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) Controlled
substance dangerous drugs used to perform euthanasia or
chemical capture shall be stored in a securely locked, substantially
constructed cabinet or safe.
(1) The cabinet
or safe shall be placed in an area that is not readily accessible to the
public. The public does not include volunteers of the animal shelter.
(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
veterinarian, registered veterinary technician, responsible person, euthanasia
technician, certified officer, dog warden, or
executive director of the shelter. All locks shall be kept in good working
order with keys removed therefrom.
(5) When not staffed by shelter 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) Only a veterinarian,
registered veterinary technician, euthanasia technician, executive director of
the shelter, certified officer, dog warden, or
the licensee's responsible person shall be able to access
the cabinet or safe.
(C)
Except as provided in paragraph (E) of this rule, controlled substance
dangerous drugs that are not used to perform euthanasia or chemical capture shall be stored in a securely
locked, substantially constructed cabinet or safe.
(1) The cabinet or safe shall be placed in a
designated drug storage area that is not accessible by the public. The public
does not include volunteers of the animal shelter.
(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
veterinarian if not being used by a veterinarian or a veterinary technician in
accordance with paragraph (C)(6)(a), (C)(6)(b), or (C)(6)(c) of this rule. All
locks shall be kept in good working order with keys removed
therefrom.
(5) When not staffed by
shelter 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 (C)(6)(a), (C)(6)(b), or (C)(6)(c) of this rule, only a
veterinarian shall be able to access the cabinet or safe.
(a) A veterinarian may provide a veterinary
technician with a temporary key for the purposes of accessing the cabinet or
safe. A veterinary technician shall return the key provided in accordance with
this paragraph to the veterinarian or a secured location with restricted access
(such as a lockbox) no later than the end of the technician's shift or if there
is no longer a veterinarian available to provide personal
supervision.
(b) A veterinarian may
provide a veterinary technician 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 veterinarian;
(ii)
The room is locked when not staffed by personnel or when there is no longer a
veterinarian 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.
(D) Except as provided in
paragraphs (B) and (E) of this rule, a registered veterinary technician may
have access to controlled substances only under the personal supervision of a
veterinarian.
(E) Employees or
volunteers of an animal shelter or county dog
warden that are designated by the responsible person or the shelter's
executive director may have unsupervised access to controlled substances only
under the following conditions:
(1) The drugs
have been personally furnished by a veterinarian or dispensed by a pharmacy for
direct administration to an animal.
(2) The drugs must be stored in an area
secured by a physical barrier with suitable locks, which may include a
substantially constructed cabinet, safe, or room. Access to the cabinet, safe,
or room shall be limited to designated staff. The cabinet or safe must be
separate from those required in paragraphs (B), (C), and (I) of this rule.
(a) The cabinet or safe shall be placed in an
area that is not readily accessible to the public. The public does not include
volunteers of the animal shelter or county dog
warden.
(b) The cabinet,
safe, or room shall remain locked and secured when not in use.
(c) In the case of a key lock, all keys shall
be maintained in a secure place that is inaccessible to anyone other than
designated staff. All locks shall be kept in good working order with keys
removed therefrom.
(d) When not
staffed by shelter 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.
(3) A record of drug administration shall be
maintained in accordance with paragraph (E) of rule
4729:5-15-03 of the
Administrative Code.
(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.
(5) The
responsible person or shelter's executive director shall maintain a current
list of all designated employees or volunteers for immediate inspection by an
agent, officer or inspector of the board.
(F) Non-controlled dangerous drugs that have
been personally furnished by a veterinarian or dispensed by a pharmacy for
direct administration may be administered by an animal shelter
or county dog warden employee or
volunteer.
(G) Only a veterinarian
shall have access to uncompleted prescription blanks used for writing a
prescription. Uncompleted prescription blanks shall be secured when not in
use.
(H)
(1) For an animal shelter
or county dog warden that is licensed in
accordance with section
4729.54 of the Revised Code:
personnel authorized by the responsible person may have access to D.E.A.
controlled substance order forms only under the personal supervision of a
veterinarian. D.E.A. controlled substance order forms shall be secured when not
in use.
(2) For an animal shelter
or county dog warden that is licensed in
accordance with section
4729.531 of the Revised Code:
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. D.E.A. controlled substance order forms shall be secured
when not in use.
(I)
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) Except as
provided for in this paragraph, the cabinet or safe shall be placed in a
designated drug storage area that is not accessible by the public. When it is
necessary for employee maintenance personnel, nonemployee maintenance
personnel, patients, business guests, or visitors to be present in or pass
through areas containing the cabinet or safe, a veterinarian or veterinary
technician shall provide for adequate observation of the area.
(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 code.
(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
veterinarian if not being used by a veterinarian. All locks shall be kept in
good working order with keys removed therefrom.
(6) When not staffed by
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 a veterinarian shall be able to
access the safe or cabinet.
(J) When not staffed by
personnel, 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. Members of the public do not include volunteers of the
animal shelter or county dog warden.
(K) When not staffed by
personnel, 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. Members of the public do not
include volunteers of the animal shelter or county dog
warden.
(L) In the event of a
change of ownership of an animal,
an employee or volunteer may transfer dangerous
drugs that have been personally furnished by a veterinarian or dispensed by a
pharmacy for direct administration to an animal to the animal's new owner or
caregiver. The transfer of controlled substances shall be documented in
accordance with paragraph (I) of rule
4729:5-15-03 of the
Administrative Code.
(M) 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 access by those who neither work for, or
volunteer at, the animal shelter
or county dog warden.
(N) 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.
(O) Upon the
initial puncture of a multiple-dose vial containing a drug, the vial shall be
labeled with a date opened. Multiple-dose vials shall be examined prior to use
for evidence of physical or chemical contamination. Vials that have any of the
following characteristics shall be deemed adulterated:
(1) Contain particulate matter, precipitates,
turbidity, or discoloration;
(2)
Mislabeled; or
(3) Noticeable
coring (damage to the rubber stopper).
(P) Adulterated drugs, including expired
drugs, shall be stored in accordance with rule
4729:5-3-06 of the
Administrative Code.
(Q) Disposal
of controlled substances shall be conducted in accordance with rule
4729:5-3-01 of the
Administrative Code.
(R) Disposal
of non-controlled dangerous drugs shall be conducted in accordance with rule
4729:5-3-06 of the
Administrative Code.
