tity that receives the human body 
or human tissue specimen di-
rectly from the applicant; and 
(ii) only if the applicant (or other ap-
propriate person) consents to the inspec-
tion of the facility that is the subject of the 
application, in accordance with subsection 
(c). 
(3) REQUIREMENTS
FOR
EXEMPTION.—The 
Secretary shall prescribe requirements under which 
a human tissue specimen shall be exempt from the 
requirements of paragraph (1). 
(b) FALSELY LABELING OR MARKING PACKAGE OR 
CONTAINER; ALTERING LABEL OR MARK.—No person 
shall falsely label or mark any package or container of 
any human tissue specimen or alter any label or mark on 
the package or container of the human tissue specimen 
so as to falsify the label or mark. 
(c) INSPECTION OF FACILITIES.— 
(1) IN GENERAL.—Any officer, agent, or em-
ployee of the Department of Health and Human 
Services, authorized by the Secretary for the pur-
pose, may during all reasonable hours enter and in-
spect any facility that is subject to a non-transplant 
tissue bank license under this section. 
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(2) INSPECTION BY NATIONALLY RECOGNIZED 
ACCREDITING BODIES.—Any authorized agent of a 
nationally recognized accrediting body authorized by 
the Secretary for the purpose, may during all rea-
sonable hours enter and inspect any such facility. 
(3) RULE OF CONSTRUCTION.—Nothing in this 
Act limits any existing authority of the Attorney 
General, any State Attorney General, or local law 
enforcement to enter and inspect any such facility. 
(d) RECALL OF SPECIMEN PRESENTING IMMINENT 
HAZARD; VIOLATIONS.— 
(1) RECALL.—Upon a determination that a 
human tissue specimen or collection of specimens of 
a tissue bank licensed under this section presents an 
imminent or substantial hazard to the public health, 
the Secretary shall issue an order immediately order-
ing the recall of such batch, lot, or other quantity 
of such product. An order under this paragraph 
shall be issued in accordance with section 554 of 
title 5, United State Code. 
(2) VIOLATIONS.—Any violation of a recall 
order under paragraph (1) shall subject the violator 
to a civil penalty of up to $10,000 per day of viola-
tion. The amount of a civil penalty under this para-
graph shall, effective December 1 of each calendar 
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year beginning 1 year or more after the effective 
date of this paragraph, be increased by the percent 
change in the Consumer Price Index for the base 
quarter of such year over the Consumer Price Index 
for the base quarter of the preceding year, adjusted 
to the nearest 1⁄10 of 1 percent. For purposes of this 
paragraph, the term ‘‘base quarter’’, as used with 
respect to a year, means the calendar quarter ending 
on September 30 of such year, and the price index 
for a base quarter is the arithmetical mean of such 
index for the 3 months comprising such quarter. 
(e) PROHIBITIONS OF SALES AND PURCHASES OF 
HUMAN TISSUE SPECIMEN.—It shall be unlawful for any 
person to knowingly sell, acquire, receive, or otherwise 
transfer any human tissue specimen for valuable consider-
ation if the transfer affects interstate commerce. 
(f) PENALTIES FOR OFFENSES.—Whoever violates 
any of the provisions of this section shall be imprisoned 
not more than 1 year, or fined not more than $10,000, 
or both. Section 3571 of title 18, United States Code, shall 
not apply to an offense under this section. 
(g) CONSTRUCTION WITH OTHER LAWS.—Nothing 
in this Act (other than subsection (f)) shall be construed 
as in any way affecting, modifying, repealing, or super-
seding any other provision of Federal law. 
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(h) DEFINITIONS.—For the purposes of this section: 
(1) Unless the context indicates otherwise, the 
term ‘‘agent’’ means the person who is expressly au-
thorized to make an anatomical donation on the do-
nor’s behalf under State law. 
(2) The term ‘‘donor’’ means a person whose 
body or whose human tissue specimen is the subject 
of an anatomical donation. 
(3) The term ‘‘human tissue specimen’’— 
(A) means legally donated anatomical seg-
ments, cells, or body fluids (including a com-
plete body) that are recovered for medical re-
search or education; and 
(B) does not include a biological product 
(as defined in section 351 of the Public Health 
Services Act (42 U.S.C. 262)). 
(4) The term ‘‘valuable consideration’’ means 
something of value, but does not include the reason-
able payments associated with the removal, transpor-
tation, processing, preservation, quality control, stor-
age, and lawful disposition of human tissue speci-
mens. 
Æ 
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