59–006 

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 indiVerDate Sep 11 2014 23:34 Jul 11, 2016 Jkt 059006 PO 00000 Frm 00001 Fmt 6659 Sfmt 6602 E:\HR\OC\HR672.XXX HR672

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1http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ 

DrugSafetyandRiskManagementAdvisoryCommittee/UCM228267.pdf (p. 15). 

viduals 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. 

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. 


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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-thecounter 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 


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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-asyou-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 


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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-thecounter 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. 


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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. 


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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. 


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(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; 


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(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 


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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 


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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 prodVerDate Sep 11 2014 23:34 Jul 11, 2016 Jkt 059006 PO 00000 Frm 00011 Fmt 6659 Sfmt 6602 E:\HR\OC\HR672.XXX HR672

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uct 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 


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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. 


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(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. 


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(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. 


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(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. 


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(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 


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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-tobaccosale 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— 


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(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 


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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 deterVerDate Sep 11 2014 23:34 Jul 11, 2016 Jkt 059006 PO 00000 Frm 00020 Fmt 6659 Sfmt 6602 E:\HR\OC\HR672.XXX HR672

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mined, 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 loVerDate Sep 11 2014 23:34 Jul 11, 2016 Jkt 059006 PO 00000 Frm 00021 Fmt 6659 Sfmt 6603 E:\HR\OC\HR672.XXX HR672

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cation 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 

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teristics, 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— 


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(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. 


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(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; 


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(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). 

* * * * * * * 

Æ 


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