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

 

 

NONRESIDENT TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS

(09/01/2004)

 

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

 

 

Sec. 4729.551  Licensing of terminal distributor; investigations and information exchange.  [Update effective 07/21/1994]

 

Each person, whether located within or outside this state, who sells dangerous drugs at retail for deliv­ery or dis­tri­bution to persons residing in this state, shall be licensed as a terminal distributor of dan­ger­ous drugs pur­su­ant to sections 4729.54 and 4729.55 of the Revised Code.

 

The board of pharmacy may enter into agreements with other states, federal agencies, and other enti­ties to ex­change information concerning the licensing and inspection of terminal distributors of dan­gerous drugs who are located within or outside this state and to investigate any alleged violations of the laws and rules governing the legal distribution of drugs by such persons.

 

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)   If the person is an emergency medical service organization, the information that is speci­fied in division (C)(1) of this section;

 

(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.

 

(C)   (1)   An emergency medical service organization that wishes to be licensed as a terminal distri­bu­tor of dan­gerous drugs shall list in its application for licensure the following additional in­for­ma­tion:

 

(a)   The units under its control that the organization determines will possess dangerous drugs for the purpose of administering emergency medical services in accordance with Chapter 4765. of the Revised Code;

 

(b)   With respect to each such unit, whether the dangerous drugs that the organization deter­mines the unit will possess are in category I, II, or III.

 

(2)   An emergency medical service organization that is licensed as a terminal distributor of dan­ger­ous drugs shall file a new application for such licensure if there is any change in the number, or location of, any of its units or any change in the category of the dangerous drugs that any unit will possess.

 

(3)   A unit listed in an application for licensure pursuant to division (C)(1) of this section may obtain the dan­gerous drugs it is authorized to possess from its emergency medical service organi­za­tion or, on a replace­ment basis, from a hospital pharmacy.  If units will obtain dan­gerous drugs from a hospital pharmacy, the organization shall file, and maintain in current form, the following items with the pharmacist who is re­spon­sible for the hospital's terminal distributor of danger­ous drugs license:

 

(a)   A copy of its standing orders or protocol;

 

(b)   A list of the personnel employed or used by the organization to provide emergency medi­cal services in accordance with Chapter 4765. of the Revised Code, who are authorized to pos­sess the drugs, which list also shall indicate the personnel who are authorized to administer the drugs.

 

(D)   Each emergency medical service organization that applies for a terminal distributor of danger­ous drugs license shall submit with its application the following:

 

(1)   A notarized copy of its standing orders or protocol, which orders or protocol shall be signed by a physician and specify the dangerous drugs that its units may carry, expressed in stan­dard dose units;

 

(2)   A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code.

 

An emergency medical service organization that is licensed as a terminal distributor shall notify the board immediately of any changes in its standing orders or protocol.

 

(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)   Except for an application made on behalf of an animal shelter, if an applicant for licensure as a limited cate­gory I, II, or III terminal distributor of dangerous drugs intends to administer danger­ous drugs to a person or ani­mal, the applicant shall submit, with the application, a notarized copy of its protocol or standing orders, which protocol or orders shall be signed by a licensed health professional authorized to prescribe drugs, specify the dangerous drugs to be admini­stered, and list personnel who are authorized to administer the dangerous drugs in accordance with federal law or the law of this state.  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 its proto­col or standing orders, or 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)   The license of an emergency medical service organization shall cover and describe all the units of the organization listed in its application for licensure.

 

(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.

 

(J)   (1)   No emergency medical service organization that is licensed as a terminal distributor of dan­ger­ous drugs shall fail to comply with division (C)(2) or (3) of this section.

 

(2)   No emergency medical service organization that is licensed as a terminal distributor of dan­ger­ous drugs shall fail to comply with division (D) of this section.

 

(3)   No licensed terminal distributor of dangerous drugs shall possess, have custody or con­trol of, or distri­bute dangerous drugs that the terminal distributor is not entitled to possess, have custody or control of, or distribute by virtue of its category of licensure.

 

(4)   No licensee that is required by division (F) of this section to notify the board of changes in its protocol or standing orders, or in personnel, shall fail to comply with that division.

 

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)   Adequate safeguards are assured that the applicant will carry on the business of a terminal distri­bu­tor of dangerous drugs in a manner that allows pharmacists and pharmacy interns em­ployed by the ter­mi­nal distributor to practice pharmacy in a safe and effective manner.

 

(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.

 

(F)   In the case of an applicant who is a food processor or retail seller of food, the applicant will main­tain supervision and control over the possession and custody of nitrous oxide.

 

(G)   In the case of an applicant who is a retail seller of oxygen in original packages labeled as re­quired by the "Federal Food, Drug, and Cosmetic Act," the applicant will maintain supervision and control over the pos­ses­sion, custody, and retail sale of the oxygen.

 

(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)   In the case of an applicant who is a retail seller of peritoneal dialysis solutions in original pack­ages labeled as required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the applicant will maintain supervision and control over the possession, custody, and retail sale of the peritoneal dialysis solutions.

 

Rule 4729-10-01  Definitions.  [Update effective 03/01/1999]

 

As used in Chapter 4729-10 of the Administrative Code:

 

(A)   “Nonresident pharmacy” means any pharmacy, as defined in section 4729.01 of the Revised Code, located outside of Ohio that ships, mails, or delivers, in any manner, drugs at retail into Ohio;

 

(B)   “Nonresident terminal distributor of dangerous drugs” means any person, as defined in sec­tion 4729.01 of the Revised Code, located outside of Ohio that ships, mails, or delivers in any manner, dangerous drugs at retail into Ohio;

 

(C)   “Pharmacist,” as used in division (B)(2) of section 4729.55 of the Revised Code, means an indi­vi­dual who holds a current license to practice pharmacy in the state where he is practicing.

 

(D)   “Dentist,” as used in division (B)(2) of section 4729.55 of the Revised Code, means an indivi­dual who holds a current license to practice dentistry in the state where he is practicing.

 

(E)   “Optometrist,” as used in division (B)(2) of section 4729.55 of the Revised Code, means an in­dividual who holds a current license to practice optometry in the state where he is prac­ticing.

 

(F)   “Physician,” as used in division (B)(2) of section 4729.55 of the Revised Code, means an indivi­dual who holds a current license to practice medicine in the state where he is prac­ticing.

 

(G)   “Veterinarian,” as used in division (B)(2) of section 4729.55 of the Revised Code, means an in­dividual who holds a current license to practice veterinary medicine in the state where he is prac­ticing.

 

(H)   “Dangerous drug” has the same meaning as given that term in section 4729.01 of the Revised Code.

 

Rule 4729-10-02  Licensure.  [Update effective 02/01/2002]

 

Each nonresident terminal distributor of dangerous drugs that sells dangerous drugs at retail in the state of Ohio shall obtain a terminal distributor of dangerous drugs license pursuant to sections 4729.54 and 4729.55 of the Revised Code and Chapter 4729-10 of the Administrative Code.

 

(A)   Conditions of licensure.  The nonresident terminal distributor of dangerous drugs shall pro­vide the fol­lowing information relative to the qualifications of a terminal distributor of dangerous drugs set forth in sec­tion 4729.55 of the Revised Code:

 

(1)   Full name, address, and telephone number of the person who desires to be licensed as a non­resident terminal distributor of dangerous drugs.

 

(a)   If incorporated, the application for licensure must include copies of the incorpora­tion papers; and names, dates of birth, addresses, and social security numbers of the officers of the corporation and all stockholders holding more than ten percent of the stock.

 

(b)   If a proprietorship, the application for licensure must include the name, address, date of birth, and social security number of the owner(s).

 

(c)   If a partnership, the application for licensure must include the names, addresses, dates of birth, and social security numbers of the partners.

 

(d)   If the entity applying for a license is a private investment group, the application for licen­sure must include the names, addresses, dates of birth, and social security num­bers of the investors.

 

(2)   Certification from the appropriate licensing authority that the  applicant maintains at all times a valid, unexpired license, permit, or registration to properly carry on the business of a distri­bu­tor of dangerous drugs in the state in which the facility is located and from where dangerous drugs are being sold at retail to residents in Ohio.  The certification(s) must include licenses, permits, or registra­tions required to cover the categories of dan­gerous drugs which the nonresident terminal distributor of dangerous drugs will be selling at retail to persons in the state of Ohio (i.e., controlled substance drug products as well as non­con­trolled substance drug products).

 

(3)   A copy of the most recent inspection report, any warning notices, notice of deficiency reports, or any other related reports issued by the regulatory licensing agency and drug law enforce­ment agen­cies of the state in which it is located or any federal agencies regu­lating and enforc­ing laws gov­ern­ing the legal distribution of drugs.

 

(4)   A narrative description of the type of business the nonresident terminal distributor of dan­ger­ous drugs will be carrying on within the category of licensure requested.  The de­scrip­tion shall include the type of professional services that will be provided in accor­dance with fed­eral and state laws governing the legal distribution of drugs and pro­fes­sional phar­macy practice.

 

(5)   If the nonresident terminal distributor is a pharmacy, the application shall be accom­pa­nied by:

 

(a)   The name and license number of the responsible pharmacist (pharmacist-in-charge).

 

(b)   Certification from the appropriate licensing authority that the responsible pharma­cist’s license is current and in good standing.

 

(c)   The telephone number where the responsible pharmacist may be reached during normal business hours.

 

(d)   A list of all pharmacists employed by the pharmacy who are dispensing dangerous drugs pursuant to prescriptions to residents of this state.  The list shall include each pharma­cist’s license number and the date that the license will expire.

 

(e)   A description of the following:

 

(i)   Normal delivery protocols and times;

 

(ii)   Any special packaging or procedures used in delivering temperature-sensitive drug products;

 

(iii)   The procedure to be followed if the patient’s prescription drug is not available at the nonresident pharmacy, or if delivery will be delayed beyond the normal deliv­ery time;

 

(iv)   The procedure to be followed upon receipt of a prescription for an acute illness that assures the patient the opportunity to obtain the medication immediately.

 

(v)   The procedure to be followed that will ensure that the patient’s medica­tion therapy is not interrupted when the nonresident pharmacy has been advised by the patient or patient’s caregiver that the patient’s prescrip­tion medica­tion has not been received within the normal delivery time.

 

(6)   Nonresident terminal distributors of dangerous drugs where the responsible person is a den­tist, optometrist, physician, or veterinarian shall submit the following information with their application:

 

(a)   The name and license number of the responsible dentist, optometrist, physician, or veterinarian.

 

(b)   Certification from the appropriate licensing authority that the responsible person’s license is current and in good standing.

 

(c)   The telephone number where the responsible dentist, optometrist, physician, or veteri­narian may be reached during normal business hours.

 

(d)   A list of all dentists, optometrists, physicians, or veterinarians employed by the non­resident terminal distributor who are selling dangerous drugs at retail to residents of this state.  The list shall include the license numbers and the date that the licenses to practice will expire.

 

Rule 4729-10-03  Compliance.  [Update effective 12/15/1994]

 

Each nonresident terminal distributor of dangerous drugs shall:

 

(A)   Maintain, in readily retrievable form, records of all dangerous drugs sold at retail to persons in Ohio.

 

(B)   Comply with all the statutory and regulatory requirements of the state of Ohio for con­trol­led sub­stances, including those that are different from federal law, unless such com­pli­ance would cause the non­resident terminal distributor of dangerous drugs to violate the statu­tory or regu­latory require­ments of the state in which it is located.

 

(C)   Supply upon request and in a timely manner all information needed by the board of pharmacy to carry out its responsibilities as a licensing, regulatory, and drug law enforcement agency of the state of Ohio.

 

(D)   Supply upon request and in a timely manner all information needed by the board of pharmacy and any local, state, or federal agency to carry out its responsibilities in enforcing the federal and state laws gov­ern­ing the distribution of drugs in the state of Ohio.

 

(E)   Supply upon request and in a timely manner all information needed by the board of pharmacy to carry out its responsibilities in licensing and regulating professional practice in the state of Ohio.

 

(F)   If the nonresident terminal distributor is a pharmacy, there must be an offer to counsel the patient issued with every prescription filled.  The offer shall be made by telephone or in writ­ing on a sep­arate docu­ment and shall accompany the prescription.  A written offer to counsel shall include the hours a phar­ma­cist is available and a telephone number where a pharmacist may be reached.  The telephone service must be available at no cost to the pharmacy’s primary patient population.  The pharmacy shall have suf­fi­cient tele­phone service to provide reasonable access to incoming callers.

 

Rule 4729-10-04  Inspection.  [Update effective 12/15/1994]

 

The facilities and records of nonresident terminal distributors of dangerous drugs shall be subject to inspec­tion by board of pharmacy agents and Ohio drug law enforcement agencies.  Satisfactory inspec­tion reports by the licens­ing entity using similar standards of the state where the pharmacy is located may be accepted in lieu of inspection by the board.

 

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