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 paragraph 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; and
(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.
(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 be able to access 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
4729:5-19-04 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
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.
Effective: 2/4/2021
Five Year Review
(FYR) Dates: 3/1/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26,
3719.28
Rule Amplifies: 3719.07
Prior Effective Dates:
03/01/2020
