Regulation Text
(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.
(1) Distribution restricted to certain facilities or physicians with special training or experience; or
(2) Distribution conditioned on the performance of specified medical procedures.
Authority
15 U.S.C. 1451-1561;21 U.S.C. 321,351,352,353,355,356b,360,360c-360f,360h-360j,371,374,379e,381;42 U.S.C. 216,241,262,263,264; sec 122,Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e),Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N,Pub. L. 116-94, 133 Stat. 3127.
Related Guidelines (3)
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
→General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases: Guidance for Industry (Status: Final)
→FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary (Status: Final)
→