Regulation Text
This subpart applies to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use. It does not apply to radiopharmaceuticals intended for therapeutic purposes. In situations where a particular radiopharmaceutical is proposed for both diagnostic and therapeutic uses, the radiopharmaceutical must be evaluated taking into account each intended use.
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.