South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-4 - Controlled Substances
Part 100 - Purpose and Scope; Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions
Section 61-4.100.102 - Definitions

(a) Act. Article 3 of Chapter 53 of Title 44 of the 1976 S.C. Code of Laws, including all amendments thereto.

(b) Administration and the Abbreviation DEA. Refer to Drug Enforcement Administration, United States Department of Justice, the successor agency to the Bureau of Narcotics and Dangerous Drugs as defined in the Act.

(c) Automated Storage Machine. A mechanical system that performs operations, other than compounding or administration, that allow medications to be provided to the patient and stored near the point of care while controlling and tracking drug distribution under the control of a licensed pharmacist.

(d) Bureau Director. The Director of the Bureau of Drug Control, DHEC.

(e) Code. The Code of Laws of South Carolina, 1976, including all amendments thereto.

(f) Commercial Container. Any bottle, jar, tube, ampoule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert, or other material kept with or within a commercial container, nor any carton, crate, box, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(g) Compounder. Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage forms of a narcotic drug listed in Schedules II, III, IV, or V for use in maintenance or detoxification treatment by another narcotic treatment program. The term "compounder" as the content requires, includes any lawfully authorized person who changes the dosage forms, mixes, or prepares any controlled substance for use by the ultimate user pursuant to the legitimate and lawful order of a practitioner acting in the regular course of professional practice or by the practitioner personally, if authorized by law to compound and dispense controlled substances.

(h) Controlled Premises:

(i) Controlled Substance. A drug, substance, or immediate precursor in Schedules I through V as described in S.C. Code Sections 44-53-190, 44-53-210, 44-53-230, 44-53-250, and 44-53-270.

(j) DHEC. The South Carolina Department of Health and Environmental Control.

(k) Director. Unless otherwise specified, the Director of the Department of Health and Environmental Control.

(l) Dispenser. An individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

(m) Detoxification Treatment. The dispensing for a period not in excess of twenty-one days, of a narcotic or narcotics drugs in decreasing dosages to an individual in order to alleviate adverse physiological or psychological effects incidental to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. SEE ALSO §§1007 through 1011 inclusive.

(n) Emergency Situation. For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the Act, the term "emergency situation" means those situations in which the prescribing practitioner determines:

(o) Hearing. Any hearing held pursuant to the provisions of the Act or of this regulation, including, but not limited to, hearings for the granting, denial, revocation, or suspension of a registration pursuant to the Act.

(p) Home Infusion Pharmacy. A pharmacy which compounds solutions for direct administration to a patient in a private residence, Long Term Care Facility or hospice setting by means of parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion.

(q) Individual Practitioner. A physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted by the United States or the State of South Carolina, or by other jurisdiction, or otherwise permitted by the United States or the State of South Carolina, or by any other jurisdiction in which he practices to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacist, a pharmacy, or any institutional practitioner.

(r) Inspector or Drug Inspector. An officer or employee of the Bureau of Drug Control authorized by the Bureau Director to make inspections under the Act, and to conduct audit procedures in relation to controlled substances, and includes the Director of the Bureau of Drug Control.

(s) Institutional Practitioner. A hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States, the State of South Carolina, or other jurisdiction in which it practices, to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacy.

(t) Interested Person. Any person adversely affected or aggrieved by any rule or proposed rule issued or issuable pursuant to the Act.

(u) Long Term Care Facility (LTCF). Nursing home, intermediate care, mental care, or other facility or institution which provides extended health care to resident patients and is licensed as such by DHEC or other appropriate State agency, which may further define the term for licensing and certification purposes.

(v) Name. The official name, common or usual name, chemical name, or brand name of a substance.

(w) Person. Includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(x) Pharmacist. Any pharmacist licensed by a state to dispense controlled substances, and shall include any person (e.g., pharmacy intern) authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State.

(y) Prescription. An order for medication which is dispensed to or for an ultimate user, but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).

(z) Proceeding. All actions taken for the issuance, amendment, or repeal of any rules and regulations issued pursuant to the Act, commencing with the publication by the Bureau Director of the proposed rule, amended rule, or appeal.

(aa) Readily Retrievable. Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some other manner visually identifiable apart from other items appearing on the records; when the term is not applicable to data processing systems, the term also means that a registrant is able to produce controlled substances records in a timely manner (usually within one hour) and that such records are segregated, sorted, or filed in such a manner that the controlled substances information may be derived from the material within a reasonable time (usually with a few hours) by an inspector.

(bb) Register and Registration. Refer only to registration required and permitted by the Act;

(cc) Registrant. Any person who is registered pursuant to the Act.

(dd) Scheduling of a Controlled Substance. Controlled substances are scheduled in accordance with provisions set forth in state law. Changes in the schedule of a controlled substance are made as set forth in S.C. Code Ann. § 44-53-160.

(ee) Any term not defined in this section shall have the definition set forth in the Act, or amendments thereto.