101 
‘‘(aa) If it is a drug and the website of the manufac-
turer of the drug does not list the country of origin for 
each active pharmaceutical ingredient and finished dosage 
form of such drug.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary shall pro-
mulgate final regulations to carry out section 502(aa) of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a). 
(c) EFFECTIVE DATE.—The requirement of section 
502(aa) of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), takes effect 2 years after the 
date of the enactment of this Act. 
SEC. 207. NONDISTRIBUTION AND RECALL OF ADULTER-
ATED OR MISBRANDED DRUGS. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by sections 102, 104, and 112 of this 
Act, is amended by adding at the end the following: 
‘‘(rr) The failure to comply with— 
‘‘(1) an order issued under section 568(a) fol-
lowing any hearing requested under section 568(b); 
or 
‘‘(2) an amended order issued under section 
568(c)(1).’’. 
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(b) NONDISTRIBUTION AND RECALL OF ADULTER-
ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 
V (21 U.S.C. 360bb et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 568. NONDISTRIBUTION AND RECALL OF ADULTER-
ATED OR MISBRANDED DRUGS. 
‘‘(a) RECALL AND CONSUMER NOTIFICATION.— 
‘‘(1) VOLUNTARY ACTIONS.—On receiving infor-
mation of a suspected adulteration or misbranding 
of a drug, if the Secretary finds that there is a rea-
sonable probability that a drug intended for human 
use would cause serious, adverse health con-
sequences or death, the Secretary shall provide all 
persons (including the manufacturer, importer, dis-
tributor, or retailer of the drug) with an opportunity 
(as determined by the Secretary)— 
‘‘(A) to cease distribution of the drug; 
‘‘(B) to notify all entities— 
‘‘(i) that produce, manufacture, pack, 
process, prepare, treat, package, distribute, 
or hold the drug, to cease immediately 
those activities with respect to the drug; or 
‘‘(ii) to which the drug has been dis-
tributed, transported, or sold, to cease im-
mediately distribution of the drug; 
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‘‘(C) to recall the drug; 
‘‘(D) in consultation with the Secretary, to 
provide notice of the finding of the Secretary to 
all consumers to which the drug was, or may 
have been, distributed and to appropriate State 
and local health officials; and 
‘‘(E) to notify State and local public health 
officials. 
‘‘(2) MANDATORY
ACTIONS.—If a person re-
ferred to in paragraph (1) does not carry out the ac-
tions described in that paragraph with respect to a 
drug within the time period and in the manner pre-
scribed by the Secretary, the Secretary shall issue an 
order requiring such person— 
‘‘(A) to immediately cease distribution of 
the drug; and 
‘‘(B) to immediately notify health profes-
sionals and drug user facilities of the order and 
to instruct such professionals and facilities to 
cease use of such drug. 
‘‘(b) HEARINGS ON ORDERS.—The Secretary shall 
provide a person subject to an order under subsection 
(a)(2) with an opportunity for an informal hearing, to be 
held not later than 10 days after the date of the issuance 
of the order, on— 
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‘‘(1) the actions required by the order; and 
‘‘(2) any reasons why the drug that is the sub-
ject of the order should not be recalled. 
‘‘(c) POST-HEARING RECALL ORDERS.— 
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for an informal hearing under 
subsection (b), the Secretary determines that an 
order under subsection (a)(2) with respect to a drug 
should be amended to include a recall or other ap-
propriate action, the Secretary shall, except as pro-
vided in paragraph (2)— 
‘‘(A) amend the order— 
‘‘(i) to require recall of the drug or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which any such recall shall occur; and 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of any such re-
call. 
‘‘(2) CONTENTS OF ORDER.— 
‘‘(A) INDIVIDUALS
AND
DRUG
USER
FA-
CILITIES.—An amended order under paragraph 
(1) shall not include— 
‘‘(i) a recall of a drug from individ-
uals; or 
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‘‘(ii) a recall of a drug from drug user 
facilities if the Secretary determines that 
the risk of recalling such drug from the fa-
cilities presents a greater health risk than 
the health risk of not recalling the drug 
from use. 
‘‘(B) NOTICE TO INDIVIDUALS SUBJECT TO 
RISKS.—An amended order under paragraph 
(1) shall provide for notice to individuals sub-
ject to the risks associated with the use of such 
drug. In providing the notice required by this 
paragraph, the Secretary may use the assist-
ance of health professionals who prescribed or 
dispensed such a drug for individuals. If a sig-
nificant number of such individuals cannot be 
identified, the Secretary shall notify such indi-
viduals pursuant to section 705(b). 
‘‘(3) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (b), the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order. 
‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
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SEC. 208. DESTRUCTION OF ADULTERATED, MISBRANDED 
OR COUNTERFEIT ARTICLES OFFERED FOR 
IMPORT. 
(a) IN GENERAL.—The fifth sentence of subsection 
(a) of section 801 (21 U.S.C. 381), as amended by sec-
tions 105(b) and 205(c), is further amended by inserting 
before the period at the end of the following: ‘‘, except 
that any article that is refused admission may, at the dis-
cretion of the Secretary, be promptly (subject to the next 
sentence) destroyed and not exported if it appears to pose 
a risk of injury or death’’. 
(b) NOTICE.—Subsection (a) of section 801 (21 
U.S.C. 381), as amended by sections 105(b) and 205(c) 
and subsection (a) of this section, is amended by inserting 
after the fifth sentence the following: ‘‘Before causing the 
destruction of an article with a value greater than $2,000 
under the preceding sentence, the Secretary shall provide 
notice and an opportunity for an informal hearing to the 
owner or consignee.’’. 
(c) IMPROPER
DESTRUCTION.—Section 801 (21 
U.S.C. 381), as amended by sections 123 and 203, is 
amended by adding at the end the following: 
‘‘(r) Any person claiming any article which has been 
destroyed under subsection (a) may, at any time within 
3 months after the date of destruction, apply to the Sec-
retary for reimbursement of the value of the article as de-
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SEC. 209. ADMINISTRATIVE DETENTION OF DRUGS THAT 
APPEAR TO VIOLATE THE LAW. 
(a) IN
GENERAL.—Section 304(g) (21 U.S.C. 
334(g)) is amended— 
(1) by inserting ‘‘drug or’’ before ‘‘device’’ each 
place it appears; and 
(2) in paragraph (1), by inserting after ‘‘adul-
terated or misbranded’’ the following: ‘‘or, in the 
case of a drug, which in the determination of the of-
ficer or employee making the inspection appears to 
be in violation of section 505,’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall take effect on a date, specified by the 
Secretary of Health and Human Services, not later than 
1 year after the date of the enactment of this Act. 
SEC. 210. PENALTIES REGARDING COUNTERFEIT DRUGS. 
Section 303(a) (21 U.S.C. 333(a)) is amended by 
adding at the end the following paragraph: 
‘‘(3) Notwithstanding paragraph (1) or (2), any per-
son who engages in any conduct described in section 
301(i)(2) knowing that the conduct concerns the rendering 
of a drug as a counterfeit drug, or who engages in conduct 
described in section 301(i)(3) knowing that the conduct 
will cause a drug to be a counterfeit drug or knowing that 
a drug held, sold, or dispensed is a counterfeit drug, shall 
be fined in accordance with title 18, United States Code, 
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109 
or imprisoned not more than 20 years, or both, except that 
if the use of the counterfeit drug by a consumer is the 
proximate cause of the death of the consumer, the term 
of imprisonment shall be any term of years or for life.’’. 
SEC. 211. CIVIL MONEY PENALTIES FOR VIOLATIVE DRUGS 
AND 
DEVICES 
AND 
IMPROPER 
IMPORT 
ENTRY FILINGS. 
(a) IN GENERAL.—Section 303(f) (21 U.S.C. 333) 
is amended— 
(1) by redesignating paragraphs (5), (6), and 
(7) as paragraphs (6), (7), and (8), respectively; 
(2) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5)(A)(i) Any person that violates a require-
ment of this Act that relates to drugs for human use 
(except a requirement referred to in paragraph (4) 
or subsection (g)) shall be liable to the United 
States for a civil penalty not to exceed— 
‘‘(I) $100,000 for an initial violation 
of such a requirement; or 
‘‘(II) $200,000 for a subsequent viola-
tion of the same requirement. 
‘‘(ii) In clause (i)(I), the term ‘initial violation’ 
means the first violation by a person of a require-
ment described in clause (i) that occurs on or after 
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the date of the enactment of the Food and Drug Ad-
ministration Globalization Act of 2009. 
‘‘(iii) Each day during which a violation con-
tinues shall be considered a separate violation under 
clause (i), except that a continuing initial violation 
shall not be treated as a subsequent violation for 
purposes of clause (i)(II). 
‘‘(B)(i) Any person that knowingly reports or 
enters false or misleading data on documents related 
to the importation of a drug shall be liable to the 
United States for a civil penalty not to exceed 
$200,000. 
‘‘(ii) Each act of reporting or entering false 
data shall be considered a separate violation under 
clause (i). 
‘‘(C) Any manufacturer, importer, distributer, 
or retailer who fails to comply with an order or an 
amended order issued under section 568(a) or 
568(c)(1), respectively, shall be liable to the United 
States for a civil penalty not to exceed $250,000 per 
day.’’. 
(3) in paragraph (6), as so redesignated, by 
striking ‘‘, or (4)’’ each place it appears and insert-
ing ‘‘(4), or (5)’’; 
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(4) in paragraph (7), as so redesignated, by 
striking ‘‘(5)(A)’’ and inserting ‘‘(6)(A)’’; and 
(5) in paragraph (8), as so redesignated, by 
striking ‘‘paragraph (6)’’ each place it appears and 
inserting ‘‘paragraph (7)’’. 
(b) APPLICABILITY.—Section 303(f)(5) (as amended 
by subsection (a)), shall apply to violations described in 
such section that occur after the date of the enactment 
of this Act. 
SEC. 212. HUMAN GENERIC DRUG APPLICATION AND SUP-
PLEMENT FEES TO COVER PRE-APPROVAL 
INSPECTION COSTS. 
(a) SENSE OF CONGRESS.—It is the sense of the Con-
gress that the amount of additional revenues generated 
from fees under this section should be used to support pre- 
approval inspections of generic drug establishments, in ac-
cordance with performance goals to be developed by the 
Secretary of Health and Human Services in consultation 
with the entities listed in subparagraphs (A) through (F) 
of section 736B(d)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h–2(d)(1)). 
(b) FEE.— 
(1) MISBRANDING.—Paragraph (o) of section 
502 (21 U.S.C. 352), as amended by subsections (a) 
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112 
and (b) of section 501, is further amended by strik-
ing ‘‘736C’’ and inserting ‘‘736C or 736D’’. 
(2) ESTABLISHMENT.—Part 2 of subchapter C 
of chapter VII (21 U.S.C. 379g et seq.), as amended 
by section 201(b), is amended by adding at the end 
the following: 
‘‘SEC. 736D. HUMAN GENERIC DRUG APPLICATION AND 
SUPPLEMENT 
FEES 
TO 
COVER 
PRE-AP-
PROVAL INSPECTION COSTS. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect a fee upon submission of any human generic drug 
application or supplement to defray increases (as de-
scribed in subsection (c)(2)(B)) in the costs of resources 
allocated for conducting inspections in connection with the 
review of human generic drug applications and supple-
ments. 
‘‘(b) FEE REVENUE AMOUNTS.—For each of fiscal 
years 2010 through 2014, fees under subsection (a) shall 
be established, subject to the provisions referred to in sub-
section (d), to generate a total revenue amount. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
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113 
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriation Acts, or otherwise made avail-
able for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available 
to defray increases in the costs of resources al-
located for conducting inspections in connection 
with the review of human generic drug applica-
tions and supplements (including increases in 
such costs for an additional number of full-time 
equivalent positions in the Department of 
Health and Human Services to be engaged in 
such review) over such costs, excluding costs 
paid from fees collected under this section, for 
fiscal year 2009 multiplied by the adjustment 
factor. 
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114 
‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS.—To 
the extent determined by the Secretary to be consistent 
with this section, the provisions of section 736 apply with 
respect to human generic drug application fees and sup-
plement fees under this section to the same extent and 
in the same manner as such provisions apply with respect 
to human drug application fees and supplement fees under 
section 736. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) The term ‘costs of resources allocated for 
conducting inspections in connection with the review 
of human generic drug applications and supple-
ments’ means the expenses that are— 
‘‘(A) incurred in connection with inspec-
tions undertaken as part of the Secretary’s re-
view of pending human generic drug applica-
tions and supplements; and 
‘‘(B) described in subparagraphs (A) 
through (D) of section 735(7), except that the 
reference in section 735(7)(D) to section 736 is 
deemed to be a reference to this section, and 
the reference is section 735(7)(D) to human 
drug applications and supplements (as defined 
in section 735(2)) is deemed to be a reference 
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to human generic drug applications and supple-
ments (as defined in this section). 
‘‘(2) The term ‘human generic drug application’ 
means an application for approval of a new drug 
submitted under section 505(j). Such term does not 
include an application or a supplement to an appli-
cation described in section 735(1). 
‘‘(3) Notwithstanding section 735(2), the term 
‘supplement’ means a request to the Secretary to ap-
prove a change in a human generic drug application 
which has been approved.’’. 
(3) 
EFFECTIVE
DATE.—The 
Secretary 
of 
Health and Human Services shall first impose the 
fee established under section 736D of the Federal 
Food, Drug, and Cosmetic Act, as added by para-
graph (2), for fiscal years beginning with fiscal year 
2010. 
(4) SUNSET DATE.—Section 736D, as added by 
paragraph (2), does not authorize the assessment or 
collection of a fee for submission of an application 
or supplement under section 505(j) of such Act (21 
U.S.C. 355(j)) occurring after fiscal year 2014. 
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116 
TITLE III—COSMETIC SAFETY 
SEC. 301. REGISTRATION OF COSMETIC ESTABLISHMENTS. 
(a) MISBRANDING.—Section 602 is amended by add-
ing at the end the following: 
‘‘(g) If it was manufactured or packaged in an estab-
lishment that is not duly registered under section 604.’’. 
(b) ANNUAL REGISTRATION.—Chapter VI is amend-
ed by adding at the end the following: 
‘‘SEC. 604. REGISTRATION OF COSMETIC ESTABLISHMENTS. 
‘‘(a) REGISTRATION.— 
‘‘(1) IN GENERAL.—The Secretary shall by reg-
ulation require that any establishment engaged in 
manufacturing or packaging cosmetics for use in the 
United States be registered annually with the Sec-
retary. To be registered— 
‘‘(A) for a domestic establishment, the 
owner, operator, or agent in charge of the es-
tablishment shall submit a registration to the 
Secretary; and 
‘‘(B) for a foreign establishment, the 
owner, operator, or agent in charge of the es-
tablishment shall submit a registration to the 
Secretary and shall include with the registration 
the name of the United States agent for the es-
tablishment. 
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‘‘(2) REGISTRATION.—An entity (referred to in 
this section as the ‘registrant’) shall submit a reg-
istration under paragraph (1) to the Secretary con-
taining information necessary to notify the Secretary 
of the name and address of each establishment at 
which, and all trade names under which, the reg-
istrant manufactures or packages cosmetics. The 
registrant shall notify the Secretary in a timely man-
ner of changes to such information. The registrant 
shall notify the Secretary of any change in the prod-
ucts, function, or legal status of each such establish-
ment (including cessation of business activities) not 
later than 30 days after the date of such change. 
‘‘(3) PROCEDURE.—Upon receipt of a com-
pleted registration described in paragraph (1), the 
Secretary shall notify the registrant of the receipt of 
such registration and assign a registration number 
to each registered establishment. 
‘‘(4) LIST.—The Secretary shall compile and 
maintain an up-to-date list of establishments that 
are registered under this section. The Secretary shall 
remove from such list the name of any establishment 
that fails to reregister in accordance with this sec-
tion and shall treat such removal as a suspension of 
the establishment’s registration. Such list and any 
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registration documents submitted pursuant to this 
subsection shall not be subject to disclosure under 
section 552 of title 5, United States Code. Informa-
tion derived from such list or registration documents 
shall not be subject to disclosure under section 552 
of title 5, United States Code, to the extent that 
such information discloses the identity or location of 
a specific registered person. 
‘‘(b) ESTABLISHMENT.—For purposes of this section: 
‘‘(1) The term ‘domestic establishment’ means 
an establishment located in any State (as defined in 
section 201). 
‘‘(2)(A) The term ‘foreign establishment’ means 
an establishment that manufactures or packages cos-
metics that are exported to the United States with-
out further processing or packaging outside the 
United States. 
‘‘(B) A cosmetic may not be considered to have 
undergone further processing or packaging for pur-
poses of subparagraph (A) solely on the basis that 
labeling was added or that any similar activity of a 
de minimis nature was carried out with respect to 
the cosmetic.’’. 
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SEC. 302. COSMETIC AND INGREDIENT STATEMENTS. 
(a) MISBRANDING.—Section 602, as amended by sec-
tion 301 of this Act, is amended by adding at the end 
the following: 
‘‘(h) If its manufacturer is in violation of section 605 
for failure to submit a cosmetic and ingredient statement 
with respect to the cosmetic.’’. 
(b) STATEMENTS.—Chapter VI, as amended by sec-
tion 301 of this Act, is amended by adding at the end 
the following: 
‘‘SEC. 605. COSMETIC AND INGREDIENT STATEMENTS. 
‘‘(a) IN GENERAL.—The Secretary shall require by 
regulation that every establishment engaged in the manu-
facture of a cosmetic intended to be marketed in the 
United States submit to the Secretary for each cosmetic 
manufactured in the establishment, within 60 days after 
beginning manufacture of the product, a cosmetic and in-
gredient statement containing— 
‘‘(1) the registration number of the manufac-
turing establishment where the cosmetic is manufac-
tured or, if the same cosmetic is manufactured in 
more than one establishment, the registration num-
ber of each establishment where it is manufactured; 
‘‘(2) the brand name or names for the cosmetic; 
‘‘(3) the applicable cosmetic category or cat-
egories for the cosmetic; 
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‘‘(4) the ingredients in the cosmetic in descend-
ing order of predominance by weight, except that— 
‘‘(A) flavors and fragrances may be des-
ignated as such; and 
‘‘(B) all variations in color, flavor, or fra-
grance may be included in one statement; and 
‘‘(5) the title and full contact information for 
the individual or individuals responsible for submit-
ting and maintaining the statement. 
The registrant shall notify the Secretary in a timely man-
ner of any change to the information required to be in 
such statement. 
‘‘(b) PROCEDURE.—Upon receipt of a completed cos-
metic and ingredient statement described in paragraph 
(a), the Secretary shall notify the registrant of the receipt 
of such statement and assign a cosmetic and ingredient 
statement number. 
‘‘(c) LIST.—The Secretary shall compile and main-
tain an up-to-date list of cosmetics and ingredients for 
which statements are submitted under this section.’’. 
SEC. 303. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTS FOR COSMETICS. 
(a) PROHIBITED ACTS.—Section 301 is amended— 
(1) in paragraph (e), by striking ‘‘or 761’’ each 
place it appears and inserting ‘‘761, or 762’’; and 
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(2) in paragraph (ii)— 
(A) by striking ‘‘or the’’ and inserting ‘‘, 
the’’; and 
(B) by striking the period at the end and 
inserting ‘‘, or the falsification of a report sub-
mitted under section 762 to the Secretary.’’. 
(b) ADVERSE EVENT REPORTING.—Subchapter H of 
chapter VII is amended by adding at the end the following: 
‘‘SEC. 762. SERIOUS AND UNEXPECTED ADVERSE EVENT RE-
PORTS FOR COSMETICS. 
‘‘(a) IN GENERAL.—The Secretary shall require by 
regulation that the manufacturer, packager, or distributor 
whose name appears on the label of a cosmetic marketed 
in the United States pursuant to section 602(b)(1) submit 
to the Secretary under subsection (b) a report containing 
information received concerning any serious and unex-
pected adverse event in the United States associated with 
the use of the cosmetic. 
‘‘(b) SUBMISSION OF REPORTS.— 
‘‘(1) IN GENERAL.—A report under subsection 
(a) shall be submitted to the Secretary no later than 
15 business days after information concerning the 
adverse event is received at the place of business la-
beled on the cosmetic under section 602(b)(1). 
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‘‘(2) CONTENTS.—A report under subsection 
(a) shall include the following information, to the ex-
tent to which the person submitting the report has 
been able to verify the information— 
‘‘(A) an identifiable patient; 
‘‘(B) an identifiable reporter; 
‘‘(C) a suspect cosmetic; and 
‘‘(D) a serious and unexpected adverse 
event. 
‘‘(3) ADDITIONAL INFORMATION.—The person 
submitting a report under subsection (a) may in-
clude in the submission any additional pertinent in-
formation and may supplement the report with addi-
tional information at a later time. 
‘‘(c) RELATION TO OTHER PROVISIONS.—A report 
under subsection (a) (including all information submitted 
in the initial report or added later) shall be considered 
to be— 
‘‘(1) a safety report under section 756; 
‘‘(2) a record about an individual under section 
552a of title 5, United States Code; and 
‘‘(3) a medical or similar file the disclosure of 
which would constitute a violation of section 
552(b)(6) of such title 5, United States Codes, and 
shall not be disclosed under section 552 of such title. 
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123 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘serious’, with respect to an ad-
verse event, means— 
‘‘(A) resulting in— 
‘‘(i) death; 
‘‘(ii) a life-threatening experience; 
‘‘(iii) inpatient hospitalization; 
‘‘(iv) a persistent and significant dis-
ability or incapacity; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(B) requiring, based on reasonable med-
ical judgment, a medical or surgical interven-
tion to prevent an outcome described in sub-
paragraph (A). 
‘‘(2) The term ‘unexpected’, with respect to an 
adverse event, means not identified in the current la-
beling for the cosmetic.’’. 
SEC. 304. GOOD MANUFACTURING PRACTICES FOR COS-
METICS. 
Section 601 is amended by adding at the end the fol-
lowing: 
‘‘(f) If the methods used in, or the facilities or con-
trols used for, its manufacture, processing, packaging, 
storage, or holding do not conform to current good manu-
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facturing practice, as prescribed by the Secretary in regu-
lations, to ensure that the cosmetic is safe and otherwise 
in compliance with this Act.’’. 
SEC. 305. AUTHORIZATION OF APPROPRIATIONS. 
Chapter VI, as amended by sections 301 and 302, 
is amended by adding at the end the following: 
‘‘SEC. 606. AUTHORIZATION OF APPROPRIATIONS. 
‘‘To carry out this chapter and section 762, there is 
authorized to be appropriated $10,000,000 for each of fis-
cal years 2010 through 2014.’’. 
SEC. 306. EFFECTIVE DATE. 
The amendments made by sections 301, 302, 303, 
and 304 shall take effect 18 months after the date of the 
enactment of this Act. 
TITLE IV—MISCELLANEOUS 
SEC. 401. REGISTRATION FOR COMMERCIAL IMPORTERS 
OF FOOD, DRUGS, DEVICES, AND COSMETICS; 
FEE. 
(a) PROHIBITIONS.—Section 301 (21 U.S.C. 331), as 
amended by sections 102, 104, 112, and 207, is amended 
by adding at the end the following: 
‘‘(ss) The importation of food, drugs, devices, or cos-
metics other than only for personal use by an importer 
that is not registered with respect to such food, drugs, 
devices, or cosmetics under section 415, 510, or 604, re-
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125 
spectively, unless the importer is registered under section 
801(t).’’. 
(b) REGISTRATION.—Section 801, as amended by 
sections 123, 203, and 208, is amended by adding at the 
end the following: 
‘‘(t) The Secretary shall by regulation require that 
an importer of food, drugs, devices, or cosmetics, other 
than only for personal use, that is not required to be reg-
istered with respect to such food, drugs, devices, or cos-
metics under section 415, 510, or 604, respectively, shall 
be registered with the Secretary in a form and manner 
specified by the Secretary. The Secretary shall assign a 
unique identification number to each importer so reg-
istered.’’. 
(c) FEE.—Subchapter C of chapter VII (21 U.S.C. 
379f et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART 6—IMPORTERS OF FOOD, DRUGS, AND 
DEVICES 
‘‘SEC. 742. IMPORTERS OF FOOD, DRUGS, AND DEVICES. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect an annual fee for the registration of an importer 
of food, drugs, or devices under section 801(t). 
‘‘(b) AMOUNT OF FEE.—The amount of the fee under 
this section shall be $10,000. 
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126 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed to authorize the assessment or collection 
of any fee from an importer of food, drugs, or devices if, 
with respect to such food, drugs, or devices, the importer 
is registered under section 415 or 510 and required to 
pay a fee under section 736C or 741.’’. 
(d) EFFECTIVE DATE.— 
(1) REGISTRATION.—Not later than 1 year 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall establish 
procedures for the registration of importers under 
section 801(t) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a). 
(2) REGISTRATION.—The amendments made by 
this section shall first apply not later than 1 year 
after the date of the enactment of this Act. 
SEC. 402. UNIQUE IDENTIFICATION NUMBER FOR FOOD, 
DRUG, AND DEVICE FACILITIES AND ESTAB-
LISHMENTS. 
(a) FOOD AND COSMETICS.—Section 415(a)(3) (21 
U.S.C. 350d(a)(3)) is amended by inserting ‘‘unique’’ be-
fore ‘‘registration number’’. 
(b) DRUGS
AND
DEVICES.—Section 510(e) (21 
U.S.C. 360(e)) is amended by adding after the first sen-
tence the following: ‘‘The registration number shall be the 
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127 
unique identification number for each such establish-
ment.’’. 
(c) EFFECTIVE DATE.—The Secretary of Health and 
Human Services shall implement the amendments made 
by this section not later than 1 year after the date of the 
enactment of this Act. 
SEC. 403. PROHIBITION AGAINST DELAYING OR LIMITING 
INSPECTION. 
Section 301(f) (21 U.S.C. 331(e)) is amended to read 
as follows: 
‘‘(f) The delay or limitation of an inspection, or the 
refusal to permit entry or inspection, as authorized by sec-
tion 510(h) or 704, including any such delay, limitation, 
or refusal by an agent of a governmental authority in a 
foreign country.’’. 
SEC. 404. DEDICATED FOREIGN INSPECTORATE. 
Section 704 (21 U.S.C. 374) is amended by adding 
at the end the following: 
‘‘(i) The Secretary shall establish and maintain a 
corps of inspectors dedicated to inspections of foreign 
food, drug, device, and cosmetics facilities and establish-
ments. This corps shall be staffed and funded by the Sec-
retary at a level sufficient to allow it to conduct inspec-
tions of foreign food, drug, device, and cosmetic facilities 
and establishments at a frequency at least equivalent to 
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128 
the inspection rate of domestic food, drug, device, and cos-
metic facilities and establishments.’’. 
SEC. 405. CONTINUED OPERATION OF FIELD LABORA-
TORIES. 
(a) IN GENERAL.—Subject to subsections (b) and 
(d), the Secretary of Health and Human Services (in this 
section referred to as the ‘‘Secretary’’) shall not— 
(1) terminate any of the 13 field laboratories 
that were operated by the Office of Regulatory Af-
fairs of the Food and Drug Administration as of 
January 1, 2007; 
(2) consolidate any such laboratory with any 
other laboratory; 
(3) terminate any of the 20 district offices or 
any of the inspection or compliance functions of any 
of the 20 district offices of the Food and Drug Ad-
ministration functioning as of January 1, 2007; or 
(4) consolidate— 
(A) any such district office with an office 
in any other district; or 
(B) transfer any of the compliance or in-
spection functions of any such district office to 
any other district. 
(b) REPORT BY SECRETARY.— 
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129 
(1) SUBMISSION.—The Secretary shall submit a 
reorganization plan involving the termination or con-
solidation of the laboratories, the district offices, or 
the functions of such district offices specified in sub-
section (a) to the Comptroller General of the United 
States, the Committee on Energy and Commerce of 
the House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate. 
(2) CONSULTATION.—In preparing the reorga-
nization plan described in paragraph (1), the Sec-
retary shall consult with personnel and unions to be 
affected by the plan. 
(c) REPORT
BY GAO.—The Comptroller General 
shall study the cost effectiveness of the reorganization 
plan described in subsection (b) and its impact on the 
safety of food, drug, and other products regulated under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) and the Public Health Service Act (42 U.S.C. 201 
et seq.) and report to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate. 
(d) REORGANIZATION.— 
(1) CONGRESSIONAL REVIEW.—The reorganiza-
tion plan described in subsection (b) is deemed to be 
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130 
a major rule (as defined in section 804(2) of title 5, 
United States Code) for purposes of chapter 8 of 
such title. 
(2) EFFECTIVE
DATE.—Notwithstanding sec-
tion 801(a)(3) of title 5, United States Code, the re-
organization plan described in subsection (b) shall 
take effect (unless disapproved under section 802 of 
such title) on the date that is specified in such plan, 
but not earlier than 180 days after the date on 
which the Comptroller General submits the report 
required by subsection (c). 
SEC. 406. FALSE OR MISLEADING REPORTING TO FDA. 
(a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 
331(q)(2)) is amended by inserting after ‘‘device’’ the fol-
lowing: ‘‘food, drug, or biological product’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to submissions made on or after 
the date of the enactment of this Act. 
SEC. 407. SUBPOENA AUTHORITY. 
Chapter III (21 U.S.C. 331 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 311. EXERCISE OF SUBPOENA AUTHORITY. 
‘‘(a) IN GENERAL.—For the purpose of— 
‘‘(1) any hearing, investigation, or other pro-
ceeding respecting a violation of the Act, or 
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131 
‘‘(2) any hearing, investigation, or other pro-
ceeding to determine if a person is in violation of a 
specific provision of the Act, 
the Commissioner may issue subpoenas requiring the at-
tendance and testimony of witnesses and the production 
of documentary evidence. Such attendance of witnesses 
and production of evidence at the designated place of such 
hearing, investigation, or other proceeding may be re-
quired from any place in the United States or in any terri-
tory or possession of the United States. Subpoenas of the 
Commissioner shall be served by a person authorized by 
the Commissioner by delivering a copy thereof to the per-
son named therein or by certified mail addressed to such 
person at such person’s last known dwelling place or prin-
cipal place of business. A verified return by the person 
so serving the subpoena setting forth the manner of serv-
ice, or, in the case of service by certified mail, the return 
post office receipt therefor signed by the person so served, 
shall be proof of service. Witnesses so subpoenaed shall 
be paid the same fees and mileage as are paid witnesses 
in the district courts of the United States. 
‘‘(b) ENFORCEMENT.—In the case of a refusal to 
obey a subpoena duly served upon any person under sub-
section (a), any district court of the United States for the 
judicial district in which such person charged with refusal 
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132 
to obey is found, resides, or transacts business, upon ap-
plication by the Commissioner, shall have jurisdiction to 
issue an order requiring such person to appear and give 
testimony or to appear and produce evidence, or both. The 
failure to obey such order of the court may be punished 
by the court as contempt thereof. Furthermore, the failure 
or refusal to obey such a subpoena shall be treated as a 
prohibited act under section 301(a). 
‘‘(c) RELATION TO OTHER PROVISIONS.—The sub-
poena authority vested in the Commissioner and the dis-
trict courts of the United States by this section is in addi-
tion to any such authority vested in the Commissioner or 
such courts by other provisions of law.’’. 
SEC. 408. WHISTLEBLOWER PROTECTIONS. 
Chapter IX (21 U.S.C. 391 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 911. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 
VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 
THIS ACT OR SECTION 351 OF THE PUBLIC 
HEALTH SERVICE ACT. 
‘‘(a) IN GENERAL.—No person that submits or is re-
quired to submit to the Secretary, a registration under 
section 415, 510, or 604, a new drug application under 
section 505(b), an abbreviated new drug application under 
section 505(j), a biologics license application under section 
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351 of the Public Health Service Act, an application for 
an investigational new drug exemption under section 
505(i), a new animal drug application under section 
512(b), an abbreviated new animal drug application under 
section 512(b), an application under section 571, a request 
under section 572, an application or report for premarket 
approval under section 515, an application for an inves-
tigational device exemption under section 520(g), a report 
under section 510(k), an application for a humanitarian 
device exemption under section 520(m), an amendment, 
supplement, or other submission with respect to any such 
registration, application, or report, or a record or report 
related to an adverse event, a postapproval study, a post-
approval clinical trial, a report, or postmarket surveillance 
under section 505(k), 505(o), 519, 522, or 760, or any 
officer, employee, contractor, subcontractor, or agent of 
such a person, may discharge, demote, suspend, threaten, 
harass, or in any other manner discriminate against an 
employee in the terms and conditions of employment be-
cause of any lawful act done by the employee, including 
within the ordinary course of the job duties of such em-
ployee— 
‘‘(1) to provide information, cause information 
to be provided, or otherwise assist in any investiga-
tion regarding any conduct which the employee rea-
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134 
sonably believes constitutes a violation of this Act or 
section 351 of the Public Health Service Act, any 
other provision of Federal law relating to the safety 
or effectiveness of a drug, biological product, or de-
vice or to the safety of a food or cosmetic, or any 
provision of Federal law prohibiting fraud against 
the Food and Drug Administration, if the informa-
tion or assistance is provided to, or an investigation 
stemming from the provided information is con-
ducted by— 
‘‘(A) a Federal regulatory or law enforce-
ment agency; 
‘‘(B) any Member of Congress or any com-
mittee of Congress; or 
‘‘(C) a person with supervisory authority 
over the employee (or such other person work-
ing for the employer who has the authority to 
investigate, discover, or terminate the mis-
conduct); 
‘‘(2) to file, cause to be filed, testify, participate 
in, or otherwise assist in a proceeding filed or about 
to be filed (with any knowledge of the employer) re-
lating to any such alleged violation; or 
‘‘(3) to refuse to commit or assist in any such 
violation. 
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135 
‘‘(b) ENFORCEMENT ACTION.— 
‘‘(1) IN GENERAL.—An employee who alleges 
discharge, or other discrimination in violation of 
subsection (a), may seek relief in accordance with 
the provisions of subsection (c), by— 
‘‘(A) filing a complaint with the Secretary 
of Labor; or 
‘‘(B) if the Secretary of Labor has not 
issued a final decision within 210 days of the 
filing of the complaint, or within 90 days after 
receiving a final decision or order from the Sec-
retary, and there is no showing that such delay 
is due to the bad faith of the claimant, bringing 
an action at law or equity for de novo review in 
the appropriate district court of the United 
States, which court shall have jurisdiction over 
such action without regard to the amount in 
controversy, and which action shall, at the re-
quest of either party to such action, be tried by 
the court with a jury. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Any action under 
paragraph (1) shall be governed under the rules 
and procedures set forth in section 42121(b) of 
title 49, United States Code. 
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136 
‘‘(B) EXCEPTION.—Notification in an ac-
tion under paragraph (1) shall be made in ac-
cordance with section 42121(b)(1) of title 49, 
United States Code, except that such notifica-
tion shall be made to the person named in the 
complaint and to the employer. 
‘‘(C) BURDENS
OF
PROOF.—An action 
brought under paragraph (1)(B) shall be gov-
erned by the legal burdens of proof set forth in 
section 42121(b) of title 49, United States 
Code. 
‘‘(D) STATUTE OF LIMITATIONS.—An ac-
tion under paragraph (1) shall be commenced 
not later than 180 days after the date on which 
the violation occurs. 
‘‘(c) REMEDIES.— 
‘‘(1) IN GENERAL.—An employee prevailing in 
any action under subsection (b)(1) shall be entitled 
to all relief necessary to make the employee whole. 
‘‘(2) ISSUANCE OF ORDER.—If, in response to 
a complaint filed under paragraph (b)(1), the Sec-
retary of Labor or the district court, as applicable, 
determines that a violation of subsection (a) has oc-
curred, the Secretary or the court shall order the 
person who committed such violation— 
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