A bill to amend the Federal Food, Drug, and Cosmetic Act to require that labeling of drugs disclose to drug users the generic names of the drugs and information concerning side effects, adverse reactions, and related information and to authorize licensed practitioners to order in the prescription of a drug that its labeling not include such information; to strengthen the records and reports authority under that act; to require the reporting of information respecting significant health hazards; to authorize conditional approval of new drugs; to authorize the suspension of approved new drug applications if necessary to reduce or eliminate a significant risk of illness, injury, or lack of effective treatment; to strengthen the Food and Drug Administration.

[AI summary unavailable — showing source text] Title I: 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 drugs 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 immediately suspend approval of a drug application upon the finding that a co…