Restrictions and use of synthetic medications and excipients
Can I use synthetic medications?
Organic livestock operations can only use synthetic medications if they are allowed per the National List. Prior to using synthetic medications, you must demonstrate adequate use of preventative practices as a first measure.
What is an excipient?
Excipients are ingredients in a medication that do not provide any therapeutic or diagnostic effects. Typically, they assist or enhance the administration and delivery of the active ingredient to maximize its effectiveness. Commonly they are found as inactive ingredients such as emulsifiers or preservatives.
Which excipients are allowed?
The National List includes an allowance for synthetic excipients with the following restriction:
“Only for use in the manufacture of drugs used to treat organic livestock when the excipient is: Identified by the FDA [Food and Drug Administration] as Generally Recognized As Safe; approved by the FDA as a food additive; or, included in the FDA review and approval of a New Animal Drug Application or New Drug Application.”
Can I use a medication prior to approval from OTCO?
OTCO recommends you submit all medications for review and approval prior to use. Upon receipt of a medication request, we will review both the active ingredient(s) and the excipients to ensure they meet the requirements for organic production. You must provide a complete ingredient statement at the time of the request.
Often medications only list active ingredients on the label. We must review all of the ingredients, including the excipients. Even when the active ingredient in a medication is allowed in organic livestock production, the medication may not be approved unless all of the excipients are also compliant. You can request a complete ingredient list from the manufacturer.
How do I request approval of a synthetic medication?
To request approval of a synthetic medication, follow the steps for adding a material to your Organic System Plan.
For a synthetic medication, be sure to include a complete ingredient list — OTCO requires manufacturer-provided lists of active and inactive ingredients — with your submission.
What does a “medication is approved with restrictions” mean?
Be mindful of and track any usage restrictions associated with approved medications. Several materials, despite approval for use, will include restrictions for how they can be used. Any other use is prohibited. You can view restrictions on your approved inputs list in MyOTCO.
As an example, glycerin is only allowed when used as the active ingredient in a livestock teat dip. Additionally, it must be produced through the hydrolysis of fats or oils. It is not allowed as an active ingredient in any other medication, or if produced by other unapproved methods.