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e-CFR data is current as of September 24, 2020

Title 21Chapter ISubchapter FPart 601Subpart E → §601.42


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.

(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.

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