Current through all regulations passed and filed through September 16, 2024
(A) The security and control of controlled
substances and 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
(G) and
(H) and 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 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 the
responsible person, a prescriber, or a pharmacist if not being used by a
prescriber, pharmacist, responsible person, or a licensed health care
professional or employee of a dog training facility 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, pharmacist
or responsible person shall have possession of the keys or access codes to the
cabinet or safe.
(a) A prescriber, pharmacist,
or responsible person may provide a licensed health care professional or an
employee of a dog training facility with a temporary key for the purposes of
accessing the cabinet or safe. A licensed health care professional or employee
shall return the key provided in accordance with this rule to the responsible
person, a prescriber, or a pharmacist or to a secured location with restricted
access (such as a lockbox) no later than the end of the person's shift or if
there is no longer a prescriber, pharmacist or the responsible person available
to provide personal supervision.
(b) A prescriber, pharmacist or the
responsible person may provide a licensed health care professional or an
employee of a dog training facility 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, pharmacist, or responsible person;
(ii) The room is locked during non-business
hours or when there is no longer a prescriber, pharmacist, or the responsible
person 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 paragraphs (D) and (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) A limited facility that is a dog trainer
affiliated with an Ohio law enforcement agency may permit access to controlled
substances to those engaged in the training of canines only under the personal
supervision of the responsible person.
(E) Only a prescriber shall have access to
uncompleted prescription blank(s) used for writing a prescription. Uncompleted
prescription blank(s) shall be secured when not in use.
(F) Personnel authorized by the responsible
person may have access to D.E.A. controlled substance order forms only under
the personal supervision of the responsible person, 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.
(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 (H)
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
4729:5-23-03 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) 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, pharmacist or responsible person if not being
used by a prescriber, pharmacist or the responsible person. 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, pharmacist, or the
responsible person shall have possession of the key, combination or access code
to the safe or cabinet specified in this paragraph.
(I)
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 or possess
hypodermics.
(J) 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 or employees
of a dog training facility.
(K) 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.
(L) 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.
(M) 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.
(N)
Adulterated drugs, including expired drugs, shall be stored in accordance with
rule 4729:5-3-06 of the
Administrative Code.
(O) Disposal of controlled substances shall be
conducted in accordance with rule
4729:5-3-01 of the
Administrative Code.
(P) Disposal of non-controlled dangerous drugs shall
be conducted in accordance with rule
4729:5-3-06 of the
Administrative Code.
(Q) Disposal of controlled substances by a dog
training facility that are not dangerous drugs 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 and one other
employee of the dog training facility;
(b) A law enforcement officer; 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 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 person or persons conducting and witnessing the disposal.
Effective: 2/4/2021
Five Year Review
(FYR) Dates: 3/1/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26,
3719.28
Rule Amplifies: 4729.54
Prior Effective Dates:
03/01/2020
