FDA Issues Draft Guidance on Limiting Use of 2 Phthalates in Pharmas
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled, "Limiting the Use of Certain Phthalates as Excepts in CDER-Regulated Products." This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation…
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
and Research's (CDER) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products,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 productions. Although comments may be submitted on any guidance at any time, FDA states comments should be submitted by May 31, 2012 to ensure FDA consideration before the agency begins work on the final version of the guidance.