South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.404 - Other Security Controls for Non-practitioners; Narcotic Treatment Programs and Compounders for Narcotic Treatment Programs

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Before distributing a controlled
				substance to any person who the registrant does not know to be registered to
				possess the controlled substance, the registrant shall make a good faith
				inquiry either with the DEA or with the state controlled registration agency to
				determine that the person is registered to possess the controlled
				substance.
(b) The registrant shall
				design and operate a system to alert the registrant of suspicious orders of
				controlled substances. The registrant shall inform the Bureau of Drug Control
				of suspicious orders when discovered by the registrant. Suspicious orders
				include orders of unusual size, orders deviating substantially from a normal
				pattern, and orders of unusual frequency.
(c) The registrant shall notify the office of
				the Bureau of Drug Control of any theft or loss of any controlled substances
				upon discovery of such theft or loss. The supplier shall be responsible for
				reporting in-transit losses of controlled substances by the contract or common
				carrier pursuant to subparagraph (e) of this section, upon discovery of such
				theft or loss. The registrant shall also complete DEA Form 106 regarding such
				theft or loss. Thefts shall be reported whether or not the controlled
				substances are subsequently recovered and/or the responsible parties are
				identified and action taken against them.
(d) The registrant shall not distribute any
				controlled substances in schedules II through V as a complimentary sample to
				any potential or current customer (1) without the prior written request of the
				customer, (2) to be used only for satisfying the legitimate medical needs of
				patients of the customer and (3) only in reasonable quantities. Such request
				shall contain the name, address, and registration number of the customer and
				the name and quantity of the specific controlled substances desired. The
				request shall be preserved by the registrant with other records of distribution
				of controlled substances. In addition, the requirements of Part 900 of the
				Regulation shall be complied with for any distribution of a controlled
				substance listed in schedule II. For purposes of this paragraph, the term
				"customer" includes a person to whom a complimentary sample of a substance is
				given in order to encourage the prescribing or recommending of the substance to
				the person.
(e) When shipping
				controlled substances, a registrant is responsible for selecting common or
				contract carriers, which provide adequate security to guard against in-transit
				losses. When storing controlled substances in a public warehouse, a registrant
				is responsible for selecting a warehouseman which will provide adequate
				security to guard against storage losses; wherever possible, the registrant
				shall store controlled substances in a public warehouse which complies with the
				requirements set forth in §
									402. In addition, the registrant
				shall employ precautions (e.g. assuring that shipping containers do not
				indicate the contents are controlled substances) to guard against storage or
				in-transit losses.
(f) When
				distributing controlled substances through agents (e.g., detail men), a
				registrant is responsible for providing adequate security to guard against
				theft and diversion while the substances are being stored or handled by the
				agent or agents.
(g) Before the
				initial distribution of etorphine hydrochloride and/or diprenorphine to any
				person, the registrant shall verify that the person is authorized to handle the
				substance(s) by contacting the Bureau of Drug Control and DEA.
(h) The acceptance of delivery of narcotic
				substances by a narcotic treatment program shall be made only by a licensed
				practitioner employed at the facility or other authorized individuals
				designated in writing. At the time of delivery, the licensed practitioner or
				other authorized individual designated in writing (excluding persons currently
				or previously dependent on narcotic drugs), shall sign for the narcotics and
				place his or her specific title (if any) on any invoice. Copies of these signed
				invoices shall be kept by the distributor.
(i) Narcotics dispensed or administered at a
				narcotic treatment program will be dispensed or administered directly to the
				patient by either (1) the licensed practitioner, (2) a registered nurse under
				the direction of the licensed practitioner, (3) a licensed practical nurse
				(LPN) under the direction of the licensed practitioner, or (4) a pharmacist
				acting under a prescription or an order issued by the licensed
				practitioner.
(j) Persons enrolled
				in a narcotic treatment program will be required to wait in an area physically
				separated from the narcotic storage and dispensing area. This requirement will
				be enforced by the program physician and employees.
(k) All narcotic treatment programs shall
				comply with standards established by the appropriate Federal authorities [see
				21 CFR §1301.74(k) ] and the Bureau of Drug Control, and the provisions of
				S.C. Code Ann. §§
									44-53-710
				through
				44-53-760
				respecting the quantities of narcotic drugs that may be provided to persons
				enrolled in a narcotic treatment program for unsupervised use.
(l) DEA and the Bureau of Drug Control may
				exercise discretion regarding the degree of security required in narcotic
				treatment programs based upon such factors as the location of the program, the
				number of patients enrolled in a program, and the number of physicians, staff
				members, and security guards. Similarly, such factors will be taken into
				consideration when evaluating existing security or requiring new security at a
				narcotic treatment program.