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. 6, June 28, 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.