Title I: Federal Drug Compendium - States that pursuant to the Federal Food, Drug, and Cosmetic Act the Secretary of Health, Education, and Welfare shall prepare a drug compendium. Directs that such compendium shall be distributed to all practitioners licensed to administer and prescribe drugs. Provides that the Secretary shall revise and keep current such compendium.
States that the compendium shall list the established name of all drugs lawfully available in the United States and their ingredients. Directs that such compendium shall also include the proprietary names of such drugs and the names of suppliers. Allows the Secretary to issue a supplement to the compendium containing price information. Provides that the Secretary shall not be required to include on the compendium any information concerning drugs of questionable safety.
Establishes procedures to insure that any person, adversely affected by the Secretary's inclusion or failure to include a drug in the compendium, be given due process of law.
Provides for the establishment of an advisory committee to advise the Secretary on matters pertaining to the compendium.
Authorizes the Secretary to require persons engaged in manufacturing, preparing, distributing or importing drugs to furnish any available information to the Secretary relating to such drug. Empowers the Secretary with the authority to require that such persons establish and maintain records of clinical experience and other such data relevant to such drugs.
Gives the Secretary authority to waive any requirement that the packages from which the drug is to be dispensed have labeling bearing information adequate for the safe use or prescribing of the drug by licensed practitioners.
States that a drug listed in the compendium which has advertising or labeling inconsistent with the compendium description shall not by reason of such inconsistency be deemed misbranded if such label is in full conformity with other applicable regulations contained in the Federal Food, Drug, and Cosmetic Act.
Title II: Drug Certification - Authorizes the Secretary to require batch-by-batch certification of drugs when he determines it necessary to adequately insure safety and efficacy of use. Directs the Secretary to promulgate regulations exempting from such requirements drugs which are to be repacked at establishments other than any establishment where manufactured, or drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by regulation, or drugs intended solely for investigational use. Provides for public hearings on petitions by interested parties upon request for action on any such regulation.
Authorizes the Secretary to declare a regulation banning a drug to be effective on an interim basis if he determines that a drug presents an unreasonable risk of illness or injury or deception.
Title III: Drug Labeling - Requires that drug labels specify the date beyond which the drug should not be sold for reasons of safety, effectiveness, or diminished potency. Directs that no drug label shall bear a date which is more than five years beyond the date on which the processing of the drug is completed.
States that the Secretary may by regulation require that drugs determined by the Secretary to be potentially dangerous when administered as directed bear a label clearly warning of such dangers. Directs that drug labels shall contain the established name of the drug in the case of a drug containing only one active ingredient, and in the case of a drug containing more than one active ingredient, a list of the active ingredients of such drug.
Authorizes the Secretary to designate an official name for any new drug upon approval of the application filed for such drug.
Provides that the provisions of this title shall become effective on the first day of the thirteenth calendar month following the month in which this Act is enacted.
Title IV: Administration and Enforcement - Provides that all drugs not recognized among qualified experts shall be designated as new drugs. Directs that all new drugs are subject to all requirements of the Federal Food, Drug, and Cosmetic Act.
Provides that misleading advertising or promotional materials may warrant misbranding just as misleading labeling.
Provides that no broadcaster or advertising agency which disseminates false advertisement or promotional material shall be held liable for violation of this Act unless he has refused, at the request of the Secretary, to furnish the Secretary the name and post office address of the manufacturer, or seller, residing in the United States.
States that restraining orders against the dissemination of false advertisements in publications published at regular intervals shall exclude any issue, the delivery of which, the court determines would be delayed.
Establishes enforcement powers to be used by the Secretary to carry out the provisions of this title.
Introduced in Senate
Referred to Senate Committee on Labor and Public Welfare.
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