[Congressional Record Volume 143, Number 122 (Monday, September 15, 1997)]
[Senate]
[Pages S9346-S9347]
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

                                 ______
                                 

                  FEINSTEIN AMENDMENTS NOS. 1179-1181

  (Ordered to lie on the table.)
  Mrs. FEINSTEIN submitted three amendments intended to be proposed by 
her to the bill, S. 830, supra; as follows:

                           Amendment No. 1179

       In section 761 of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 807(a), add the following new subsection:
       ``(g) Regulations.--
       ``(1) Requirement.--Not later than 2 years after the date 
     of enactment of the Food and Drug Administration 
     Modernization and Accountability Act of 1997, the Secretary 
     shall promulgate final regulations (after notice and comment) 
     that establish the criteria and conditions under which a 
     State may apply for and receive an exemption under subsection 
     (b).
       ``(2) Effective date.--No exemption may be provided under 
     subsection (b) until the date on which the Secretary has 
     promulgated the regulations referred to in paragraph (1).''.
                                  ____


                           Amendment No. 1180

       At the appropriate place in title VIII, insert the 
     following:

     SEC.  . RULE OF CONSTRUCTION REGARDING STATE LAWS.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     804, is further amended by adding at the end thereof the 
     following:

     ``SEC. 908, RULE OF CONSTRUCTION REGARDING STATE LAWS.

       ``Nothing in this Act shall be construed to prohibit any 
     State or political subdivision from imposing any requirements 
     that are more stringent than those imposed by this Act, 
     including, but not limited to, requirements relating to 
     embargoing products, the licensing and inspection of 
     manufacturers' facilities, advertising, labeling, packaging, 
     the regulation of the quality and nature of ingredients, and 
     the provision of warnings or other communications to protect 
     the public health.''.
                                  ____


                           Amendment No. 1181

       On page 141, after line 24, add the following:
       ``(8) Consideration of information as public information.--
     The certification, summary of the proposed protocol, and the 
     schedule for the proposed protocol under this subsection, 
     excluding proprietary information, shall be considered to be 
     public information.
                                 ______
                                 

                    HATCH AMENDMENTS NOS. 1182-1183

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

                           Amendment No. 1182

       Beginning on page 4, strike line 11 and all that follows 
     through page 5, line 6, and insert the following:
       ``(1) In general.--The Secretary, acting through the 
     Commissioner, in consultation with experts in science, 
     medicine, and public health, and in cooperation with 
     consumers, users, manufacturers, importers, packers, 
     distributors, and retailers of regulated products, shall 
     protect the public health by taking actions that help ensure 
     that
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs, including biologic, are 
     safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Secretary, acting through the 
     Commissioner, shall promptly and efficiently review clinical 
     research and take appropriate action on the marketing of 
     regulated products in a manner that does not unduly impede 
     innovation or product availability. The Secretary, acting 
     through the Commissioner, shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.
                                  ____


                           Amendment No. 1183

       At the appropriate place, insert the following:

     SEC.   . SAFETY REPORT DISCLAIMERS.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     804, is further amended by adding at the end the following:

     ``SEC. 908. SAFETY REPORT DISCLAIMERS.

       ``With respect to any entity that submits or is required to 
     submit a safety report or other information in connection 
     with the safety of a product (including a product which is a 
     food, drug, new drug, device, dietary supplement, or 
     cosmetic) under this Act (and any release by the Secretary of 
     that report of information), such report or information shall 
     not be construed to necessarily reflect a conclusion by the 
     entity or the Secretary that the report or information 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience, or otherwise caused or 
     contributed to a death, serious injury, serious illness, or 
     malfunction. Such an entity need not admit, and may deny, 
     that the report or information submitted by the entity 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience or caused or contributed 
     to a death, serious injury, serious illness, or 
     malfunction.''.
                                 ______
                                 

                     HUTCHINSON AMENDMENT NO. 1184

  (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:

       Strike section 809 and insert the following:

     SEC. 809. 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 compounded 
     product--
       ``(i) by a licensed pharmacist in a State licensed pharmacy 
     or a Federal facility, or a licensed physician, or 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 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;
       ``(iv) 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

[[Page S9347]]

     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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