S.C. Code Regs. § § 61-4.200.203

Current through Register Vol. 48, 12, December 27, 2024

Section 61-4.200.203 - Research Protocols

(a) Applicants for "Researcher" registration in Schedule I shall submit a research protocol containing all the information required for Federal Schedule I research protocol set forth under 21 CFR §1301.32.

(b) Practitioners registered with DHEC desiring to perform incidental research on or with controlled substances under the provisions of S.C. Code Ann. § 44-53-300(c) are not required to furnish the formal protocol (except for narcotic substances as is required under Federal law), but shall instead provide a written summary of the proposed research, including the scope, the substance to be utilized, the number of research subjects (and their identity if protection from prosecution is desired), the duration of the research and the estimated usage of the controlled substance. Insofar as is practical, the dispensing of the controlled substance utilized in a valid research project shall be performed by the researcher or a particular dispenser or small group of dispensers in order to maintain adequate control. While not imperative to DHEC, notice of any participating dispensaries or pharmacies should be made to the Bureau of Drug Control in order that inadvertent and unnecessary investigations of normally unusual dispensing practices may be avoided.

(c) DHEC may require additional information or updating of protocols from time to time, but not more often than annually, unless a major change or deviation from previously submitted protocols or summaries is discovered. It is the responsibility of the person conducting the research project to notify to Department prior to any change in a protocol.

S.C. Code Regs. § 61-4.200.203

Replaced and Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.