FDA and Pharmacy Weekly Digest – October 2020 #2 | BakerHostetler – JD Supra

FDA and Pharmacy Weekly Digest – October 2020 #2 | BakerHostetler – JD Supra

Food

FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food. Food establishment management and food employees can use the question-and-answer format of the handbook to prevent the spread of disease.

FDA Warned Companies Selling Dietary Supplement Containing Cesium Chloride – The FDA issued warning letters letters to companies labeling cesium chloride as a dietary supplement. According to the FDA, the “FDA is not aware of any information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the United States before October 15, 1994.” Firms must provide certain safety-related information about the ingredient to the FDA before including it in a dietary supplement.

Drugs

FDA to Hold Virtual Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) – The BsUFA authorizes the FDA to collect user fees to support the review of biosimilar biological products. Interested stakeholders may register for the Nov. 19 meeting.

FDA Extends Delayed Enforcement Under Track and Trace – The Drug Supply Chain Security Act (DSCSA) established product tracing, product identifier, authorized trading partner and verification requirements for manufacturers, wholesale distributors, repackagers and dispensers. Under the act, wholesale distributors must verify saleable returned product. Under updated guidance, the FDA does not intend to take action against wholesale distributors that do not, prior to Nov. 27, 2023, verify a product identifier before further distributing returned product as required under the DSCSA. Additionally,
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