Do I need a safety data sheet (SDS) for a tablet or capsule?
Here at Affygility Solutions, we often get asked "Do I need a safety data sheet (formerly know as a material safety data sheet) for my pharmaceutical product?
In the United States, the Occupational Safety and Health Administration has indicated that under the exemption in paragraph 29 CFR 1910.1200 (b)(6) of the standard that the hazard communication standard (HCS) does not apply to "Any drug...in solid final form for direct administration to the patient..."
This can be interpreted that the tablet or capsule must be "solid" form and it must be in quantities typically encountered by a medical practitioner or patient. Therefore; liquids, gels, powders, or bulk quantities of tablets or capsules are not exempt from the SDS requirements. In addition, if you are a pharmaceutical manufacturer, in general, the major pharmacies require that you provide them with a Global Harmonization System (GHS) compliant SDS. Sometimes it's not worth the battle arguing with them and just do what they request.
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