Ohio Admin. Code 4729:5-16-02 - Security, control and storage of dangerous drugs
(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.
(C)
An
employee or researcher of the laboratory may have access to controlled
substances only under the personal supervision of the laboratory's responsible
person or the responsible person's designee. A responsible person may have more
than one designee. All designees shall meet the requirements of the responsible
person set forth in rule
4729:5-2-01 of the
Administrative Code. A laboratory shall maintain a current list of all approved
designees for immediate inspection by an agent, officer or inspector of the
board.
(D)
Only a prescriber shall only have access to uncompleted
prescription blank(s) used for writing a prescription. Uncompleted prescription
blank(s) shall be secured when not in use.
(E)
Personnel
authorized by the responsible person may have access to D.E.A. controlled
substance order forms under the personal supervision of the laboratory's
responsible person. D.E.A. controlled substance order forms shall be secured
when not in use.
(F)
Controlled substances in the process of testing, use,
or research shall be returned to the required storage location upon completion
of each such process.
(G)
All samples containing, or suspected of containing, a
dangerous drug or controlled substance shall be treated as schedule I and II
controlled substances.
(H)
Thiafentanil, carfentanil, etorphine hydrochloride and
diprenorphine shall be stored in a separate safe or steel cabinet equivalent to
a U.S. government class V security container from all other controlled
substances.
(1)
There is no minimum size or weight requirement but if the
cabinet or safe weighs less than seven hundred fifty pounds, it must be secured
to the floor or wall in such a way that it cannot be readily
removed.
(2)
The cabinet or safe shall be placed in an area that is
not readily accessible to the public.
(3)
The cabinet or
safe shall remain locked and secured when not in use.
(4)
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 or access codes.
(5)
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 or the responsible
person's designee. All locks shall be kept in good working order with keys
removed therefrom.
(6)
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.
(7)
Only the responsible person or the responsible person's
designee shall have possession of the key, combination or access code to the
safe or cabinet.
(8)
This paragraph does not apply to exempt chemical
preparations as defined in rule
4729:5-16-01 of the
Administrative Code.
(I)
When the
laboratory is not in use by authorized personnel, non-controlled dangerous
drugs, exempt chemical preparations, and hypodermics shall be stored in an area
secured by a physical barrier with suitable locks, which may include a
substantially constructed cabinet or safe, drawer, locked room, or secured
facility.
(J)
All records relating to the administration,
distribution, personal furnishing, and sale of dangerous drugs and controlled
substances shall be maintained under appropriate supervision and control to
restrict unauthorized access.
(K)
All areas where
dangerous drugs and controlled substances are stored shall be dry, well-lit,
well-ventilated, and maintained in a clean and orderly condition. Unless
otherwise required by a documented research study, storage areas shall be
maintained at temperatures and conditions which will ensure the integrity of
the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or
distributor's labeling.
Refrigerators and freezers used for the storage of drugs and controlled substances shall comply with the following:
(1)
Maintain either of the following to ensure proper
refrigeration and/or freezer temperatures are maintained:
(a)
Temperature logs
with, at a minimum, daily observations; or
(b)
A temperature
monitoring system capable of detecting and alerting staff of a temperature
excursion.
(2)
The terminal distributor shall develop and implement
policies and procedures to respond to any out of range individual temperature
readings or excursions to ensure the integrity of stored drugs and controlled
substances.
(3)
The terminal distributor shall develop and implement a
policy that no food or beverage products are permitted to be stored in
refrigerators or freezers used to store drugs and controlled substances.
(L)
Upon the initial puncture of a multiple-dose vial
containing a drug, the vial shall be labeled with a beyond-use date or date
opened. The beyond-use date for an opened or entered (e.g., needle punctured)
multiple-dose container with antimicrobial preservatives is twenty-eight days,
unless otherwise specified by the manufacturer. A multiple-dose vial that
exceeds its beyond-use date shall be deemed adulterated.
(M)
Adulterated
drugs, including expired drugs, shall be stored in accordance with rule
4729:5-3-06 of the
Administrative Code. This paragraph does not apply to drugs submitted to crime
laboratories for analysis or laboratories conducting research using adulterated
drugs.
(N)
Laboratories shall comply with all state and federal
laws, rules and regulations governing the use of controlled substances for the
purpose of research or chemical analysis.
(O)
Unless consumed
as part of an analysis, disposal of controlled substance dangerous drugs shall
be conducted in accordance with rule
4729:5-3-01 of the
Administrative Code.
(P)
Unless consumed as part of an analysis, disposal of
non-controlled dangerous drugs shall be conducted in accordance with rule
4729:5-3-06 of the
Administrative Code.
(Q)
Unless consumed as part of an analysis, disposal of
controlled substances that are not dangerous drugs or any unused portion of a
submitted anonymous sample for scientific analysis shall be conducted as
follows:
(1)
The method of disposal shall render the drug or substance
non-retrievable as defined in rule
4729:5-3-01 of the
Administrative Code.
(2)
Disposal shall be conducted by any of the
following:
(a)
The responsible person or the responsible person's designee
and one other employee of the laboratory;
(b)
Two employees of
the laboratory designated by the responsible person; or
(c)
A contracted
waste disposal company in compliance with all federal, state and local laws,
rules and regulations.
(3)
Records for the
disposal of the drug or substance shall contain the actual identification of
the drug or substance, form, and quantity disposed, the date disposed, the
method of disposal and, if disposal is conducted on-site, the positive
identification of the two personnel conducting and witnessing the
disposal.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.09, 4729.51, 4729.55
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