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.

Thanks,
Mary

Mary Biersack
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