[Congressional Record Volume 143, Number 122 (Monday, September 15, 1997)]
[Senate]
[Pages S9350-S9351]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 THE FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT 
    OF 1997 PRESCRIPTION DRUG USERS FEE REAUTHORIZATION ACT OF 1997

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                     HUTCHINSON AMENDMENT NO. 1189

  (Ordered to lie on the table.)
  Mr. HUTCHINSON submitted an amendment intended to be proposed by him 
to the bill, S. 830, supra; as follows:

       In lieu of the matter proposed to be inserted, insert the 
     following:

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

       Section 503 (21 U.S.C. 353) is amended by adding at the end 
     the following:
       ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 
     507 shall not apply to a drug product if--
       ``(A) the drug product is compounded for an identified 
     individual patient, based on a medical need for a compound 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, on the 
     prescription order of a licensed physician or other licensed 
     practitioner authorized by State law to prescribe drugs; or
       ``(ii) by a licensed pharmacist or licensed physician in 
     limited quantities, prior to the

[[Page S9351]]

     receipt of a valid prescription order for the identified 
     individual patient, and is compounded based on a history of 
     the licensed pharmacist or licensed physician receiving valid 
     prescription orders for the compounding of the drug product 
     that have been generated solely within an established 
     relationship between the licensed pharmacist, or licensed 
     physician, and--
       ``(I) the individual patient for whom the prescription 
     order will be provided; or
       ``(II) the physician or other licensed practitioner who 
     will write such prescription order; and
       ``(B) the licensed pharmacist or licensed physician--
       ``(i) compounds the drug product using bulk drug 
     substances--
       ``(I) that--
       ``(aa) comply with the standards of an applicable United 
     States Pharmacopeia or National Formulary monograph; or
       ``(bb) in a case in which such a monograph does not exist, 
     are drug substances that are covered by regulations issued by 
     the Secretary under paragraph (3);
       ``(II) that are manufactured by an establishment that is 
     registered under section 510 (including a foreign 
     establishment that is registered under section 510(i)); and
       ``(III) that are accompanied by valid certificates of 
     analysis for each bulk drug substance;
       ``(ii) compounds the drug product using ingredients (other 
     than bulk drug substances) that comply with the standards of 
     an applicable United States Pharmacopeia or National 
     Formulary monograph and the United States Pharmacopeia 
     chapter on pharmacy compounding;
       ``(iii) only advertises or promotes the compounding service 
     provided by the licensed pharmacist or licensed physician and 
     does not advertise or promote the compounding of any 
     particular drug, class of drug, or type of drug;
       ``(iv) does not compound a drug product that appears on a 
     list published by the Secretary in the Federal Register of 
     drug products that have been withdrawn or removed from the 
     market because such drug products or components of such drug 
     products have been found to be unsafe or not effective;
       ``(v) does not compound a drug product that is identified 
     by the Secretary in regulation as presenting demonstrable 
     difficulties for compounding that reasonably demonstrate an 
     adverse effect on the safety or effectiveness of that drug 
     product; and
       ``(vi) does not distribute compounded drugs outside of the 
     State in which the drugs are compounded, unless the principal 
     State agency of jurisdiction that regulates the practice of 
     pharmacy in such State has entered into a memorandum of 
     understanding with the Secretary regarding the regulation of 
     drugs that are compounded in the State and are distributed 
     outside of the State, that provides for appropriate 
     investigation by the State agency of complaints relating to 
     compounded products distributed outside of the State.
       ``(2)(A) The Secretary shall, after consultation with the 
     National Association of Boards of Pharmacy, develop a 
     standard memorandum of understanding for use by States in 
     complying with paragraph (1)(B)(vi).
       ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed 
     pharmacist or licensed physician, who does not distribute 
     inordinate amounts of compounded products outside of the 
     State, until--
       ``(i) the date that is 180 days after the development of 
     the standard memorandum of understanding; or
       ``(ii) the date on which the State agency enters into a 
     memorandum of understanding under paragraph (1)(B)(vi),

     whichever occurs first.
       ``(3) The Secretary, after consultation with the United 
     States Pharmacopeia Convention Incorporated, shall promulgate 
     regulations limiting compounding under paragraph 
     (1)(B)(i)(I)(bb) to drug substances that are components of 
     drug products approved by the Secretary and to other drug 
     substances as the Secretary may identify.
       ``(4) The provisions of paragraph (1) shall not apply--
       ``(A) to compounded positron emission tomography drugs as 
     defined in section 201(ii); or
       ``(B) to radiopharmaceuticals.
       ``(5) In this subsection, the term `compound' does not 
     include to mix, reconstitute, or perform another similar act, 
     in accordance with directions contained in approved drug 
     labeling provided by a drug manufacturer.''.

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