S.C. Code Regs. § § 61-4.400.402

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-4.400.402 - Physical Security Controls for Non-practitioners; Storage Areas

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

(1) 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-minutes against lock manipulation, and 20 man-minutes 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 that 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 registrant, or such other protection as the Bureau Director may approve.

(2) 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 and

(3) A vault constructed after September 1, 1971:

(i) The walls, floors, and ceilings of which vaults 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 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 local 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 registrant as the Bureau of Drug Control may approve and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(v) 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 Bureau of Drug Control.

(b) 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:

(1) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a)(1) of this section;

(2) A vault which complies with the requirements set forth in either paragraph (a)(2) or (3) of this section; equipped with an alarm system as described in paragraph (b) (4) (v) of this section; or

(3) 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 paragraph (b) (4) (v) of 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 of the agent or registrant 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;

(4) 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 posts, which posts are:

(a) At least one inch in diameter;

(b) Set in concrete or installed with lag bolts that are pinned or brazed; and

(c) Which are placed no more than 10 feet apart with horizontal one and one-half inch reinforcements every sixty inches;

(ii) Having a mesh construction with openings of not more than two and one-half 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 of the requirements of subparagraph (b)(3)(ii) of this section; 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 a 24-hour control station operated by the registrant, or to such other source of protection that the Bureau Director may approve;

(5) An enclosure of masonry or other material, approved in writing by the Bureau Director as providing security comparable to a cage;

(6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor, agency, BNDD, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment from DEA (BNDD) has been received for the area in which such building or enclosure is situated;

(7) Such other secure storage areas as may be approved by the Bureau Director after consulting with DEA and the factors listed in § 401(b)(1) through (14) of this regulation;

(8)

(i) Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by paragraph (a) of this section;

(ii) 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 substances has been obtained in advance, in writing, from both the Bureau Director and the DEA agent in charge of the area in which such storage area is situated [See 21 CFR §1301.72(b)(8)(ii) ]. Any such permission shall be based upon the determination that the storage of such items does not diminish security for the controlled substances.

(c) Multiple store areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g. returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.

(d) 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 registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

S.C. Code Regs. § 61-4.400.402

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