part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
subpart_code: "H"
subpart_subject: "Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses"
section_number: "314.520"
section_subject: "Approval with restrictions to assure safe use."
cfr_reference: "21 CFR 314.520"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)If FDA concludes that a drug 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 drug 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 drug product.