The concept of forming an industry organization focused on pharmaceutical excipient safety and functionality issues first surfaced during a USP Open Conference 30 years ago. 
On January 30 to February 1, 1991 at the Sheraton World Resort in Orlando, Florida, a Joint Pharmacopeial Open Conference on International Harmonization of Excipient Standards was held. It was during a wine and cheese reception where the creation of an organization focused on excipients was discussed. On March 19th, 1991, in Wilmington, Delaware, an inaugural meeting was held.
According to notes from the March 19 meeting,
….“Lou Blecher reviewed the needs leading up to the formation of the International Pharmaceutical Excipients Council (IPEC). There has been no formal method outlined for safety testing of excipients. Until recently, there had been few efforts to harmonize excipient standards among pharmacopeias. The concept of an IPEC type organization has long been discussed among a number of individuals in the industry. At a recent Excipients Standards Harmonization meeting sponsored by the USP, Jerry Halperin, CEO, USP, encouraged the development of an IPEC type trade group.
Pharmaceutical excipients were defined as everything in a finished pharmaceutical dosage form EXCEPT for the active ingredients (API). After some discussion, it was decided that excipient was an accepted and well understood term.”
The organizational structure and interests were also established proceeding the formation of IPEC. Three committees were identified as being essential to IPEC.
- Organizational Committee: the purpose of this committee is to make proposals on matters relating to the operation of IPEC.
- Harmonization Committee: The purpose of the Harmonization Committee is to devise an approach for working with USP and other pharmacopeias to harmonized excipient standards worldwide. It is recognized that ideally, all pharmacopeias would agree on standard methods and limits for excipients worldwide.
- Safety Committee: The purpose of the Safety Committee is to formulate a plan to expand the USP Pharmaceutical Excipient Subcommittee so it can become a respected expert committee on safety of pharmaceutical excipients.
The International Pharmaceutical Excipients Council was then founded to address issues concerning pharmaceutical use of excipients. Following is a list of individuals who participated in one or both of the 1991 events and who, over time, came to be recognized as the original founders of IPEC.
- Ralph Shangraw (University of Maryland School of Pharmacy)
- Jerry Halperin (USP)
- Robert G. Pinco, Esq. (Baker & Hostetler)
- Louis Blecher (GAF)
- Dr. Marshall Steinberg (Hercules)
- Joe Johnson – (Aqualon)
- Keith Weertz – (Aqualon)
- Dr. Keith Marshall – (SmithKline Beecham)
- Dr. Carolyn Green- (Rhone Poulenc)
- Dr. Ashok Katdare – (Merck)
- Dr. Stuart Porter – (Colorcon)
- David R. Schoneker – (Colorcon)
- Christopher DeMerlis – (FMC)
- Dr. Sidney Goode – (Dow)
- Gerry Ford – (Eastman)
- Dr. Waseem Malick – (Hoffmann-LaRoche)
It is with deep gratitude that we acknowledge and recognize these individuals for their vision, dedication, determination and commitment. IPEC-Americas is honored to continue their pursuit, advancing the mission and goals of IPEC.