Standards-Setting Activities of USP's Council of Experts - Pharmaceutical Technology

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Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.

Pharmaceutical Technology
Volume 35, Issue 3, pp. 78-88

USP Pharmacists'Pharmacopeia: Compounding Expert Committee

The charge of the Compounding Expert Committee is to increase the number of evidence-based USP-NF compounding monographs—and to develop new chapters and to keep key general chapters up-to-date and relevant. These monographs appear in USP, and also, with additional authorized material, in a line extension named USP Pharmacists' Pharmacopeia. The Expert Committee reviews and revises existing compounding chapters if needed and develops new general chapters as appropriate. Text may be both official and authorized: official text is enforceable by FDA according to the FD&C Act, and authorized text is not yet approved as official or is informational.

Standards in USP-NF for compounded preparations may be enforced by both the states (pharmacy practice/compounding traditionally is regulated by state boards of pharmacy) and by FDA (compounded preparations are subject to the adulteration and misbranding provisions of the FD&C Act, which requires conformance to USP-NF standards).

The work plan of the Compounding Expert Committee for the 2010-2015 cycle includes the following activities:
  • Identify and develop priority monographs, working with FDA, State Boards of Pharmacy, Pharmacy Compounding Accreditation Boards, and others
  • Develop and validate a stability-indicating HPLC method and establish beyond-use dating for compounding preparation monographs
  • Continue revisions to Pharmaceutical CompoundingNonsterile Preparations <795> and Pharmaceutical CompoundingSterile Preparations <797>, Update Pharmaceutical Calculations <1160> and Prescription Balances and Volumetric Apparatus <1176>
  • Develop new compounding general chapters on compounding of hazardous drugs and compounding for clinical trials
  • Work with the Nomenclature, Safety, and Labeling Expert Committee to standardize compounded preparation titles and educate compounding professionals
  • Work with the appropriate Small Molecules Expert Committees as necessary on compounding standards for radiopharmaceuticals.


This report presents the initial work plan of the USP Council of Experts for the 2010-2015 revision cycle. As noted, specific Expert Committee work plans will be posted on the USP website and will be periodically updated. This publication will be allied with a final report to the Convention, which oversees the work of the Council of Experts, continuing a time-honored process begun in 1820. USP encourages comments and questions from the scientific community and other stakeholders.


1. L. Bhattacharyya et al., Pharm. Res. 21 (10) 1725-1731 (2004), pmid:15553215.

2. R.L. Williams, Project Team 4, The 2000-2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, and USP Staff and Consultant, J. Pharm. Biomed. Anal. 40 (3) 3-15 (2006), doi:10.1016/j.jpba.2005.07.017.

3. USP, USP Bylaws,

4. USP, USP Council of Experts—Overview, .

5. USP, Rules and Procedures of the 2010-2015 Council of Experts,

6. USP, USP Dictionary of USAN and International Drug Names (Rockville, MD, 2010).

7. USP, USP Nomenclature Policy,

8. USP, Medicare Model Guidelines,

9. USP Model Guidelines Expert Committee, USP Staff, Ann. Intern. Med. 145 (2006) 448-453.

10. USP, USP Pending Guidelines,

11. T.L. Cecil, PharmacopeialForum 34 (6) 1638-1640 (2008).


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