PPB October 2020

conditions under which these products may be manufactured. (Note: The FDA defines drug as “(a) substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Hand sanitizers aid in the prevention of disease.) The Food and Drug Act of 1906 required manufacturers to accurately identify a product’s content and concentration as well as the volume or count of the product contained in the package. The FDA’s mandate expanded in 1938 to include cosmetics and medical devices. The new scope included standardization of the drug approval process (pre-market screening) and added a requirement that all drugs be labeled with safe dosage and usage information. The broadened mandate also laid the groundwork for modern FDA factory inspections and certifications. Literally thousands of drug products have been removed from the U.S. market as a result of the enactment of these regulations because those drugs lacked evidence of safety and/ or effectiveness. Meeting Compliance Standards As Companies Pivot to Manufacturing / Importing Hand Sanitizer Registering Your Company And Your Product All companies involved in any aspect of the manufacturing, packaging or labeling of an OTC drug product are required to register with the FDA (see box below for this link and others). While a more rigorous regulatory process is in place for prescription drugs, the FDAmaintains well-defined procedures for classifying OTC drugs as safe and effective. Manufacturers are required to detail the quantities of active ingredients contained in the recommended dosage—or, in the case of hand sanitizer, an application—providing animal and human safety studies (controlled, partially controlled and uncontrolled) relating to the individual active ingredients, combinations of the active ingredients and the finished product. Even if a formula is deemed safe, potential for contamination or other harm exists in how the product is manufactured, packaged or labeled. The FDA requires all participants in the OTC supply chain to adhere to Current Good Manufacturing Practices (cGMP) (21 CFR Parts 1-99, 200-299, 300-499, 600-799 and 800-1299) validated through an onsite audit that includes a review of production records, traceability of manufactured product and a recall process. EUAs: The COVID Wildcard Because of an increased demand for hand sanitizer during the coronavirus pandemic, the Resources • To register products with the FDA: www.accessdata.fda.gov/scripts/cder/training/OTC/topic4/topic4/ da_01_04_0040.htm • Learn more about Current Good Manufacturing Practices (cGMP): www.fda.gov/drugs/pharmaceutical- quality-resources/facts-about-current-good-manufacturing-practices-cgmps • Emergency Use Authorization letter (FDA-2020-D-1106): www.fda.gov/regulatory-information/search- fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand- sanitizer-products-during • Guidance for local production: www.who.int/gpsc/5may/Guide_to_Local_Production.pdf?ua=1 www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19 • Drug labeling: www.fda.gov/drugs/drug-information-consumers/otc-drug-facts-label https://www.osha.gov/dsg/hazcom/ghsguideoct05.pdf • USP Alcohol and USP Dehydrated Alcohol monographs: www.uspnf.com/notices/methanol-testing-nitr- 20200731?utm_campaign=SBIA%3A%20Hand%20Sanitizers&utm_medium=email&utm_source=Eloqua Since the start of the pandemic earlier this year, the Food andDrug Administration (FDA) has recommended a 60-75-percent ethanol-based solution that largely follows the formula of the original patent. | OCTOBER 2020 | 81 THINK