Drug Regulation Reform Act of 1979

[AI summary unavailable — showing source text] Drug Regulation Reform Act of 1979 - Title I: Drug Regulation Reform - States the findings of Congress. Prohibits the manufacture, importation, export, or distribution of a drug entity or a drug product without the prior issuance by the Department of Health, Education, and Welfare of a monograph containing a description of such drug and requirements and guidelines for the contents of information labeling for the forms of drug products eligible for licensing under such monograph. Authorizes the Secretary of Health, Education, and Welfare to require, in a monograph, postmarketing surveillance of any drug, old or new, for a period of up to five years. Limits the issuance of such monographs to drugs determined safe and effective. Defines "safe" as meaning the health benefits of the drug entity or product clearly outweigh the risks it presents, taking into account pertinent standards and requirements. Defines "effective" to mean that a drug entity when incorporated into a drug product used in accordance with the use conditions set forth on the drug label, will have the effect represented. Provides for amendment, suspension, or revocation of a monograph under specified conditions. Author…