OHIO STATE BOARD OF PHARMACY;  77 S. HIGH STREET, ROOM 1702;  COLUMBUS, OHIO 43215-6126

Tel: 614/466-4143         Fax: 614/752-4836          Eml: licensing@bop.state.oh.us          Web: www.pharmacy.ohio.gov

 

 

LICENSING OF ANIMAL SHELTERS TO EUTHANIZE

(09/01/2004)

 

Sec. -- Ohio Revised Code Laws      Rule -- Ohio Administrative Code Rules

 

 

 

Sec. 4729.01  Definitions.  [Update effective 06/26/2003]

 

*   *   *

 

(V)   "Animal shelter" means a facility 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.

 

*   *   *

 

 

Sec. 4729.531  License for euthanasia of animals by use of drugs. 

[Effective 06/29/1994]

 

(A)   The state board of pharmacy may issue a limited license to animal shelters solely for the pur­pose of pur­chas­ing, possessing, and administering combination drugs that contain pentobar­bital and at least one non­con­trol­led substance ingredient, in a manufactured dosage form, whose only indication is for euthanizing animals, or other substances described in section 4729.532 of the Revised Code.  No such license shall authorize or permit the distribution of these drugs to any person other than the ori­ginating wholesale dis­tri­bu­tor of the drugs.  An application for licensure shall include the infor­ma­tion the board requires by rule under this section.  If the appli­cation meets the requirements of the rules adopted under this section, the board shall issue the license.

 

(B)   The board, in accordance with Chapter 119. of the Revised Code, shall adopt any rules necessary to admini­ster and enforce this section.  The rules shall do all of the following:

 

(1)   Require as a condition of licensure of the facility that an agent or employee of an animal shelter, other than a registered veterinary technician as defined in section 4741.01 of the Revised Code, has successfully completed a euthanasia technician certification course described in section 4729.532 of the Revised Code;

 

(2)   Specify the information the animal shelter must provide the board for issuance or renewal of a license;

 

(3)   Establish criteria for the board to use in determining whether to refuse to issue or renew, sus­pend, or revoke a license issued under this section;

 

(4)   Address any other matters the board considers necessary or appropriate for the admini­stra­tion and enforcement of this section.

 

 

Sec. 4729.532  Method and requirements for euthanasia of animals by use of drugs. 

[Effective 06/29/1994]

 

(A)   No agent or employee of an animal shelter shall perform euthanasia by means of lethal injection on an animal by use of any substance other than 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, or other substance that the state veterinary medical licensing board and the state board of pharmacy both approve by rule adopted in accordance with Chapter 119. of the Revised Code.

 

The agent or employee of an animal shelter when using a lethal solution to perform euthanasia on an animal shall use such solution in accordance with the following methods and in the following order of preference:

 

(1)   Intravenous injection by hypodermic needle;

 

(2)   Intraperitoneal injection by hypodermic needle;

 

(3)   Intracardial injection by hypodermic needle, but only on a sedated or unconscious animal;

 

(4)   Solution or powder added to food.

 

(B)   Except as provided in division (D) of this section, no agent or employee of an animal shelter, other than a reg­istered veterinary technician as defined in section 4741.01 of the Revised Code, shall per­form eutha­na­sia by means of lethal injection on an animal unless he has received cer­tification after suc­cess­fully completing a eutha­nasia technician certification course as described in this division.

 

The curriculum for a euthanasia technician certification course shall be one that has been approved by the state veterinary medical licensing board, shall be at least sixteen hours in length, and shall include information in at least all of the following areas:

 

(1)   The pharmacology, proper administration, and storage of euthanasia solutions;

 

(2)   Federal and state laws regulating the storage and accountability of euthanasia solutions;

 

(3)   Euthanasia technician stress management;

 

(4)   Proper disposal of euthanized animals.

 

(C)   (1)   Except as provided in division (D) of this section, no agent or employee of an animal shelter shall per­form euthanasia by means of lethal injection on animals under this section unless the facility in which he works or is employed is licensed with the state board of pharmacy under sec­tion 4729.531 of the Re­vised Code.

 

(2)   Any agent or employee of an animal shelter performing euthanasia by means of lethal injec­tion shall do so only in a humane and proficient manner that is in conformity with the methods described in division (A) of this section and not in violation of Chapter 959. of the Revised Code.

 

(D)   An agent or employee of an animal shelter who is performing euthanasia by means of lethal injec­tion on ani­mals on or before the effective date of this section may continue to perform such euthanasia and is not re­quired to be certified in compliance with division (B) of this section until ninety days after the effective date of the rules adopted in compliance with Section 3 of House Bill No. 88 of the 120th general assembly.

 

 

Sec. 4729.54  Categories of licenses of terminal distributors of dangerous drugs; applications; authority; fees; requirements upon licensure. 

[Update effective 06/30/1999]

 

(A)   As used in this section:

 

(1)   "Category I" means single-dose injections of intravenous fluids, including saline, Ringer's lac­tate, five per cent dextrose and distilled water, and other intravenous fluids or paren­teral solutions included in this category by rule of the board of pharmacy, that have a volume of one hundred mil­liliters or more and that contain no added substances, or single-dose injections of epinephrine to be administered pursuant to sec­tions 4765.38 and 4765.39 of the Revised Code.

 

(2)   "Category II" means any dangerous drug that is not included in category I or III.

 

(3)   "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.

 

(4)   "Emergency medical service organization" has the same meaning as in section 4765.01 of the Revised Code.

 

(5)   "Person" includes an emergency medical service organization.

 

(6)   "Schedule I, schedule II, schedule III, schedule IV, and schedule V" mean controlled sub­stance sched­ules I, II, III, IV, and V, respectively, as established pursuant to section 3719.41 of the Revised Code and as amended.

 

(B)   A person who desires to be licensed as a terminal distributor of dangerous drugs shall file with the execu­tive director of the board of pharmacy a verified application that contains the follow­ing:

 

(1)   Information that the board requires relative to the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code;

 

(2)   A statement that the person wishes to be licensed as a category I, category II, category III, limited category I, limited category II, or limited category III terminal distributor of danger­ous drugs;

 

(3)   If the person wishes to be licensed as a limited category I, limited category II, or limited category III terminal distributor of dangerous drugs, a notarized list of the dangerous drugs that the person wishes to possess, have custody or control of, and distribute, which list shall also specify the purpose for which those drugs will be used and their source;

 

(4)   *  *  *

 

(5)   Except for an emergency medical service organization, the identity of the one establish­ment or place at which the person intends to engage in the sale or other distribution of dan­gerous drugs at retail, and maintain possession, custody, or control of dangerous drugs for purposes other than the person's own use or consumption.

 

*   *   *

 

(E)   There shall be six categories of terminal distributor of dangerous drugs licenses, which categor­ies shall be as follows:

 

(1)   Category I license.  A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I.

 

(2)   Limited category I license.  A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I that were listed in the application for licensure.

 

(3)   Category II license.  A person who obtains this license may possess, have custody or con­trol of, and distribute only the dangerous drugs described in category I and category II.

 

(4)   Limited category II license.  A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I or category II that were listed in the application for licensure.

 

(5)   Category III license.  A person who obtains this license may possess, have custody or control of, and distribute the dangerous drugs described in category I, category II, and category III.

 

(6)   Limited category III license.  A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I, category II, or category III that were listed in the application for licensure.

 

(F)   . . .  An application made on behalf of an animal shelter shall include a notarized list of the dan­gerous drugs to be administered to animals and the personnel who are authorized to administer the drugs to animals in accordance with section 4729.532 of the Revised Code.  After obtaining a terminal distributor license, a licensee shall notify the board immediately of any changes . . . in such personnel.

 

(G)   (1)   Except as provided in division (G)(2) of this section, each applicant for licensure as a terminal distributor of dangerous drugs shall submit, with the application, a license fee determined as fol­lows:

 

(a)   For a category I or limited category I license, forty-five dollars;

 

(b)   For a category II or limited category II license, one hundred twelve dollars and fifty cents;

 

(c)   For a category III or limited category III license, one hundred fifty dollars.

 

(2)   For a professional association, corporation, partnership, or limited liability company organ­ized for the purpose of practicing veterinary medicine, the fee shall be forty dollars.

 

Fees assessed under divisions (G)(1) and (2) of this section shall not be returned if the applicant fails to qualify for registration.

 

(H)   (1)   The board shall issue a terminal distributor of dangerous drugs license to each person who submits an application for such licensure in accordance with this section, pays the required license fee, is determined by the board to meet the requirements set forth in section 4729.55 of the Re­vised Code, and satisfies any other applicable requirements of this section.

 

(2)   The license of a person other than an emergency medical service organization shall describe the one establishment or place at which the licensee may engage in the sale or other distribution of dangerous drugs at retail and maintain possession, custody, or control of dangerous drugs for purposes other than the licensee's own use or consumption.  The one establishment or place shall be that which is described in the application for licensure.

 

No such license shall authorize or permit the terminal distributor of dangerous drugs named in it to en­gage in the sale or other distribution of dangerous drugs at retail or to maintain possession, custody, or control of dangerous drugs for any purpose other than the distributor's own use or consumption, at any estab­lish­ment or place other than that described in the license, except that an agent or employee of an animal shel­ter may pos­sess and use dangerous drugs in the course of business as provided in division (D) of section 4729.532 of the Revised Code.

 

(3)   *  *  *

 

(4)   The license of every terminal distributor of dangerous drugs shall indicate, on its face, the category of licensure.  If the license is a limited category I, II, or III license, it shall specify, and shall authorize the licensee to possess, have custody or control of, and distribute only, the dan­gerous drugs that were listed in the application for licensure.

 

(I)   All licenses issued pursuant to this section shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the board for a like period, annually, according to the provisions of this section, and the standard renewal procedure of Chapter 4745. of the Revised Code.  A person who desires to renew a license shall submit an application for renewal and pay the required fee on or before the thirty-first day of December each year.  The fee required for the re­newal of a license shall be the same as the fee paid for the license being renewed, and shall accompany the application for renewal.

 

A license that has not been renewed during December in any year and by the first day of Febru­ary of the fol­low­ing year may be reinstated only upon payment of the required renewal fee and a penalty fee of fifty-five dollars.

 

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Sec. 4729.55  Minimum qualifications for licensure as a terminal distributor of dangerous drugs.  [Update effective 02/12/2001]

 

No license shall be issued to an applicant for licensure as a terminal distributor of dangerous drugs unless the applicant has furnished satisfactory proof to the STATE board of pharmacy that:

 

(A)   The applicant is equipped as to land, buildings, and equipment to properly carry on the busi­ness of a terminal distributor of dangerous drugs within the category of licensure approved by the board.

 

(B)   A pharmacist, licensed health professional authorized to prescribe drugs, animal shelter licensed with the state board of pharmacy under section 4729.531 of the Revised Code, or a lab­ora­tory as defined in section 3719.01 of the Revised Code will maintain supervision and control over the possession and cus­tody of dangerous drugs that may be acquired by or on behalf of the appli­cant.

 

(C)   Adequate safeguards are assured to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs.

 

(D)   *  *  *

 

(E)   If the applicant, or any agent or employee of the applicant, has been found guilty of violating section 4729.51 of the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the federal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729. of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the re­currence of the violation.

 

*   *   *

 

(H)   If the application is made on behalf of an animal shelter, at least one of the agents or employ­ees of the animal shelter is certified in compliance with section 4729.532 of the Revised Code.

 

(I)   *  *  *

 

 

Rule 4729-9-11  Security and control of dangerous drugs.  [Update effective 01/01/2001]

 

A pharmacist, prescriber, or responsible person pursuant to paragraph (C) of rule 4729-13-01 or para­graph (C) of rule 4729-14-01 of the Administrative Code, who has signed as being responsible for a terminal distributor of dangerous drugs license, shall provide "supervision and control" of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, and "adequate safeguards" to assure that dangerous drugs are being dis­tributed in accordance with all state and federal laws as re­quired in section 4729.55 of the Revised Code, by the following procedures:

 

(A)   *  *  *

 

(B)   In other terminal distributors of dangerous drugs, including but not limited to, emergency medical ser­vices pursuant to division (C) of section 4729.54 of the Revised Code, first-aid depart­ments pursuant to rule 4729-9-04 of the Administrative Code, approved laboratories pursuant to paragraph (A) of rule 4729-13-01 of the Administrative Code, and animal shelters pursuant to paragraph (A) of rule 4729-14-01 of the Admini­stra­tive Code, dangerous drugs must be stored in an area secured by either a physical barrier with suit­able locks and/or an electronic barrier to deter and detect unauthorized access.

 

(C)   A pharmacist, prescriber, or responsible person for a terminal distributor of dangerous drugs license pursuant to paragraph (C) of rule 4729-13-01 or paragraph (C) of rule 4729-14-01 of the Administrative Code who has signed as being responsible for a ter­minal distributor of dangerous drugs license is responsible to monitor for suspicious orders, unusual usage, or questionable dis­position of dangerous drugs.

 

 

Rule 4729-9-22  Records of dangerous drugs.  [Update effective 01/01/2004]

 

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dangerous drugs received, administered, dispensed, distributed, sold, destroyed, or used.

 

(A)   Records of receipt shall contain a description of all dangerous drugs received, the kind and quan­tity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

 

(B)   Records of administering, dispensing, or using dangerous drugs shall contain a de­scrip­tion of the kind and quantity of the dangerous drugs administered, dispensed, sold, or used, the date, the name and address of the person to whom or for whose use, or the owner and iden­ti­fi­ca­tion of the animal for which, the dan­gerous drug was administered, dispensed, or used.

 

(C)   Records of dangerous drugs, other than controlled substances, administered, dis­pensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the re­quire­ments of para­graph (B) of this rule.

 

(D)   All records of receipt, distribution, administering, dispensing, selling, destroying, or using dan­gerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located.  Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy by certi­fied mail, re­turn receipt requested; if not contested by the board within sixty days, it will stand as approved.  A copy of the re­quest with the return receipt shall be main­tained with the other records of dangerous drugs.  Any such alternate location shall be secured and accessible only to represen­tatives of the terminal distributor.

 

 

Rule 4729-14-01  Definitions.  [Update effective 11/25/1994]

 

(A)   "Animal shelter" means a facility 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.

 

(B)   "Registration numbers" means the numbers assigned to each person registered under the fed­eral drug abuse control laws and/or Chapter 4729. of the Revised Code.

 

(C)   "Responsible person" means the individual whom the licensee has designated as the person who will main­tain supervision and control over the possession and custody of the dangerous drugs that may be acquired and utilized by the licensee.

 

(D)   "D.E.A." means the federal drug enforcement administration or its successor agency.

 

(E)   “Registered veterinary technician” has the same meaning as given that term in section 4741.01 of the Revised 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.

 

 

Rule 4729-14-02  Procedure for licensure as an animal shelter. 

[Update effective 01/01/2004]

 

(A)   A person, as defined in division (s) of section 4729.01 of the Revised Code, desiring to be licensed by the state board of pharmacy as an animal shelter shall file with the state board of pharmacy a com­pleted application containing information relative to the qualifications for approval as set forth in rule 4729-14-03 of the Admini­strative Code.

 

(B)   The state board of pharmacy shall issue a limited terminal distributor of dangerous drugs license, pursuant to sections 4729.531 and 4729.532 of the Revised Code, at the establishment or place de­scribed in the application to each person who has submitted an application and has paid the required license fee if the board determines that such applicant meets the requirements set forth in Chapter 4729-14 of the Administrative Code.

 

(C)   All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year.  A license shall be renewed by the state board of pharmacy for a like period, annually, according to the provisions of this rule, and the standard renewal proce­dure of sec­tions 4745.01 to 4745.03 of the Revised Code.

 

(D)   The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

 

(E)   A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the thirty-first day of December each year.

 

(F)   The state board of pharmacy, within thirty days after receipt of a complete application filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed.  If the board deter­mines that such license will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license will not be issued or renewed.

 

 

Rule 4729-14-03  Qualifications for licensure as an animal shelter. 

[Update effective 11/25/1994]

 

(A)   No license shall be issued to an applicant for licensure as a limited terminal distributor of danger­ous drugs unless the applicant has furnished satisfactory proof to the board of pharmacy that:

 

(1)   The applicant is equipped as to land, buildings, and equipment to properly carry on the busi­ness of a terminal distributor of dangerous drugs within the category of license requested.

 

(2)   A responsible person shall maintain supervision and control over the possession and custody of such dangerous drugs that may be acquired by or on behalf of the applicant.

 

(3)   Adequate safeguards are assured to prevent the illegal acquisition, distribution, or utilization of dan­ger­ous drugs or their diversion into illicit channels.

 

(4)   If the applicant, or any agent or employee of the applicant, has been found guilty of violating section 4729.51 of the Revised Code, the "Federal Food, Drug and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the Federal narcotic law, sections 3715.01 to 3715.72 of the Revised Code, Chapter 2925., 3719., or 4729. of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the recur­rence of such violation.

 

(B)   The applicant shall submit a current copy of the renewal certificate for each regis­tered veterinary technician.

 

(C)   The applicant shall submit a copy of each euthanasia technician’s certificate.  This certificate shall document that that individual successfully completed a certification course as described in section 4729.532 of the Revised Code.

 

(D)   The notarized drug list required by section 4729.54 shall include the statement: “The drug(s) listed on this document will be purchased and stored at this location for the sole purpose of the performance of euthanasia on animals by registered veterinary technicians or euthanasia technicians pursuant to section 4729.531 and 4729.532 of the Revised Code."  This statement shall be signed by the respon­sible person and at least one registered veterinary technician or euthanasia technician.

 

 

Rule 4729-14-04  Records of dangerous drugs.  [Update effective 11/25/1994]

 

(A)   Each limited terminal distributor of dangerous drugs shall keep records in accordance with rules 4729-9-14 and 4729-9-22 of the Administrative Code.

 

(B)   Destruction of controlled substances shall be conducted in accordance with rule 4729-9-06 of the Admini­stra­tive Code.

 

 

Rule 4729-14-05  Security controls for animal shelters.  [Update effective 01/01/2004]

 

(A)   Areas designated for the storage of dangerous drugs shall meet the security requirements in para­graph (B) of rule 4729-9-11 of the Administrative Code.

 

(B)   Controlled substances shall be stored in a securely locked and substantially constructed cabinet.

 

(C)   The responsible person shall notify the board of pharmacy and local law enforcement authori­ties of the theft or significant loss of any dangerous drug immediately upon discovery of such theft or loss.  If the drug is a controlled substance, the responsible person shall also notify the regional office of the federal D.E.A. in his region pursuant to rule 4729-9-15 of the Administra­tive Code.

 

 

Rule 4729-14-06  Responsible person for an approved animal shelter. 

[Update effective 01/01/2004]

 

(A)   An individual shall be the responsible person for no more than one such location except with writ­ten per­mis­sion from the board.  A written request shall be submitted outlining the circum­stances re­quiring an indi­vi­dual to be responsible for more than one location and the period of time during which the circumstances will exist.  An indi­vi­dual shall not be designated the re­sponsible person for a loca­tion unless that person shall be physically present in the facility a sufficient amount of time to provide supervision and control.

 

(B)   The responsible person whose name appears on the limited terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the busi­ness.

 

(C)   The responsible person is responsible for maintaining adequate supervision and control over the dangerous drugs acquired, utilized, or administered by the approved animal shelter and is responsible for maintaining all re­quired records.

 

(D)   If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

 

(1)   This notice to the board of pharmacy shall be made by completing, signing, and returning the form sup­plied by the board by certified mail, return receipt requested.

 

(2)   Included with this notice to the board shall be a notarized drug list prepared pursuant to para­graph (D) of rule 4729-14-03 of the Administrative Code.

 

(3)   A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regu­la­tions, with the new responsible person.  The new responsible person shall be responsible for com­plet­ing and maintaining this inventory record at the site of the terminal distributor of danger­ous drugs.

 

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ALL APPLICATIONS FOR LICENSURE TO PRACTICE PHARMACY IN OHIO MUST BE MADE UNDER OATH BEFORE A QUALIFIED OFFICER.  It is a Misdemeanor of the First Degree for any person to make a false statement under oath for the purpose of securing licensure for him/herself or for another person.  Certificates of Licensure obtained by fraud or upon false repre­sentation may be revoked by the Board.