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

Safety and labeling activities:

  • Better definition of USP's role in development of safety standards and possible development of assessment criteria for monitoring the need for and development of safety and labeling standards
  • Implementation and education initiatives for the "Labeling of Ferrules and Cap Overseals" section of general chapter Injections <1>
  • Development, using a design-phase approach, of general chapter Labeling <7> (to coordinate with revisions to general chapter <1>)
  • Development, using an Expert Panel, of general chapter Prescription Container Labeling <17>; education and implementation initiatives and incorporation into state pharmacy laws
  • Revision of general chapter Labeling of Inactive Ingredients <1091> (including coordinating with the Excipients Expert Committee)
  • Clarification of USP's standards on single- and multiple-dose vials (in coordination with FDA)
  • Development of four concentration standards (with FDA, the American Society of Health-system Pharmacists, and others)
  • Assessment of developing enhanced "Tall Man" lettering standards (in coordination with FDA and others).

Model guidelines activities: An Expert Panel of the NSL Expert Committee is charged with concluding recommendations for Versions 5.0 (2011) and 6.0 (2014) of the Medicare Model Guidelines (9). The recommendations will be considered and acted upon by the NSL Expert Committee with delivery thereafter to the Centers for Medicare and Medicaid Services.

Monograph development expert committees

Chemical Molecules. Four Expert Committees focus on developing monographs for chemical molecule ingredients and their associated drug products. These Expert Committees face a backlog as a result of missing monographs and monographs that require modernization. In addition, the number of missing monographs increases as FDA approves drugs. Assuming that each new molecular entity is associated with three or four dosage forms, USP estimates that the number of missing monographs increases each year by approximately 100. Collectively, these Expert Committees are responsible for approximately 3600 official monographs, and an additional 1500 monographs are absent. Monographs are distributed among the committees according to therapeutic categories. In addition to the monograph content, these Expert Committees are also responsible for approving the use of USP reference standards in their assigned monographs.

Following is a list of key initiatives affecting each of these Expert Committees:

New monograph development. This work involves an ongoing effort to establish new standards for drug substances and drug products in support of USP's public health mission. These Expert Committees are responsible for new monograph development for USP and the pending monographs initiative. USP posts pending monographs on its website for drug substances, drug products, and excipients that have been submitted or soon will be submitted to FDA for marketing approval but have not yet received this approval (10).

Monograph modernization . A key initiative in this cycle, modernization of monographs is needed to replace outdated tests or procedures with updated methodology and to add critical quality tests such as impurities. Focus areas include impurities and nonspecific identification and assay tests. To date, USP has identified at least 700 drug substance and drug product monographs for prescription and over-the-counter (OTC) medications that require modernization. The Expert Committees will collaborate with Expert Committees in other areas (e.g., general chapters), Expert Panels, USP staff, regulators, and stakeholders to outline strategies and implement tactics for monograph modernization.

OTC monograph development. This is a relatively new area as USP begins to address the absence of or inadequate public standards for OTC products. USP includes monographs for OTC ingredients and some drug products, but in several OTC product categories USP includes only a minimum number of monographs or, in some cases, none. Expert Committees plan to work with manufacturers and regulators to consider strategies for OTC product monograph development and revision.


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