La. Admin. Code tit. 46 § LIII-2715

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2715 - Physical Security Controls for Non-Practitioners, Narcotic Treatment Programs, and Compounders for Narcotic Treatment Programs

A. Storage Areas

1. Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedule I or II shall be stored in one of the following secure storage areas:

a. Where small quantities permit, a safe or steel cabinet:

i. which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;

ii. which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way it cannot be readily removed; and

iii. which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the licensee, or such other protection as the board or its designee may approve;

b. a vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or

c. a vault constructed after September 1, 1971:

i. the walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;

ii. the door and frame unit of which vault shall conform to the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;

iii. which vault, if operations require it to remain open for frequent access, is equipped with a "day-gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;

iv. the walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the licensee, or such other protection as the board or its designee may approve, and, if necessary, alarm buttons at strategic points of entry to the perimeter area of the vault;

v. the door of which vault is equipped with contact switches; and

vi. which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the board or its designee.

2. Schedules III, IV and V. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedules III, IV and V shall be stored in one of the following secure storage areas:

a. a safe or steel cabinet as described in this Section;

b. a vault as described in this Section equipped with an alarm system as described in this Section;

c. a building used for storage of Schedules III through V controlled substances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications:

i. has an electronic alarm system as described in this Section;

ii. is equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use and when in use is kept under direct observation of a responsible employee or agent of the licensee is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination or key lock type and:

(a). in the case of key locks, shall require key control which limits access to a limited number of employees; or

(b). in the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination;

d. a cage, located within a building on the premises, meeting the following specifications:

i. having walls constructed of not less than No. 10 gauge steel fabric mounted on steel posts, which posts are:

(a). at least 1 inch in diameter;

(b). set in concrete or installed with lag bolts which are pinned or brazed; and

(c). placed no more than 10 feet apart with horizontal 1 1/2 inch reinforcements every 60 inches;

ii. having a mesh construction with openings of not more than 2 1/2 inches across the square;

iii. having a ceiling constructed of the same material, or in the alternative, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height;

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 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.

La. Admin. Code tit. 46, § LIII-2715

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2135 (October 2008).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.