Section 312.8 permits only the sponsor of the IND to request FDA’s authorization to charge for an investigational drug for use under the IND. The sponsor of the IND is not always the manufacturer of the drug.

For example, if the manufacturer of an unapproved drug is not the sponsor of the IND under which the drug will be used, the manufacturer is not required to obtain authorization from FDA to charge the sponsor of the IND for the unapproved drug. However, in such a situation, if the sponsor wants to charge patients to recover the cost charged by the manufacturer, the sponsor must obtain FDA’s written authorization before it can begin charging patients.