According to FD&C Act, the term “drug” means articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals which also includes articles intended for use a component of a drug.
As per FD&C Act “new animal drug” is a drug intended for use in animals which is not in GRASE (Generally Recognized as Safe and Effective) , in other words, if a drug is in GRASE list, then it is not a new animal drug under FDA&C Act.
Unapproved Animal Drugs are new animal drugs that cannot be marketed legally. FDA does not approve or index them. It is not legal to market unapproved new animal drugs as they didn’t gone through FDA pre-market review and got legal marketing status under FD&C Act. Unapproved animal drugs may not meet FDA’s standard for safety and effectiveness and also may not be properly manufactured or labeled.
There are three ways to get a Legal Marketing status of an animal drug.
- Approval
- Conditional Approval
- Indexing
Approval: An approved animal drug has to go through NADA (New Animal Drug Application) process or for an ANADA (Abbreviated New Animal Drug Application) process for an approved generic animal drug. FDA approval means the drug is safe and effective when the drug is used as per the label and also it makes sure that the drug’s strength, quality are consistent for each production and the labeling is correct not misleading.
Conditional Approval: Conditional approval is only for drugs for major species with minor uses. FDA‘s Conditional approval means the drug is safe to use and has reasonable effectiveness when used as per the label instruction. This approval is valid only for one year. Drug companies can ask FDA to renew the approval for up to four more years. So during that 5 year period, companies can sell the drug legally and can also collect effectiveness data. After collecting the data, the company can submit the application to FDA for full approval.
Indexing: An indexed animal drug is a drug listed on the FDA’s Index of Legally Marketed Unapproved New Animal drugs for minor species which is unapproved by FDA but has legal marketing status. Indexing is allowed for drugs used on minor species such as pet birds, hamsters and ornamental fish which are non-food producing. Indexing is different from regular drug approval process. A panel of qualified experts outside FDA will review the drug’s safety and effectiveness in the specific minor species. If FDA agrees with the panel, it will add the drug to the Index.
All domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA and also list all of their drugs that are commercially. Also all the establishments that are registered with FDA are required to renew their registration between October 1st and December 31st every year to keep their registration active.
Liberty Management Group Ltd, a leading FDA consulting firm provides assistance with drug establishment registration, drug listing and US agent service to foreign establishments.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us