Regulatory References

General Regulatory Links

United States

* FDA email contacts for questions

* FDA Common Excipient Guidance Documents

* FDA Common Excipient Websites


Product Regulatory Data Sheet
Regulatory Information Compendia/Regulations


Regulatory Information - BSE/TSE


Regulatory information – GMOs


Site Quality Overview

IPEC Excipient GMP Related Guidance Documents (Guides are available in the Document Depot, inside the Reference Center)

Compliance evidence:

IPEC GMP compliance details

  • IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients (this guide is available in the Document Depot, inside the Reference Center)

Miscellaneous site information

Site and Supply Chain Security Overview 

Site and supply chain security

Security information

Safety and environmental information