DCHAS-L Archives, Jan 06 2016 - Re: [DCHAS-L] do preclinical drugs require SDS?

Whenever you send someone a research sample that meets the OSHA definition of hazardous, an SDS is required, regardless of the quantity.

While there is a limited SDS exemption for drugs under paragraph (b)(5)(iii) of 29 CFR 1910.1200, the OSHA Hazard Communication Standard, the materials you describe do not, in my reading, meet the criteria for exemption - see http://www.ilpi.com/msds/osha/1910_1200.html#1910.1200(b)(5)(iii)

(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;

Specifically, while drug ingredients are exempt, the key phrase is "when they are subject to the labeling requirements under those Acts…" I make the assumption here that drugs that are not approved (which are basically laboratory research samples) are not subject to such labeling requirements which would reveal the pharmacological, health hazards, and physical properties.

Therefore, like any laboratory research sample sent to another laboratory, SDS's are required.

As you create that SDS remember that no testing is required and "if no relevant information is found for any given subheading within a section, the SDS shall clearly indicate that no applicable information is available." The exception is Sections 12-15 which are not mandatory within the US, but are a good idea to fill out anyway.

Rob Toreki

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On Jan 6, 2016, at 1:37 PM, "Secretary, ACS Division of Chemical Health and Safety" <secretary**At_Symbol_Here**DCHAS.ORG> wrote:

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

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