A bill to amend the Public Health Service Act to provide for a National Center for Clinical Pharmacology, to provide support for the study of clinical pharmacology and clinical pharmacy, and to provide for review of drug prescribing; and to amend the Federal Food, Drug, and Cosmetic Act to provide for additional regulation of drug promotions, to provide for recordkeeping and reporting for all drugs, to provide for certification of programs respecting manufacturer's representatives, to provide for the submission of data relating to therapeutic equivalence of drugs, to provide for the certification of certain drugs, to provide for a national drug compendium, to provide additional drug information to consumers, to establish a code system for the identification of all drugs and for other purposes.
Drug Utilization Improvement Act - Title I: National Center for Clinical Pharmacology - Establishes, under the Public Health Service Act and within the Department of Health, Education, and Welfare, the National Center for Clinical Pharmacology to provide support in the nature of grants for the study of clinical pharmacology. Enumerates the nature and general provisions of such grants.
Provides for the collection of data regarding drug experiences and adverse drug reactions. Directs a study to be conducted on the inappropriate prescribing of drugs and on whether controls are needed for such inappropriate prescribing.
Requires all organizations receiving assistance under this Act to review the prescribing and administering of all drugs in the course of delivery of health care.
Authorizes to be appropriated $8,000,000 for fiscal year 1976, and $9,000,000 for fiscal year 1977 for grants and projects.
Authorizes to be appropriated $2,000,000 for fiscal year 1976, and $4,000,000 for fiscal year 1977 for the collection of data regarding drug experience.
Authorizes to be appropriated $1,000,000 for fiscal year 1976, and $3,000,000 for fiscal year 1977 for the study of inappropriate prescription of drugs.
Title II: Promotional Practices - Prohibits the transfer of any gift, product, premium, prize, or other thing of value, to any individual if the purpose of such transfer is to influence the prescribing, administering, or dispensing of such drug.
Prohibits the transfer of any free drug, including any sample, to any individual by any person engaged in manufacturing except pursuant to a written request of a practitioner licensed by law to prescribe and administer such drugs.
Prohibits the inspection of any written prescription or evidence of any oral prescription without the express consent of the prescribing physician and of the individual for whom the prescription was given. Prohibits the use by any person of any information contained in such files for any purpose.
Requires that information regarding the price at which such drug is available to various classes of purchasers be included in advertisements concerning such drug.
Prohibits the Secretary from exempting any advertisement with respect to specified required information.
Prohibits anyone engaged in the manufacture or distribution of any drug to promote its use to any individual engaged in the delivery of health care unless certified by the Secretary under this Act.
Directs every person engaged in the manufacture or distribution of any drug to register with the Secretary a list of employees, agents, or other representatives engaged in the promotion of any drug.
Directs the Secretary to appoint at least one advisory committee to advise him in the certification of programs.
Title III: Drug Quality - Requires the Secretary to establish requirements for proof of therapeutic equivalence to assure reasonably uniform therapeutic performance among chemically equivalent drug formulations for each drug or class of drugs subject to this Act.
Revises the standard for determining whether or not a drug or device shall be deemed to be adulterated to require that such drug conform to current good manufacturing practice as determined by regulations of the Secretary, and to require that its label bear the date beyond which the drug should not be used.
Empowers the Secretary to provide for batch by batch certification of drugs, whenever the protection of the public health cannot be adequately assured without such certification.
Requires any person subject to registration to establish and maintain such records and make such reports to the Secretary as the Secretary may by regulation require to assist him in carrying out the purposes of this Act.
Title IV: National Drug Compendium - Directs the Secretary to prepare and publish a drug compendium which shall list all drugs requiring prescription that are lawfully available in the United States. States that such drugs shall be arranged by the therapeutic classification. Requires the Secretary to include in such compendium the proprietary names or designations under which a drug is listed in the compendium.
Establishes in the Department an advisory committee consisting of persons qualified in pharmacology, safety, efficacy, and relative therapeutic value of drugs, appointed by the Secretary, to advise the Secretary on matters pertaining to the compendium.
Empowers the Secretary in order to prepare the compendium to obtain from any person in drug commerce any information available for such compendium, and to require such persons to establish and maintain such records, and permit access to such records as the Secretary by regulation may require.
Grants the district courts of the United States jurisdiction to issue orders requiring compliance with a Secretary's order, and to punish as contempt the failure to obey such order.
Title V: Consumer Drug Information - Requires that drugs subject to the Act bear a label containing the established name, and in the case of a drug fabricated from two or more active ingredients, a list of the active ingredients of such drug by their established name.
Directs the Secretary to establish by regulation a uniform code of symbols representing: (1) manufacturer; (2) the identity of the drug; (3) the identity of the final packager of the drug; (4) the dosage form and strength of the drug; and (5) the number of drug units. Declares a drug to be misbranded whose label does not contain such code. Prohibits the doing of any act which causes a drug to be misbranded, and permits any drug that is misbranded to be proceeded against on libel of information.
Requires every person who owns or operates a pharmacy or other establishment subject to applicable local law, and which regularly dispenses drugs upon prescription of practitioners, to display a list of those drugs most frequently sold in the area, the professional services associated with the dispensing of such drugs, and the charges of such pharmacy to the public for such services.
Introduced in Senate
Referred to Senate Committee on Labor and Public Welfare.
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