From: "Wright, Mike" <mwright**At_Symbol_Here**USW.ORG>
Subject: Re: [DCHAS-L] do preclinical drugs require SDS?
Date: Thu, 7 Jan 2016 12:35:36 +0000
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: 673A00C44C25834BA3198AADFC1EB7AE297C9D05**At_Symbol_Here**PIT-MAIL01.uswa-us.local
In-Reply-To <1770590425.405365737.1452119188560.JavaMail.zimbra**At_Symbol_Here**>

The OSHA guidance is correct, but it's based on the old Hazard Communication standard that's been replaced by a new one, based on the "Globally Harmonized System."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,


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.


Mike Wright



Michael J. Wright

Director of Health, Safety and Environment

United Steelworkers


412-562-2580 office

412-370-0105 cell


See us on the web at


From: DCHAS-L Discussion List [mailto:dchas-l**At_Symbol_Here**] On Behalf Of Frankie Wood-Black
Sent: Wednesday, January 06, 2016 5:26 PM
Subject: Re: [DCHAS-L] do preclinical drugs require SDS?


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.



From: "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**>?

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.


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




Frankie Wood-Black, Ph.D., REM, MBA

Principal - Sophic Pursuits

6855 Lake Road

Ponca City, OK 74604




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