RU-486 Patient Health and Safety Protection Act

RU-486 Patient Health and Safety Protection Act - Restricts the prescribing of the drug mifepristone (commonly referred to as RU-486, to be marketed as Mifeprex) to physicians who meet specified requirements.

[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 251 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 251

 To require the Food and Drug Administration to establish restrictions 
 regarding the qualifications of physicians to prescribe the abortion 
                     drug commonly known as RU-486.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 6, 2001

 Mr. Hutchinson (for himself, Mr. Hagel, Mr. DeWine, and Mr. Smith of 
New Hampshire) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require the Food and Drug Administration to establish restrictions 
 regarding the qualifications of physicians to prescribe the abortion 
                     drug commonly known as RU-486.

    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 ``RU-486 Patient Health and Safety 
Protection Act''.

SEC. 2. RESTRICTIONS FOR PRESCRIBING ABORTION DRUG.

    With respect to the application that was submitted under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
for the drug mifepristone (commonly referred to as RU-486, to be 
marketed as MIFEPREX), and that was approved on September 28, 2000, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall promptly modify the conditions of the approval 
of such drug to establish the additional restriction that the drug may 
not be prescribed by any person other than a licensed physician who 
meets the following requirements:
            (1) The physician is qualified to handle complications 
        resulting from an incomplete abortion or ectopic pregnancy.
            (2) The physician has been trained to perform surgical 
        abortions and has met all applicable legal requirements to 
        perform such abortions.
            (3) The physician is certified for ultrasound dating of 
        pregnancy and detecting ectopic pregnancy.
            (4) The physician has completed a program regarding the 
        prescribing of such drug that uses a curriculum approved by the 
        Secretary.
            (5) The physician has admitting privileges at a hospital to 
        which the physician can travel in one hour or less, determined 
        on the basis of starting at the principal medical office of the 
        physician and traveling to the hospital, using the 
        transportation means normally used by the physician to travel 
        to the hospital, and under the average conditions of travel for 
        the physician.
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