Modafinil, a DEA schedule IV controlled substance, is indicated for the treatment of excessive sleepiness from narcolepsy, obstructive sleep apnea or shift work sleep disorder. In July 2010, the EMEA's Committee for Medicinal Products for Human Use (CHMP) reported on its safety review of modafinil. The committee concluded that the benefits of modafinil only outweighed the risks in narcolepsy. For all other indications the risk of developing skin or hypersensitivity reactions and neuropsychiatric disorders outweighed efficacy. Therefore, the CHMP concluded that all indications except narcolepsy should be withdrawn from the marketing authorizations for modafinil.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Modafinil, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.