South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-4 - Controlled Substances
Part 1000 - Prescriptions
Section 61-4.1000.1011 - Departmental Approval; When Required

(a) Prior approval by DHEC for methadone use as set forth in § 1010 of this regulation is not required.

(b) Prior approval of DHEC and registration as provided by Title 21, §1301.22(a)(6) of the Code of Federal Regulations and S.C. Code Ann. § 44-53-290(i), is required of all persons desiring to operate a treatment program utilizing methadone (i.e., a "methadone maintenance program").

(c) Prior approval by DHEC in the manner set forth by § 1012 of this regulation is not required to dispense methadone to outpatients of a hospital licensed by DHEC. Prior approval of DHEC is not required for "take home" methadone preparations which are lawfully dispensed by a methadone maintenance treatment facility.

(d) Approvals by DHEC, as required by §§ 1009 through 1012 of this regulation, may be granted by the Bureau of Drug Control in its discretion. If the Bureau finds that it cannot approve a request, the request shall be submitted to the Director, along with the Bureau's reasons for non-approval. The Director, in his or her discretion, may then approve or deny the request, but if he or she shall deny such request, the person making the request shall be entitled to a hearing to determine the public interest, in the manner provided for "contested cases" in the South Carolina Administrative Procedures Act.

(e) DHEC may require further information from any applicant in order to obtain sufficient information to be utilized in approving or denying any request.