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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.

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                      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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