use, both in number and volume of sales, in-
cluding any sales made by the Internet or other 
means; and 
‘‘(B) excludes any entity listed in subpara-
graph (A) that does not sell any covered drug 
described in paragraph (1)(A).’’. 
(c) CIVIL PENALTIES.—Section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend-
ed by adding at the end the following: 
‘‘(h) A retailer that violates section 301(eee) shall not 
be subject to subsection (a) or any civil monetary penalty 
under this Act for such violation except as follows: 
‘‘(1) If the Secretary finds that a retailer fails 
to have a verification system in violation of section 
301(eee)— 
‘‘(A) upon the first such finding, the Sec-
retary shall issue a formal notice of violation 
and give the retailer a period of at least 30 
days (beginning on the receipt of such notice) 
to correct the violation; 
‘‘(B) upon the second such finding, the re-
tailer shall be subject to a civil penalty of not 
more than $1,000; 
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‘‘(C) upon the third such finding, the re-
tailer shall be subject to a civil penalty of not 
more than $2,000; and 
‘‘(D) upon the fourth and any subsequent 
such finding, the retailer shall be subject to a 
civil penalty of not more than $5,000. 
‘‘(2) In determining the amount of a civil pen-
alty under this subsection for a retailer, the Sec-
retary shall consider whether the retailer has taken 
appropriate steps to prevent subsequent violations, 
such as the establishment and administration of a 
documented employee training program to ensure all 
employees are familiar with, and abiding by, the re-
tailer’s verification system established pursuant to 
section 506H, where such program includes— 
‘‘(A) educating employees regarding cov-
ered drugs; 
‘‘(B) instruction on the correct method of 
checking a purchaser’s identification card; and 
‘‘(C) notifying employees of the civil pen-
alties under this subsection. 
‘‘(3) If a retailer transacts sales of covered 
drugs at more than one physical location, for pur-
poses of determining the number of violations by 
that retailer under this subsection, each individual 
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physical location operated by that retailer shall be 
considered a separate retailer. 
‘‘(4) The Secretary shall notify retailers found 
to have violated section 301(eee) as soon as prac-
ticable after the Secretary discovers such violation. 
Such notification shall include the date and time 
when the failure to have a verification system as re-
quired by such section was observed to occur. 
‘‘(5) In this subsection, the terms ‘covered 
drug’ and ‘retailer’ have the meanings given such 
terms in section 506H.’’. 
(d) APPLICABILITY.—The amendments made by sub-
sections (a), (b), and (c) shall apply with respect to drugs 
sold or offered for sale on or after the date that is one 
year after the date of enactment of this Act. 
(e) SENSE OF CONGRESS REGARDING COMMUNICA-
TION BY ORGANIZATIONS NOMINATED BY MANUFACTUR-
ERS.—It is the sense of Congress that organizations nomi-
nated by manufacturers of covered drugs (as defined in 
section 506H of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (c)) should make reasonable 
efforts to communicate to retailers (as defined in such sec-
tion 506H) the requirements of such section 506H, includ-
ing by making available upon request materials (which 
may include signage, manuals, materials, or programs) to 
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assist with educating employees regarding such covered 
drugs. 
SEC. 
3. 
RESTRICTIONS 
ON 
DISTRIBUTION 
OF 
BULK 
DEXTROMETHORPHAN. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended— 
(1) in section 301 (21 U.S.C. 331) (as amended 
by section 2(a)) by adding at the end the following: 
‘‘(ggg) The possession, receipt, or distribution of un-
finished dextromethorphan in violation of section 506I.’’; 
(2) by inserting after section 506H (as added 
by section 2(b)) the following: 
‘‘SEC. 506I. RESTRICTIONS ON THE DISTRIBUTION OF BULK 
DEXTROMETHORPHAN. 
‘‘(a) IN GENERAL.—No person shall— 
‘‘(1) 
possess 
or 
receive 
unfinished 
dextromethorphan, unless the person is registered 
under section 510 or otherwise registered, licensed, 
or approved pursuant to Federal or State law to en-
gage in— 
‘‘(A) the practice of pharmacy; or 
‘‘(B) drug or drug ingredient discovery, 
production, manufacture, or distribution; or 
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‘‘(2) distribute unfinished dextromethorphan to 
any person other than a person described in para-
graph (1). 
‘‘(b) EXCEPTION
FOR COMMON CARRIERS.—This 
section does not apply to a common carrier that possesses, 
receives, or distributes unfinished dextromethorphan for 
purposes 
of 
distributing 
such 
unfinished 
dextromethorphan between persons described in sub-
section (a). 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) The term ‘common carrier’ means any per-
son that holds itself out to the general public as a 
provider for hire of the transportation by water, 
land, or air of merchandise, whether or not the per-
son actually operates the vessel, vehicle, or aircraft 
by which the transportation is provided, between a 
port or place and a port or place in the United 
States. 
‘‘(2) The term ‘unfinished dextromethorphan’ 
means dextromethorphan that is not contained in a 
drug that is in finished dosage form.’’; and 
(3) by amending section 303, as amended by 
section 2(c), by adding at the end the following: 
‘‘(i) A person that violates section 301(ggg) shall not 
be subject to subsection (a) or any civil monetary penalty 
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under this Act for such violation except such person shall 
be subject to a civil penalty in an amount of not more 
than $100,000.’’. 
(b) APPLICABILITY.—The amendments made by this 
section apply beginning on the date of enactment of this 
Act. 
Æ 
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