The OSHA guidance is correct, but it's based on the old Hazard Communication standard that's been replaced by a new one, based on the "Globally Harmonized System." The legal designation for the standard is 29 CFR 1900.1200. You can find it on the OSHA website, www.osha.gov.
Drugs and drug ingredients are exempt from labeling requirements only when they subject to FDA labeling. (29 CFR 1900.1200(b)(5)(iii)
Laboratories have to maintain labels and safety data sheets sent by the supplier, and obtain a safety data sheet if an employee requests one. And, as the guidance states, if you ship anything out - other than the FDA labeled materials - you have to supply labels and safety data sheets. (b)(3)
That's the law. Of course, best practice is to get as much information as possible about what you are working with. I'd demand a safety data sheet from anyone sending you any chemical or mixture. And in almost every case, the supplier has the legal requirement to send one.
Michael J. Wright
Director of Health, Safety and Environment
See us on the web at www.usw.org
You may get a better response from a couple of the folks that are doing SDS - however, this is the old MSDS guidance for materials that are not completely characterized.
"ACS Division of Chemical Health and Safety Secretary" <secretary**At_Symbol_Here**DCHAS.ORG>
Sent: Wednesday, January 6, 2016 12:37:47 PM
Subject: [DCHAS-L] do preclinical drugs require SDS?
From: Mary Biersack <Mary.Biersack**At_Symbol_Here**westpharma.com>?
Re: do preclinical drugs require SDS?
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
Frankie Wood-Black, Ph.D., REM, MBA
Principal - Sophic Pursuits
6855 Lake Road
Ponca City, OK 74604
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