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However, this list is yet to be finalized and until the FDA evaluates and publishes a final rule regarding a substances inclusion on the 503A bulks list, the FDA has stated that it does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians who compound drugs using bulk substances provided the following circumstances are met: The bulk drug substance is listed in 503A Category 1 on the FDAs website

Due to differences in the bioavailability of oral versus injectable formulations, further phase 3 trial evidence is needed to establish both efficacy and safety

In Studies JMDB and JMCH, among patients who received vitamin supplementation, incidence of Grade 3 to 4 neutropenia was 15% and 23%, the incidence of Grade 3 to 4 anemia was 6% and 4%, and incidence of Grade 3 to 4 thrombocytopenia was 4% and 5%, respectively