Drug Regulation Reform Act of 1979

[AI summary unavailable — showing source text] Drug Regulation Reform Act of 1979 - Title I: Amendments to Federal Food, Drug, and Cosmetic Act - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "person" subject to the coverage of the Act to include an agency of government. Establishes civil penalties for any violation of such Act and criminal penalties for negligent commission of prohibited acts. Requires any new drug to meet standards of identity, stability, and bioavailability, as well as of strength, quality, and purity. Requires drug manufacturers and distributors to prepare information labeling for patients containing: (1) a summary of the benefits and risks of use of a drug; (2) adequate directions for use; and (3) information about proper storage and handling. Requires pharmacies to keep a book available to patients containing the labeling information for the 100 most frequently sold prescription drugs. Authorizes the Secretary of Health, Education,and Welfare to require retail drug sellers to post the retail prices of designated prescription drugs. Requires manufacturers and distributors to prepare information labeling for practitioners regarding indications, contraindications, and other pert…