definiens: means current Good Manufacturing Practice as promulgated by the FDA under and i n accordance with the U.S. Federal Food, Drug and Cosmetic Act ( Title 21 of the U.S. Code, Section 301 et seq . ), Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA that relate to the t esting, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs . also includes the practices and standards described in the Guide to Good Manufacturing Practices for Medicinal Products as promulgated by the European Commission under European Directive 2003/94 / EC, similar standards, guidelines and regulations * * * INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED . ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE S ECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED