Frequently Asked Questions
No, the USAN Council reviews USAN applications throughout the year on a continuous basis. Once a complete application is received by USAN staff, processing begins and the negotiation is sent electronically to the USAN Council. Once we have received reviews from all USAN Council members, and a specific USAN option is acceptable to all, USAN staff notifies the applicant with the USAN Council's recommendation. The applicant is then asked to inform USAN staff whether or not the decision is acceptable to them.
The USAN Council meets twice a year, usually in January/February and again in July. The purpose of these meetings is primarily to review and set USAN policy, review INN Expert Committee decisions, discuss multiple round negotiations and address open negotiations. Because these issues require face-to-face discussions, time to review new negotiations is very limited. Typically, less than 20 new negotiations are reviewed at USAN Council meetings. This does not present a timing problem because new negotiations are continually reviewed throughout the year, as they are sent electronically to the USAN Council for their review and decision.
At the time the USAN application is submitted, all we require is a preliminary, potential conflict review on the suggested USAN. What this entails is an Internet search through a search engine such as Google or Yahoo, a search on MedNet and a search on the USAN Web site and USP database. Additional searches can include the United States Patent and Trademark Office and the Office for Harmonization in the Internal Market (Trademarks and Designs) which provides information regarding the European Community.
We do not require a lengthy, detailed commissioned analysis or linguistic research activity of suggested names. If, however, you, as the applicant, choose to perform a detailed, commissioned analysis or linguistic report of the suggested name, it should be performed upon notification of the USAN Council's recommended name. Please keep in mind that the USAN Council could, and often does, recommend changes to the suggested names initially submitted by an applicant.
Lately, more and more new stem requests are received by USAN staff. However, with over 300 established USAN stems, and over 100 infixes, the chances are that a current stem or infix exists that would correctly and meaningfully describe your compound to health care practitioners. The goal of the USAN Program is to provide meaningful, informative designations for compounds to enhance correct prescribing practices and patient safety. It is up to the sponsor to convince the USAN Council that the compound warrants a new stem:
a. Include information about why this compound is not similar to other compounds in an established stem class.
b. Include information on the product's method of action, such as published research or an investigational brochure. It is preferable that the stem convey meaning to practitioners such as an abbreviation of the action or receptor to which the compound pertains.
c. Explain the structural differences.
d. Include a rationale supporting your new stem selection. Stem selections should not contain more than two syllables and should not conflict with existing stems. The same letter restrictions for USAN apply to USAN stem suggestions (no w, k, h, ph, j or y).
The USAN Council and the INN Expert Committee are very reluctant to approve new stems. Effort is made to identify stem classes that would describe the compound. Very often, sponsor's stem selections, if a new stem is deemed necessary, are modified by the USAN Council and the INN Expert Committee because of conflicts with "working stems" yet to be published.
USAN and INN stems are building blocks of nonproprietary names. Nonproprietary names, by their very nature, are in the public domain. Both USAN and INN cannot be owned by any individual company. These stems will be utilized in creating USAN and INN for compounds manufactured by several pharmaceutical companies and are not available for ownership. Failure to recognize this is an impediment to the work of the USAN Council in establishing new USAN in a class of drugs and the freedom of both the USAN and INN programs in selecting further nonproprietary names in the same series of substances is seriously diminished.
USAN are published in the USP Dictionary of USAN and International Drug Names and monthly on the USAN Web site.
The International Nonproprietary Names (INN) Programme maintains both the proposed INN (pINN) and recommended INN (rINN) lists. Once an applicant has accepted a USAN Council recommendation and sent payment for the INN application, the name is sent to and deliberated by the INN Expert Committee at either the fall or spring meetings after which the applicant is informed of the decision. The name is then published later in the year as a pINN in WHO Drug Information as well as on the INN Web site. A four-month objection period follows. The period allows for comments and/or objections to the published names to be raised. Applicants are asked to not use the pINN until it has become a rINN to avoid confusion if the name is modified. Please note that objections to pINNs are very rare occurrences but USAN cannot guarantee an objection will not occur. Following the pINN's objection period, the final stage of the process is the rINN. According to INN Guidelines, once a name has been published as a rINN it will not normally be modified further and is ready for use in labeling and publications on drug information. Current INN lists can be viewed on the World Health Organization Web site.
The USAN Program assigns a USANM to a substance when another form of it has already received a USAN. If the parent substance does not have a USAN, the sponsor must apply for a new USAN. A fee of $8,000 applies only to USANM submissions for salts.
Sponsors who plan to market a salt or ester must name the form that will be marketed. If you are planning to market a salt (e.g., chloride, hydrochloride, acetate) you must apply to name both the parent and the salt.
To name a salt or ester and its parent, you may submit applications for a new USAN and a USANM concurrently. The new USAN is adopted after the usual negotiation process, and the USANM is adopted usually one to two months later. Under the new USAN application policy, both names may be requested with a single form, Form A.
The USAN Program's definition of a salt includes counterions, coprecipitated solvent or acid molecules, and metal ion chelates. Esters are usually carboxylic acid derivatives, but may have other forms, such as phosphate esters.
A USANR is a USAN resulting from an application where the manufacturer requests revisions to USAN support information. A fee of $5,000 applies to USANR applications.
In the case of a USANR, revisions in support information would necessitate an application for a USANR. Any one of the following revisions would require a USANR application:
- changes in chemistry; wrong structure due to error or a revised structure due to changes in overall chemical information
- change of internal code designations
- therapeutic claim revision
- addition of tradename
- relicensing issues and/or change of sponsor (i.e., has your company changed hands? are there licensing issues with your parent company? are you dealing with an international company?)
- CAS Issues (i.e., have you changed/updated your CAS information?)
With each USANR application, please make sure to clearly note your requested revisions. Please also include the information you've sent to CAS regarding your requested revisions. When writing the introduction letter, please list each change needed along with the reason why. Also, if providing the change for sponsor name, please provide information documenting the "official" change of hands.
Prescriptions are verbal communications, either oral or written, and should be spelled correctly and consistently. By the same token, an oral prescription should be pronounced correctly and consistently. With written prescriptions, and when considering proposed names, the USAN Council must take into account things like name conflicts, correct stem usage, appropriate prefixes, etc., as well as differences in things like handwriting and individual accents. For this reason, the basic pronunciation should be definite, just as the spelling is definite. Prescriptions are transmitted orally from perhaps a physician to a patient or office aide, or perhaps directly to a pharmacist or pharmacy technician in a busy hospital or store pharmacy, through a nurse or nurse's aide in a hospital, etc. In addition to this, the age of technology and voice recognition is upon us and the requirements of oral prescribing through computers and other electronic devices must be recognized and acomodated.
Once the USAN Council initiates the application review, refunds are no longer possible.