New Monograph Items

USP seeks sponsors to aid in developing the following list of monographs that are not part of the official USP-NF. The list contains drug substance, drug product, and excipient monographs. We may accept any qualified sponsor for a monograph estimated to make generic market entry within 5 years. We will work exclusively with approved manufacturers on monographs expected to make generic market entry in more than 5 years. These articles have been approved by the FDA and are published in the Approved Drug Products with Therapeutic Equivalence (Orange Book).

Consult the missing monograph list here:

If you are interested in becoming a product sponsor, contact Michael Goede, Senior Standards Acquisition Manager, at

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