PPB October 2020

FDA has issued two Emergency Use Authorization (EUA) letters. The EUAs still effectively require new participants in the hand sanitizer supply chain to adhere to all existing regulations. The first permits existing drug compounders to produce ethyl alcohol-based hand sanitizer for public distribution. The second letter (FDA- 2020-D-1106), relevant to the promotional products industry, allows newmanufacturers, repackagers and distributors of alcohol-based hand sanitizers to temporarily register their manufacturing facilities and their hand-sanitizer products, as long as they adhere to both United States Pharmacopeia (USP) guidance for ingredients and formulas, and the WHO Guide to Local Production. Per the letter, the FDA is waiving validation enforcement actions. Violative, unsafe product remains subject to recall. Labeling Hand Sanitizer Labels inform the end user about the product, how it is intended to be used and the cautions to be exercised. For hand sanitizer, labels not only perform this function for the consumer, but also for other members of the supply chain. Drug Facts The FDA published the final OTC Drug Facts Label regulation inMarch 1999. The following information, in this order, must appear on all OTC product distributed into the market: • The product’s active ingredients, including the amount in each dosage unit. • The purpose of the product. • The uses (indications) for the product. • Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. • This section also describes side effects that could occur and substances or activities to avoid. • Dosage instructions: when, how and how often to take the product. • The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction. The main drug facts title, all headings, subheadings and other informationmust be printed in a single, clear, easy-to-read type style with no more than 39 characters per inch. Titles and headings should be bolded italic with subheadings in bold only. Headings should be no smaller than eight-point type, while subheadings and all other information should be no smaller than six-point type. The approved format of the label is as shown in Figure 1 . Warning For Potential Hazards Ensuring safe usage of any drug product starts with understanding who the ultimate customer is, how the product is intended to be used and the properties of the drug’s ingredients. The ethyl alcohol base of hand sanitizers, despite its efficacy as an antiseptic and disinfectant, poses a number of hazards for those whomay come in contact with the product. Ethyl alcohol is highly flammable and categorized as a Class 3 Dangerous Good (DG). A 65-70-percent (v/v) solution (the concentration common among most promotional hand sanitizers) has a flashpoint of 73° Fahrenheit or 23° Celsius. Figure 1 For hand sanitizer, labels not only perform this function for the consumer, but also for other members of the supply chain. 82 | OCTOBER 2020 | THINK