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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:5-15 | Animal Shelters

 
 
 
Rule
Rule 4729:5-15-01 | Animal Shelters - Definitions.
 

As used in Chapter 4729:5-15 of the Administrative Code:

(A) "Animal shelter" means a facility licensed as terminal distributor of dangerous drugs in accordance with section 4729.531 of the Revised Code or section 4729.54 of the Revised Code. An animal shelter shall be operated by a humane society or any society organized under Chapter 1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the Revised Code and shall comply with all requirements set forth in this chapter.

(1) An animal shelter that does not have a licensed veterinarian serving as the responsible person shall obtain a limited license as terminal distributor of dangerous drugs in accordance with section 4729.531 of the Revised Code.

(2) An animal shelter shall ensure that all agents and employees who perform euthanasia, other than registered veterinary technicians or licensed veterinarians, shall successfully complete a euthanasia technician certification course described in section 4729.532 of the Revised Code.

(3) An animal shelter shall comply with the initial licensure and renewal requirements set forth in rule 4729:5-2-02 of the Administrative Code.

(4) The board may suspend, revoke, restrict, limit, or refuse to grant or renew any animal shelter license in accordance with rule 4729:5-4-01 of the Administrative Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(C) "Controlled substance dangerous drugs used to perform euthanasia" means any of the following:

(1) Combination drugs that contain pentobarbital and at least one noncontrolled substance active ingredient, in a manufactured dosage form, whose only indication is for euthanizing animals; and

(2) Pursuant to division (A) of section 4729.532 of the Revised Code, the board approves the following substances to be administered by euthanasia technicians only for the purpose of anesthetizing an animal as part of the euthanasia process:

(a) Tiletamine and zolazepam for injection; and

(b) Ketamine hydrochloride.

(D) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

Pursuant to division (A) of section 4729.532 of the Revised Code, the board approves xylazine as a substance to be administered by euthanasia technicians only for the purpose of sedating an animal as part of the euthanasia process.

(E) "Euthanasia" has the same meaning as in paragraph (A) of rule 901:12-1-01 of the Administrative Code.

(F) "Euthanasia technician" is an individual that has successfully completed a euthanasia certification course, the curriculum of which has been approved by the veterinary medical licensing board pursuant to section 4729.532 of the Revised Code, and is in possession of a certificate which documents the successful completion of the certification course. For the purposes of this chapter, a euthanasia technician is considered a certified health care professional.

(G) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(H) "Personally furnish" or "personally furnishing" means the distribution of dangerous drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting. For the purposes of this chapter, the prescriber shall be a veterinarian. A veterinarian at an animal shelter who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-20-02 of the Administrative Code.

(I)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(J) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(K) "Registered veterinary technician" has the same meaning as in section 4741.01 of the Revised Code.

(L) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

(M) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

Last updated June 21, 2021 at 4:11 PM

Supplemental Information

Authorized By: 4729.26, 4729.532
Amplifies: 4729.01
Five Year Review Date: 3/12/2025
Prior Effective Dates: 8/16/1994 (Emer.), 11/25/1994, 1/20/2015
Rule 4729:5-15-02 | Security and control of dangerous drugs.
 

(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 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, 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, or the shelter'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 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 shelter 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 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.

(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 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 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 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 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.

(7) Only a veterinarian shall be able to access the safe or cabinet.

(J) When not staffed by shelter 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.

(K) When not staffed by shelter 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.

(L) In the event of a change of ownership of an animal, a shelter 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 shelter.

(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.

Last updated June 21, 2021 at 4:11 PM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.531, 4729.532, 4729.54, 4729.55
Five Year Review Date: 3/12/2025
Prior Effective Dates: 3/1/1999, 1/1/2004, 1/20/2015
Rule 4729:5-15-03 | Record Keeping.
 

(A) An animal shelter shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold or transferred.

(B) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt. An invoice from a drug distributor licensed in accordance with division 4729:6 of the Administrative Code containing the required information may be used to meet this requirement.

(C) Records of temperature control monitoring described in paragraph (N) of rule 4729:5-15-02 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(2) For temperature monitoring systems capable of detecting and alerting staff of a temperature excursion, maintain reports that provide information on any temperature excursion that includes the date, time, temperature recorded, and length of each excursion.

(D) Records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished, the name or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the date the drug is personally furnished and, if applicable, the date the drug is received by the animal's owner or caregiver. A veterinarian shall be required to document the final association of a controlled substances dangerous drug with a patient using positive identification

(E)

(1) Records of administration shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered, the name or identification of the animal to whom or for whose use the dangerous drugs were administered, and the date of administration. For controlled substance dangerous drugs, the administration record shall also include the positive identification of the person administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(3) Orders for the administration of controlled substances shall be documented using positive identification. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(4) Paragraph (E)(3) of this rule does not apply in any of the following instances:

(a) Administration of dangerous drugs authorized under Chapter 4729. of the Revised Code to perform euthanasia by means of lethal injection by a veterinarian, registered veterinary technician, or euthanasia technician; and

(b) Administration of dangerous drugs pursuant to paragraph (E) of rule 4729:5-15-02 of the Administrative Code.

(F) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the identification of the person that performed the disposal.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory, including drugs maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, is performed on-site, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient or controlled substances maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.

(H) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, expiration date, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(I) Records of controlled substances transferred in accordance with paragraph (L) of rule 4729:5-15-02 of the Administrative Code shall contain the name, strength, dosage form, and quantity of the dangerous drugs transferred, the name or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the positive identification of the animal shelter employee or volunteer transferring the drug, the date the drug is transferred, and the date the drug is received by the animal's owner or caregiver.

(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(K) In addition to the inventory requirements set forth in rule 4729:5-3-07 of the Administrative Code, the responsible person for an animal shelter that maintains controlled substance dangerous drugs used to perform euthanasia listed in paragraph (C)(2) of rule 4729:5-15-01 of the Administrative Code shall be responsible for completing a monthly inventory, in accordance with rule 4729:5-3-07 of the Administrative Code, of those drugs to deter and detect diversion.

(L) An animal shelter licensed as a limited category II or limited category III terminal distributor of dangerous drugs may only possess dangerous drugs that are on the drug list submitted to the board pursuant to section 4729.54 of Revised Code and only at locations licensed by the state board of pharmacy. The responsible person may modify the drugs that may be possessed and administered by the limited facility by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(M) All records maintained in accordance with this rule and rule 4729:5-15-02 of the Administrative Code shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(N) All records maintained pursuant to this rule and rule 4729:5-15-02 of the Administrative Code may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated June 21, 2021 at 4:11 PM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.51, 4729.531, 4729.532, 4729.54, 4729.55
Five Year Review Date: 3/12/2025
Prior Effective Dates: 11/25/1994