Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-16 - Laboratories › Section 4729:5-16-02 - Security, control and storage of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								The security and control of dangerous drugs and
			 controlled substances is the responsibility of the responsible person on the
			 terminal distributor of dangerous drugs license and the terminal
			 distributor.
(B)
								Except as provided in paragraph (H) of this rule,
			 controlled substances shall be stored in a securely locked, substantially
			 constructed cabinet or safe to deter and detect unauthorized access.
(1)
									The cabinet or
			 safe shall be placed in an area that is not readily accessible to the
			 public.
(2)
									The cabinet or safe shall remain locked and secured
			 when not in use.
(3)
									In the case of a combination lock or access code, the
			 combination or access code shall be changed upon termination of employment of
			 an employee having knowledge of the combination.
(4)
									In the case of a
			 key lock, all keys shall be maintained in a secure place that is inaccessible
			 to anyone other than the responsible person or the responsible person's
			 designee if not being used by the responsible person, responsible person's
			 designee, or a laboratory employee or researcher in accordance with paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in
			 good working order with keys removed therefrom.
(5)
									When the
			 laboratory is not in use by authorized personnel, the cabinet or safe shall be
			 maintained in an area secured by a physical barrier with suitable locks, which
			 may include a locked room or secure facility.
(6)
									Except as
			 provided in paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only the
			 responsible person or the responsible person's designee shall have possession
			 of keys, combinations or access codes to the cabinet or safe.
(a)
										A responsible
			 person or the responsible person's designee may provide a laboratory employee
			 or researcher with a temporary key for the purposes of accessing the cabinet or
			 safe. An employee or researcher shall return the key provided in accordance
			 with this paragraph to the responsible person or responsible person's designee
			 or a secured location with restricted access (such as a lockbox) no later than
			 the end of the employee's shift, the end of the researcher's activity, or if
			 there is no longer a responsible person or designee available to provide
			 personal supervision.
(b)
										A responsible person or the responsible person's
			 designee may provide an employee or researcher with a key, combination or
			 access code for the purposes of accessing the cabinet or safe, if all the
			 following conditions apply:
(i)
											The cabinet or safe is maintained in a room secured by
			 a physical barrier with suitable locks that can only be unlocked by the
			 responsible person or the responsible person's designee;
(ii)
											The room is
			 locked during non-business hours or when there is no longer a responsible
			 person or responsible person's designee available to provide personal
			 supervision.
(c)
										Any other method approved by the board's executive
			 director or the director's designee that provides effective controls and
			 procedures to guard against theft and diversion.