BRIEFING

 〈86〉 Bacterial Endotoxins Test Using Recombinant Reagents. This proposed new test chapter provides additional techniques using nonanimal derived reagents to the Bacterial Endotoxins Test 〈85〉.

 This general chapter is not currently being introduced into a specific monograph or listed in General Notices. It is the responsibility of the user to review the supplier's primary validation package and to verify product suitability for use in testing specific products or materials. This verification must include specific experiments to confirm that the method is suitable for its intended purpose under the conditions of use for the material, drug substance, and/or drug product. The selected verification experiments should be based on an assessment of the complexity of the material to which the method is being applied. The user should refer to Verification of Compendial Procedures 〈1226〉. Regulatory authorities may require supplemental data prior to acceptance. An example of supplemental data may include a comparative study of the material tested by techniques described in this chapter and those in 〈85〉.

 Under the Rules and Procedures of the Council of Experts, all comments submitted to USP in response to proposals published in the Pharmacopeial Forum, as well as the identities of the commenters, are considered public information unless clearly and specifically designated as confidential.

 (GCM: L. Furr)

 Correspondence Number—C325222