By donating a monograph modernization procedure, the donor has a direct impact on setting the resulting USP standard, which
provides an appropriate standard to be enforced by regulatory authorities. To acknowledge the generosity of donors, USP recently
enhanced and expanded its Donor Recognition Program. Elements include a Certificate of Appreciation; public recognition (for
those donors who wish to be recognized) in formats such as the USP–NF or during scientific meetings; donor-specific progress reports; and complementary or discounted USP products and services.
To maintain consistency with FDA–approved specifications and control strategies, USP prefers to receive submissions from manufacturers
of FDA–approved products (including drug substances and excipients used in FDA–approved products) or manufacturers seeking
FDA approval. The latter category of submissions will be considered for publication as Pending standards. Submissions, especially
new impurity procedures, from other sources (e.g., contract laboratories, academic institutions, analytical instrumentation
or equipment manufacturers) will be accepted on a case–by–case basis and should follow the International Conference on Harmonization's
Q3 guideline. Some modernization proposals may generate new USP Reference Standards, and USP invites the sponsor of the proposal
to donate the necessary bulk reference materials.
Manufacturers may be concerned that updated monographs will lead to added costs for correspondingly upgraded equipment and
processes. However, many manufacturers of the medications involved have already, of their own initiative, improved tests since
the monograph was first published. These updates occur regularly as technologies and methods advance. In fact, USP is hoping
to take advantage of these types of initiatives and growth so that they may be reflected in the compendia through updated
tests and limits.
The partnership among USP, FDA, and CHPA represents a united front in the effort to safeguard public health. USP appreciates
and strongly encourages widespread industry participation early in the monograph-modernization process.
For more information
Karen Russo, PhD, is vice-president of small molecules, and Shawn Dressman, PhD, is vice-president of standards acquisition, both at the US Pharmacopeial Convention (USP), email@example.com