[House Report 114-672]
[From the U.S. Government Publishing Office]
114th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 114-672
======================================================================
DXM ABUSE PREVENTION ACT OF 2015
_______
July 8, 2016.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3250]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3250) to amend the Federal Food, Drug, and
Cosmetic Act to prevent the abuse of dextromethorphan, and for
other purposes, having considered the same, report favorably
thereon without amendment and recommend that the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 1
Background and Need for Legislation.............................. 2
Hearings......................................................... 2
Committee Consideration.......................................... 2
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Statement of General Performance Goals and Objectives............ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 6
Duplication of Federal Programs.................................. 6
Disclosure of Directed Rule Makings.............................. 6
Advisory Committee Statement..................................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
Purpose and Summary
H.R. 3250 amends the Federal Food, Drug, and Cosmetic Act
to ban the sale of drugs containing dextromethorphan (DXM) to
individuals under age 18 unless such individuals have a
prescription or are actively enrolled in the military. H.R.
3250 would also place restrictions on the distribution of bulk
dextromethorphan.
Background and Need for Legislation
This legislation builds on recommendations by the Food and
Drug Administration's (``FDA'') Drug Safety and Risk Management
Advisory Committee (``DSaRM'') made during a September 14, 2010
meeting to discuss dextromethorphan. The meeting agenda
included discussion of the abuse potential of dextromethorphan,
public health benefits and risks of dextromethorphan use as a
cough suppressant in prescription and non-prescription drug
products, bulk sales of dextromethorphan, and strategies for
addressing abuse concerns. Before the meeting, the Drug
Enforcement Administration (``DEA'') requested the Department
of Health and Human Services (``HHS'') provide a scientific and
medical evaluation and scheduling recommendation for
dextromethorphan in response to increased incidence of abuse,
especially among adolescents.\1\ The DSaRM discussed this issue
at length and concluded that HHS should not recommend the DEA
schedule dextromethorphan. However, DSaRM recognized other
actions were needed to balance two competing public health
concerns: (1) the rising rates of teens abusing large amounts
of cough medicine containing dextromethorphan to get high; and,
(2) the need for millions of Americans to have access to
dextromethorphan-containing medications to alleviate cough
symptoms. Consumer education and age verification were two
ideas discussed with potential to help resolve this tension.
---------------------------------------------------------------------------
\1\http://www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
DrugSafetyandRiskManagementAdvisoryCommittee/UCM228267.pdf (p. 15).
---------------------------------------------------------------------------
There has been private sector collaboration to help educate
parents and teens about the dangers of abusing cough
medications containing dextromethorphan. Additionally, twelve
states have passed laws that prohibit sales of these products
to minors and require age verification when these products are
purchased. As a result of such efforts, rates of teen abuse of
dextromethorphan-containing products is on the decline. H.R.
3250 requires retailers across the country to have systems in
place for age verification. By limiting teen access to these
products, teen abuse of dextromethorphan should decrease even
further without impacting the millions of consumers that
purchase these products for medically valid reasons.
Hearings
The Subcommittee on Health has not held hearings on H.R.
3250.
Committee Consideration
On April 20, 2016, the Subcommittee on Health met in open
markup session and forwarded H.R. 3250 to the full Committee,
without amendment, by a voice vote. On April 26, 27, and 28,
2016, the full Committee on Energy and Commerce met in open
markup session and ordered H.R. 3250 reported to the House,
without amendment, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 3250 reported.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held hearings
on this legislation.
Statement of General Performance Goals and Objectives
The goal of H.R. 3250 is to help reduce rates of
dextromethorphan abuse by requiring retailers selling cough
medicine containing dextromethorphan to implement age
verification systems that prohibit sales to children under 18.
H.R. 3250 would also prohibit sales of raw or ``bulk''
dextromethorphan to individuals that are not registered,
licensed, or approved under Federal or state law to engage in
the practice of pharmacy or drug or drug ingredient discovery,
production, manufacture, or distribution.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
3250 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 3250 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
H.R. 3250--DXM Abuse Prevention Act of 2015
Summary: H.R. 3250 would prohibit the sale of certain over-
the-counter drug products containing dextromethorphan (DXM) to
individuals under the age of 18 and would restrict the
distribution of unfinished DXM. The bill would also authorize
civil penalties if those restrictions are not followed. CBO
estimates that the Food and Drug Administration's (FDA's)
programs to enforce compliance with the bill's prohibitions
would cost $232 million over the 2017-2021 period, assuming
appropriation of the necessary amounts. In addition, CBO
estimates that the bill would increase revenues from civil
penalties by less than $500,000 over the 2017-2026 period
because we expect that retailers and other distributors will
abide by the bill's restrictions.
Pay-as-you-go procedures apply because enacting H.R. 3250
would affect revenues. CBO estimates that enacting H.R. 3250
would not increase net direct spending or on-budget deficits in
any of the four consecutive 10-year periods beginning in 2027.
The bill would impose an intergovernmental and private-
sector mandate as defined in the Unfunded Mandates Reform Act
(UMRA) on retailers that sell over-the-counter drugs containing
DXM. The bill would impose additional private-sector mandates
on purchasers of over-the-counter drugs containing DXM and
purchasers and sellers of unfinished DXM. Based on information
from FDA and industry sources, CBO estimates that the cost of
complying with the mandates would fall below the annual
thresholds established in UMRA for intergovernmental and
private-sector mandates ($77 million and $154 million in 2016,
respectively, adjusted annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary effect of H.R. 3250 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2017 2018 2019 2020 2021 2017-2021
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level........................... 20 41 64 66 68 259
Estimated Outlays....................................... 14 33 55 63 66 232
----------------------------------------------------------------------------------------------------------------
Notes: H.R. 3250 would also increase revenues; however, CBO estimates those increases would be insignificant.
Components may not sum to totals because of rounding.
Basis of estimate: H.R. 3250 would require all retailers
who sell products containing DXM to have a verification system
in place to ensure that those products are not sold to persons
less than 18 years of age without a prescription. The bill
would require FDA to create a program to enforce those
restrictions.
The FDA is responsible for similar activities under the
Tobacco Retail Compliance Check Program. Through that program,
FDA contracts with states to assist in inspecting the
verification systems of retailers that sell tobacco products.
In fiscal year 2015, FDA awarded about $45 million in contracts
to participating states for these purposes. Assuming that FDA
would develop a similar enforcement program for DXM sales and
appropriation of the necessary amounts, CBO estimates that
implementing H.R. 3250 would cost $232 million over the 2017-
2021 period.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. CBO estimates that the net changes in revenues that
are subject to those pay-as-you-go procedures would not be
significant.
Increase in long-term direct spending and deficits: CBO
estimates that enacting the legislation would not increase net
direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2027.
Intergovernmental and private-sector impact: The bill would
impose intergovernmental and private-sector mandates as defined
in UMRA. Based on information from FDA and industry sources,
CBO estimates that the cost of complying with the mandates
would fall below the annual thresholds established in UMRA for
intergovernmental and private-sector mandates ($77 million and
$154 million in 2016, respectively, adjusted annually for
inflation).
Mandates that affect both public and private entities
The bill would require retailers that sell over-the-counter
drugs containing DXM to implement a verification system to
ensure that purchasers of those drugs are at least 18 years
old. Affected retailers would include pharmacies and
convenience stores at public institutions, although they make
up a fraction of the total number of entities affected by the
bill. According to data from the Census Bureau, hundreds of
thousands of entities sell over-the-counter drugs. However,
based on information from industry sources, CBO expects that
most sales of products with DXM occur in states with laws that
already prohibit sales to minors or are sold by retailers with
company policies that prohibit such sales. Consequently, CBO
expects that many retailers already comply with the bill's
requirements. Moreover, based on a review of the regulatory
cost analyses of similar federal requirements, CBO estimates
that the incremental cost to the industry of complying with the
mandate would not be significant relative to the annual
thresholds in UMRA.
Mandates that affect private entities only
The bill would impose a private-sector mandate on some
individuals by requiring them to show identification to
purchase over-the-counter drugs containing DXM. Additionally,
the bill would impose a mandate on individuals under the age of
18 by prohibiting them from purchasing such products. CBO
estimates that the cost of showing identification would be
negligible. Additionally, CBO estimates that the cost to comply
with the prohibition would be minimal because a minor would
generally be able to either buy a substitute product or have
other individuals (for example, a parent or guardian) purchase
products with DXM for them if needed.
The bill also would impose a mandate by requiring any
entity that possesses or receives unfinished DXM to be
registered, licensed, or approved under federal or state law to
practice pharmacy, engage in pharmaceutical production, or
manufacture or distribute drug ingredients. Based on
information from industry sources, CBO estimates that the cost
of the mandate would be minimal, because entities that possess
or receive unfinished DXM are typically registered, licensed,
or approved under those federal or state laws. The bill would
also impose a mandate on sellers of unfinished DXM by requiring
them to confirm that the buyer is legally allowed to make the
purchase. This verification process would require additional
administrative work for sellers, but CBO estimates that the
cost would be negligible.
Estimate prepared by: Federal Costs: Ellen Werble; Impact
on State, Local, and Tribal Governments: Leo Lex; Impact on the
Private Sector: Amy Petz.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 3250 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 3250
specifically directs to be completed 0 rule makings within the
meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides the short title of DXM Abuse Prevention
Act of 2015.
Section 2. Sales of over-the-counter drugs containing dextromethorphan
This section requires retailers that sell products
containing dextromethorphan, within one year of enactment, to
establish a system to verify that purchasers are at least 18
years of age, or have a military ID, or a prescription.
Section 3. Restrictions on distribution of bulk dextromethorphan
This section prohibits bulk sales of unfinished
dextromethorphan to individuals that are not registered,
licensed, or approved under Federal or state law to engage in
the practice of pharmacy, pharmaceutical production,
manufacture, or distribution of drug ingredients.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
prohibited acts
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) The introduction or delivery for introduction into
interstate commerce of any food, drug, device, tobacco product,
or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug,
device, tobacco product, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug,
device, tobacco product, or cosmetic that is adulterated or
misbranded, and the delivery or proffered delivery thereof for
pay or otherwise.
(d) The introduction or delivery for introduction into
interstate commerce of any article in violation of section 404,
415, 505, or 564.
(e) The refusal to permit access to or copying of any record
as required by section 412, 414, 417(j), 416, 504, 564, 703,
704(a), 760, or 761; or the failure to establish or maintain
any record, or make any report, required under section 412,
414(b), 417, 416, 504, 505 (i) or (k), 512(a)(4)(C), 512 (j),
(l) or (m), 572(i), 515(f), 519, 564, 760, 761, 909, or 920 or
the refusal to permit access to or verification or copying of
any such required record; or the violation of any recordkeeping
requirement under section 204 of the FDA Food Safety
Modernization Act (except when such violation is committed by a
farm).
(f) The refusal to permit entry or inspection as authorized
by section 704.
(g) The manufacture within any Territory of any food, drug,
device, tobacco product, or cosmetic that is adulterated or
misbranded.
(h) The giving of a guaranty or undertaking referred to in
section 303(c)(2), which guaranty or undertaking is false,
except by a person who relied upon a guaranty or undertaking to
the same effect signed by, and containing the name and address
of, the person residing in the United States from whom he
received in good faith the food, drug, device, tobacco product,
or cosmetic; or the giving of a guaranty or undertaking
referred to in section 303(c)(3), which guaranty or undertaking
is false.
(i)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark,
stamp, tag, label, or other identification device authorized or
required by regulations promulgated under the provisions of
section 404 or 721.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate,
stone, or other thing designed to print, imprint, or reproduce
the trademark, trade name, or other identifying mark, imprint,
or device of another or any likeness of any of the foregoing
upon any drug or container or labeling thereof so as to render
such drugs a counterfeit drug.
(3) The doing of any act which causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for
sale or dispensing, of a counterfeit drug.
(j) The using by any person to his own advantage, or
revealing, other than to the Secretary or officers or employees
of the Department, or to the courts when relevant in any
judicial proceeding under this Act, any information acquired
under authority of section 404, 409, 412, 414, 505, 510, 512,
513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708,
721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any
method or process which as a trade secret is entitled to
protection; or the violating of section 408(i)(2) or any
regulation issued under that section. This paragraph does not
authorize the withholding of information from either House of
Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of such
joint committee.
(k) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the
doing of any other act with respect to, a food, drug, device,
tobacco product, or cosmetic, if such act is done while such
article is held for sale (whether or not the first sale) after
shipment in interstate commerce and results in such article
being adulterated or misbranded.
(m) The sale or offering for sale of colored oleomargarine or
colored margarine, or the possession or serving of colored
oleomargarine or colored margarine in violation of section
407(b) or 407(c).
(n) The using, in labeling, advertising or other sales
promotion of any reference to any report or analysis furnished
in compliance with section 704.
(o) In the case of a prescription drug distributed or offered
for sale in interstate commerce, the failure of the
manufacturer, packer, or distributor thereof to maintain for
transmittal, or to transmit, to any practitioner licensed by
applicable State law to administer such drug who makes written
request for information as to such drug, true and correct
copies of all printed matter which is required to be included
in any package in which that drug is distributed or sold, or
such other printed matter as is approved by the Secretary.
Nothing in this paragraph shall be construed to exempt any
person from any labeling requirement imposed by or under other
provisions of this Act.
(p) The failure to register in accordance with section 510 or
905, the failure to provide any information required by section
510(j), 510(k), 905(i), or 905(j), or the failure to provide a
notice required by section 510(j)(2) or 905(i)(3).
(q)(1) The failure or refusal--
(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), 907, 908, or 915;
(B) to furnish any notification or other material or
information required by or under section 519, 520(g),
904, 909, or 920; or
(C) to comply with a requirement under section 522 or
913.
(2) With respect to any device or tobacco product, the
submission of any report that is required by or under this Act
that is false or misleading in any material respect.
(r) The movement of a device or tobacco product in violation
of an order under section 304(g) or the removal or alteration
of any mark or label required by the order to identify the
device or tobacco product as detained.
(s) The failure to provide the notice required by section
412(c) or 412(e), the failure to make the reports required by
section 412(f)(1)(B), the failure to retain the records
required by section 412(b)(4), or the failure to meet the
requirements prescribed under section 412(f)(3).
(t) The importation of a drug in violation of section
801(d)(1), the sale, purchase, or trade of a drug or drug
sample or the offer to sell, purchase, or trade a drug or drug
sample in violation of section 503(c), the sale, purchase, or
trade of a coupon, the offer to sell, purchase, or trade such a
coupon, or the counterfeiting of such a coupon in violation of
section 503(c)(2), the distribution of a drug sample in
violation of section 503(d) or the failure to otherwise comply
with the requirements of section 503(d), the distribution of
drugs in violation of section 503(e), failure to comply with
the requirements under section 582, the failure to comply with
the requirements under section 584, as applicable, or the
failure to otherwise comply with the requirements of section
503(e).
(u) The failure to comply with any requirements of the
provisions of, or any regulations or orders of the Secretary,
under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
(v) The introduction or delivery for introduction into
interstate commerce of a dietary supplement that is unsafe
under section 413.
(w) The making of a knowingly false statement in any
statement, certificate of analysis, record, or report required
or requested under section 801(d)(3); the failure to submit a
certificate of analysis as required under such section; the
failure to maintain records or to submit records or reports as
required by such section; the release into interstate commerce
of any article or portion thereof imported into the United
States under such section or any finished product made from
such article or portion, except for export in accordance with
section 801(e) or 802, or with section 351(h) of the Public
Health Service Act; or the failure to so export or to destroy
such an article or portions thereof, or such a finished
product.
(x) The falsification of a declaration of conformity
submitted under section 514(c) or the failure or refusal to
provide data or information requested by the Secretary under
paragraph (3) of such section.
(y) In the case of a drug, device, or food--
(1) the submission of a report or recommendation by a
person accredited under section 523 that is false or
misleading in any material respect;
(2) the disclosure by a person accredited under
section 523 of confidential commercial information or
any trade secret without the express written consent of
the person who submitted such information or secret to
such person; or
(3) the receipt by a person accredited under section
523 of a bribe in any form or the doing of any corrupt
act by such person associated with a responsibility
delegated to such person under this Act.
(z) The dissemination of information in violation of section
551.
(aa) The importation of a prescription drug in violation of
section 804, the falsification of any record required to be
maintained or provided to the Secretary under such section, or
any other violation of regulations under such section.
(bb) The transfer of an article of food in violation of an
order under section 304(h), or the removal or alteration of any
mark or label required by the order to identify the article as
detained.
(cc) The importing or offering for import into the United
States of an article of food by, with the assistance of, or at
the direction of, a person debarred under section 306(b)(3).
(dd) The failure to register in accordance with section 415.
(ee) The importing or offering for import into the United
States of an article of food in violation of the requirements
under section 801(m).
(ff) The importing or offering for import into the United
States of a drug or device with respect to which there is a
failure to comply with a request of the Secretary to submit to
the Secretary a statement under section 801(o).
(gg) The knowing failure to comply with paragraph (7)(E) of
section 704(g); the knowing inclusion by a person accredited
under paragraph (2) of such section of false information in an
inspection report under paragraph (7)(A) of such section; or
the knowing failure of such a person to include material facts
in such a report.
(hh) The failure by a shipper, carrier by motor vehicle or
rail vehicle, receiver, or any other person engaged in the
transportation of food to comply with the sanitary
transportation practices prescribed by the Secretary under
section 416.
(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 760
or 761) or the falsification of a serious adverse event report
(as defined under section 760 or 761) submitted to the
Secretary.
(jj)(1) The failure to submit the certification required by
section 402(j)(5)(B) of the Public Health Service Act, or
knowingly submitting a false certification under such section.
(2) The failure to submit clinical trial information required
under subsection (j) of section 402 of the Public Health
Service Act.
(3) The submission of clinical trial information under
subsection (j) of section 402 of the Public Health Service Act
that is false or misleading in any particular under paragraph
(5)(D) of such subsection (j).
(kk) The dissemination of a television advertisement without
complying with section 503B.
(ll) The introduction or delivery for introduction into
interstate commerce of any food to which has been added a drug
approved under section 505, a biological product licensed under
section 351 of the Public Health Service Act, or a drug or a
biological product for which substantial clinical
investigations have been instituted and for which the existence
of such investigations has been made public, unless--
(1) such drug or such biological product was marketed
in food before any approval of the drug under section
505, before licensure of the biological product under
such section 351, and before any substantial clinical
investigations involving the drug or the biological
product have been instituted;
(2) the Secretary, in the Secretary's discretion, has
issued a regulation, after notice and comment,
approving the use of such drug or such biological
product in the food;
(3) the use of the drug or the biological product in
the food is to enhance the safety of the food to which
the drug or the biological product is added or applied
and not to have independent biological or therapeutic
effects on humans, and the use is in conformity with--
(A) a regulation issued under section 409
prescribing conditions of safe use in food;
(B) a regulation listing or affirming
conditions under which the use of the drug or
the biological product in food is generally
recognized as safe;
(C) the conditions of use identified in a
notification to the Secretary of a claim of
exemption from the premarket approval
requirements for food additives based on the
notifier's determination that the use of the
drug or the biological product in food is
generally recognized as safe, provided that the
Secretary has not questioned the general
recognition of safety determination in a letter
to the notifier;
(D) a food contact substance notification
that is effective under section 409(h); or
(E) such drug or biological product had been
marketed for smoking cessation prior to the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007; or
(4) the drug is a new animal drug whose use is not
unsafe under section 512.
(mm) The failure to submit a report or provide a notification
required under section 417(d).
(nn) The falsification of a report or notification required
under section 417(d).
(oo) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
(pp) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification
device upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate,
stone, or other item that is designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing upon any tobacco product or container or labeling
thereof so as to render such tobacco product a counterfeit
tobacco product.
(3) The doing of any act that causes a tobacco product to be
a counterfeit tobacco product, or the sale or dispensing, or
the holding for sale or dispensing, of a counterfeit tobacco
product.
(rr) The charitable distribution of tobacco products.
(ss) The failure of a manufacturer or distributor to notify
the Attorney General and the Secretary of the Treasury of their
knowledge of tobacco products used in illicit trade.
(tt) Making any express or implied statement or
representation directed to consumers with respect to a tobacco
product, in a label or labeling or through the media or
advertising, that either conveys, or misleads or would mislead
consumers into believing, that--
(1) the product is approved by the Food and Drug
Administration;
(2) the Food and Drug Administration deems the
product to be safe for use by consumers;
(3) the product is endorsed by the Food and Drug
Administration for use by consumers; or
(4) the product is safe or less harmful by virtue
of--
(A) its regulation or inspection by the Food
and Drug Administration; or
(B) its compliance with regulatory
requirements set by the Food and Drug
Administration;
including any such statement or representation
rendering the product misbranded under section 903.
(uu) The operation of a facility that manufactures,
processes, packs, or holds food for sale in the United States
if the owner, operator, or agent in charge of such facility is
not in compliance with section 418.
(vv) The failure to comply with the requirements under
section 419.
(ww) The failure to comply with section 420.
(xx) The refusal or failure to follow an order under section
423.
(yy) The knowing and willful failure to comply with the
notification requirement under section 417(h).
(zz) The importation or offering for importation of a food if
the importer (as defined in section 805) does not have in place
a foreign supplier verification program in compliance with such
section 805.
(aaa) The failure to register in accordance with section
801(s).
(bbb) The failure to notify the Secretary in violation of
section 568.
(ccc)(1) The resale of a compounded drug that is labeled
``not for resale'' in accordance with section 503B.
(2) With respect to a drug to be compounded pursuant to
section 503A or 503B, the intentional falsification of a
prescription, as applicable.
(3) The failure to report drugs or adverse events by an
entity that is registered in accordance with subsection (b) of
section 503B.
(ddd)(1) The manufacture or the introduction or delivery for
introduction into interstate commerce of a rinse-off cosmetic
that contains intentionally-added plastic microbeads.
(2) In this paragraph--
(A) the term ``plastic microbead'' means any solid
plastic particle that is less than five millimeters in
size and is intended to be used to exfoliate or cleanse
the human body or any part thereof; and
(B) the term ``rinse-off cosmetic'' includes
toothpaste.
(ddd) The failure of a retailer to implement a verification
system as required by section 506G (relating to sales of over-
the-counter drugs containing dextromethorphan).
* * * * * * *
penalties
Sec. 303. (a)(1) Any person who violates a provision of
section 301 shall be imprisoned for not more than one year or
fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section, if any person commits such a violation after a
conviction of him under this section has become final, or
commits such a violation with the intent to defraud or mislead,
such person shall be imprisoned for not more than three years
or fined not more than $10,000 or both.
(b)(1) Notwithstanding subsection (a), any person who
violates section 301(t) by--
(A) knowingly importing a drug in violation of
section 801(d)(1),
(B) knowingly selling, purchasing, or trading a drug
or drug sample or knowingly offering to sell, purchase,
or trade a drug or drug sample, in violation of section
503(c)(1),
(C) knowingly selling, purchasing, or trading a
coupon, knowingly offering to sell, purchase, or trade
such a coupon, or knowingly counterfeiting such a
coupon, in violation of section 503(c)(2), or
(D) knowingly distributing drugs in violation of
section 503(e)(1),
shall be imprisoned for not more than 10 years or fined not
more than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug
samples by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or
distributor, violated section 301(t) because of a violation of
section 503(c)(1) or violated any State law prohibiting the
sale, purchase, or trade of a drug sample subject to section
503(b) or the offer to sell, purchase, or trade such a drug
sample shall, upon conviction of the representative for such
violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each
of the first two such violations resulting in a
conviction of any representative of the manufacturer or
distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for
each violation resulting in a conviction of any
representative after the second conviction in any 10-
year period.
For the purposes of this paragraph, multiple convictions of one
or more persons arising out of the same event or transaction,
or a related series of events or transactions, shall be
considered as one violation.
(3) Any manufacturer or distributor who violates section
301(t) because of a failure to make a report required by
section 503(d)(3)(E) shall be subject to a civil penalty of not
more than $100,000.
(4)(A) If a manufacturer or distributor or any representative
of such manufacturer or distributor provides information
leading to the institution of a criminal proceeding against,
and conviction of, any representative of that manufacturer or
distributor for a violation of section 301(t) because of a
sale, purchase, or trade or offer to purchase, sell, or trade a
drug sample in violation of section 503(c)(1) or for a
violation of State law prohibiting the sale, purchase, or trade
or offer to sell, purchase, or trade a drug sample, the
conviction of such representative shall not be considered as a
violation for purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the
sale, purchase, or trade of a drug or the offer to sell,
purchase, or trade a drug, it is shown, by clear and convincing
evidence--
(i) that the manufacturer or distributor conducted,
before the institution of a criminal proceeding against
such representative for the violation which resulted in
such conviction, an investigation of events or
transactions which would have led to the reporting of
information leading to the institution of a criminal
proceeding against, and conviction of, such
representative for such purchase, sale, or trade or
offer to purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function,
despite diligent implementation by the manufacturer or
distributor of an independent audit and security system
designed to detect such a violation, the manufacturer
or distributor could not reasonably have been expected
to have detected such violation,
the conviction of such representative shall not be considered
as a conviction for purposes of paragraph (2).
(5) If a person provides information leading to the
institution of a criminal proceeding against, and conviction
of, a person for a violation of section 301(t) because of the
sale, purchase, or trade of a drug sample or the offer to sell,
purchase, or trade a drug sample in violation of section
503(c)(1), such person shall be entitled to one-half of the
criminal fine imposed and collected for such violation but not
more than $125,000.
(6) Notwithstanding subsection (a), any person who is a
manufacturer or importer of a prescription drug under section
804(b) and knowingly fails to comply with a requirement of
section 804(e) that is applicable to such manufacturer or
importer, respectively, shall be imprisoned for not more than
10 years or fined not more than $250,000, or both.
(7) Notwithstanding subsection (a)(2), any person that
knowingly and intentionally adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d)
of section 501 and has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals shall be imprisoned for not more than 20 years or fined
not more than $1,000,000, or both.
(c) No person shall be subject to the penalties of subsection
(a)(1) of this section, (1) for having received in interstate
commerce any article and delivered it or proffered delivery of
it, if such delivery or proffer was made in good faith, unless
he refuses to furnish on request of an officer or employee duly
designated by the Secretary the name and address of the person
from whom he purchased or received such article and copies of
all documents, if any there be, pertaining to the delivery of
the article to him; or (2) for having violated section 301(a)
or (d), if he establishes a guaranty or undertaking signed by,
and containing the name and address of, the person residing in
the United States from whom he received in good faith the
article, to the effect, in case of an alleged violation of
section 301(a), that such article is not adulterated or
misbranded, within the meaning of this Act, designating this
Act, or to the effect, in case of an alleged violation of
section 301(d), that such article is not an article which may
not, under the provisions of section 404 or 505, be introduced
into interstate commerce; or (3) for having violated section
301(a), where the violation exists because the article is
adulterated by reason of containing a color additive not from a
batch certified in accordance with regulations promulgated by
the Secretary under this Act, if such person establishes a
guaranty or undertaking signed by, and containing the name and
address of, the manufacturer of the color additive, to the
effect that such color additive was from a batch certified in
accordance with the applicable regulations promulgated by the
Secretary under this Act; or (4) for having violated section
301 (b), (c), or (k) by failure to comply with section 502(f)
in respect to an article received in interstate commerce to
which neither section 503(a) nor section 503(b)(1) is
applicable, if the delivery or proffered delivery was made in
good faith and the labeling at the time thereof contained the
same directions for use and warning statements as were
contained in the labeling at the time of such receipt of such
article; or (5) for having violated section 301(i)(2) if such
person acted in good faith and had no reason to believe that
use of the punch, die, plate, stone, or other thing involved
would result in a drug being a counterfeit drug, or for having
violated section 301(i)(3) if the person doing the act or
causing it to be done acted in good faith and had no reason to
believe that the drug was a counterfeit drug.
(d) No person shall be subject to the penalties of subsection
(a)(1) of this section for a violation of section 301 involving
misbranded food if the violation exists solely because the food
is misbranded under section 403(a)(2) because of its
advertising.
(e)(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human
growth hormone for any use in humans other than the treatment
of a disease or other recognized medical condition, where such
use has been authorized by the Secretary of Health and Human
Services under section 505 and pursuant to the order of a
physician, is guilty of an offense punishable by not more than
5 years in prison, such fines as are authorized by title 18,
United States Code, or both.
(2) Whoever commits any offense set forth in paragraph (1)
and such offense involves an individual under 18 years of age
is punishable by not more than 10 years imprisonment, such
fines as are authorized by title 18, United States Code, or
both.
(3) Any conviction for a violation of paragraphs (1) and (2)
of this subsection shall be considered a felony violation of
the Controlled Substances Act for the purposes of forfeiture
under section 413 of such Act.
(4) As used in this subsection the term ``human growth
hormone'' means somatrem, somatropin, or an analogue of either
of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f)(1)(A) Except as provided in subparagraph (B), any person
who violates a requirement of this Act which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not
to exceed $1,000,000 for all such violations adjudicated in a
single proceeding. For purposes of the preceding sentence, a
person accredited under paragraph (2) of section 704(g) who is
substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to
public health or fails to act in a manner that is consistent
with the purposes of such section, shall be considered to have
violated a requirement of this Act that relates to devices.
(B) Subparagraph (A) shall not apply--
(i) to any person who violates the requirements of
section 519(a) or 520(f) unless such violation
constitutes (I) a significant or knowing departure from
such requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of
section 519(e) or 519(g) (only with respect to
correction reports) if such person demonstrates
substantial compliance with such section, or
(iii) to violations of section 501(a)(2)(A) which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article
of food that is adulterated within the meaning of section
402(a)(2)(B) or any person who does not comply with a recall
order under section 423 shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual
and $250,000 in the case of any other person for such
introduction or delivery, not to exceed $500,000 for all such
violations adjudicated in a single proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this
section to sanction such person for the introduction or
delivery for introduction into interstate commerce of the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the seizure authorities of section 304 or
the injunction authorities of section 302 with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this
paragraph, the presiding officer shall have the same authority
with regard to compelling testimony or production of documents
as a presiding officer has under section 408(g)(2)(B). The
third sentence of paragraph (5)(A) shall not apply to any
investigation under this paragraph.
(3)(A) Any person who violates section 301(jj) shall be
subject to a civil monetary penalty of not more than $10,000
for all violations adjudicated in a single proceeding.
(B) If a violation of section 301(jj) is not corrected within
the 30-day period following notification under section
402(j)(5)(C)(ii), the person shall, in addition to any penalty
under subparagraph (A), be subject to a civil monetary penalty
of not more than $10,000 for each day of the violation after
such period until the violation is corrected.
(4)(A) Any responsible person (as such term is used in
section 505-1) that violates a requirement of section 505(o),
505(p), or 505-1 shall be subject to a civil monetary penalty
of--
(i) not more than $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated
in a single proceeding; or
(ii) in the case of a violation that continues after
the Secretary provides written notice to the
responsible person, the responsible person shall be
subject to a civil monetary penalty of $250,000 for the
first 30-day period (or any portion thereof) that the
responsible person continues to be in violation, and
such amount shall double for every 30-day period
thereafter that the violation continues, not to exceed
$1,000,000 for any 30-day period, and not to exceed
$10,000,000 for all such violations adjudicated in a
single proceeding.
(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into
consideration whether the responsible person is making efforts
toward correcting the violation of the requirement of section
505(o), 505(p), or 505-1 for which the responsible person is
subject to such civil penalty.
(5)(A) A civil penalty under paragraph (1), (2), (3), (4), or
(9) shall be assessed, or a no-tobacco-sale order may be
imposed, by the Secretary by an order made on the record after
opportunity for a hearing provided in accordance with this
subparagraph and section 554 of title 5, United States Code.
Before issuing such an order, the Secretary shall give written
notice to the person to be assessed a civil penalty, or upon
whom a no-tobacco-sale order is to be imposed, under such order
of the Secretary's proposal to issue such order and provide
such person an opportunity for a hearing on the order. In the
course of any investigation, the Secretary may issue subpoenas
requiring the attendance and testimony of witnesses and the
production of evidence that relates to the matter under
investigation.
(B) In determining the amount of a civil penalty, or the
period to be covered by a no-tobacco-sale order, the Secretary
shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the
violator, ability to pay, effect on ability to continue to do
business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require. A
no-tobacco-sale order permanently prohibiting an individual
retail outlet from selling tobacco products shall include
provisions that allow the outlet, after a specified period of
time, to request that the Secretary compromise, modify, or
terminate the order.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed
under paragraph (1), (2), (3), (4), or (9). The amount of such
penalty, when finally determined, or the amount agreed upon in
compromise, may be deducted from any sums owing by the United
States to the person charged.
(D) The Secretary may compromise, modify, or terminate, with
or without conditions, any no-tobacco-sale order.
(6) Any person who requested, in accordance with paragraph
(5)(A), a hearing respecting the assessment of a civil penalty
or the imposition of a no-tobacco-sale order and who is
aggrieved by an order assessing a civil penalty or the
imposition of a no-tobacco-sale order may file a petition for
judicial review of such order with the United States Court of
Appeals for the District of Columbia Circuit or for any other
circuit in which such person resides or transacts business.
Such a petition may only be filed within the 60-day period
beginning on the date the order making such assessment was
issued, or on which the no-tobacco-sale order was imposed, as
the case may be.
(7) If any person fails to pay an assessment of a civil
penalty--
(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (6), or
(B) after a court in an action brought under
paragraph (6) has entered a final judgment in favor of
the Secretary,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (6) or
the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
(8) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph (1).
Prior to the entry of a no-sale order under this paragraph, a
person shall be entitled to a hearing pursuant to the
procedures established through regulations of the Food and Drug
Administration for assessing civil money penalties, including
at a retailer's request a hearing by telephone, or at the
nearest regional or field office of the Food and Drug
Administration, or at a Federal, State, or county facility
within 100 miles from the location of the retail outlet, if
such a facility is available.
(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements.--
(A) In general.--Subject to subparagraph (B), any
person who violates a requirement of this Act which
relates to tobacco products shall be liable to the
United States for a civil penalty in an amount not to
exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated
in a single proceeding.
(B) Enhanced penalties.--
(i) Any person who intentionally violates a
requirement of section 902(5), 902(6), 904,
908(c), or 911(a), shall be subject to a civil
monetary penalty of--
(I) not to exceed $250,000 per
violation, and not to exceed $1,000,000
for all such violations adjudicated in
a single proceeding; or
(II) in the case of a violation that
continues after the Secretary provides
written notice to such person, $250,000
for the first 30-day period (or any
portion thereof) that the person
continues to be in violation, and such
amount shall double for every 30-day
period thereafter that the violation
continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed
$10,000,000 for all such violations
adjudicated in a single proceeding.
(ii) Any person who violates a requirement of
section 911(g)(2)(C)(ii) or 911(i)(1), shall be
subject to a civil monetary penalty of--
(I) not to exceed $250,000 per
violation, and not to exceed $1,000,000
for all such violations adjudicated in
a single proceeding; or
(II) in the case of a violation that
continues after the Secretary provides
written notice to such person, $250,000
for the first 30-day period (or any
portion thereof) that the person
continues to be in violation, and such
amount shall double for every 30-day
period thereafter that the violation
continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed
$10,000,000 for all such violations
adjudicated in a single proceeding.
(iii) In determining the amount of a civil
penalty under clause (i)(II) or (ii)(II), the
Secretary shall take into consideration whether
the person is making efforts toward correcting
the violation of the requirements of the
section for which such person is subject to
such civil penalty.
(g)(1) With respect to a person who is a holder of an
approved application under section 505 for a drug subject to
section 503(b) or under section 351 of the Public Health
Service Act, any such person who disseminates or causes another
party to disseminate a direct-to-consumer advertisement that is
false or misleading shall be liable to the United States for a
civil penalty in an amount not to exceed $250,000 for the first
such violation in any 3-year period, and not to exceed $500,000
for each subsequent violation in any 3-year period. No other
civil monetary penalties in this Act (including the civil
penalty in section 303(f)(4)) shall apply to a violation
regarding direct-to-consumer advertising. For purposes of this
paragraph: (A) Repeated dissemination of the same or similar
advertisement prior to the receipt of the written notice
referred to in paragraph (2) for such advertisements shall be
considered one violation. (B) On and after the date of the
receipt of such a notice, all violations under this paragraph
occurring in a single day shall be considered one violation.
With respect to advertisements that appear in magazines or
other publications that are published less frequently than
daily, each issue date (whether weekly or monthly) shall be
treated as a single day for the purpose of calculating the
number of violations under this paragraph.
(2) A civil penalty under paragraph (1) shall be assessed by
the Secretary by an order made on the record after providing
written notice to the person to be assessed a civil penalty and
an opportunity for a hearing in accordance with this paragraph
and section 554 of title 5, United States Code. If upon receipt
of the written notice, the person to be assessed a civil
penalty objects and requests a hearing, then in the course of
any investigation related to such hearing, the Secretary may
issue subpoenas requiring the attendance and testimony of
witnesses and the production of evidence that relates to the
matter under investigation, including information pertaining to
the factors described in paragraph (3).
(3) The Secretary, in determining the amount of the civil
penalty under paragraph (1), shall take into account the
nature, circumstances, extent, and gravity of the violation or
violations, including the following factors:
(A) Whether the person submitted the advertisement or
a similar advertisement for review under section 736A.
(B) Whether the person submitted the advertisement
for review if required under section 503B.
(C) Whether, after submission of the advertisement as
described in subparagraph (A) or (B), the person
disseminated or caused another party to disseminate the
advertisement before the end of the 45-day comment
period.
(D) Whether the person incorporated any comments made
by the Secretary with regard to the advertisement into
the advertisement prior to its dissemination.
(E) Whether the person ceased distribution of the
advertisement upon receipt of the written notice
referred to in paragraph (2) for such advertisement.
(F) Whether the person had the advertisement reviewed
by qualified medical, regulatory, and legal reviewers
prior to its dissemination.
(G) Whether the violations were material.
(H) Whether the person who created the advertisement
or caused the advertisement to be created acted in good
faith.
(I) Whether the person who created the advertisement
or caused the advertisement to be created has been
assessed a civil penalty under this provision within
the previous 1-year period.
(J) The scope and extent of any voluntary, subsequent
remedial action by the person.
(K) Such other matters, as justice may require.
(4)(A) Subject to subparagraph (B), no person shall be
required to pay a civil penalty under paragraph (1) if the
person submitted the advertisement to the Secretary and
disseminated or caused another party to disseminate such
advertisement after incorporating each comment received from
the Secretary.
(B) The Secretary may retract or modify any prior comments
the Secretary has provided to an advertisement submitted to the
Secretary based on new information or changed circumstances, so
long as the Secretary provides written notice to the person of
the new views of the Secretary on the advertisement and
provides a reasonable time for modification or correction of
the advertisement prior to seeking any civil penalty under
paragraph (1).
(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed
under paragraph (1). The amount of such penalty, when finally
determined, or the amount charged upon in compromise, may be
deducted from any sums owed by the United States to the person
charged.
(6) Any person who requested, in accordance with paragraph
(2), a hearing with respect to the assessment of a civil
penalty and who is aggrieved by an order assessing a civil
penalty, may file a petition for de novo judicial review of
such order with the United States Court of Appeals for the
District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may
only be filed within the 60-day period beginning on the date
the order making such assessments was issued.
(7) If any person fails to pay an assessment of a civil
penalty under paragraph (1)--
(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (6), or
(B) after a court in an action brought under
paragraph (6) has entered a final judgment in favor of
the Secretary,
the Attorney General of the United States shall recover the
amount assessed (plus interest at currently prevailing rates
from the date of the expiration of the 60-day period referred
to in paragraph (6) or the date of such final judgment, as the
case may be) in an action brought in any appropriate district
court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be
subject to review.
(h) Notwithstanding subsection (a), the following provisions
shall apply to violations of section 301(ddd):
(1) A person who violates section 301(ddd) shall--
(A) receive a violation notification from the
Secretary for the first such violation; and
(B) be subject to a civil penalty in an
amount--
(i) not more than $1,000 for the
second such violation by a person;
(ii) not more than $2,000 for the
third such violation by a person; and
(iii) not more than $5,000 for the
fourth such violation, or a subsequent
such violation, by a person.
(2) In determining the amount of a civil penalty
under this subsection for a person who is a retailer,
the Secretary 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 provisions of section 301(ddd), where
such program includes--
(A) educating employees regarding products
containing dextromethorphan;
(B) instruction on the correct method of
checking a purchaser's identification card; and
(C) notifying employees of the civil
penalties under this subsection.
(3) If a person who is a retailer transacts sales of
products containing dextromethorphan at more than one
physical location, for purposes of determining the
number of violations by that person under this
subsection, each individual physical location operated
by that retailer shall be considered a separate person.
(4) The Secretary shall notify persons found to have
violated section 301(ddd) as soon as practicable after
the Secretary discovers such violation. Such
notification shall include the date and time when the
violation was observed to occur.
(5) Notwithstanding any other provision of this
subsection or section 301(ddd), an employee shall not
be subject to penalties under this subsection unless
such employee knowingly and willfully participates in a
conspiracy to violate section 301(ddd). For purposes of
this paragraph, a conspiracy shall consist of an
agreement between two or more persons with the intent
to violate section 301(ddd) and the commission of at
least one overt act in furtherance of the agreement.
(6) In this subsection--
(A) the term ``employee'' means an individual
who is employed by a retailer in a clerical or
other non-managerial position; and
(B) the term ``retailer'' means a grocery
store, general merchandise store, drug store,
pharmacy, convenience store, or other entity or
person whose activities as a distributor
relating to products containing
dextromethorphan are limited almost exclusively
to sales for personal use, both in number of
sales and volume of sales, including any sales
made by the Internet or other means.
(i) Notwithstanding subsection (a), a person who violates
section 506H shall be subject to a civil penalty of not more
than $100,000.
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
adulterated drugs and devices
Sec. 501. A drug or device shall be deemed to be
adulterated--
(a)(1) If it consists in whole or in part of any filthy,
putrid, or decomposed substance; or (2)(A) if it has been
prepared, packed, or held under insanitary conditions whereby
it may have been contaminated with filth, or whereby it may
have been rendered injurious to health; or (B) if it is a drug
and the methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that such
drug meets the requirements of this Act as to safety and has
the identity and strength, and meets the quality and purity
characteristics, which it purports or is represented to
possess; or (C) if it is a compounded positron emission
tomography drug and the methods used in, or the facilities and
controls used for, its compounding, processing, packing, or
holding do not conform to or are not operated or administered
in conformity with the positron emission tomography compounding
standards and the official monographs of the United States
Pharmacopoeia to assure that such drug meets the requirements
of this Act as to safety and has the identity and strength, and
meets the quality and purity characteristics, that it purports
or is represented to possess; or (3) if its container is
composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(4) if (A) it bears or contains, for purposes of coloring only,
a color additive which is unsafe within the meaning of section
721(a), or (B) it is a color additive the intended use of which
in or on drugs or devices is for purposes of coloring only and
is unsafe within the meaning of section 721(a); or (5) if it is
a new animal drug which is unsafe within the meaning of section
512; or (6) if it is an animal feed bearing or containing a new
animal drug, and such animal feed is unsafe within the meaning
of section 512.
(b) If it purports to be or is represented as a drug the name
of which is recognized in an official compendium, and its
strength differs from, or its quality or purity falls below,
the standards set forth in such compendium. Such determination
as to strength, quality, or purity shall be made in accordance
with the tests or methods of assay set forth in such
compendium, except that whenever tests or methods of assay have
not been prescribed in such compendium, or such tests or
methods of assay as are prescribed are, in the judgment of the
Secretary, insufficient for the making of such determination,
the Secretary shall bring such fact to the attention of the
appropriate body charged with the revision of such compendium,
and if such body fails within a reasonable time to prescribe
tests or methods of assay which, in the judgment of the
Secretary, are sufficient for purposes of this paragraph, then
the Secretary shall promulgate regulations prescribing
appropriate tests or methods of assay in accordance with which
such determination as to strength, quality, or purity shall be
made. No drug defined in an official compendium shall be deemed
to be adulterated under this paragraph because it differs from
the standard of strength, quality, or purity therefor set forth
in such compendium, if its difference in strength, quality, or
purity from such standards is plainly stated on its label.
Whenever a drug is recognized in both the United States
Pharmacopeia and the Homeopathic Pharmacopeia of the United
States it shall be subject to the requirements of the United
States Pharmacopeia unless it is labeled and offered for sale
as a homeopathic drug, in which case it shall be subject to the
provisions of the Homeopathic Pharmacopeia of the United States
and not to those of the United States Pharmacopeia.
(c) If it is not subject to the provisions of paragraph (b)
of this section and its strength differs from, or its purity or
quality falls below, that which it purports or is represented
to possess.
(d) If it is a drug and any substance has been (1) mixed or
packed therewith so as to reduce its quality or strength or (2)
substituted wholly or in part therefor.
(e)(1) If it is, or purports to be or is represented as, a
device which is subject to a performance standard established
under section 514, unless such device is in all respects in
conformity with such standard.
(2) If it is declared to be, purports to be, or is
represented as, a device that is in conformity with any
standard recognized under section 514(c) unless such device is
in all respects in conformity with such standard.
(f)(1) If it is a class III device--
(A)(i) which is required by an order issued under
subsection (b) of section 515 to have an approval under
such section of an application for premarket approval
and which is not exempt from section 515 under section
520(g), and
(ii)(I) for which an application for premarket
approval or a notice of completion of a product
development protocol was not filed with the Secretary
within the ninety-day period beginning on the date of
the issuance of such order, or
(II) for which such an application was filed and
approval of the application has been denied, suspended,
or withdrawn, or such a notice was filed and has been
declared not completed or the approval of the device
under the protocol has been withdrawn;
(B)(i) which was classified under section 513(f) into
class III, which under section 515(a) is required to
have in effect an approved application for premarket
approval, and which is not exempt from section 515
under section 520(g), and
(ii) which has an application which has been
suspended or is otherwise not in effect; or
(C) which was classified under section 520(l) into
class III, which under such section is required to have
in effect an approved application under section 515,
and which has an application which has been suspended
or is otherwise not in effect.
(2)(A) In the case of a device classified under section
513(f) into class III and intended solely for investigational
use, paragraph (1)(B) shall not apply with respect to such
device during the period ending on the ninetieth day after the
date of the promulgation of the regulations prescribing the
procedures and conditions required by section 520(g)(2).
(B) In the case of a device subject to an order issued under
subsection (b) of section 515, paragraph (1) shall not apply
with respect to such device during the period ending--
(i) on the last day of the thirtieth calendar month
beginning after the month in which the classification
of the device in class III became effective under
section 513, or
(ii) on the ninetieth day after the date of the
issuance of such order,
whichever occurs later.
(3) In the case of a device with respect to which a
regulation was promulgated under section 515(b) prior to the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, a reference in this subsection to an order
issued under section 515(b) shall be deemed to include such
regulation.
(g) If it is a banned device.
(h) If it is a device and the methods used in, or the
facilities or controls used for, its manufacture, packing,
storage, or installation are not in conformity with applicable
requirements under section 520(f)(1) or an applicable condition
prescribed by an order under section 520(f)(2).
(i) If it is a device for which an exemption has been granted
under section 520(g) for investigational use and the person who
was granted such exemption or any investigator who uses such
device under such exemption fails to comply with a requirement
prescribed by or under such section.
(j) If it is a drug and it has been manufactured, processed,
packed, or held in any factory, warehouse, or establishment and
the owner, operator, or agent of such factory, warehouse, or
establishment delays, denies, or limits an inspection, or
refuses to permit entry or inspection.
For purposes of paragraph (a)(2)(B), the term ``current good
manufacturing practice'' includes the implementation of
oversight and controls over the manufacture of drugs to ensure
quality, including managing the risk of and establishing the
safety of raw materials, materials used in the manufacturing of
drugs, and finished drug products.
(k) If it is unfinished dextromethorphan and is possessed,
received, or distributed in violation of section 506H.
* * * * * * *
SEC. 506H. 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 engage in the practice of
pharmacy, pharmaceutical production, or manufacture or
distribution of drug ingredients; or
(2) distribute unfinished dextromethorphan to any
person other than a person registered under section 510
or otherwise registered, licensed, or approved pursuant
to Federal or State law to engage in the practice of
pharmacy, pharmaceutical production, or manufacture or
distribution of drug ingredients.
(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 subsection (a) as registered, licensed, or
approved.
(c) Definitions.--In this section:
(1) The term ``common carrier'' means any person 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 person 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.
SEC. 506G. SALES OF OVER-THE-COUNTER DRUGS CONTAINING DEXTROMETHORPHAN.
(a) Verification System.--Any retailer selling or offering
for sale in interstate commerce dextromethorphan shall
implement a verification system to ensure compliance with this
section. Such a system may ensure such compliance by means of--
(1) an electronic point-of-sale system coded to
prompt for verification of the age of all purchasers of
drugs described in subsection (b) and deny sales to
those under the age of 18;
(2) training manuals or materials instructing
employees to verify the age of all purchasers of such
drugs and deny sales to those under the age of 18;
(3) signage in and around the sales counter outlining
the age restriction on sales of such drugs;
(4) designating one on-duty employee to approve all
sales of such drugs; or
(5) any other verification measure deemed valid by
the Secretary.
(b) Prohibition.--Except as provided in subsection (c), each
retailer shall verify that no individual is under 18 years of
age who purchases any drug that--
(1) contains dextromethorphan; and
(2) is not subject to section 503(b)(1).
(c) Exceptions.--
(1) Individuals over 26.--Subsection (b) does not
require verification of the age of any individual over
the age of 26.
(2) Valid prescription.--Subsection (b) does not
apply to any sale made pursuant to a validly issued
prescription.
(3) Valid military identification card.--Subsection
(b) does not apply to any sale to an individual under
18 years of age if such individual supplies proof at
the time of such sale that such individual is actively
enrolled in the military and presents a valid military
identification card.
(d) Affirmative Defense.--It shall be an affirmative defense
to an alleged violation of subsection (b) that the individual
selling a drug containing dextromethorphan--
(1) examined the purchaser's identification card; and
(2) based on that examination, reasonably concluded
that the identification was valid and indicated that
the purchaser was not less than 18 years of age.
(e) Definition.--In this paragraph, the term ``identification
card'' means an identification card that--
(1) includes a photograph and the date of birth of
the individual; and
(2) is issued by a State or the Federal Government or
is considered acceptable for purposes of sections
274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) of title
8, Code of Federal Regulations (including any successor
regulations).
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