Before the Food and Drug Administration: Over-the-Counter Drugs – Reply Comments

by Council on Wage and Price Stability on January 7, 1977
by Council on Wage and Price Stability

On September 9, 1976, the Food and Drug Administration (FDA) proposed to establ ish conditions ‘under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic drugs are generally recognized as safe and effective and not misbranded (41 FR 38312). This proposal is in the form of a “monograph” prepared by FDA from the findings and recommendations of the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products. The FDA published the monograph as a proposed regulation prior to full evaluation by the Commissioner to stimulate discussion and comment. Comments were due on December 8, 1976, with reply comments due January 7, 1977. These reply comments are based upon our review of comments submitted to FDA on December 8, 1976, as well as our review of the instant proposal.

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