Over-the-counter (OTC) medicines and dietary supplements help consumers live healthier and more comfortable lives. The safety of these products is paramount to CHPA and its member companies.
CHPA works with Members of Congress on legislation to address concerns about the safety of drug ingredients manufactured outside the United States. Current federal regulations require that all CHPA member companies follow very specific good manufacturing practices, and CHPA’s members are committed to continuously improving manufacturing processes to ensure the highest quality.
Most recently, Congress approved the fourth reauthorization of the Prescription Drug User Fee Act (PDUFA; P.L. 112-144), which allows the FDA to collect user fees for its prescription drug and medical device approval processes. This new version creates new user fee programs for generic drugs and generic biologic drugs, as well as a new section dedicated to improving the quality of the drug supply chain. Among the regulations included in this section, FDA will move to a risk-based inspection schedule, which has been long-favored by CHPA, and drug manufacturers will now have to identify the manufacturers of the excipients they use. The reauthorization of PDUFA was signed into law by President Barack Obama on July 9, 2012.
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