1. Combination Products Regulation. Title 21 US Code of Federal Regulations, Part 3.2(e).
2. Donor Eligibility Regulation. Title 21 US Code of Federal Regulations, Part 1271.45.
3. Exemptions and Alternatives Regulation. Title 21 US Code of Federal Regulations, Part 1271.155.
4. Federal Food, Drug and Cosmetic Act, Title 21, USC §321(g), §201(g).
5. General Biological Product Standards Regulation. Title 21 US Code of Federal Regulations, Part 610.