Or. Admin. R. 333-102-0040 - In Vivo Testing in Humans for H. Pylori Using Carbon-14 Labeled Urea

(1) Except as provided in sections (3) and (4) of this rule, any person is exempt from the requirements for a specific license pursuant to this division and divisions 116 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kBq (1 microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

NOTE: "Nominal variation" as used in this context means + 10% of the reported per capsule dose.

(2) Any person who desires to use the capsules for research involving human subjects must apply for and receive a specific license pursuant to division 102 of this chapter.
(3) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules must apply for and receive a specific license pursuant to 10 CFR 32.21.
(4) Nothing in this rule relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.


Or. Admin. R. 333-102-0040
PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

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