[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1060 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 1060

    To amend the Federal Food, Drug, and Cosmetic Act to authorize 
     compounding of drugs and devices under certain circumstances.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 13, 1997

  Mr. Burr of North Carolina (for himself, Mr. Condit, Mr. DeLay, Mr. 
McCollum, Mr. Nethercutt, Mr. Canady of Florida, Mr. Andrews, Mr. Deal 
    of Georgia, Mr. Holden, Mr. Hastert, Mr. Watts of Oklahoma, Mr. 
DeFazio, Mr. Klug, Mr. Livingston, Mr. Spratt, Mr. McIntosh, Ms. Furse, 
  Mr. Saxton, Mr. Coburn, Mr. Peterson of Minnesota, Mr. LaHood, Mr. 
 Ehlers, Mr. Barton of Texas, Mr. Norwood, and Mr. Miller of Florida) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to authorize 
     compounding of drugs and devices under certain circumstances.

    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 ``Pharmacy Compounding Act''.

SEC. 2. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF PHARMACY 
              COMPOUNDING.

    (a) In General.--Section 503 (21 U.S.C. 353) is amended by adding 
at the end the following:
    ``(h)(1) Sections 501(a)(2)(B), 501(f), 501(h), 502(f)(1), 502(l), 
502(o), 502(s), 502(t), 505, and sections 510 through 520 shall not 
apply to a drug or device that is compounded by a licensed pharmacist 
or licensed physician or other licensed practitioner authorized by 
State law to prescribe drugs or devices or both--
            ``(A) on the order of such a licensed physician or other 
        licensed practitioner for an individual patient; or
            ``(B) in limited quantities, as determined by the principal 
        State agency of jurisdiction which regulates the practice of 
        pharmacy for that pharmacist, before receiving a valid order 
        for an individual patient if the compounding of the drug or 
        device is based on a history of receiving valid orders that 
        have been generated solely within an established relationship 
        between the pharmacist, and (i) the patient for whom the order 
        will be given, or (ii) the physician or other licensed 
        practitioner who will write such order.
Such sections shall not apply to a drug or device if such pharmacist or 
physician or other licensed practitioner does no more than advertise or 
otherwise promote the compounding service and does not advertise or 
otherwise promote the compounding of a particular drug or device.
    ``(2) None of the provisions of this Act referred to in paragraph 
(1) shall apply to a bulk drug product or other drug, including an 
imported drug, that is intended for use by a licensed pharmacist or 
licensed physician or other licensed practitioner in compounding a drug 
or device on the order of a licensed physician or other licensed 
practitioner for an individual patient, except to the extent that the 
provision relates directly to the quality, purity, potency, or identity 
of such drug.''.
    (b) Withdrawal of Proposed Rule and Guideline.--The proposed rule 
of the Secretary of Health and Human Services concerning exceptions to 
the current good manufacturing practices for makers of positron 
emission tomography drug products and the draft guideline on the 
manufacture of positron emission tomography drug products published in 
the Federal Register of February 27, 1995 (at 60 FR 10517-10520 and 60 
FR 10593-10594) are null and void and the Secretary of Health and Human 
Services may not propose another proposed regulation or guideline 
respecting the same matters covered by the proposed regulation and 
guideline described in this subsection.
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