South Carolina Code 44-53-1830. Cannabidiol for use in clinical trials
Current as of: 2023 | Check for updates
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(A) Expanded access clinical trials conducted pursuant to a statewide investigational new drug application established pursuant to this chapter only shall utilize cannabidiol which is:
(1) from an approved source; and
Terms Used In South Carolina Code 44-53-1830
- Approved source: means a provider approved by the United States Food and Drug Administration which produces cannabidiol that:
(a) has been manufactured and tested in a facility approved or certified by the United States Food and Drug Administration or similar national regulatory agency in another country which has been approved by the United States Food and Drug Administration; and
(b) has been tested in animals to demonstrate preliminary effectiveness and to ensure that it is safe to administer to humans. See South Carolina Code 44-53-1810 - Cannabidiol: means a finished preparation containing, of its total cannabinoid content, at least 98 percent cannabidiol and not more than 0. See South Carolina Code 44-53-1810
(2) approved by the United States Food and Drug Administration to be used for treatment of a condition specified in an investigational new drug application.
(B) The principal investigator and any subinvestigator may receive cannabidiol directly from an approved source or authorized distributor for an approved source for use in the expanded access clinical trials.