request shall be preserved by the licensee with other records of distribution of controlled substances. In addition, the procurement requirements of §2743 of this Chapter 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 by the person.
4.When shipping controlled substances, a licensee 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 licensee is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the licensee shall store controlled substances in a public warehouse which complies with the requirements set forth in §2715.A of this Chapter. In addition, the licensee shall employ precautions (e.g., assuring that shipping containers do not indicate that contents are controlled substances) to guard against storage or in-transit losses.
5.When distributing controlled substances through agents (e.g., sales representatives), a licensee is responsible for providing and requiring adequate security to guard against theft and diversion while the substances are being stored or handled.
6.Before the initial distribution of carfentanil etorphine hydrochloride and/or diprenorphine to any person, the licensee shall verify that the person is authorized to handle the substances(s) by contacting the DEA.
7.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 specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.
8.Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either:
a.the licensed practitioner;
b.a registered nurse under the direction of the licensed practitioner;
c.a licensed practical nurse under the direction of the licensed practitioner; or
d.a pharmacist under the direction of the licensed practitioner.
9.Persons enrolled in a narcotic treatment program shall 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.
10.All narcotic treatment programs shall comply with standards established by the department respecting the quantities of narcotic drugs which may be provided to persons enrolled in a narcotic treatment program for unsupervised use.
11.The board may exercise discretion regarding the degree of security required in narcotic treatment programs based on such factors as the location of a 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.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2135 (October 2008).
§2717.Physical Security Controls for Practitioners and Pharmacies
A.Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
B.Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
C.This Section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration.
D.Carfentanil etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
E.The licensee shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this Subsection, the term "for cause" includes surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances.
F.The licensee shall notify the board and the Field Division Office of the DEA in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The licensee shall also complete, and submit to the board and the Field Division Office of the DEA in his area, DEA Form 106, or its electronic equivalent, regarding the loss or theft. When determining whether a loss is significant, a licensee should consider, among others, the following factors:
1.the actual quantity of controlled substances lost in relation to the type of business;
2.the specific controlled substances lost;
3.whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
4.a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;
5.whether the specific controlled substances are likely candidates for diversion;
Louisiana Register Vol. 34, No. 10 October 20, 2008