Ohio Admin. Code 3701:1-40-39 - Radioactive drug: capsules containing carbon-14 urea for "in vivo" diagnostic use for humans
(A)
Except as
provided in paragraphs (B) and (C) of this rule, any person is exempt from the
requirements for a license set forth in this chapter and Chapter 3701:1-58 of
the Administrative Code, provided that such person receives, possesses, uses,
transfers, owns, or acquires capsules containing thirty-seven kilobecquerels
(one microcurie) carbon-14 urea (allowing for nominal variation that may occur
during the manufacturing process) each, for "in vivo" diagnostic use for
humans.
(B)
Any person who desires to use the capsules for
research involving human subjects shall apply for and receive a specific
license under Chapter 3701:1-58 of the Administrative Code.
(C)
Any person who
desires to manufacture, prepare, process, produce, package, repackage, or
transfer for commercial distribution such capsules shall apply for and receive
a specific license under Chapter 3701:1-46 of the Administrative Code.
(D)
Nothing in this rule relieves persons from complying with applicable United
States food and drug administration, other federal, and state requirements
governing receipt, administration, and use of drugs.
Replaces: 3701:1-40-03
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 07/22/2001, 08/15/2005, 10/04/2010
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 7/22/2001, 8/15/05, 10/04/10
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.