FDA Guidance for Industry: Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
Title:
FDA Guidance for Industry: Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM294086.pdf
Content:
This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP