A BA/BE study in humans does not require an IND if all of the following conditions are met: The drug product does not contain a new chemical entity (21 CFR 314.108), is not radioactively labeled, and is not cytotoxic. The dose (single or total daily dose) does not exceed the dose specified in the labeling of the approved version of the drug product. The sponsor meets the requirements for retention of test article samples and safety reporting (21 CFR 320.31).