21 C.F.R. § 601.42 Approval with restrictions to assure safe use.
Title 21 - Food and Drugs
(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: (1) Distribution restricted to certain facilities or physicians with special training or experience; or (2) Distribution conditioned on the performance of specified medical procedures. (b) The limitations imposed will be commensurate with the specific safety concerns presented by the biological product.
Title 21: Food and Drugs
PART 601—LICENSING
Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
§ 601.42 Approval with restrictions to assure safe use.
