g) and insert the following:
‘‘(g) APPLICATION OF FEDERAL FOOD, DRUG, AND
COSMETIC ACT.—
‘‘(1) IN GENERAL.—Section 351 of the Public
Health Service Act (42 U.S.C. 262), as amended by
subsection (d), is further amended by adding at the
end the following:
‘‘‘(j) The Federal Food, Drug, and Cosmetic Act ap-
plies to a biological product subject to regulation under
this section, except that—
‘‘‘(1) a product for which a license has been ap-
proved under subsection (a) shall not be required to
have an approved application under section 505 of
such Act; and
‘‘‘(2) the amendments made to section 505 of
such Act by title I of Public Law 98–417 shall not
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apply to a biological product for which a license has
been approved under subsection (a).’’’.
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in
this Act or the amendments made by this Act shall
affect the question of the applicability of any provi-
sion of section 505 of the Federal Food, Drug, and
Cosmetic Act to a biological product for which an
application has been approved under section 505 of
such Act.’’.
(3) In section 125(d)(2) of the bill, in the mat-
ter preceding subparagraph (A), insert after ‘‘anti-
biotic drug’’ the second place such term appears the
following: ‘‘(including any salt or ester of the anti-
biotic drug)’’.
(4) In section 127(a) of the bill: In section
503A of the Federal Food, Drug, and Cosmetic Act
(as proposed to be inserted by such section 127(a)),
in the second sentence of subsection (d)(2), strike
‘‘or other criteria’’ and insert ‘‘and other criteria’’.
(5) In section 412(c) of the bill:
(A) In subparagraph (1) of section 502(e)
of the Federal Food, Drug, and Cosmetic Act
(as proposed to be amended by such section
412(c)), in subclause (iii) of clause (A), insert
H.L.C.
before the period the following: ‘‘or to prescrip-
tion drugs’’.
(B) Strike ‘‘(c) MISBRANDING.—Subpara-
graph (1) of section 502(e)’’ and insert the fol-
lowing:
‘‘(c) MISBRANDING.—
‘‘(1) IN GENERAL.—Subparagraph (1) of sec-
tion 502(e)’’.
(C) Add at the end the following:
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in
this Act or the amendments made by this Act shall
affect the question of the authority of the Secretary
of Health and Human Services regarding inactive
ingredient labeling for prescription drugs under sec-
tions of the Federal Food, Drug, and Cosmetic Act
other than section 502(e)(1)(A)(iii).’’.
(6) Strike section 501 of the bill and insert the
following:
‘‘SEC. 501. EFFECTIVE DATE.
‘‘(a) IN GENERAL.—Except as otherwise provided in
this Act, this Act and the amendments made by this Act
shall take effect 90 days after the date of enactment of
this Act.
‘‘(b) IMMEDIATE EFFECT.—Notwithstanding sub-
section (a), the provisions of and the amendments made
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by sections 111, 121, 125, and 307 of this Act, and the
provisions of section 510(m) of the Federal Food, Drug,
and Cosmetic Act (as added by section 206(a)(2)), shall
take effect on the date of enactment of this Act.’’.