Drug, and Cosmetic Act (21 U.S.C. 321); 
and 
(ii) includes a biological product, as 
defined in section 351 of the Public Health 
Service Act (42 U.S.C. 262). 
(B) The term ‘‘over-the-counter’’, with re-
spect to a drug, means not subject to section 
503(b)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(b)(1)). 
(C) The term ‘‘prescription’’, with respect 
to a drug, means subject to section 503(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)(1)). 
(6) FUNDING.—The Administrator shall carry 
out this subsection using funds appropriated out of 
the Water Protection and Reinvestment Trust Fund 
that are allocated for that purpose under section 
102. 
(b) LABELING OF DRUGS AND BIOLOGICAL PROD-
UCTS.— 
(1) PROHIBITION ON LABELING RECOMMENDA-
TIONS
TO
DISPOSE
OF
DRUGS
AND
BIOLOGICAL 
PRODUCTS BY FLUSHING.—Section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended by adding at the end the following: 
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‘‘(w) NO LABELING RECOMMENDATIONS TO DIS-
POSE BY FLUSHING.—In approving an application for a 
drug under this section, the Secretary of Health and 
Human Services shall ensure that the labeling for such 
drug does not include any recommendation or direction to 
dispose of the drug by means of a public or private waste-
water treatment system, such as by flushing down the toi-
let.’’. 
(2) BIOLOGICAL
PRODUCTS.—Section 351 of 
the Public Health Service Act (42 U.S.C. 262) is 
amended by adding at the end the following: 
‘‘(k) NO LABELING RECOMMENDATIONS TO DISPOSE 
BY FLUSHING.—In licensing any biological product under 
this section, the Secretary shall ensure that the labeling 
for such product does not include any recommendation or 
direction to dispose of the product by means of a public 
or private wastewater treatment system, such as by flush-
ing down the toilet.’’ 
(3) DRUGS
AND
BIOLOGICAL
PRODUCTS
AL-
READY MARKETED.— 
(A) LABELING REVISION.—With respect to 
drugs and biological products that are legally 
marketed under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.) or part 
F of title III of the Public Health Service Act 
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(42 U.S.C. 262 et seq.) as of the date of enact-
ment of this Act, the Secretary of Health and 
Human Services, acting through the Commis-
sioner of Food and Drugs— 
(i) shall conduct a review of the label-
ing of such drugs and biological products; 
and 
(ii) for any such labeling that includes 
a recommendation or direction to dispose 
of the drug or biological product by means 
of a public or private wastewater treatment 
system, such as by flushing down the toi-
let, shall order the labeling to be revised to 
exclude such recommendation or direction. 
(B) PENALTY.—Any drug or biological 
product whose labeling is in violation of an 
order issued under subparagraph (A)(ii) is 
deemed to be misbranded under section 502 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352). 
(C) EFFECTIVE
DATE.—An order issued 
under subparagraph (A)(ii) shall take effect not 
later than one year after the date of enactment 
of this Act. 
(D) DEFINITIONS.—In this subsection: 
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(i) BIOLOGICAL PRODUCT.—The term 
‘‘biological product’’ has the meaning given 
to such term in section 351 of the Public 
Health Service Act (42 U.S.C. 262). 
(ii) 
DRUG
AND
LABELING.—The 
terms ‘‘drug’’ and ‘‘labeling’’ have the 
meanings given to such terms in section 
201 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321). 
SEC. 410. STATE REVOLVING FUND REVIEW PROCESS. 
As soon as practicable after the date of enactment 
of this Act, the Administrator shall— 
(1) consult with States, utilities, nonprofit orga-
nizations, and other Federal agencies providing fi-
nancial assistance to identify ways to expedite and 
improve the application and review process for the 
provision of assistance from— 
(A) the State water pollution control re-
volving funds established under title VI of the 
Federal Water Pollution Control Act (33 U.S.C. 
1381 et seq.); and 
(B) the State drinking water treatment re-
volving loan funds established under section 
1452 of the Safe Drinking Water Act (42 
U.S.C. 300j–12); 
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(2) consider the needs of treatment works and 
public water systems in carrying out such Acts and 
this Act; 
(3) take such administrative action as is nec-
essary to expedite and improve the process as the 
Administrator has authority to take under existing 
law; 
(4) collect information relating to innovative ap-
proaches taken by any State to simplify the applica-
tion process of the State and provide the information 
to each State; and 
(5) submit to Congress a report that, based on 
the information identified under paragraph (1), con-
tains recommendations for legislation to facilitate 
further streamlining and improvement of the process 
described in paragraph (1). 
Æ 
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