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The author of those regulations, Compounding and Enforcement Committee Chair Maria Serpa, has repeatedly stated that the proposed regulations do not exceed guidelines imposed by the FDA and United States Pharmacopoeia, the highly respected group which sets standards for the quality of medicines, dietary supplements, and health care products in the United States

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Studies have found decreased activities and levels of antioxidant enzymes in conjunction with increased lipid peroxide generation [380]

Your laboratory equipment lacked sufficient controls to prevent and detect deletion or manipulation of your laboratory's electronic raw data." 8 Detailed Analysis of the Violation Spectroscopy Audit Trails: The FDA noted that "ultraviolet-visible (UV-vis) and infrared (IR) spectroscopy equipment was found to lack audit-trail functionality".8 Historically, regulatory focus has been on HPLC and GC data