Science and Technology Regulatory Relief Act of 2012

Science and Technology Regulatory Relief Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a state or political subdivision from conducting or requiring an inspection of a factory, warehouse, or establishment in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor for introduction into interstate commerce, or after such introduction, for purposes of verifying compliance with such Act, Public Health Service Act requirements regarding the regulation of biological products, or any similar requirements established pursuant to state law.

Makes exceptions for such an inspection if: (1) the state or subdivision makes a determination that a drug or device presents a threat of serious adverse health consequences or death; (2) the Secretary of Health and Human Services (HHS) orders a recall of a drug, biological product, or device manufactured, processed, packed, or held at the factory, warehouse, or establishment; or (3) the Secretary requests or authorizes the state to conduct or require the inspection.

[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4056 Introduced in House (IH)]

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.


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                    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) 
 introduced 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 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Science and Technology Regulatory 
Relief Act of 2012''.

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 Inspect.--
            ``(1) In general.--Except as provided in paragraph (2), no 
        State or political subdivision of a State may conduct or 
        require an inspection of a factory, 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 commerce 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:
                    ``(A) The State or political subdivision (or a 
                department or agency thereof) makes a determination, 
                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 manufactured, 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.''.
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