For those of us who operate in an FDA regulated industry, we are, in most cases, subject to test procedures and requirements as outlined by the USP (United States Pharmacopeia). The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to develop and revise standards that help protect public health worldwide. Their mission statement is clear and concise: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
While we can all understand and appreciate the role USP plays in our industry, we all face the challenge of remaining up to date with the constant state of revision and improvement that the USP is producing and publishing. This is no easy task, and one that, for many larger organizations, requires a dedicated staff to ensure it gets done. For those that do not have the luxury of a dedicated staff to track USP changes, outlined within this article are some of the available tools to help navigate the USP flow of information. These may be used to ensure awareness of any changes that might affect your organization.
Pharmacopeial Forum (PF) – is the bimonthly online journal in which USP publishes proposed revisions to USP–NF for public review and comment. To encourage and broaden participation in the standards-setting process, USP transitioned PF from a subscription-based print and online publication to a free, online-only resource with the release of PF 37 (1) on January 3, 2011. New issues are posted online every two months at the beginning of the month. The comment period is 90-days and ends on the last day of the month. To make it easier for users to identify and respond to proposed changes to USP–NF standards, PF now contains only proposals for which USP is seeking public comment and information, including:
· In-Process Revisions
· Proposed Interim Revision Announcements (IRAs)
· PDG Harmonization Proposals (Stage 4)
· Stimuli Articles
In addition, PF provides access to previously published issues of PF Online dating back to 2002. Other information previously in PF, including official text (final IRAs), is now published on the USP website or in other publications.
USP–NF Compendial Notices- these notices are designed to inform stakeholders of the changing status of USP–NF monographs and general chapters and other USP–NF standards-setting initiatives. Compendial Notices include General Announcements, Notices of Intent to Revise, and Publication Corrections. This section also includes a link to the Notices of Stage 6 Harmonized Text. Notices are generally posted at the end of the month, but can be posted at any time depending upon the urgency of the notice. USP posts Compendial Notices by general chapter (numerical order), then by monograph name (alphabetical order). The “New Notices” section includes the most recently posted Compendial Notices in chronological order. Key sections of the compendial notice section include:
· General Announcements
· Notices of Intent to Revise
· Reference Changes
· Publications Corrections
· USP-NF Redesigned Monographs
Reference Changes – USP and its Expert Committees periodically deem it necessary to modify general chapter titles or similar text that may be referenced in other standards throughout the USP–NF. When this occurs, USP staff undertakes a rigorous process for identifying and updating such references. These updates may occur through a routine revision or, if an update appears to present no significant change in the affected standard, through a direct update of the referencewithout opportunity for notice and comment. In all cases, USP will publish on its website a notice indicating the source change, any resulting references, and whether those references will be updated through a routine revision or a direct update. Updates made through direct publication in the USP–NF will be clearly identified by symbols and shading in the print and electronic publications.
USP–NF Redesigned Monographs – the USP, on its Web Site, publishes a downloadable Excel file that lists titles of monographs appearing in an official publication (USP–NF or Supplement) in the redesigned format. Monographs are redesigned either through USP’s revision process in the Pharmacopeial Forum (PF), accelerated revision, or as part of USP’s ongoing redesign process. The list can be sorted by monograph type, Expert Committee designation, or publication vehicle in which the monograph initially appeared in the redesigned format. This list is updated with the publication of each new USP–NF and Supplement. Currently, some drug substance monographs do not include the chemical structure of the article or may incorrectly include a structure in a dosage form monograph. As part of the redesign effort, the chemical structure of the article is being deleted or added to these monographs as an editorial change.
As someone who uses the USP document on an almost daily basis, I admit I am one of its most vocal critics. It is common for me to refer to the USP as one of the most poorly written documents I have encountered. Being more of a realist and less of a critic, I should concede that the USP does in fact publish and manage a large plethora of information on a wide variety of scientific and sometimes very complex topics. While their process can be frustrating and time consuming (and thus sometimes out of date), I must give credit for the effort being made. The tools outlined above are an example of this effort. The USP does have programs in place, all of which are available online, to help people navigate and decipher information. Hopefully the tools I have described can help you better understand and navigate these voluminous documents in a more efficient and effective way.