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

Chapter 4729-9 | Dangerous Drugs

 
 
 
Rule
Rule 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) "Adulterated drug" includes a dangerous drug to which any of the following applies:

(1) A compounded dangerous drug if it exceeds the beyond use date as indicated in United States pharmacopeia chapters 795 and 797, USP 38 - NF 33, or any official supplement thereto (10/16/2016).

(2) Meets any of the requirements described in section 3715.63 of the Revised Code.

(3) Is beyond the expiration date as stated by the manufacturer, packer, or distributor in its labeling or it is not stored, dispensed or personally furnished 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 or licensure with the state board of pharmacy and have complied with 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 or registration rendering such license or registration void and such license or registration may not be reissued. "Revoke" is an action that is permanent against the license/registration and licensee/registrant.

(F) "Suspend", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license or registration rendering such license or registration 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 or registration 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) "Summary suspension", as used in Chapters 3719. and 4729. of the Revised Code, means to take immediate action against a license or registration without a prior hearing rendering such license or registration without force and effect for a period of time as indicated in section 3719.031, 3719.121, 4729.561 or 4729.571 of the Revised Code. The board may suspend a license or registration issued pursuant to Chapters 3719. and 4729. of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.

(H) "Place on probation", as used in Chapter 4729. of the Revised Code, means to take action against a license or registration suspending some or all of the sanctions imposed by the board against that license or registration. 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.

(I) "Refuse to grant or renew", as used in Chapter 4729. of the Revised Code, means to deny original or continued licensure or registration for a period of at least twelve months. After twelve months, or such period of time as the individual board order may require, an individual or facility licensed or registered by the board or an individual or facility seeking to attain such status by licensure or registration, and whose license or registration 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 or facility that seeks to attain such status by licensure or registration, 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.

(J) "Campus", as used to describe a type of terminal distributor of dangerous drugs license issued pursuant to 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.

(K) "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)."

(L) "Abandoned application" means an application submitted for licensure or registration that meets the requirements in paragraphs (L)(1) and (L)(2) of this rule. An applicant forfeits all fees associated with an abandoned application. The board shall not be required to act on any abandoned application and the application may be destroyed by board staff. If the application is abandoned, the applicant shall be required to reapply for licensure or registration, submit the required fee and comply with the requirements in effect at the time of reapplication.

(1) An application shall be deemed abandoned if any of the following apply:

(a) An applicant fails to complete all application requirements within thirty days after being notified of the incomplete application by the board.

(b) An applicant for a terminal distributor of dangerous drugs that fails to demonstrate compliance with rules 4729-5-11, 4729-9-11 and 4729-9-05 of the Administrative Code within ninety days of receipt of a completed application. The applicant may submit a request to the director of licensing for a one-time ninety-day extension.

(c) An applicant for a wholesale distributor of dangerous drugs that fails to demonstrate compliance with rule 4729-5-11 and the applicable licensing rules pursuant to Chapter 4729-9 of the Administrative Code within ninety days of receipt of a completed application. The applicant may submit a request to the director of licensing for a one-time ninety-day extension.

(d) An applicant for a wholesale distributor of dangerous drugs with an outsourcing facility classification that fails to demonstrate compliance with rules 4729-5-11 and 4729-16-02 of the Administrative Code.

(e) An applicant for licensure as a pharmacist pursuant to rules 4729:1-2-01 and 4729:1-2-02 of the Administrative Code.

(2) An application shall not be deemed abandoned if the application is subject to any of the following:

(a) An administrative proceeding; or

(b) If there is discipline pending against the applicant.

Supplemental Information

Authorized By: 3715.91, 3719.28, 4729.26
Amplifies: 3715.88, 3715.89, 3715.90, 3715.92, 3719.01, 3719.03, 4729.01, 4729.16, 4729.56, 4729.57
Five Year Review Date: 12/1/2020
Prior Effective Dates: 1/1/2001, 4/28/2016
Rule 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 have access to 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.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.54, 4729.55
Five Year Review Date: 5/22/2019
Prior Effective Dates: 9/10/1976, 7/1/1992
Rule 4729-9-11 | Security and control of dangerous drugs.
 

A pharmacist, prescriber, and responsible person pursuant to rule 4729-5-11 of the Administrative Code 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 ensure 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) Except as provided in paragraph (A)(2) of this rule, a pharmacist shall provide personal supervision of the dangerous drugs, exempt narcotics, hypodermics, poisons, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, at all times in order to deter and detect theft or diversion;

(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, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, 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, unless otherwise authorized by the board.

(h) Any designated area outside the prescription department at the location licensed as a terminal distributor of dangerous drugs intending to be used for the storage of dangerous drugs, D.E.A. controlled substance order forms, exempt narcotics, hypodermics, poisons, records relating to the distribution of dangerous drugs except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to rules 4729-9-14 and 4729-9-22 of the Administrative Code, and every other item or product that requires the personal supervision or sale by a pharmacist shall meet the following requirements:

(i) The designated area shall be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect unauthorized entry. Such a barrier, before being put into use, must be approved by the state board of pharmacy.

(ii) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the designated area, unless authorized by the board of pharmacy.

(iii) Authorized personnel may have access if there is on-site supervision by a pharmacist.

(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, shall comply with all of the following:

(1) Dangerous drugs, exempt narcotics, uncompleted prescription blank(s) used for writing a prescription, D.E.A. controlled substance order forms, hypodermics and poisons must be stored in an area secured by either a physical barrier with suitable locks, which may include a substantially constructed cabinet, and/or an electronic barrier to deter and detect unauthorized access;

(2) All records relating to the dispensing, distribution, personal furnishing and sale of dangerous drugs shall be maintained on-site under appropriate supervision and control to restrict unauthorized access.

(3) Paragraph (B)(1) of this rule does not apply to hypodermics at veterinary facilities if all of the following conditions are met:

(a) During non-business hours, hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, and/or an electronic barrier to deter and detect unauthorized access;

(b) During normal business hours, hypodermics shall not be stored in areas where members of the public are not supervised by individuals authorized to administer injections.

(C) A pharmacist, prescriber, or responsible person for a terminal distributor of dangerous drugs license pursuant to rule 4729-5-11 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 dangerous 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 use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise directed by the board. Records relating to the distribution of dangerous drugs shall be maintained in a secure manner that ensures the integrity of the information.

(E) Only individuals authorized under state laws or rules shall have unsupervised access to dangerous drugs.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 3719.09, 3719.172, 4729.27, 4729.28, 4729.51, 4729.531, 4729.55, 4729.57
Five Year Review Date: 8/15/2021
Prior Effective Dates: 7/1/1994, 1/1/2001, 1/1/2006
Rule 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, personally furnished, 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, personally furnishing or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, personally furnished 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 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 year 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, personally furnishing, 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.

Supplemental Information

Authorized By: 3719.28
Amplifies: 3719.07, 4729.541
Five Year Review Date: 6/30/2019
Prior Effective Dates: 7/1/1989
Rule 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.

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.521, 3715.63, 3715.64, 3719.07, 3719.08
Five Year Review Date: 10/1/2020
Prior Effective Dates: 3/1/1999
Rule 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, personally furnished, 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, personally furnishing, 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, personally furnished, 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, personally furnishing, 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.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.37, 4729.541
Five Year Review Date: 5/10/2022
Prior Effective Dates: 1/1/2004
Rule 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.

Supplemental Information

Authorized By:
Amplifies:
Five Year Review Date: