Are you required to generate a Safety Data Sheet (SDS) for your newly synthesized chemical, investigational new drug, or drug intermediate? If you will be shipping any of these materials, or otherwise distributing them to another workplace, the answer is yes. Even if only small quantities are being shipped, an SDS is required if the material meets OSHA’s definition of hazardous. Activities that might require this include shipments to CMOs for scale-up or CROs for sample testing, analysis, or other services. There is no exemption based on sample size!
OSHA has also clarified that there is no exemption from SDS requirements for newly synthesized and uncharacterized chemicals, drugs products, and intermediates. That said, OSHA does not specifically require the testing of new materials to determine physical and health effects. However, any relevant information which is known about the chemical or the mixture must be conveyed on the SDS. While much of the specific information for the newly synthesized material may not be available, the SDS must be as complete as possible. This information provides a basis of knowledge for the recipient location and is the best, and often only, source of information they will have when they receive the substance.
Are there any circumstances which don’t require the generation of an SDS? OSHA’s position is that SDSs are generally not required when chemicals and drug products are produced solely for in-house analysis. The rationale for this is that because the OSHA lab standard address protections for employees in the laboratory, generation of an SDS for in-house use is less critical, as the in-house researchers already have access to the basic information that downstream users derive from an SDS.
Are there any other exemptions that might apply? Although drugs regulated by the FDA are covered by the Hazard Communication Standard, the standard exempts FDA regulated drugs when in solid final form, such as tablets or pills, for direct administration to the patient. If a drug came in a liquid oral form, a tablet form and an injectable form, only the tablet form would be exempt from SDS requirements. Capsules, powders and ointments generally do not fit OSHA’s definition of a tablet, so they are not exempt from the requirement to generate an SDS.
For additional information on how to comply with OSHA’s SDS generation requirements, please email [email protected]. Stay safe and compliant!