Which USP Chapters are considered enforceable?

The enforceable USP chapters are those between 1 and 999. These chapters provide essential guidelines and standards for pharmaceutical practices, including compounding, testing, and storage of sterile products, and they are subject to regulatory enforcement. Compliance with these chapters ensures the safety, quality, and efficacy of drugs, as they establish the minimum requirements that must be met by compounding pharmacies and manufacturers. Chapters beyond this range, such as those from 1000 to 1999 or 2000 to 2999, serve as informational or guidance documents and are not enforceable in the same manner. Thus, understanding the range that contains enforceable standards is critical for professionals in the field of sterile compounding.