If a drug meets the criteria in the preceding paragraph, CTEP may initiate a formal application to the FDA to authorize Group C distribution for the specific indication. Such authorization is not equivalent to formal FDA approval of effectiveness for this indication. A physician should request drugs under Group C if he or she wishes to treat a patient with an indication specifically authorized for the requested drugs, as listed in Appendix XV . The list of current drugs classified as Group C is subject to change as drugs receive FDA approval. It also contains a FDA-approved informed consent, which must be used if there has been no local IRB review.
Additional information is available by phone at the number listed in Appendix IV .
A drug classified in Group C for a certain indication may still be under active clinical investigation for the same or other indications. Group C must not be used to obtain drug to conduct clinical trials. Requesting a Group C Drug You may request a Group C drug by contacting the Clinical Research Pharmacy Section, PMB, by telephone or in writing. The amount of patient information required varies specifically for each Group C drug. Physicians should contact the DMAS for the specific requirements.