PPB October 2020

• Products fraudulentlymarketed as “FDA-approved” • Failure to comply with GMP requirements º Verify your manufacturer’s registration in the FDA’s Inspection Classification Database Search at this link: www.accessdata. fda.gov/scripts/inspsearch/ ?utm_campaign=SBIA%3A%20 Hand%20Sanitizers&utm_ medium=email&utm_ source=Eloqua. Which Hand Sanitizer Is Right for Your Customer? The CDC has identified ethyl alcohol-based hand sanitizers as themost effective hand sanitizer in the fight against coronavirus. When selecting a hand sanitizer for your client: • Check themanufacturer’s / importer’s FDA registration • Ask for the list of ingredients and the testing that validates content and product safety • Check the label for active ingredients and warnings • Check the packaging for batch number and expiry date • Avoid colorants and fruity scents • Avoid packaging that looks like liquor bottles • Monitor hand sanitizer recalls The FDA has also announced steps to address the gap in current testing protocols that allowed the flood of tainted hand sanitizer. An updated monograph for hand sanitizer was published for comment on July 31, 2020. Among the revisions is the addition of a methanol limit test to be added to the USP Alcohol and USP Dehydrated Alcohol monographs. Contact your laboratory service provider for more information. The issues that have emerged around hand sanitizer during the current health- care crisis demandmanufacturers and importers be especially diligent in adhering to compliance processes that protect the consumer. Companies that are unfamiliar with FDA regulations for drug products should consider the regulatory requirements and the scope of the EUA and should then determine if compliance, under these specified conditions, is achievable. D.E. Fenton was most recently executive director at Quality Certification Alliance. After 12 years, the organization concluded its mission and wrapped up operations as of August 1. | OCTOBER 2020 | 89 THINK