The United States Pharmacopeia (USP) is in the process of revising the General Notices of United States Pharmacopeia (USP) and National Formulary (NF) and the General Provisions and Requirements of Food Chemicals Codex (FCC). These documents are key resources for users of USP–NF and FCC.
Since the third revision of USP (i.e., USP III, 1850) a Preliminary Notices (now the General Notices) section has assisted practitioners by defining certain terms and procedures that are used throughout the compendia.
For those who are not familiar with FCC, a brief background note is in order. FCC is a compendium of internationally recognized standards for purity and identity of food-grade substances and has been published by the Institute of Medicine (IOM) since 1966. FCC allows manufacturers of food, food chemicals, and food ingredients to comply with standards that have been created and vetted by a highly rigorous and transparent scientific process. Many pharmaceutical manufacturing processes were adapted from the food processing industry (e.g., tablet coating), and both industries share many ingredients (excipients).
The processes of revising USP–NF and FCC both rely on volunteer scientific experts whose work is open to public review and comment. USP acquired FCC from IOM in August 2006 with the goal of providing full support for the continuing revision and update of the compendium. Biennial revisions to the fifth edition of FCC are underway, and publication of the sixth edition is scheduled for February 2008. Further information is available at the USP website (
http://www.usp.org/). USP has created a Food Additives Stakeholder Forum, which convened its first meeting on Feb. 23, 2007.
Rationale for revisions to the General Notices
Proposed changes to General Notices will:
- Make it clear that all compendia published by USP are covered by the General Notices, which is important because the General Notices contain terms essential for understanding all monographs
- Standardize language among the compendia to make it easier for users who refer to both NF and FCC
- Update the language, some of which dates to 1920 and periodically suffers from archaisms
- Add headings to aid navigation and to allow users to refer to specific sections of the General Notices—for example, draft section 6 could take the following form:
6. Terms and Definitions
- 6.1 Abbreviations
- 6.2 About
- 6.3 Alcohol Content
- 6.4 Atomic Weights
- 6.5 Blank Determinations
- 6.6 Concomitantly
- The combination of headings and numbers will both facilitate and clarify references to the General Notices. Instead of citing page, column, and line number along with an extensive quotation, users will be able to cite section number and title
- Refocus the text on essential information by moving other material to the Mission and Preface or to a General Chapter
- Accommodate new USP initiatives: FCC, Pending Standards, and Standards for Articles Legally Marketed outside the United States (SALMOUS)
- Clarify circumstances under which alternative procedures should be submitted to USP for evaluation as potential supplemental or replacement procedures (cf. Validation of Compendial Procedures <1225>)
- Clarify the intended application of text to, for example, compounded preparations versus drug products and active pharmaceutical ingredients versus excipients.