iv.is equipped with a door constructed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects conforms to all federal requirements; and
v.is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond, or to a 24-hour control station operated by the licensee, or to such other source of protection as the board or its designee may approve;
e.an enclosure of masonry or other material, approved in writing by the board or its designee as providing security comparable to a cage;
f.a building or enclosure within a building which has been inspected and approved by DEA or its predecessor agency, the United States Bureau of Narcotics and Dangerous Drugs, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment has been made by the special agent in charge of DEA for the area in which such building or enclosure is situated; or
g.such other secure storage areas as may be approved by the board after considering the factors listed in §2713 of this Chapter.
3.Mixing of Schedules
a.Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by this Section.
b.Non-controlled drugs, substances and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by this Section, provided that permission for such storage of non-controlled items is obtained in advance, in writing, from the special agent in charge of DEA for the area in which such storage area is situated. Any such permission tendered shall be upon the special agent in charge's written determination that such non-segregated storage does not diminish security effectiveness for Schedules III through V controlled substances.
4.Multiple Storage Areas. Where several types or classes of controlled substances are handled separately by the licensee or applicant for different purposes (e.g., returned goods, or goods in process), the controlled substances may be stored separately, provided each storage area complies with the requirements set forth in this Section.
5.Accessibility to Storage Areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the licensee shall provide for adequate observation of the area by an employee specifically authorized in writing.
B.Manufacturing and Compounding Areas
1.Before distributing a controlled substance to any person who the licensee does not know to be registered to possess the controlled substance, the licensee shall make a good faith inquiry, either with the DEA or the board, to determine that the recipient is registered to possess the
controlled dangerous substance.
2.All manufacturing and compounding activities (including processing, packaging and labeling) involving controlled substances listed in any schedule shall be conducted in accordance with the following.
a.All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked. If security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the licensee.
b.Manufacturing activities with controlled substances shall be conducted in an area of clearly defined limited access under surveillance by an employee(s) designated in writing as responsible for the area. Limited access may be provided, in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated responsible for the area may be engaged in the particular manufacturing operation being conducted, provided he is able to provide continuous surveillance of the area to ensure unauthorized individuals do not enter or leave the area without his knowledge.
c.During the production of controlled substances, the manufacturing areas shall be accessible only to those employees required for efficient operation. When employee maintenance personnel, non employee maintenance personnel, business guests, or visitors are present during production of controlled substances, the licensee shall provide for adequate observation of the area by an employee specifically authorized in writing.
C.Other Requirements/Narcotic Treatment Programs
1.Before distributing a controlled substance to any person who the licensee does not know to be registered to possess the controlled substance, the licensee shall make a good faith inquiry either with the DEA or the board to determine that the person is registered to possess the controlled substance.
2.The licensee shall design and operate a system to disclose to the licensee suspicious orders of controlled substances. The licensee shall inform the New Orleans Field Division Office of the DEA, or its successor, of suspicious orders when discovered by the licensee. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
3.a.The licensee shall not distribute any controlled substance listed in Schedules II through V as a complimentary sample to any potential or current customer:
i.without the prior written request of the customer;
ii.to be used only for satisfying the legitimate medical needs of patients of the customer; and
iii.only in reasonable quantities.
b.Such request shall contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substance desired. The
Louisiana Register Vol. 34, No. 10 October 20, 2008