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 61-4.100.109 - Exemption of Agents and Employees; Affiliated Practitioners
Current through Register Vol. 48, No. 9, September 27, 2024
(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment. (For example, a pharmacist employed by a pharmacy need not be individually registered to conduct lawful business activity in preparing and dispensing of controlled substances if the pharmacy in which he or she is employed is properly registered under the Act; a manufacturer's sales representative may lawfully distribute samples of controlled substances manufactured by his or her employer, provided the manufacturer-employer is lawfully registered and the distribution is made to a registrant authorized to possess controlled substances and not to a non-registrant employee of the recipient of the sample.)
(b) An individual practitioner who is affiliated with one or more other individual practitioners in any legitimate and lawful form of business arrangement (i.e., partnership, professional association, etc.) shall be registered individually with DHEC prior to engaging in any form of controlled substances activity, pursuant to the provisions of S.C. Code Ann. §§ 44-53-290 and 44-53-370(a)(1). With the written Power of Attorney of another affiliated practitioner within the group, any other affiliate individual practitioner may administer or dispense (other than by prescribing) controlled substances within the regular course of professional practice if and to the extent the practitioner granting the power of attorney has authorized. (For example, Dr. X and Dr. Y are partners; they shall be individually registered in order to utilize controlled substances in their practice; if Dr. X desired, he or she could issue Dr. Y a power of attorney to utilize Dr. X's office stock of controlled substances to administer an injection of product CRx to Dr. Y's Patient, Mrs. A. while she is in the office. Dr. Y may not, however, sign Dr. X's name to prescriptions, nor may Dr. Y use Dr. X's registration number to obtain stocks of controlled substances for himself or herself or his or her own office stock.) Any power of attorney, once granted, may be revoked by the grantor in writing. Nothing in this Section shall be construed to relieve the grantor of any power of attorney of any responsibility for the proper storage, record keeping, handling, or legitimate use of any controlled substances acquired by the grantor; nor shall anything be construed as relieving the grantee practitioner from full and complete responsibility for his or her actions conducted pursuant to the power of attorney or for controlled substances acquired or utilized pursuant to this paragraph.
(c) Pharmacists listed with the S.C. Board of Pharmacy as the "pharmacist-in-charge" of a pharmacy holding a permit issued by that Board to operate as a retail pharmacy, shall be considered as a "registrant" within the meaning of the Act and this Regulation, and shall be primarily responsible for the controlled substances activity at the registered location of the pharmacy. Nothing in this paragraph shall be construed as relieving an owner, partner, corporate officer, or any other person who may be a registrant-in-fact (due to his or her position within the business entity) from any direct or vicarious liability which may be incurred due to unlawful or ultra vires activity, nor shall it be construed to relieve any employee of the business entity from direct responsibility for his or her own unlawful acts.
(d) Individual practitioners permitted under the provisions of Federal Regulation Regulation 21 CFR §1301.24 to dispense, administer, or prescribe controlled substances under the registration of a hospital or other institution which is registered, in lieu of personal registration, are prohibited from this practice by the provisions of S.C. Code Ann. §§ 44-53-290 and 44-53-370(a)(1). No prescriptions issued within this State shall be dispensed by any person registered with DHEC unless the individual practitioner issuing the prescription holds a valid individual practitioner registration with DEA. Nothing shall prevent the dispensing of such prescriptions if they are co-signed by an individual practitioner holding a valid individual registration with the DEA and DHEC, providing that the co-signing practitioner has established a valid practitioner-patient relationship as set forth by §§1103 and 1204 of this Regulation prior to the dispensing of the controlled substance. Nothing in this paragraph shall preclude any pharmacy or dispensary operated by the Federal government on any property or enclave not subject to State jurisdiction from any act permitted under Federal law or regulation, nor shall it preclude the dispensing of out-of-state prescriptions as permitted by § 114 of this Regulation.