I 
112TH CONGRESS 
2D SESSION 
H. R. 4056 
To amend the Federal Food, Drug, and Cosmetic Act to prevent a State 
or political subdivision thereof from conducting or requiring duplicative 
inspections of establishments in which a drug or device is manufactured, 
processed, packed, or held by a manufacturer or wholesale distributor 
of the drug or device. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 16, 2012 
Mr. BILBRAY (for himself, Mrs. DAVIS of California, Mr. LEWIS of California, 
Mr. ROYCE, Mr. CALVERT, Mrs. BONO MACK, and Mr. HUNTER) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
prevent a State or political subdivision thereof from con-
ducting or requiring duplicative inspections of establish-
ments in which a drug or device is manufactured, proc-
essed, packed, or held by a manufacturer or wholesale 
distributor of the drug or device. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Science and Tech-
nology Regulatory Relief Act of 2012’’. 
VerDate Mar 15 2010 
05:43 Feb 17, 2012
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4056.IH
H4056
smartinez on DSK6TPTVN1PROD with BILLS
SEC. 2. LIMITATION OF STATE AUTHORITY TO INSPECT. 
Section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) is amended by adding at the end the 
following: 
‘‘(h) LIMITATION
OF STATE AUTHORITY TO IN-
SPECT.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), no State or political subdivision of a 
State may conduct or require an inspection of a fac-
tory, warehouse, or establishment in which a drug or 
device is manufactured, processed, packed, or held 
by a manufacturer or wholesale distributor of the 
drug or device, for introduction into interstate com-
merce or after such introduction, for purposes of 
verifying compliance with— 
‘‘(A) the requirements of— 
‘‘(i) section 351 of the Public Health 
Service Act; or 
‘‘(ii) this Act; or 
‘‘(B) any similar requirements established 
pursuant to State law. 
‘‘(2) EXCEPTIONS.—Paragraph (1) does not 
apply to an inspection of such a factory, warehouse, 
or establishment by a State or a political subdivision 
of a State in any of the following circumstances: 
VerDate Mar 15 2010 
05:43 Feb 17, 2012
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4056.IH
H4056
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(A) The State or political subdivision (or 
a department or agency thereof) makes a deter-
mination, based on receipt of a complaint or 
otherwise, that a drug or device presents a 
threat of serious adverse health consequences or 
death, and the inspection relates to such risk. 
‘‘(B) The Secretary orders a recall of a 
drug, biological product, or device manufac-
tured, processed, packed, or held at the factory, 
warehouse, or establishment, and the inspection 
relates to such recall. 
‘‘(C) The Secretary requests or authorizes 
the State to conduct or require the inspection.’’. 
Æ 
VerDate Mar 15 2010 
05:43 Feb 17, 2012
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\H4056.IH
H4056
smartinez on DSK6TPTVN1PROD with BILLS