Compassionate Drug Availability Act of 1981

Summary

Compassionate Drug Availability Act of 1981 - Amends the Federal Food, Drug, and Cosmetic Act to define: (1) "orphan drug" as a drug which is or may be unique or provide an advance in the diagnosis, prevention, or treatment of a human disease or condition of low incidence and has little or no projected commercial value; and (2) "individual compassionate drug treatment" as those treatments primarily intended to provide diagnosis, treatment, or prevention for users rather than to assess the risks and effectiveness of the drug product. Exempts orphan drugs and compassionate drug treatments from application and certification requirements under such Act, except that practitioners administering such care shall maintain case records of medical treatment and conform to applicable rules and regulations pertaining to investigational use. Allows orphan drugs to be exported if the Secretary of Health and Human Services determines that such drugs are not contrary to public health and safety and are approved by the countries intended for export.

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1 official file

• Introduced in House

  summary · EN · 27 April 1981

  Open at official source

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