1. MUMS Indexing is a multi-step process whereby a “requester” (the manufacturer of the product), first applies to the FDA to make a determination that the drug is eligible for Indexing. Then, if the FDA determines the drug to be eligible for Indexing, the requester hires an expert panel that meets certain criteria set by the FDA to examine and prepare a written report on the safety and efficacy of the drug. This report is submitted to the FDA with additional documentation to request that the drug be included on the Index list. Once listed, there are certain labeling requirements that must be adhered to.
2. MUMS Indexing is only for minor species—not for minor use in major species – where there is reasonable certainty that the animals will not be consumed by humans.
3. Meetings- every requester is entitled to one or more meetings to discuss requirements for Indexing.
4. If FDA makes a decision denying eligibility or an application in entirety, the requester is entitled to an informal conference, whereby a written report of the meeting would be provided thereafter.
5. For additional information see the FDA's Info page on MUMS .
6. Please review the FDA's Small Entities Compliance Guide for more information on the Index of Legally Marketed Unapproved Drugs for Minor Species and the Final Guidance Document on the Index of Legally Marketed Unnapproved Drugs for Minor Species for more detailed and up to date information.

(FDA makes this decision without input from expert panel)

1. Each request is for one drug (or one combination of drugs).
2. Each request must be submitted separately.
3. Each request may not be for the same drug in the same dosage form for the same intended use as an already approved (or conditionally approved) drug.
4. A request may be for multiple intended uses and or multiple intended species. (In this case, if a part of the request is denied—for one use or one species, then the entire request is denied.)
5. What must be provided to the FDA?
   1. Two copies of a dated request signed by an authorized agent, which includes:
      1. Identification of the minor species, or group of minor species for which the drug is intended,
      2. Information regarding the drug components and composition,
      3. A statement of the intended use of the drug for the identified species (i.e. for the treatment of what condition…),
      4. A statement of the proposed conditions of use—(i.e. dosage, route of administration, contraindications, warnings, or any other significant limitations.)
      5. A brief discussion of the need for the drug for the particular use,
      6. An estimate of the anticipated annual distribution of the drug—in terms of the total quantity of the active ingredient,
      7. Information to establish that the drug is for a minor species and there is a reasonable certainty that the drug will not be consumed by humans or food –producing animals. (There are different criteria for early life stage of a minor use food-producing animal.)
      8. A description of production methods and facilities for manufacturing, processing and packing of the drug to demonstrate that the requester has established appropriate specifications for the manufacture and control of the drug and an understanding of current good manufacturing practices.
      9. An environmental assessment or a categorical exclusion
      10. Information indicating that the drug is safe for the persons exposed to the drug while manufacturing it.
      11. The name and address of the contact person or permanent resident US agent.
6. FDA is to notify the requester within 90 days of filing the request whether the drug is eligible for Indexing.
7. The Eligibility request may be denied, if:
   1. If the same drug intended for the same us is already approved, or conditionally approved. (NADA)
   2. Insufficient information provided that the drug is intended for use.
   3. The drug is contained in or a product or a transgenic animal.
   4. There is insufficient information provided to indicate any of the criteria established above, or any untrue statements are provided in the request.

1. Establishment of a qualified expert panel:
   1. The panel is to make recommendations to the FDA as to safety and efficacy.
   2. Panel can not be established until eligibility determined.
   3. FDA must determine whether panel meets selection criteria, before the panel can begin its work.
2. Selection Criteria for Expert Panel:
   1. Must have at least 3 members, none of which can be an FDA employee.
   2. Must be an expert qualified by training and experience to evaluate a significant aspect of target animal safety or effectiveness of the drug. The panel must be comprised with a range of expertise, so that the panel as a whole can evaluate the drugs safety and effectiveness.
   3. Expert must certify that he has a working knowledge of the Indexing provisions of the rule and the Act.
   4. The expert cannot have a disqualifying financial interest in the drug, or appearance of conflict unless the FDA makes an exception to this requirement (if, for example, limited numbers of experts).
      1. Conflict of interest requirements are detailed but generally consider whether a financial or other interest could impair a person’s objectivity or create an unfair competitive advantage. Factors include:
         1. whether the expert is related to the requester,
         2. whether seeking or receiving funding from the requester through a contract or research grant,
         3. whether the expert has an employment or contractual relationship with the requester, whether there is ownership or financial interest in the drug,
         4. provided consultative services on the drug within one year,
         5. participated in the design or manufacture or distribution of the drug, or
         6. accepted an arrangement where the fees charged by the expert are contingent on the drugs approval.
      2. There are specific requirements as to what information must be provided to the FDA to indicate there is no conflict of interest.
3. Requester’s obligations with regard to the expert panels:
   1. Provide panel members with the law and rules and obtain a certification that the expert has a working knowledge of the information contained in the rule and law.
   2. Provide each panel member with a written description of the purpose and scope of the expert’s participation, including their duties and responsibilities, including that they need to prepare and submit a written report; and obtain a certification from the expert that they have read and understand the information. The report must be submitted to the FDA in a timely manner.
   3. Obtain information indicating that the panel member has the expertise to qualify for the panel.
   4. The requester must submit the names and addresses of the panel members to the FDA with sufficient information for the FDA to determine whether the panel member is qualified to serve.
   5. After FDA approves of the panel, the requester must provide the panel with all information known to the requester that is relevant to animal safety and effectiveness.
   6. Requester must notify the FDA of panel leader.
   7. If panel member cannot complete the evaluation, or no longer meets the selection criteria, FDA must be notified with the name of a proposed new panel member or requester must justify why the panel should continue work without an additional member.
   8. Requester must keep copies of all information provided to or received from the panel for 2 years after the completion of the report, and these documents are to be made available to the FDA.
4. Expert Panel’s Obligations:
   1. Ongoing obligation to meet FDA’s selection criteria.
   2. Act professionally and ethically.
   3. Review all information provided by requester and any other information otherwise known to panel members including anecdotal information.
   4. All panel members must participate in the preparation of a written report and sign off on it.
   5. Provide information on any conflict of interests or any change in conflict status, and certify when submitting the report and that there is no change in conflict status.
   6. Panel leader serves as point of contact between panel and requester
   7. The written report must describe the panel’s evaluation of all information on safety and effectiveness that was reviewed.
   8. Give the opinion as to whether the benefits of using the drug outweighs its risk to the target animal, considering any harm in not having the drug available to the target animal.
   9. If benefit outweighs risk, the panel must provide draft labeling language and whether the drug should be limited to use under supervision of a veterinarian.

1. Once eligibility determination is made and expert report submitted, two copies of a request to be included on the Index list should be submitted to FDA.
2. Numerous documents must be submitted including: proposed labeling, the FDA's written determination that expert panel meets the selection criteria, the written report, the proposed Index entry, the estimated annual distribution of the active ingredient, a written commitment to manufacture the drug according to good manufacturing practices, and other documents.
3. The label of an Indexed drug must include the following language: "NOT APPROVED by FDA-- Legally marketed as an FDA Indexed product. Extra-label use is prohibited. This product is not to be used in animals intended for use as food for humans or other animals."
4. FDA will publish a list of Indexed drugs on its web site. The Index list will include: the name of the person that holds the index listing, the name of the drug and its intended use and conditions of use, product labeling and any conditions or limitations that FDA deems necessary.