I agree with Monona about the literature search as well as tapping into any EU supplier SDSs. EU SDSs are generally far more thorough and accurately written
as they have been writing them under a far more prescriptive system (DPD/DSD) prior to adopting the CLP regulations. Addionally, they have robust information with respect to classification and concentration thresholds if that is known, about a substance.
In absence of any data, which is often the case when developing new molecules or drugs, I typically look for acceptable data or studies for conjugates of the new molecule and try to predict hazard classification from there.
Nicole Shoshenskiy
Authoring Services Team Lead
MSDSonline
Secretary, ACS Chicago Chapter 2015 and 2016
From: DCHAS-L Discussion List [mailto:dchas-l**At_Symbol_Here**med.cornell.edu]
On Behalf Of Monona Rossol
Sent: Thursday, January 7, 2016 8:25 AM
To: DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU
Subject: Re: [DCHAS-L] do preclinical drugs require SDS?
It shouldn't be hard to meet the SDS requirement. It doesn't require that you know anything about the chemical, just that you provide information on what is known
and make a guess about any serious physical hazards that may be present during transport. And remember, under our legal system, you can't be blamed if there was no way you could know that something was hazardous. So a thorough literature search is all you
really have to do.
As for toxicological effects, in most of the rest of the world, you also have to indicate what is NOT known with the words "no data available." Section 11 on
Toxicology in most of the rest of the world there are requirements for information on 10 standard tox tests, assorted acute and chronic. But if the test hasn't been done, you can just say so.
OSHA does not require that "no data" admission, so you can be REALLY misleading legally here and just provide the little that is known with no further comment.
That leads people to assume that the substance has no additional hazards. And then you can top it off in the U.S. (only) with the required statement that the chemical is not listed as a carcinogen by IARC, NTP and OSHA---which, of course actually means it's
never been tested for cancer effects.
OSHA-compliant SDSs are a crock. Should be a piece of cake to write one.
But if you really want to know something about a chemical, get information from an E.U. SDS or from a major supplier who exports.
Monona Rossol, M.S., M.F.A., Industrial Hygienist
President: Arts, Crafts & Theater Safety, Inc.
Safety Officer: Local USA829, IATSE
New York, NY 10012 212-777-0062
-----Original Message-----
From: Wright, Mike <mwright**At_Symbol_Here**USW.ORG>
To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Sent: Thu, Jan 7, 2016 7:37 am
Subject: Re: [DCHAS-L] do preclinical drugs require SDS?
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.
Director of Health, Safety and Environment
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.
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
Frankie Wood-Black, Ph.D., REM, MBA
Principal - Sophic Pursuits
