To meet the challenge, USP exercises a vigorous standards-setting process that draws on both public comments and meticulous scientific review. As an independent organization, USP does not have the authority to compel submission of information for standards. Rather, we have worked hard to build relationships with pioneer and generic pharmaceutical manufacturers and experts, many of whom have a strong appreciation for the value of public quality standards. Over time, these (and many other) relationships have allowed the number of monographs in the US Pharmacopeia to grow from the original 1820 tally of 621 to the current total of over 4000.
The worldwide array of pharmaceutical manufacturers and experts who choose to participate in this effort provide proposed new monographs, General Chapters, and a wealth of data. But that's just part of the story. In addition to industry cooperation, public input and interaction are vital to the development of USP standards. Once materials are received, USP's scientific staff and volunteer experts review the input, conduct laboratory tests, where necessary, and then publish the proposals in Pharmacopeial Forum—USP's bimonthly journal of standards development and compendial review—for public comment. A USP Expert Committee subjects all comments to scientific scrutiny before making the recommendation to publish a standard in the US Pharmacopeia–National Formulary (USP–NF). To further ensure transparency, all communications with USP regarding standards become a matter of legal record.This public process helps refine and finalize information before its official publication in USP–NF. It is important to note that the volunteer experts are themselves vetted for scientific knowledge and expertise in an open and competitive election process at USP's five-year convention. Expert Committee members serve as unbiased volunteers under strict conflict-of-interest and confidentiality regulations. The combination of fully available public commentary and highly qualified expert oversight ensures both rigor and a broad range of scientific input. For a public standard to be credible, this two-fold approach is key to establishing confidence.
An explanation is never as clear as an actual example. Consider the progress of General Chapter ‹797› Pharmaceutical Compounding–Sterile Preparations, which is currently headed toward official publication in USP–NF (at a date still to be determined). The last time ‹797› was revised, USP did so entirely through the efforts of staff working with volunteer experts. The practitioner community was not involved, not by intent but because compounding pharmacists tend not to be subscribers of USP–NF. The Sterile Compounding Expert Committee, responding to growing concern about the quality and consistency of compounded preparations, revised the 1995 General Chapter ‹1206› Sterile Products for Home Use. The revisions were extensive and included the renumbering of the General Chapter to ‹797›. This is significant, of course, because it moved the General Chapter from informational (those numbered over ‹1000›) to enforceable (those numbered under ‹1000›). The impact was even greater given the growing importance of compounding as a means of tailoring a drug dose to an individual patient, or in replacing a discontinued manufactured drug.