Which statement about USP Chapters is true?

The statement that chapters under 1000 are federally enforceable is accurate. The United States Pharmacopeia (USP) sets quality standards for medicines and their ingredients. Chapters that are numbered under 1000, particularly those that deal with compounding and sterile preparations, are deemed enforceable by the FDA as they are part of the official standards for pharmaceutical production and practice in the United States. This means that compliance with these chapters is required for manufacturers and pharmacies to ensure that they are meeting safety and quality standards.

Chapters over 1000 generally provide guidelines and recommendations related to best practices but are not viewed as enforceable regulations. Therefore, while they are important for ensuring quality and safety, adherence is often seen more as a matter of professional standard rather than a legal requirement.

The other options do not accurately reflect how USP chapters are organized or regulated. The assertion that they are all federally enforceable is incorrect, as only specific chapters under 1000 receive that designation. The claim that chapters under 900 are loosely regulated misrepresents the nature of these chapters, as they address significant compounding issues. Lastly, stating that chapters only apply to hospitals is misleading because USP chapters are applicable to all entities involved in the preparation and dispensing of pharmaceuticals,