New USP Draft Chapter <1168> Compounding for Phase I Investigational Studies

The USP Compounding Expert Committee republished a draft of a new General Chapter <1168> Compounding for Phase I Investigational Studies for public comment. The chapter was previously published in Pharmacopeial Forum 39(5) [Sep.-Oct. 2013] for public comment and has been revised based on stakeholder input received.

The USP posted its Notice of Intent to Revise online together with a PDF of the current proposed chapter containing line numbers on April 28, 2017. Additionally, the draft chapter has been published in Pharmacopeial Forum (PF) 43(3) [May–June 2017]. The comment deadline is July 31, 2017. 

Due to the complexity of the drug development process, the pharmaceutical industry applies various tools to improve efficiency. One of these tools is the use of compounding to supply investigational preparations for Phase I clinical studies. The USP says that the "General Chapter <1168> was developed to provide guidance on compounding for investigational preparations for Phase I clinical studies. Compounding of investigational preparations requires additional considerations because it is likely that the agents in these preparations have never been administered to humans."

Major changes from the previous chapter published in PF 39(5) include:

• Clarification of information that a compounder should know as part of participating in a study involving the compounding of investigational preparations;
• Clarification of personnel responsibilities on materials management.

Additionally, minor editorial changes have been made to update this chapter to current USP style.

The structure of the proposed chapter is as follows:
 
1. INTRODUCTION 
  1.1 Scope  
  1.2 Background  
  1.3 Applicable Regulatory Requirements  
  1.4 Best Practices  
  
2. PERSONNEL TRAINING  
3. BUILDINGS AND FACILITIES  

4. EQUIPMENT AND COMPONENTS 
  4.1 Equipment  
  4.2 Components  
  
5. STANDARD OPERATING PROCEDURES  

6. PREPARATION ACTIVITIES 
  6.1 Retention Samples  
  6.2 Disposition of Unused Materials and Preparations  
  
7. RELEASE OF INVESTIGATIONAL AGENT/PREPARATION  
8. LABELING  
9. ESTABLISHING BEYOND-USE DATES  
10. QUALITY ASSURANCE AND QUALITY CONTROL  

11. STORAGE, HANDLING, PACKAGING, AND TRANSPORT 
  11.1 Storage  
  11.2 Handling  
  11.3 Packaging  
  11.4 Transport  
  
12. DOCUMENTATION 
  12.1 Safety Data Sheets  
  12.2 Certificate of Analysis  
  12.3 Records Management  
  
APPENDIX   

The complete draft chapter can be found on the USP Notices website. Comments can be submitted by using the electronic form Public Comments on Proposed USP General Chapter <1168>.