The manufacturer of the drug will usually add the physician as a clinical investigator on its IND. If the sponsor will not, or if there is no commercial sponsor, the physician can file an individual IND directly with the FDA (phone numbers: 301-827-0531/301-594-2000/after hours 202-857-8400). An IND number will usually be given over the phone which permits the sponsor to ship the drug. An appropriate informed consent form must be constructed for use of the drug and informed consent obtained from the patient or responsible relative prior to giving the drug.

When the situation is life threatening and there is no time for CPHS approval, the physician may use the drug without such approval. A second non-involved physician should concur in the use of the investigational article. The CPHS MUST be subsequently notified.

If the physician/clinical investigator anticipates that there will be more such use of the same drug, for the same patient or any additional patients, review and approval of a protocol at a convened CPHS meeting is necessary.