What is GFI-256?
The FDA has updated their guidelines for compounding with bulk chemicals which is outlined by GFI-256, click here to read the document. This guidance adds additional requirements for prescribing these products in order to ensure that the best decision is made in regards to the wellbeing of the animal.
How does this affect placing an order?
Patient-Specific Orders
- For items that are being ordered under a specific patient, a rationale must be provided for why the drug being ordered must be compounded using the bulk chemical as opposed to the commercially available product. There are numerous reasons why this is the case and many times the rationale for the drug needing to be compounded with the bulk chemical is the same as why it is being compounded in the first place. Such as the FDA approved drug not being available commercially, or the commercially available product being too bitter which would prevent the animal from taking the medication. In order to make this process as quick and painless as possible, we have provided a list of rationales to choose from when placing an order. Or if a suitable rationale is not available, you can provide your own.
Clinic Use Orders
- For States that allow items to be ordered under Clinic Use, the FDA has decided that only items that would cause undue harm to the animal if the product was not supplied in house and a commercially available product that could be used as a substitute cannot be available. In order to know which drugs are available to order under office use, the FDA has compiled a List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. They are also currently allowing any drugs off of the Bulk Drug Substances Currently Under Review list to be ordered under office use as well. We have also compiled a list of all of the drugs currently approved or under review in an easy to read format, click here for the most up to date list.
- All of the drugs on the approved and under review list were requested by pharmacies and veterinarians like you. So if there is a drug that you feel is missing off of the list, click to go to the FDA docket where you can comment on the docket and attach a proposal form for the drug you would like to see added to the list.
