(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.