Drug Safety Amendments

Summary

Drug Safety Amendments - Requires, under the Federal Food, Drug, and Cosmetic Act, the insertion on packages of any drug which may be sold only upon prescription, the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor and, in the case of any other drug or device, the name and place of business of the manufacturer, packer, or distributor. Requires reports on, and recordkeeping pertaining to, clinical and preclinical investigation of drug or substances intended for use as a drug. Provides that if the Secretary of Health, Education, and Welfare determines that any information obtained or received by him reasonably supports a conclusion that such a drug introduced for commercial distribution may present a significant hazard to human health, or may cause cancer in animals, he shall mail or cause to be mailed to all practitioners licensed by law to administer drugs, a summary of such information. Provides for the conditional approval of new drugs by the Secretary. Authorizes the Secretary to suspend approval of a drug application if a condition has not been met. Authorizes the Secretary, acting through the National Institutes of Health and in consultation with the Commissioner of the Food and Drug Administration, to support studies of the short-term or long-term use of drugs and alternative forms of drug therapy and studies involving the comparison of drugs. Authorizes the appropriation of $10,000,000 for each fiscal year for such studies. Requires the Secretary to make an annual report to the Congress on the activities undertaken or supported under this Act. Grants the Secretary authority to suspend approved applications for a new drug, a new animal drug, or a feed containing such a drug upon a finding that such suspension is necessary to reduce or eliminate a significant risk of illness or injury.

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1 official file

• Introduced in House

  summary · EN · 10 January 1977

  Open at official source

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