Federal Register Notice: FDA is making available a draft guidance for industry, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. It provides the pharmaceutical industry with CDER’s current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). The document recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products. To download this guidance, click here. To view this notice, click here.