Current through all regulations passed and filed through September 16, 2024
(A) The security and control of dangerous
drugs is the responsibility of the responsible person on the terminal
distributor of dangerous drugs license and the terminal distributor of
dangerous drugs.
(B) Except as
provided in paragraphs (F) and (G)
of this rule, controlled substance dangerous drugs 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 or access
code.
(4) In the case of a key
lock, all keys shall be maintained in a secure place that is inaccessible to
anyone other than a prescriber or pharmacist if not being used by a prescriber,
pharmacist or a licensed health care professional 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) During non-business hours, 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 a prescriber or
pharmacist shall be able to access the cabinet or safe.
(a) A prescriber or pharmacist may provide a
licensed health care professional with a temporary key for the purposes of
accessing the cabinet or safe. A licensed health care professional shall return
the key provided in accordance with this rule to the prescriber or pharmacist
or to a secured location with restricted access (such as a lockbox) no later
than the end of the provider's shift or if there is no longer a prescriber or
pharmacist available to provide personal supervision.
(b) A prescriber or pharmacist may provide a
licensed health care professional 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 a prescriber or pharmacist;
(ii) The room is locked during non-business
hours or when there is no longer a prescriber or pharmacist 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 of controlled
substances.
(C)
Except as provided in paragraph (G) of this rule,
a licensed health care professional,
acting within the scope of the professional's practice may have access to
controlled substances only under the personal supervision of a prescriber or
pharmacist.
(D) Only a prescriber
shall have access to uncompleted prescription blanks used for writing a
prescription. Uncompleted prescription blanks 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 only under the personal supervision of a prescriber
or a
person delegated power of attorney in accordance with
21 CFR 1305.05
(9/30/2019). D.E.A. controlled substance order forms shall be secured
when not in use.
(F) 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 a prescriber or pharmacist if not being used by a prescriber
or pharmacist. All locks shall be kept in good working order with keys removed
therefrom.
(6) During non-business
hours, 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 a prescriber or
pharmacist shall have possession of the key, combination or access code to the
safe or cabinet.
(G)
A registered nurse licensed under Chapter 4723. of the
Revised Code may have unsupervised access to controlled substances only under
the following conditions:
(1)
The drugs have been personally furnished by a
prescriber or dispensed by a pharmacy for direct administration to a
patient.
(2)
The drugs must be stored in a securely locked,
substantially constructed cabinet or safe with access that is limited to
prescribers, pharmacists, and registered nurses. The cabinet or safe must be
separate from those required in paragraphs (B) and (F) of this rule.
(a)
The cabinet or
safe shall be placed in an area that is not readily accessible to the
public.
(b)
The cabinet or safe shall remain locked and secured
when not in use.
(c)
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 code.
(d)
In the case of a
key lock, all keys shall be maintained in a secure place that is inaccessible
to anyone other than a prescriber, pharmacist or registered
nurse.
(e)
During non-business hours, 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.
(3)
A record of drug
administration shall be maintained in accordance with paragraph (E) of rule
4729:5-22-03 of the
Administrative Code and shall also include the date and time the drugs are
accessed from the cabinet or safe.
(4)
The responsible
person shall report the theft or significant loss of drugs maintained pursuant
to this paragraph in accordance with rule
4729:5-3-02 of the
Administrative Code.
(H) During
non-business hours, hypodermics shall be stored in an area secured by a
physical barrier with suitable locks, which may include a substantially
constructed cabinet, locked room, or secured facility. During normal business
hours, hypodermics shall not be stored in areas where members of the public are
not supervised by individuals authorized to administer injections.
(I)
During non-business hours, non-controlled dangerous drugs shall be stored in an
area secured by a physical barrier with suitable locks, which may include a
substantially constructed cabinet, locked room, or secured facility. During
normal business hours, non-controlled dangerous drugs shall not be stored in
areas where members of the public are not supervised by individuals authorized
to administer such drugs.
(J) All records
relating to the receipt, administration, distribution, personal furnishing and
sale of dangerous drugs shall be maintained under appropriate supervision and
control to restrict unauthorized access.
(K) All areas where dangerous drugs and devices are
stored shall be dry, well-lit, well-ventilated, and maintained in a clean and
orderly condition. 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 devices 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.
(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 dangerous
drugs.
(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.
(N) Disposal of controlled substances shall be
conducted in accordance with rule
4729:5-3-01 of the
Administrative Code.
(O) Disposal of non-controlled dangerous drugs shall
be conducted in accordance with rule
4729:5-3-06 of the
Administrative Code.
