Whenever you send someone a research sample that meets the OSHA definition of hazardous, an SDS is required, regardless of the quantity.
(b)(5)This section does not require labeling of the following chemicals:(snip)(b)(5)(iii)Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;
From: Mary Biersack <Mary.Biersack**At_Symbol_Here**westpharma.com>?Re: do preclinical drugs require SDS?Hello,
Our company tests a lot of drug products from other companies for container integrity/leachables. Does anyone know if these outside companies are required to send/have an SDS for these preclinical drug products? I was told that all clinical phase I or higher drug products are required to have SDS if they are going to be shipped (DOT) but what about drug products in the preclinical stage? I appreciate any guidance on this.
Lab Safety and Chemical Hygiene Specialist
West Pharmaceutical Services, Inc.
P: +1 610-594-3278
530 Herman O. West Drive | Exton, PA 19341 | United States
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