Code of Federal Regulations Title 21. Food and Drugs § 21.601.42 Approval with restrictions to assure safe use

(a) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as:

(b) The limitations imposed will be commensurate with the specific safety concerns presented by the biological product.