16-18 November 2021
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:
Additionally, minor editorial changes have been made to update this chapter to current USP style.
The structure of the proposed chapter is as follows:
1.3 Applicable Regulatory Requirements
1.4 Best Practices
2. PERSONNEL TRAINING
3. BUILDINGS AND FACILITIES
4. EQUIPMENT AND 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
9. ESTABLISHING BEYOND-USE DATES
10. QUALITY ASSURANCE AND QUALITY CONTROL
11. STORAGE, HANDLING, PACKAGING, AND TRANSPORT
12.1 Safety Data Sheets
12.2 Certificate of Analysis
12.3 Records Management
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>.