Federal Drug Compendium Act

Summary

Federal Drug Compendium Act - Revises the Federal Food, Drug, and Cosmetic Act. Directs the Secretary of Health, Education, and Welfare to prepare a drug compendium to be distributed to all practitioners licensed by law 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 in 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 is given due process of law. Provides for the establishment of an advisory committee within the Department of Health, Education, and Welfare 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 drugs. Empowers the Secretary 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 package from which the drug is to be dispensed have on it 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.

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1 official file

• Introduced in Senate

  summary · EN · 24 March 1975

  Open at official source

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