Regulatory Focus™ > News Articles > USP Sets Date for Overhaul of Monograph Naming Policy

USP Sets Date for Overhaul of Monograph Naming Policy

Posted 20 November 2012 | By

The US Pharmacopeia (USP) has released a new policy it says will bring both clarity and consistency to the naming of new drug products based on their clinically active components.

In a 19 November 2012 press release, USP said the new naming policy will come into effect on 1 May 2013, and will apply prospectively-not retroactively-to all drug product and compounded preparation monographs appearing in its compendia.

The new policy, Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (The Monograph Naming Policy), requires the drug product or compounded formulation to be named in accordance with the "portion of the molecule responsible for clinical activity," often referred to as the active ingredient (AI) or active pharmaceutical ingredient (API).

"The development of USP's Monograph Naming Policy is designed to provide concise and consistent names for drug products," said Roger Williams, chief executive officer of USP and chair of the Council of Experts. "This consistency in drug product names ultimately will benefit manufacturers, regulators, practitioners, and, most importantly, patients."

A New Standard

The new policy is both wide-ranging and important, USP explained. Under federal law-specifically the Federal Food, Drug and Cosmetic Act-if a monograph exists for a drug product, all products using the monograph as a reference for conformity must adopt its nonproprietary name.

"USP has worked closely with the US Food and Drug Administration (FDA) and industry stakeholders over a number of years to develop the new policy," it explained. The policy has been in draft form since at least 2007, when USP released it to the public. The Monograph Naming Policy will eventually replace USP Nomenclature policy (General Chapter <1121>).

Until the policy is implemented, products approved by FDA with no existing monograph will be considered on what USP calls a "case-by-case" basis, though it added that it anticipated accepting interim drug names and would do its best to avoid retrospective changes in those cases.

After the implementation of the policy, some deviations will be allowed to occur, but must also be considered on a case-by-case basis. Those exceptions might include products where the product is, for historical reasons, named for a salt or if a long-standing monograph family would be better served by consistency.

USP said it encourages sponsors of products not yet approved by FDA to contact it in order to avoid potential complications. "We do not anticipate many changes in the names of existing products, which would be confusing to patients and practitioners. Rather, the changes will occur prospectively over time," concluded Williams.


Tags: Monograph, Naming, USP

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