S.C. Code Regs. § 61-4.400.404

Current through Register Vol. 48, No. 34, August 23, 2024

Section 61-4.400.404 - Other Security Controls for Non-practitioners; Narcotic Treatment Programs and Compounders for Narcotic Treatment Programs

(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.

S.C. Code Regs. 61-4.400.404

Replaced and Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.