A bill to amend the Federal Food, Drug, and Cosmetic Act and related provisions of law.

Summary

Title I: Drug Amendments - Comprehensive Drug Amendments - Amends the Federal Food, Drug, and Cosmetic Act to: (1) redefine "new drug" and "new animal drug;" (2) increase criminal penalties and establish civil penalties under such Act; (3) permit nonprescription labels without a statement of the quantity of each active ingredient of the drug; (4) require certain labeling information on prescription drugs; (5) require certain labeling information regarding proper use; (6) establish a "new drug evaluation agreement" procedure and require it be met before any new drug can be marketed; (7) require the public release of safety and effectiveness data; (8) amend the procedures concerning confidential information; and (9) require that imported drugs come from registered establishments. Title II: Food and Drug Administration - Food and Drug Administration Act - Establishes a Food and Drug Administration within the Department of Health, Education, and Welfare. Establishes an Office of Drug Information within the Administration. Transfers to the Administration all functions of such Department under certain specified Acts.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Introduced in Senate

  summary · EN · 5 August 1977

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.