Chapter 4729-9 Dangerous Drugs

4729-9-01 Definitions.

(A) "Dangerous drug," as defined in section 4729.01 of the Revised Code, means any drug or drug product whose commercial package bears a label containing the symbol "Rx only", the legend "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian", or any similar restrictive statement.

(B) A dangerous drug is adulterated if beyond the expiration date as stated by the manufacturer, packer, or distributor in its labeling or if it is not stored or dispensed according to the requirement of the federal act as indicated in the product labeling. This does not apply to expired drugs that are donated pursuant to sections 3715.88 to 3715.92 of the Revised Code.

(C) "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is provided on an outpatient basis.

(D) As used in Chapters 3719. and 4729. of the Revised Code, "registered" and "licensed" mean that an individual or facility has met the initial qualifications for registration and licensure with the state board of pharmacy and, if they are still actively practicing pharmacy or distributing drugs, have complied with annual renewal procedures, including payment of applicable fees.

(E) "Revoke", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license rendering such license void and such license may not be reissued. "Revoke" is an action that is permanent against the license and licensee.

(F) "Suspend", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license rendering such license without force and effect for a period of time as determined by the state board of pharmacy. The board may require that an individual whose license has been suspended may not be employed by or work in a facility licensed by the state board of pharmacy to possess or distribute dangerous drugs during such period of suspension.

(G) "Place on probation", as used in Chapter 4729. of the Revised Code, means to take action against a license suspending some or all of the sanctions imposed by the board against that license. The terms of the probation shall state the period of time covered by the probation and may include other conditions as determined by the state board of pharmacy.

(H) "Refuse to grant or renew", as used in Chapter 4729. of the Revised Code, means to deny original or continued licensure for a period of at least twelve months. After twelve months or such period of time as the individual board order may require, a pharmacist, a pharmacy intern, a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, a wholesaler of controlled substances, a manufacturer of controlled substances, or an individual or facility who desires to attain such status by licensure, and whose license the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license. A pharmacist, or an individual who desires to attain such status by licensure, whose license the state board of pharmacy has refused to grant or renew must meet any requirements established by the board or must pass any examination required by the board.

(I) "Campus", as used to describe a type of terminal distributor of dangerous drugs license issued pursuant to division (E) of section 4729.51 of the Revised Code, means an establishment or place consisting of multiple buildings where dangerous drugs are stored that are located on a contiguous plot of land. All such buildings and stocks of dangerous drugs shall be under common ownership and control.

(J) "Certified diabetes educator", as used in Chapters 3719. and 4729. of the Revised Code, means a person who has been certified to conduct diabetes education by the "National Certification Board for Diabetes Educators (NCBDE)".

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3715.91 , 3719.28 , 4729.26
Rule Amplifies: 3715.88 , 3715.89 , 3715.90 , 3715.92 , 3719.01 , 3719.03 , 4729.01 , 4729.16 , 4729.56 , 4729.57
Prior Effective Dates: 1/1/63, 2/15/82, 3/21/88, 7/1/91, 7/1/92, 1/17/97, 2/1/98, 3/1/99, 1/1/01, 1/1/09

4729-9-02 Minimum standards for a pharmacy.

(A) Library

(1) All pharmacists working in a pharmacy must be able to access all current federal and state laws, regulations, and rules governing the legal distribution of drugs in Ohio;

(2) The pharmacy shall carry and utilize the references necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws; and

(3) Telephone number of a poison control center.

(B) Equipment

The pharmacy shall carry and utilize the equipment necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws.

(C) Stock of drugs

The stock of drugs shall include such chemicals, drugs, and preparations sufficient to compound and prepare all types of prescriptions offered by the pharmacy.

(D) Prescription containers

The stock of prescription containers shall include such containers as are necessary to dispense drugs in accordance with federal and state laws, including the provisions of the federal Poison Prevention Act of 1970 and compendial standards, or as recommended by the manufacturer or distributor for non-compendial drug products.

(E) Space and fixtures

(1) The stock, library, and equipment shall be housed in a suitable, well-lighted and well-ventilated room or department with clean and sanitary surroundings primarily used for the compounding and preparing of prescriptions and for the manufacture of pharmaceutical preparations.

(2) All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise indicated by the board.

(3) All storage areas shall provide adequate physical security for all dangerous drugs in accordance with rules 4729-9-05 and 4729-9-11 of the Administrative Code.

(F) Pharmacy hours

Notice to the public of operating hours of the pharmacy department must be posted.

(G) Personnel

The pharmacy shall be appropriately staffed to operate in a safe and effective manner pursuant to section 4729.55 of the Revised Code. An employee of a pharmacy that may have contact with patients or the general public must be identified by a nametag that includes the employee's job title.

(H) Additional minimum standards are required for specialized pharmacy practices pursuant to Chapters 4729-15, 4729-17, and 4729-19 of the Administrative Code.

Effective: 01/01/2009
R.C. 119.032 review dates: 12/01/2012
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55
Prior Effective Dates: 9/10/1976, 9/1/1985, 3/21/1988, 7/1/1990, 7/1/1992, 7/1/1994, 3/1/1999, 1/1/2006

4729-9-03 Minimum standards for a first-aid department.

(A) A first-aid department is any entity which stocks, administers, and/or uses dangerous drugs in conjunction with the treatment of medical emergencies, except that this does not include the offices of a prescriber as defined in section 4729.01 of the Revised Code or an entity licensed in any other manner as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

(B) Each first-aid department which stocks, administers, and/or provides dangerous drugs must obtain a limited category I, II, or III terminal distributor of dangerous drugs license pursuant to section 4729.54 of the Revised Code. The license and the addendum shall be maintained in a readily available place in the principal location of such business for inspection by a state board of pharmacy designated agent. The application and license shall be signed by a person licensed pursuant to Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery. This person shall maintain supervision and control over the possession and custody of the dangerous drugs and is responsible for their legal use and distribution in accordance with state and federal laws and rules.

(C) When one first-aid department purchases dangerous drugs for first-aid departments in other locations and redistributes them, this supplying first-aid department must also be registered as a wholesale distributor of dangerous drugs.

All purchase, sale, and distribution records for dangerous drugs and inventory for controlled substances shall be kept for at least three years and shall be available for inspection during regular business hours by a state board of pharmacy designated agent. The first-aid department must be able to account for the acquisition, administration, and distribution of all dangerous drugs.

(D) All purchase orders or requisitions for dangerous drugs must be signed by the responsible person who signed the dangerous drug license pursuant to paragraph (B) of this rule and who is in charge of the first-aid department.

(E) Dangerous drugs which are not controlled substances shall be administered only by certified/licensed health care personnel who are functioning within the scope of their practice in accordance with written standing orders or protocol filed with the state board of pharmacy pursuant to section 4729.54 of the Revised Code. Controlled substances may be administered only after personally contacting a prescriber and obtaining an oral order. No dangerous drugs are to be administered except pursuant to the written standing orders or protocol or where a written or oral order is issued by such prescriber for the particular patient. Oral orders shall be immediately recorded in writing,

Including the name and strength of drug, dosage form, quantity used, name of patient, name of prescriber, name of person receiving order, name of person administering drug, time of administration, and the date. This record shall be kept on file at the first-aid department and be co-signed by the prescriber within thirty days.

(F) All dangerous drugs are to be kept in a safe and secure place, such as an enclosure or cabinet, which is to be kept locked.

(G) The responsible prescriber shall visit the first-aid department at least once each month and shall review the records, accountability procedures, controls, and security.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/90, 3/1/99

4729-9-04 Returned drugs.

(A) No drug that has been dispensed pursuant to a prescription and has left the physical premises of the terminal distributor of dangerous drugs shall be dispensed again except:

(1) Drugs dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the Administrative Code provided that:

(a) The drugs are packaged in unopened, single-dose or tamper-evident containers and

(b) The drugs have not been in the possession of the ultimate user.

(2) Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility licensed with the state board of pharmacy provided that:

(a) The drugs are packaged in unopened, single-dose or tamper-evident containers and

(b) The drugs have not been in the possession of the ultimate user.

(B) Drugs that have not been dispensed or possessed in accordance with this rule are considered to be adulterated.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.63 , 3719.05
Prior Effective Dates: 9/10/76, 7/1/90, 7/1/91, 7/1/92, 1/17/97, 3/1/99, 2/1/02

4729-9-05 Security requirements.

(A) All registrants shall provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs. In order to determine whether a registrant has provided effective and approved controls against diversion, the state board of pharmacy shall use the security requirements set forth in rule 4729-9-11 of the Administrative Code as standards for the security controls and operating procedures necessary to deter and detect diversion.

(B) Substantial compliance with the standards set forth in rule 4729-9-11 of the Administrative Code may be deemed sufficient by the state board of pharmacy after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the state board of pharmacy may consider any of the following factors, as they deem relevant, for strict compliance with security requirements:

(1) The type of activity conducted;

(2) Type and form of dangerous drugs handled;

(3) Quantity of dangerous drugs handled;

(4) Location of the premises and the relationship such location bears on security needs;

(5) Type of building construction comprising the facility and the general characteristics of the building or buildings;

(6) Type of vaults, safes, and secure enclosures or other storage system (e.g.-automatic storage and retrieval system) used;

(7) Type of closures on vaults, safes, and secure enclosures;

(8) Adequacy of key control systems and/or combination lock control systems;

(9) Adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources;

(10) Extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

(11) Adequacy of supervision over employees having access to areas containing dangerous drugs;

(12) Procedures for handling business guests, visitors, maintenance personnel, and non-employee service personnel;

(13) Availability of local police protection or of the registrant's or applicant's security personnel, and;

(14) Adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of dangerous drugs in its operation.

(C) When physical security controls become inadequate as a result of a significant increase in the quantity of dangerous drugs in the possession of the registrant during normal business operation, the physical security controls shall be expanded and extended accordingly.

(D) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in rule 4729-9-11 of the Administrative Code may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the state board of pharmacy.

(E) The state board of pharmacy shall be notified of any new facilities, work or storage areas to be constructed or utilized for dangerous drugs or of any changes in operation of the registrant before being used or implemented.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.26
Prior Effective Dates: 9/10/76, 2/1/98, 3/1/99

4729-9-06 Disposal of dangerous drugs which are controlled substances.

(A) Any person legally authorized under Chapters 3719. and 4729. of the Revised Code to possess dangerous drugs which are controlled substances may dispose of such drugs by the following procedure:

(1) If the person is a registrant or prescriber required to keep records pursuant to Chapters 3719. and 4729. of the Revised Code, the responsible pharmacist or prescriber shall send the state board of pharmacy a list of the dangerous drugs which are controlled substances containing the name, strength, dosage form, and quantity to be disposed of.

(2) If the person is not a registrant or prescriber, he shall submit to the state board of pharmacy a letter stating:

(a) The full name and address of the person possessing the dangerous drugs which are controlled substances to be disposed of;

(b) The name, strength, dosage form, and quantity of each controlled substance;

(c) How the applicant obtained the controlled substances; and

(d) The full name, address, and registration number of the person who possessed the controlled substances prior to the applicant, if known.

(B) The executive director, or his/her designee, shall authorize and instruct the applicant to dispose of the dangerous drugs which are controlled substances in one of the following manners:

(1) By transfer to persons registered under Chapters 3719. and 4729. of the Revised Code, and authorized to possess the controlled substances;

(2) By destruction in the presence of a state board of pharmacy officer, agent, or inspector or other authorized person; or

(3) By such other means as the state board of pharmacy may determine to assure that the controlled substances do not become available to unauthorized persons.

(C) In the event that a registrant is required regularly to dispose of dangerous drugs which are controlled substances, the executive director may authorize the registrant to dispose of such controlled substances, in accordance with paragraph (B)(1) of this rule, without prior approval of the state board of pharmacy in each instance on the condition that the registrant keep records of such disposals and file periodic reports with the state board of pharmacy summarizing the disposals made by the registrant. In granting such authority, the executive director may place conditions on the disposal of dangerous drugs which are controlled substances including, but not limited to, the method of disposal and the frequency and detail of reports.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.06 , 3719.07
Prior Effective Dates: 9/10/76, 7/1/93, 2/1/98, 3/1/99, 4/27/07

4729-9-07 Procedure for discontinuing business as a wholesale or a terminal distributor of dangerous drugs.

(A) A wholesale or terminal distributor of dangerous drugs who plans to discontinue business activities shall file a written notice with the board of pharmacy. The written notice shall be submitted to the board of pharmacy in person, by verified facsimile, or by registered or certified mail, return receipt requested, at least fourteen days in advance of the proposed date of discontinuing business, unless the board waives this time limitation in individual instances. This notice shall include the following information:

(1) The name, address, and wholesale or terminal distributor of dangerous drugs number of the registrant discontinuing business.

(2) The name, address, and wholesale or terminal distributor of dangerous drugs number to whom the dangerous drugs will be transferred.

(3) The name and address of the secured location where the records of purchase and dispensing will be kept in accordance with section 4729.37 of the Revised Code. The storage of dispensing records must comply with the confidentiality requirements of rule 4729-5-29 of the Administrative Code.

(4) The proposed date of discontinuing business.

(B) Unless the registrant is informed by the executive director before the proposed date of discontinuing business that the transfer of dangerous drugs and records may not occur, the registrant discontinuing business may transfer the dangerous drugs and records in accordance with the following:

(1) On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed of according to rule 4729-9-06 of the Administrative Code, shall be made. The inventory shall list the name, strength, dosage form, and quantity of all controlled substances transferred or disposed of.

(2) This inventory shall serve as the final inventory of the registrant discontinuing business and the initial inventory of the registrant to whom the controlled substances are being transferred. A copy of the inventory shall be included in the records of each registrant involved in the transfer.

(C) Upon discontinuing business, the registrant shall return to the board of pharmacy, in person or by registered or certified mail, return receipt requested, the wholesale distributor of dangerous drugs license or the terminal distributor of dangerous drugs license for cancellation.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 4729.62
Prior Effective Dates: 9/10/76, 7/1/92, 1/1/01

4729-9-08 Change in description of terminal or wholesale dangerous drug facility.

For the purpose of division (E) of section 4729.51 and division (D) of section 4729.52 of the Revised Code, any change in the ownership, business or trade name, category, or address of a terminal or wholesale distributor of dangerous drugs requires a new application, required fee, and license.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51 , 4729.52 , 4729.54
Prior Effective Dates: 9/10/1976, 2/1/1998, 2/1/2003

4729-9-09 Security of prescription blanks and D.E.A. controlled substance order forms.

For the purpose of aiding compliance with section 2925.23 of the Revised Code, a prescriber, responsible pharmacist, or responsible person shall provide security and control for their prescription blanks and D.E.A. controlled substance order forms by limiting their availability only to authorized persons.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.09 , 4729.51
Prior Effective Dates: 9/10/76, 3/21/88, 7/1/93, 2/1/98, 3/1/99

4729-9-10 Occasional sale.

The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a drug by a pharmacist who is a terminal distributor of dangerous drugs or is employed by a terminal distributor of dangerous drugs and the buyer shall be a wholesale distributor of dangerous drugs, a terminal distributor of dangerous drugs, or a prescriber as defined in section 4729.01 of the Revised Code.

The total value of all dangerous drugs distributed by the terminal distributor of dangerous drugs pursuant to this rule shall not exceed five per cent of the total value of dangerous drugs purchased by the terminal distributor of dangerous drugs during the same calendar year. In addition, the total amount of controlled substances sold pursuant to this rule shall not exceed the allowable amount as specified in 21 C.F.R. 1307.11 .

The value of the dangerous drugs shall be based on the cost of the dangerous drugs to the terminal distributor of dangerous drugs.

Effective: 10/27/2011
R.C. 119.032 review dates: 08/10/2011 and 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51
Prior Effective Dates: 4/1/65, 3/19/87, 7/1/93, 3/1/99

4729-9-11 Security and control of dangerous drugs.

A pharmacist, prescriber, or responsible person pursuant to paragraph ( F) of rule 4729-13-01 or paragraph( H) 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) In a pharmacy.

(1) Personal supervision by a pharmacist of the dangerous drugs at all times to deter and detect theft or diversion; except,

(2) Whenever personal supervision of the dangerous drugs is not provided by a pharmacist, physical or electronic security of the dangerous drugs must be provided according to the following requirements:

(a) The prescription department or stock of dangerous drugs must be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry at a time the pharmacist is not present. Such a barrier, before being put into use, must be approved by the state board of pharmacy.

(b) The prescription department must contain all dangerous drugs, exempt narcotics, hypodermics, poisons, and every other item or product that requires the personal supervision or sale by a pharmacist.

(c) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the prescription department.

(d) Except as provided in rule 4729-17-03 of the Administrative Code, only a pharmacist may have access to the prescription department or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, exempt narcotics, hypodermics, poisons, and any other item or product that requires the personal supervision or sale by a pharmacist.

(e) No prescription, dangerous drug, exempt narcotic, hypodermic, nor any other item or product that requires the personal supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the prescription department is closed.

(f) New or refill prescription orders may be deposited into a secured area within the building where the pharmacy is located when a pharmacist is not present. Only a pharmacist may have access to this secured area.

(g) If a pharmacy utilizes a board approved delivery system that securely stores and releases a dispensed prescription drug to a patient the pharmacy must be open for business and a pharmacist must be physically present and available for consultation.

(3) Areas designated for the dispensing, compounding, and storage of dangerous drugs shall meet the security requirements in rule 4729-9-05 of the Administrative Code. No person may be within the physical confines of the area designated for the dispensing, compounding, and storage of dangerous drugs unless under the personal supervision of a pharmacist.

(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 4729-9-03 of the Administrative Code, approved laboratories pursuant to paragraph ( D) 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 ( F) of rule 4729-13-01 or paragraph( H) 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.

(D) All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will insure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise directed by the board.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.05 , 3719.09 , 4729.27 , 4729.28 , 4729.51 , 4729.531 , 4729.55 , 4729.57
Prior Effective Dates: 10/1/71, 4/1/78, 4/1/89, 7/1/94, 8/16/94 (Emer.), 11/25/94, 3/1/99, 1/1/01, 1/1/06, 10/19/07

4729-9-12 Verification of license as a distributor of dangerous drugs or exempt status of a prescriber.

(A) Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a terminal distributor of dangerous drugs, the wholesale distributor must obtain a copy of the current certificate of license as a terminal distributor from the purchaser pursuant to division (A) of section 4729.60 of the Revised Code.

(1) The purchaser shall furnish a copy of the certificate of license as a terminal distributor to the wholesale distributor of dangerous drugs. If the certificate of license indicates a limited category I, II, or III license, the terminal distributor shall furnish the wholesale distributor a copy of the current license addendum listing those drugs the purchaser is authorized to possess.

(2) If no certificate of license as a terminal distributor is obtained or furnished before the sale, both the seller and the purchaser shall be considered to be in violation of section 4729.60 of the Revised Code.

(B) Before a terminal distributor of dangerous drugs may make a purchase of dangerous drugs at wholesale, the purchaser must obtain from the seller the wholesale distributor registration number pursuant to division (B) of section 4729.60 of the Revised Code.

(1) The seller shall furnish the wholesale distributor registration number and registration expiration date to the terminal distributor of dangerous drugs.

(2) If no registration number of the wholesale distributor is obtained or furnished before the purchase, both the purchaser and the seller shall be considered to be in violation of section 4729.60 of the Revised Code.

(C) Before a wholesale distributor of dangerous drugs may make a sale of a dangerous drug to a prescriber as defined in division (I) of section 4729.01 of the Revised Code, the wholesale distributor must obtain:

(1) A copy of the current certificate of license as a terminal distributor from the prescriber pursuant to division (A) of section 4729.60 of the Revised Code and, if the license is limited, a copy of the addendum listing the drugs the licensee is authorized to purchase and possess; or

(2) Copies of all documents required to establish that the prescriber is exempt from licensure as a terminal distributor of dangerous drugs pursuant to divisions (B)(1)(a), (B)(1)(j), and (B)(1)(k) of section 4729.51 of the Revised Code and is authorized by federal and state laws to purchase the dangerous drugs for use in the course of his/her professional practice. The required documents are as follows:

(a) An individual prescriber doing business as a sole proprietor (not incorporated in any manner) as set forth in division (B)(1)(a) of 4729.51 of the Revised Code, an individual prescriber doing business as a sole shareholder of a corporation or a limited liability company pursuant to division (B)(1)(j) of section 4729.51 of the Revised Code, and a dentist pursuant to division (B)(1)(k) of 4729.51 of the Revised Code must provide a copy of his/her current license to practice and the license must authorize the use of the drugs requested from the wholesaler in his/her practice. Also, a prescriber doing business as a sole shareholder of a corporation or a limited liability company must also provide official documentation that states he/she is the sole shareholder;

(b) The address of all sites of practice where the drugs will be delivered to and stored for use by the prescriber in his/her professional practice pursuant to federal and state laws;

(c) Verification from the licensing board that the prescriber's license is in good standing and that there are no restrictions on his/her license to practice and use drugs in his/her practice. If the license has been restricted by the licensing board, a copy of the official documents restricting the license to practice and use drugs in the course of professional practice must be furnished to the wholesaler and maintained by the wholesaler with all other documents establishing the prescriber's exemption from licensure as a terminal distributor of dangerous drugs;

(d) If an exempted prescriber wishes to purchase and possess dangerous drugs which are also controlled substances, the prescriber must submit a copy of his/her current registration with the federal drug enforcement administration and provide verification that the DEA registration and authority to use controlled substances in the course of professional practice has not been restricted by the appropriate professional licensing board or the federal drug enforcement administration.

(D) Dangerous drugs may not be shipped by a wholesale distributor of dangerous drugs to any address other than those listed by the business entity meeting the definition of a prescriber and filed with the wholesale distributor in paragraph (B) of this rule. Controlled substances may only be shipped to those addresses registered with the federal drug enforcement administration for the purpose of storing controlled substances.

(E) All documents establishing the fact that a prescriber is exempt from licensure as a terminal distributor of dangerous drugs shall be current and maintained for a period of three years by the wholesale distributor of dangerous drugs.

(F) Copies of licenses to practice and verification that there are no restrictions on a prescriber's license by either the appropriate professional licensing board or the federal drug enforcement administration shall be obtained within fifteen days of the date of renewal of such licenses. No dangerous drugs may be sold and delivered to a prescriber until the required documentation has been obtained by the wholesale distributor.

(G) Each wholesale distributor of dangerous drugs registered with the state board of pharmacy shall report any suspicious purchases of any dangerous drugs by a prescriber exempted from licensure as a terminal distributor of dangerous drugs. A suspicious purchase includes, but is not limited to, any drugs that the prescriber is not authorized to use in the course of his/her professional practice.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.04 , 4729.51 , 4729.54 , 4729.541 , 4729.60
Prior Effective Dates: 10/1/71, 3/19/87, 7/1/91, 3/13/95, 1/10/96, 3/1/99, 1/1/09

4729-9-13 Distributor of dangerous drugs samples.

No manufacturer, manufacturer's representative, or wholesale dealer in pharmaceuticals may furnish a sample of a drug of abuse as defined in section 3719.011 of the Revised Code to a prescriber unless requested by the prescriber and unless the company is registered as a wholesale distributor of dangerous drugs and maintains a record of such distribution which will be available to the state board of pharmacy.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.81
Prior Effective Dates: 9/10/76, 2/1/98, 3/1/99

4729-9-14 Records of controlled substances.

(A) Each prescriber or terminal distributor of dangerous drugs shall keep a record of all controlled substances received, administered, dispensed, sold, destroyed, or used. The acts of prescribing, administering, dispensing, and destroying of a controlled substance must be documented with the positive identification of the responsible individual pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code. These records may be kept electronically if the method is approved by the state board of pharmacy and the records are backed-up each business day.

(1) Records of receipt shall contain a description of all controlled substances received, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

(2) Records of administering, dispensing, or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, 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 controlled substance was administered, dispensed, or used.

(3) Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

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

(B) Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all controlled substances as follows:

(1) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.

(a) The name of the substance.

(b) The total quantity of the substance.

(i) Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter).

(ii) The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

(iii) The number of commercial containers of each such finished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

(c) If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

(d) If the substance is listed in schedule III, IV, or V, the prescriber or terminal distributor of dangerous drugs may make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

(2) A separate inventory shall be made for each place or establishment where controlled substances are in the possession or under the control of the prescriber or terminal distributor. Each inventory for each place or establishment shall be kept at the place or establishment.

(3) An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administering, dispensing, or use of controlled substances. In the event the prescriber or terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

(4) Each prescriber or terminal distributor of dangerous drugs shall take a new inventory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

(5) When a substance is added to the schedule of controlled substances by the federal drug enforcement administration or the state board of pharmacy, each prescriber or terminal distributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

(C) All records of receipt, distribution, administering, dispensing, inventory, destruction, or using controlled substances shall be kept for a period of three years at the place where the controlled substances are located. Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send a written request to the state board of pharmacy. The request shall contain the terminal distributor of dangerous drug name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy will send written notification to the terminal distributor of dangerous drugs documenting the approval or denial of the request. A copy of the board's approval shall be maintained with the other records of controlled substances. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor of dangerous drugs.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3719.28
Rule Amplifies: 3719.07
Prior Effective Dates: 4/1/1978, 1/1/1981, 7/1/1989, 3/1/1999, 3/31/2000, 1/1/2004, 10/19/2007

4729-9-15 Report of theft or loss of dangerous drugs, controlled substances, and drug documents.

(A) Each prescriber, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the prescriber, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs:

(1) The state board of pharmacy, by telephone immediately upon discovery of the theft or significant loss;

(2) If a controlled substance, the drug enforcement administration (DEA) pursuant to 21 C.F.R.1301.76(b);

(3) Law enforcement authorities pursuant to section 2921.22 of the Revised Code.

(B) Controlled substance thefts must also be reported by using the federal DEA report form whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them. A copy of the federal form regarding such theft or loss shall be filed with the state board of pharmacy within thirty days following the discovery of such theft or loss.

(1) An exemption may be obtained upon sufficient cause if the federal form cannot be filed within thirty days.

(2) A request for a waiver of the thirty-day limit must be requested in writing.

(C) Each prescriber, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs immediately upon discovery of any theft or loss of:

(1) Uncompleted prescription blank(s) used for writing a prescription, written prescription order(s) not yet dispensed, and original prescription order(s) that have been dispensed, shall notify the state board of pharmacy and law enforcement authorities.

(2) Official written order form(s) as defined in division (Q) of section 3719.01 of the Revised Code shall notify the state board of pharmacy and law enforcement authorities, and the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1305.12(b) .

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.07 , 4729.55
Prior Effective Dates: 4/1/78, 2/15/82, 7/1/90, 2/15/95, 1/17/97, 3/1/99, 1/1/06

4729-9-16 Minimum requirements for wholesalers.

The following minimum requirements shall apply to all persons distributing dangerous drugs at wholesale in Ohio :

(A) The following information shall be required on a form supplied by the state board of pharmacy from each person making application for a license as a wholesale distributor of dangerous drugs:

(1) The name, full business address (not a post office box), and telephone number;

(2) All trade or business names used by the licensee, any trade or business names under which licensee was previously or is presently licensed;

(3) Addresses, telephone numbers, and the full names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of dangerous drugs;

(4) The type of ownership or operation (i.e., sole proprietorship, partnership, corporation, or government agency);

(5) The full name(s) of the owner and/or operator of the licensee, including:

(a) If a sole proprietorship, the full name of the sole proprietor, and the name of the business entity;

(b) If a partnership, the full name of each partner, and the name of the partnership;

(c) If a corporation, the full name and title of each corporate officer and director, the corporate names, the name of the state of incorporation, the corporation number, and a copy of the corporation papers;

(d) If a government agency, the name of the agency, and the full name of each officer and director of the agency.

(6) If the entity making application for a wholesale distributor of dangerous drugs license is located outside the boundaries of the state of Ohio, part of the licensing process shall be an inquiry to the licensing authority of the state in which that entity is located. This inquiry will determine whether the entity possesses a current and valid license to distribute dangerous drugs in that state and the experience the licensing authority has had with the entity. This information will be used as part of the consideration in licensing the entity by the Ohio state board of pharmacy. The Ohio board will respond to inquiries of a similar nature from other states about licensees in Ohio.

(7) Pursuant to division (A)(1) of section 4729.53 of the Revised Code, a new wholesale distributor of dangerous drug license will not be issued until the owner(s), or if incorporated the officers, of the wholesale operation submit fingerprints to the Ohio bureau of criminal identification and investigation (BCI&I) for a criminal records check. Additionally, a criminal records check is required every time there is a change in officers. The criminal records check shall consist of both a BCI&I criminal records check and a federal bureau of investigations records check (FBI). The results of the criminal records check must be sent directly to the Ohio state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months. After the board receives the results of all of the required criminal records checks the license process will proceed. The owner(s) or officers may submit electronic fingerprint impressions pursuant to rule 4729-5-12 of the Administrative Code, or if located outside of Ohio they may submit ink fingerprint impressions as instructed on a form provided by the board.

(B) Prior to the end of the licensing period, a renewal application requesting such information as the state board of pharmacy may require will be sent to the address of record to the attention of the responsible person. Such renewal application form shall be completed and returned with the applicable fee on or before the established deadline.

(C) All facilities where dangerous drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) Have a quarantine area for storage of dangerous drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened. Such drugs shall be stored no longer than two years pursuant to rule 4729-9-17 of the Administrative Code;

(4) Be maintained in a clean and orderly condition;

(5) Be free from infestation by insects, rodents, birds, or vermin of any kind.

(D) All facilities used for wholesale drug distribution shall be secure from unauthorized entry.

(1) Access from outside the premises shall be kept to a minimum and be well controlled.

(2) The outside perimeter of the premises shall be well lighted.

(3) Entry into areas where dangerous drugs are held shall be limited to authorized personnel.

(4) All facilities where dangerous drugs are held shall be equipped with a state board of pharmacy approved alarm system to detect unauthorized entry after hours.

(5) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(E) All dangerous drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States pharmacopoeia/national formulary (USP/NF).

(1) If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of dangerous drugs.

(3) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all stored drugs.

(F) All shipments of dangerous drugs shall be examined in accordance with the following:

(1) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated dangerous drugs or dangerous drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents;

(2) Each outgoing shipment shall be carefully inspected for identity of the dangerous drug products and to ensure that there is no delivery of dangerous drugs that have been damaged in storage or held under improper conditions;

(3) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all incoming and outgoing dangerous drugs.

(G) All returned, damaged, and outdated, dangerous drugs shall be handled in the following manner:

(1) Dangerous drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other dangerous drugs until they are destroyed or returned to their supplier.

(2) Any dangerous drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other dangerous drugs until they are either destroyed or returned to the supplier.

(3) If the conditions under which a dangerous drug has been returned cast doubt on the drug's safety, identify, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in paragraph (H) of this rule shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated dangerous drugs.

(H) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of dangerous drugs.

(1) These records shall include but not be limited to the following information:

(a) The source of the drugs, including the name and principle address of the seller or transferor, and the address of the location from which the drugs were shipped.

(b) The identity and quantity of the drugs received and distributed or disposed of.

(c) The dates of receipt and distribution of the drugs.

(d) A system of records and procedures shall be maintained which prevent the sale or other distribution of dangerous drugs to any person not authorized by division (B) of section 4729.51 of the Revised Code.

(e) A system of procedures shall be designed and operated to disclose orders for controlled substances and other dangerous drugs subject to abuse.

(i) The wholesaler shall inform the state board of pharmacy of suspicious orders for drugs, as described in paragraph (H)(1)(e) of this rule, when discovered. Suspicious orders are those which, in relation to the wholesaler's records as a whole, are of unusual size, unusual frequency, or deviate substantially from established buying patterns.

(ii) Reports, generated by the system as described in paragraph (H)(1)(e) of this rule, shall be furnished to the state board of pharmacy within three working days of receipt of a request from the board. The reports shall include the name and address of the purchaser, date of purchases, product trade name, national drug code (NDC) number, size of package, and quantity purchased.

(2) Inventories and records shall be made available for inspection and photocopying by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law enforcement agency officials for a period of three years following disposition of the drugs.

(3) Records described in this rule that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.

(a) Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law enforcement agency officials.

(b) Wholesalers intending to maintain records, described in this rule, at a location other than the place licensed by the state board of pharmacy must first send notification to the board.

(I) Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures which shall be followed for the receipt, security, storage, inventory, and distribution of dangerous drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies and procedures the following:

(1) A procedure whereby the oldest approved stock of a dangerous drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.

(2) A procedure to be followed for handling recalls and withdrawals of dangerous drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

(a) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other government agency, including the state board of pharmacy;

(b) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market;

(c) Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(3) A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(4) A procedure to ensure that any outdated dangerous drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated dangerous drugs. This documentation shall be maintained for three years after disposition of the outdated drugs.

(J) Wholesale distributors of dangerous drugs shall establish and maintain accurate and current lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications. When there is a change in the designated contact person to whom communications with the state board of pharmacy may be directed, the board shall be notified of the new contact person within thirty days on a board approved form. This notice to the board shall be sent by certified mail, return receipt requested, or by verified facsimile transmission.

(K) Personnel employed in the wholesale distribution of dangerous drugs shall be required to have appropriate education and/or experience to assume responsibility for positions related to compliance with the licensing regulations.

(L) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws and regulations.

(1) Wholesale drug distributors shall permit properly identified and authorized state board of pharmacy designated agents, federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures at reasonable times and in a reasonable manner, to the extent authorized by law.

(2) Any entity making a wholesale sale of a controlled substance shall be required to possess a license as a wholesale distributor of dangerous drugs and a license as a wholesaler or manufacturer of controlled substances, except that a licensed terminal distributor of dangerous drugs may make an occasional sale of a controlled substance pursuant to rule 4729-9-10 of the Administrative Code.

(M) Wholesale drug distributors shall be subject to the provisions of any applicable federal, state, or local laws or regulations that relate to dangerous drug salvaging or reprocessing.

(N) The state board of pharmacy shall be notified of any new facilities, work or storage areas to be constructed or utilized for dangerous drugs or of any changes in operation of the registrant being used or implemented.

Effective: 10/27/2011
R.C. 119.032 review dates: 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.03 , 4729.53
Prior Effective Dates: 6/1/82, 7/1/90, 7/1/92, 1/17/97, 3/1/99, 4/27/07, 1/1/09,1/1/11

4729-9-17 Storage of adulterated drugs.

To prevent their use, adulterated drugs shall be stored in a separate and secure area apart from the storage of drugs used for dispensing and administration.

(A) Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by those holding a terminal distributor of dangerous drugs license or two years by those holding a wholesale distributor of dangerous drugs license only.

(B) Drugs, other than controlled substances, may be destroyed utilizing proper methods of disposal and following the record keeping requirements noted in rule 4729-9-22 of the Administrative Code, or may be donated to a pharmacy school pursuant to sections 3715.88 to 3715.92 of the Revised Code.

(C) Drugs that are controlled substances may be disposed of pursuant to rule 4729-9-06 of the Administrative Code.

(D) Methods of disposal shall prevent the possession of the drugs by unauthorized persons.

R.C. 119.032 review dates: 11/22/2011 and 11/15/2016
Promulgated Under: 119.03
Statutory Authority: 3715.91 , 3719.28 , 4729.26
Rule Amplifies: 3715.88 , 3715.89 , 3715.90 , 3715.92 , 3719.05 , 3719.06 , 4729.53 , 4729.55
Prior Effective Dates: 3/21/88, 7/1/93, 1/1/09

4729-9-18 Availability of terminal, wholesale, or manufacturer license.

Each entity possessing a current license as a terminal distributor of dangerous drugs, wholesale distributor of dangerous drugs, wholesaler of controlled substances, or manufacturer of controlled substances shall maintain such license in a readily available place in the principal location of such business;

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51
Prior Effective Dates: 7/1/91, 2/1/98

4729-9-19 Violations as evidence for denial of terminal, wholesale, or manufacturer license.

(A) The state board of pharmacy may consider as evidence of a person not meeting the requirements provided in sections 4729.53 and 4729.55 of the Revised Code, and may deny a person registration as a wholesale distributor of dangerous drugs or licensure as a terminal distributor of dangerous drugs in Ohio if such person:

(1) Has been convicted of a felony;

(2) Has been convicted of violating any state or federal pharmacy or drug law;

(3) Is not of good moral character and habits;

(4) Is addicted to or abusing liquor or drugs;

(5) Has been disciplined by the Ohio state board of pharmacy pursuant to section 4729.16 of the Revised Code; or

(6) Has been disciplined by any professional licensing board.

(B) When a request for licensure as a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or as a wholesaler or manufacturer of controlled substances is made, the state board of pharmacy may consider as evidence of the facility not meeting the requirements for licensure as provided in Chapters 3719. and 4729. of the Revised Code, or may deny issuance of such licensure, if:

(1) The ownership of such facility, or pharmacy previously located in such facility, has been transferred from a licensee whose license has been revoked by the state board of pharmacy to the spouse or other family member;

(2) The ownership of such facility, or pharmacy previously located in such facility, has been transferred from a licensee whose license has been revoked by the state board of pharmacy to another who employs the former owner or who allows the former owner to be present within the physical confines of the location to be licensed.

(3) The facility knowingly employs a person who has been denied the right to work in such a facility by the state board of pharmacy as part of an official order of the board.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51
Prior Effective Dates: 7/1/91, 1/10/96, 3/1/99

4729-9-20 Drugs repackaged or relabeled by a pharmacy.

(A) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall contain, but not be limited to, the following:

(1) Name of drug, strength, and dosage form;

(2) The identification of the repackager by name or by the final seven digits of their terminal distributor of dangerous drugs license number;

(3) Pharmacy control number;

(4) Pharmacy's expiration date or beyond-use date, which shall be within the proven period of stability of the drug. This expiration or beyond-use date shall be no later than the manufacturer's expiration date of a not previously opened manufacturer's container.

(B) A record of all drugs repackaged and stored within a pharmacy prior to being dispensed shall be kept for at least three years or one year past manufacturer's expiration date, whichever is greater. This record shall include at least the following:

(1) Name of drug, strength, dosage form, and quantity;

(2) Manufacturer's or distributor's control number;

(3) Manufacturer's or distributor's name, if a generic drug is used;

(4) Pharmacy control number;

(5) Manufacturer's or distributor's expiration date;

(6) The pharmacy's expiration date or beyond-use date;

(7) Positive identification of the pharmacist responsible for the repackaging of the drug.

(C) Supplemental labels created by a pharmacy that contain a barcode for the purpose of identifying a drug shall contain a means of identifying the positive identification of the pharmacist responsible for:

(1) The creation of the barcode; and

(2) Affixing the barcode label to the drug product.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.521 , 3715.63 , 3715.64 , 3719.07 , 3719.08
Prior Effective Dates: 7/1/91, 1/10/96, 3/1/99, 1/1/06, 1/1/09

4729-9-21 Drugs compounded in a pharmacy.

(A) In order to compound prescriptions, a pharmacy shall meet the minimum standards for a pharmacy pursuant to rule 4729-9-02 of the Administrative Code.

(B) Parenteral and sterile product prescriptions shall be compounded in accordance with Chapter 4729-19 and/or Chapter 4729-15 of the Administrative Code.

(C) For all compounded prescriptions, the pharmacist shall:

(1) Inspect and approve the compounding process;

(2) Perform the final check of the finished product.

(D) For all compounded prescriptions, the pharmacist shall be responsible for:

(1) All compounding records;

(2) The proper maintenance, cleanliness, and use of all equipment used in compounding.

(E) Personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel shall be worn as necessary to protect personnel from chemical exposure and drug products from contamination.

(F) A prescription shall be compounded and dispensed only pursuant to a specific order for an individual patient issued by a prescriber. A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(G) A compounded prescription that is dispensed to a patient must be labeled according to rule 4729-5-16 of the Administrative Code.

(H) Labels for a compounded prescription that is prepared in anticipation of a prescription drug order shall contain, but not be limited to, the following:

(1) The name, strength, and quantity of each drug used in the compounded prescription;

(2) The identification of the repackager by name or by the final seven digits of its terminal distributor of dangerous drugs license number;

(3) Pharmacy control number;

(4) The pharmacy's expiration date or beyond use date.

Effective: 01/01/2009
R.C. 119.032 review dates: 12/01/2009 and 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.521 , 3715.63 , 3715.64 , 3719.05 , 4729.28 , 4729.55
Prior Effective Dates: 7/1/1994, 3/1/1999, 2/1/2005

4729-9-22 Records of dangerous drugs.

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dangerous drugs received, administered, dispensed, distributed, sold, destroyed, or used. The acts of prescribing, administering, dispensing, and destroying of a dangerous drug must be documented with the positive identification of the responsible individual pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code. These records may be kept electronically if the method is approved by the state board of pharmacy and the records are backed-up each business day.

(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 drug destructions, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date destroyed, the method of destruction, the positive identification of the prescriber or responsible person that performed the destruction, and if used the positive identification of the person that witnessed the destruction.

(D) 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.

(E) 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 and upon request provided to a state board of pharmacy officer, agent, and/or inspector within three working days, excluding weekends and holidays. Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send a written request to the state board of pharmacy. The request shall contain the terminal distributor of dangerous drug name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy will send written notification to the terminal distributor of dangerous drugs documenting the approval or denial of the request. A copy of the board's approval 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 of dangerous drugs.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.37
Prior Effective Dates: 7/1/1994, 3/1/1999, 3/31/2000, 1/1/2004, 10/19/2007

4729-9-23 Dispensing of multiple drugs in single-dose containers.

Multiple drugs may be packaged in the same container such that the different drugs are in contact with each other only under the following conditions:

(A) The number of drugs placed in one package cannot exceed the capability of the receptacle to prevent damage to the dosage forms.

(B) The quantity dispensed may not be more than a thirty-one-day supply.

(C) The labels must be of sufficient size to properly and clearly label a thirty-one-day or less supply with all information required by state and federal law including accessory labels.

(D) Each individual package must include a beyond-use date of not more than sixty days from the date the drugs were placed in the package.

(E) Medications which have been packaged in multi-dose packaging are considered adulterated if returned to the pharmacy for any reason and may not be returned to stock or re-dispensed.

(F) The packaging is tamper-evident.

(G) Any pharmacist or pharmacy using multi-dose packaging must implement policies and procedures which will exclude drugs having the following characteristics from such packaging:

(1) The U.S.P. monograph or official labeling requires dispensing in the original container;

(2) The drugs or dosage forms are incompatible with packaging components or each other;

(3) The drugs are therapeutically incompatible when administered simultaneously;

(4) The drug products require special packaging.

R.C. 119.032 review dates: 03/17/2014 and 03/17/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 4729.26
Rule Amplifies: 3715.521 , 3715.63 , 3715.64
Prior Effective Dates: 03/01/1999

4729-9-24 Retail and wholesale sales of dangerous drugs on-line.

(A) All persons selling or offering to sell dangerous drugs at retail or wholesale into, out of, or within Ohio must be properly licensed or registered with the Ohio state board of pharmacy as a dangerous drug distributor.

(B) All dangerous drug distributors registered or licensed with the Ohio state board of pharmacy and who sell or offer to sell dangerous drugs at retail or wholesale on the "Internet" to persons located in Ohio or any other state must make such sales only in compliance with all state and federal laws governing the legal distribution of dangerous drugs.

(C) "Internet" sites owned and/or maintained by Ohio registered or licensed dangerous drug distributors must provide the following information to the public on the "Internet" site and no drugs are to be shipped at wholesale or retail except in accordance with Ohio's drug laws:

(1) Name under which the dangerous drug distributor is licensed to do business as in Ohio.

(2) Full address of licensed or registered site.

(3) Name of responsible person as it appears on the dangerous drug distributor license.

(4) Telephone number where responsible person may be contacted.

(5) A list of the states in which the dangerous drug distributor may legally sell prescription drugs at wholesale or retail.

(6) The name, address, and how the drug law enforcement agency may be contacted in each state in which the person is authorized to do business. This may include a link to the drug law enforcement agency's "Internet" site and/or their e-mail address.

(D) Any Ohio licensed or registered dangerous drug distributor requesting personal information from the public by way of the "Internet" site (questionnaire forms or e-mail) must provide for security and confidentiality of the information. This portion of the "Internet" site must also provide information regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such information is not used for purposes not disclosed without the written informed consent of the patient or person submitting personal information.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3719.04 , 3719.05 , 4729.51 , 4729. 551
Prior Effective Dates: 3/1/1999, 1/1/2004

4729-9-25 Drugs compounded for direct administration by a prescriber.

The following requirements do not apply to the compounding of radiopharmaceuticals by a nuclear pharmacy. Radiopharmaceuticals must be prepared pursuant to Chapter 4729-15 of the Administrative Code.

A pharmacist may compound a drug pursuant to a request made by a prescriber, or by an agent of the prescriber, for a drug to be used by the prescriber for the purpose of the direct administration to patients in the course of the prescriber's practice pursuant to division (C)(5) of section 4729.01 of the Revised Code and the following:

(A) The drug is compounded and provided to a prescriber as an occasional exception to the normal practice of dispensing drugs pursuant to patient specific prescriptions:

(1) A pharmacy may provide compounded drug preparations to prescribers for direct administration to patients as long as the total value of those compounded preparations does not exceed five percent of the pharmacy's total dollar amount of sales of patient specific compounded prescriptions within the past twelve months.

(2) The pharmacy shall only provide those compounded drugs that are not commercially available to a prescriber which are needed:

(a) To treat an emergency situation;

(b) For an unanticipated procedure for which a time delay would negatively affect a patient outcome;

(c) For diagnostic purposes.

(B) A pharmacy shall not supply more than a seventy-two hour supply of a compounded drug to a prescriber. A prescriber shall not have more than a seventy-two hour supply of a compounded drug on hand at any given time. The seventy-two hour supply provided to the prescriber shall be determined by previous administration patterns provided by a prescriber to the pharmacist. The limitation of a seventy-two hour supply shall not apply to either of the following:

(1) Compounded non-sterile drug preparations for topical administration, pursuant to paragraphs (A)(2)(b) and (A)(2)(c) of this rule, shall be supplied to a prescriber in a single container in which the quantity does not exceed sixty grams or sixty milliliters. A prescriber shall not have more than one full container of sixty grams or sixty milliliters of a compounded drug on hand at any given time; or (2) Compounded non-sterile drug preparations intended to treat an emergency situation, pursuant to paragraph (A)(2)(a) of this rule, may be provided to a prescriber in a quantity required to sufficiently treat individuals in the event of an emergency situation.

(C) A pharmacy shall not sell a compounded drug to another pharmacy or wholesaler.

(D) Prescribers shall only administer a requested compounded drug directly to their own patients. Prescribers shall not:

(1) Dispense a compounded drug to a patient;

(2) Sell a compounded drug to another prescriber;

(3) Sell a compounded drug to a pharmacy; or

(4) Return a compounded drug to the supplying pharmacy.

(E) Compounded drug preparations shall be assigned beyond use dates that are based on stability and sterility for sterile compounded drug preparations and stability for non-sterile compounded drug preparations pursuant to the following:

(1) Beyond use dates for non-sterile compounded preparations shall be determined by the compounding pharmacy through drug product testing pursuant to acceptable practice standards; by published peer reviewed pharmaceutical literature that have been critically reviewed by unbiased independent experts; or in compliance with requirements in the current edition of an official compendium, such as the "United States Pharmacopoeia/National Formulary".

(2) Beyond use dates for sterile compounded preparations shall be determined by the compounding pharmacy through drug product testing pursuant to acceptable practice standards or shall be based on the following "United States Pharmacopoeia/National Formulary" standards:

(a) Low risk level compounded drug preparations shall be assigned a beyond use date of not more than forty-eight hours when stored at controlled room temperature at twenty to twenty-five degrees celsius, or fourteen days when refrigerated at two to eight degrees celsius, or forty-five days in solid frozen state at minus twenty-five to minus ten degrees celsius.

(b) Medium risk level compounded drug preparations shall be assigned a beyond use date of not more than thirty hours when stored at controlled room temperature at twenty to twenty-five degrees celsius, or nine days when refrigerated at two to eight degrees celsius, or forty-five days in solid frozen state at minus twenty-five to minus ten degrees celsius.

(c) High risk level compounded drug preparations shall be assigned a beyond use date of not more than twenty-four hours when stored at controlled room temperature at twenty to twenty-five degrees celsius, or three days when refrigerated at two to eight degrees celsius, or forty-five days in solid frozen state at minus twenty-five to minus ten degrees celsius.

(F) The labeling of a compounded drug preparation must contain the following:

(1) The statement "For direct patient administration only" displayed prominently;

(2) The statement "Not for resale" displayed prominently;

(3) Proper storage conditions;

(4) Beyond use dates pursuant to paragraph (E) of this rule;

(5) The name(s) of the active and inactive ingredients;

(6) The amount or percentage of active drug ingredients;

(7) The quantity of compounded drug provided;

(8) The route of administration;

(9) The pharmacy name, address, and telephone number;

(10) The pharmacy control number assigned to the compounded drug preparation.

(G) Compounded drug preparation containers that are too small to bear a complete label pursuant to paragraph (F) of this rule must bear a label that contains at least the following information: (1) "Not for resale";

(2) The storage conditions if other than room temperature;

(3) The beyond use date;

(4) The drug name(s);

(5) The drug strength;

(6) The route of administration;

(7) The pharmacy control number;

(8) The pharmacy name.

In all cases, a complete label meeting the requirements of paragraph (F) of this rule must be applied to the outside container in which such compounded preparation is supplied.

(H) The sale of a compounded drug preparation to a prescriber is considered a wholesale sale as defined in section 4729.01 of the Revised Code. A pharmacy is required to follow the record keeping requirements for wholesale sales listed in paragraph (H) of rule 4729-9-16 of the Administrative Code.

(I) A pharmacy must follow the compounding requirements pursuant to rules 4729-5-25 and 4729-9-21 of the Administrative Code, Chapter 4729-19 of the Administrative Code, current professional compounding standards, and all applicable federal and state laws, rules, and regulations.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 4729.01
Prior Effective Dates: 1/1/06

4729-9-26 Criminal records check for pain management clinics.

Pursuant to division (B) of section 4729.552 of the Revised Code, a new terminal distributor of dangerous drug license with a pain management clinic classification will not be issued until the physician owner(s), or if incorporated the physician officers, of the pain management clinic submit fingerprints to the Ohio bureau of criminal identification and investigation (BCI&I) for a criminal records check. Additionally, a criminal records check is required every time there is a change in ownership for each new owner(s) or officer(s). The criminal records check shall consist of both a BCI&I criminal records check and a federal bureau of investigations (FBI) records check. The results of the criminal records check must be sent directly to the Ohio state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months. After the board receives the results of all of the required criminal records checks the license process will proceed. The physician owner(s) or physician officers must submit electronic fingerprint impressions pursuant to rule 4729-5-12 of the Administrative Code. Physician owner(s) or physician officers are required to have all employees submit to a BCI&I and FBI criminal records check to ensure that no person has been previously convicted of, or pleaded guilty to a theft offense that would constitute a felony as described in division (K)(3) of section 2913.01 of the Revised Code of a felony drug abuse offense as defined in section 2925.01 of the Revised Code. Employees must submit electronic fingerprint impressions to the physician owner(s) or physician officers pursuant to rule 4729-4-04 of the Administrative Code.

Effective: 10/27/2011
R.C. 119.032 review dates: 10/01/2016
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 4729.552
Rule Amplifies: 4729.552 , 4776.02 , 4776.04