Chapter 4729-17 Institutional and Health Care Facilities

4729-17-01 Definitions; institutional facility.

As used in Chapter 4729-17 of the Administrative Code:

(A) "Institutional facility" means a hospital as defined in section 3727.01 of the Revised Code, or a facility licensed by the Ohio state board of pharmacy and the Ohio department of health, the Ohio department of rehabilitation and correction, or the Ohio department of developmental disabilities at which medical care is provided on site and a medical record documenting episodes of care, including medications ordered and administered, is maintained, including but not limited to:

(1) Convalescent homes;

(2) Developmental facilities;

(3) Long term care facilities;

(4) Nursing homes;

(5) Psychiatric facilities;

(6) Rehabilitation facilities;

(7) Developmental disability facilities.

(B) "Inpatient" means any person who receives drugs for use while within the institutional facility.

(C) "Inpatient prescription" means a written, electronic, or oral order for a drug to be dispensed for use in treating an inpatient.

(D) "Dispensing of a drug pursuant to an inpatient prescription" means the professional review by a pharmacist required to place a specific drug in final association with the name of a particular inpatient pursuant to the lawful order of a prescriber. In the case of an automated drug delivery system meeting the requirements of rule 4729-5-35 of the Administrative Code, the final association with the name of a particular inpatient will be deemed to have occurred when the pharmacist has given final approval to the patient specific order in the system.

(E) "Contingency drugs" are those drugs which may be required to meet the therapeutic needs of inpatients when a licensed pharmacist is not available and personally in full and actual charge of the institutional pharmacy.

(F) "Emergency drugs" are those drugs which are required to meet the immediate therapeutic needs of inpatients in order to sustain life in an emergency crisis.

(G) "Outpatient" means any person who receives drugs for use outside of the institutional facility.

(H) "Electronic drug record keeping system" means a system of storing drug records electronically and capturing the positive identification of the person responsible for a specific drug transaction including, but not limited to, the prescribing, administering, or dispensing of a drug.

(I) "Positive identification" has the same meaning as paragraph (N) of rule 4729-5-01 of the Administrative Code except that a specific hospital having a closed electronic drug record keeping system may be permitted to use identifiers utilizing both a password combined with a personal identifier to document the positive identification of each user for, but not limited to, the prescribing and administration of a drug if approved by the board of pharmacy.

(1) At a minimum, the following items will be considered during the approval process:

(a) Adequate audit controls are in place to detect and deter drug diversion;

(b) Adequate access controls are in place to assure the identity of a user and to assign accountability of the user for any drug transaction;

(c) Adequate safeguards are in place to prevent and detect the unauthorized use of an individual's password and personal identifier;

(d) An ongoing quality assurance program is in place to ensure that paragraphs (I)(1)(a) to (I)(1)(c) of this rule are being fulfilled and reviewed; and

(e) Appropriate policies and procedures are in place to address all of the items in paragraphs (I)(1)(a) to (I)(1)(d) of this rule.

(2) Positive identification pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code shall always be used to document the:

(a) Dispensing, compounding, or repackaging of a drug;

(b) Removal and possession of a controlled substance to administer to a patient;

(c) Waste of a controlled substance.

(J) "Password" means a private identification that is created by a user to obtain access to an electronic drug record keeping system.

(K) "Personal identifier" means a unique user name or number for identifying and tracking a specific user's access to an electronic drug record keeping system such as social security number, user identification number, or employee number.

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: 3719.01 , 4729.01
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/91, 3/13/95, 1/10/96, 3/1/99, 2/1/05, 1/1/06, 4/27/07

4729-17-02 Responsible person for an institutional pharmacy.

Each institutional pharmacy shall be directed by a pharmacist who holds a current identification card to practice pharmacy in Ohio pursuant to the provisions of section 4729.12 of the Revised Code.

(A) The institutional pharmacy director or designated pharmacist shall be the pharmacist-in-charge pursuant to section 4729.27 of the Revised Code, the responsible person pursuant to rule 4729-5-11 of the Administrative Code, and the pharmacist responsible for maintaining supervision and control over the possession and custody of all dangerous drugs acquired by the institutional facility pursuant to division (B) of section 4729.55 of the Revised Code.

(B) A pharmacist shall be the responsible person for no more than one pharmacy except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a pharmacist to be responsible for more than one pharmacy and the period of time during which the circumstances will exist. A pharmacist shall not be designated the responsible person for a pharmacy unless he/she will be physically present in the pharmacy a sufficient amount of time to provide supervision and control.

(C) The terminal distributor of dangerous drugs license issued to the institutional facility shall be signed by the responsible person and maintained in a readily available place in the pharmacy.

(D) The responsible person shall:

(1) Be responsible for the practice of pharmacy performed within the institution;

(2) Develop, implement, supervise, and coordinate all services provided by the pharmacy;

(3) In conjunction with the appropriate interdisciplinary committees, be responsible for the development of written policies and procedures which are consistent with this chapter of the Administrative Code and other applicable federal and state laws and rules governing the legal distribution of drugs, assure adherence to these policies and procedures in order to provide for the safe and efficient distribution of drugs in all areas of the institution, and make available a current copy of these written policies and procedures for inspection and/or copying by an employee of the state board of pharmacy;

(4) Be responsible for the security and control of all drugs within the institution;

(5) Be responsible for the maintenance of all records, required by state or federal law to be kept at the licensed location, of the acquisition, use, distribution, and disposition of all drugs.

(E) An institutional pharmacy director or designated pharmacist, who becomes the responsible person shall:

(1) File a written notice to the state board of pharmacy by regular mail, or by verified facsimile transmission within thirty days. This notice shall include:

(a) The name, address, and dangerous drug distributor license number(s) of the institutional pharmacy;

(b) His/her name and pharmacist registration identification number; and

(c) The date on which he/she became the responsible person.

(2) Take a complete inventory, pursuant to federal regulations, of the controlled substances on hand at the pharmacy with the old or previous responsible person at the time he/she ceases to be the responsible person.

(a) The original copy of the inventory shall be maintained in the pharmacy with all other required controlled substance records;

(b) This inventory shall serve as the inventory of controlled substances for which the new or acting responsible person is responsible.

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 , 3719.07 , 4729.27 , 4729.55
Prior Effective Dates: 9/10/76, 11/1/85, 7/1/90, 7/1/91, 1/10/96, 3/1/99, 1/1/09

4729-17-03 Security and control of drugs in an institutional facility.

(A) In the absence of a licensed pharmacist, drugs ordered by a prescriber for patient treatment may be obtained in the following manner:

(1) Where a licensed pharmacist is not present twenty-four hours-a-day, drugs for patient treatment may be made available to licensed health care professionals authorized pursuant to the Revised Code to administer drugs in the course of their professional practice by the use of contingency drug supplies pursuant to the provisions of paragraph (A)(2) of this rule. A licensed pharmacist shall be available for emergencies when the institutional pharmacy is closed.

(2) Contingency drugs shall be used only in the absence of a licensed pharmacist, and shall be stored in a locked cabinet(s) or other enclosure(s) constructed and located outside of the institutional pharmacy. The storage area must be sufficiently secure to deny access, without obvious damage, to unauthorized persons. The responsible person shall:

(a) Designate those who may obtain access to the drug supply;

(b) Determine, in conjunction with the appropriate interdisciplinary committees, the drugs that are to be included in the contingency drug supply;

(c) Ensure that such drugs are properly labeled and packaged in sufficient quantities to provide drug therapy during the period when the institutional pharmacy is not open;

(d) Provide controls adequate to prevent diversion of the drugs, and institute record keeping procedures to account adequately for the drugs when used and the positive identification of the person who obtained the drugs from the drug supply;

(e) Provide procedures for the inspection of the contingency drug inventory to assure proper utilization and replacement of the drug supply.

(3) For a pharmacy located on the premises of the institutional facility, when a drug is not available from the contingency drug supply and such drug is required to treat the immediate needs of an inpatient or outpatient whose health would otherwise be jeopardized, such drug may be obtained from the institutional pharmacy pursuant to written policies and procedures implemented by the responsible person.

(a) The policies and procedures shall:

(i) Identify the personnel authorized to access the pharmacy and the conditions under which access may be gained to the pharmacy;

(ii) Ensure a minimum of two employees of the institution, one of whom shall be a health care professional licensed pursuant to Chapter 4723. (Nursing Practice Act) or 4731. (Medical Practice Act) of the Revised Code and authorized by such chapter to administer drugs in the course of their professional practice, to accompany each other when accessing the pharmacy;

(iii) Provide a written record documenting emergency access to the pharmacy. Such record shall include the names, titles, and positive identification of all institutional personnel accessing the pharmacy, date and time of access, the name and quantity of drugs obtained, the name of the patient, and the name of the ordering prescriber.

(b) The written record of each access to the institutional pharmacy when it is closed and a pharmacist is not present shall be filed, within twenty-four hours, with the responsible person and maintained in the pharmacy for three years.

(B) Supplies of dangerous drugs may be maintained in patient care areas according to written policies and procedures developed and implemented by the responsible person. The policies and procedures shall:

(1) Provide for a limited quantity of dangerous drugs to be maintained at any one location;

(2) Provide for the proper storage and labeling of all such drugs;

(3) Provide for storage in a secure area. If dangerous drugs cannot be stored in a secure area, they shall be stored in a container which is sealed with a tamper-evident seal that must be broken to gain access to the drugs;

(4) Provide for notification of the responsible person, or designated pharmacist, when the dangerous drug supply has been accessed and/or drugs used;

(5) Provide for replacement of the drugs used, and the dangerous drug supply to be re-sealed;

(6) Provide for inspection of the dangerous drug supply, on a regular basis, to detect unauthorized use of such drugs and which drugs have exceeded their expiration or beyond use date;

(7) Provide adequate record keeping procedures to document the disposition of drugs from the supply.

(C) Security

(1) All areas occupied by an institutional pharmacy shall be capable of being secured by key, or other effective mechanism, so as to prevent access by unauthorized personnel.

(2) In the absence of a licensed pharmacist, all areas occupied by an institutional pharmacy shall be secured so as to prevent access by unauthorized personnel.

(3) The responsible person shall develop and implement policies and procedures which will detect and deter the diversion and/or adulteration of drugs.

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: 3719.09 , 4729.28 , 4729.51
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/91, 1/10/96, 3/1/99, 1/1/06, 1/1/09

4729-17-04 Records; institutional pharmacy.

All drug records shall be maintained for a period of three years pursuant to section 4729.37 of the Revised Code. All drug records must be readily retrievable within three working days, excluding holidays and weekends, of all drug transactions within the previous three years. Electronic drug record keeping systems, computerized record keeping systems, or subsequent storage of such records, must be readily retrievable via CRT display, hard copy printout, or other mutually agreeable transfer medium. If an electronic drug record keeping system is being utilized as defined in paragraph (H) of rule 4729-17-01 of the Administrative Code the method(s) of achieving positive identification must be approved by the state board of pharmacy prior to implementation pursuant to paragraph (I) of rule 4729-17-01 of the Administrative Code. The responsible person shall be responsible for maintaining the following records:

(A) A record of all drugs purchased, the quantity received, and the name, address, and wholesale distributor registration number of the person from whom the drugs were purchased.

(B) All drug orders and records relating to the practice of pharmacy.

(1) Records of drugs dispensed shall include, but are not limited to:

(a) The name, strength, and quantity of drugs dispensed;

(b) The date of dispensing;

(c) The name of the inpatient to whom, or for whose use, the drug was dispensed; and

(d) Positive identification of all pharmacists involved in the dispensing.

(2) All other records relating to the practice of pharmacy other than dispensing shall include, but are not limited to:

(a) The name of the inpatient to whom, or for whose benefit, the activity was performed;

(b) The practice of pharmacy activity performed;

(c) The results of the activity, if applicable; and

(d) Positive identification of all pharmacists involved in the activity, identifying the function performed by each pharmacist.

(3) Records of drugs dispensed for outpatients shall be maintained pursuant to rule 4729-5-27 of the Administrative Code.

(C) A record of all drugs compounded or repackaged for use only within the institution, which shall include at least the following:

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

(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 compounding or repackaging of the drug.

(D) A record of the distribution of dangerous drugs to other areas of the institution for administration or use as described in paragraph (B) of rule 4729-17-03 of the Administrative Code, which shall include at least the following:

(1) The name, strength, dosage form, and amount of drug distributed;

(2) The area receiving the drug;

(3) The date distributed;

(4) Positive identification of the individual receiving the drug if it is a controlled substance;

(5) The area of the institution receiving the dangerous drug shall make a record of all such drugs administered to patients. Such records shall include at least the following:

(a) Name of the patient;

(b) Name, dosage form, and strength when applicable of the drug;

(c) Date and time the drug was administered;

(d) Quantity administered;

(e) Positive identification of the personnel administering the drug.

(E) A log that must be maintained of all changes made to a drug record in an electronic drug record keeping system or a computerized record keeping system after a drug transaction has been made. Such log may be accessible for review, but shall be protected from being altered in any way. The log must contain at least, but is not limited, to the following:

(1) Date and time of change;

(2) Changes made;

(3) Person making the change.

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: 3719.09 , 4729.28 , 4729.51
Prior Effective Dates: 9/1/85, 7/1/91, 1/10/96, 2/1/98, 3/1/99, 1/1/06, 1/1/09

4729-17-05 Controlled substance recordkeeping.

(A) All controlled substances dispensed to inpatients in an institutional facility in quantities exceeding a seventy-two-hour supply shall be dispensed and maintained according to the following requirements:

(1) All controlled substances dispensed in quantities exceeding a seventy-two-hour supply shall be packaged in tamper-evident, unit-of-use containers except multidose liquids and injectables where unit-of-use packaging is not available;

(2) The drugs shall be stored in a secure location with access limited to authorized individuals;

(3) A proof-of-use sheet or other board-approved recordkeeping system shall be maintained for each drug and shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity obtained,

(d) The positive identification of the person doing the administration, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(4) At every change of shift, a reconciliation must be conducted by both the leaving and arriving licensed health care professional responsible for the security of these drugs in the area in which they are stored and must include at least the following:

(a) A physical count and reconciliation of the controlled substances and proof-of-use sheets, if applicable, to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified.

(B) All controlled substances maintained as stock in areas outside of the pharmacy pursuant to paragraph (B) of rule 4729-17-03 of the Administrative Code shall meet the following requirements, unless they are stored in a secure, automated storage system that meets the requirements of paragraph (C) of this rule:

(1) The drugs shall be stored in a secure location with access limited to authorized individuals;

(2) A proof-of-use sheet or other board approved recordkeeping system shall be maintained for each drug and shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity obtained,

(d) The positive identification of the person doing the administration, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(3) At every change of shift, a reconciliation must be conducted by both the leaving and arriving licensed health care professional responsible for the security of these drugs in the area in which they are stored and must include at least the following:

(a) A physical count and reconciliation of the controlled substances and proof-of-use sheets, if applicable, to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified;

(4) All controlled substances shall be packaged in tamper-evident containers except multidose liquids and injectables where unit-of-use packaging is not available.

(C) All controlled substances maintained as stock in areas outside of the pharmacy pursuant to paragraph (B) of rule 4729-17-03 of the Administrative Code that are stored in a secure, automated storage system shall be handled as in paragraph (B) of this rule unless the automated storage system meets all of the following requirements:

(1) The drugs shall be stored in a secure location with access limited to authorized individuals;

(2) The system shall document the positive identification of every person accessing the system and shall record the date and time of access;

(3) A recordkeeping system shall be maintained that shall include at least, but is not limited to, the following information:

(a) Patient name,

(b) Date and time of access,

(c) Drug name, strength, and quantity removed,

(d) The positive identification of the person removing the drug, and, if applicable,

(e) The positive identification of both the person and the witness who waste a partial dose of a controlled substance;

(4) Periodically, the responsible person shall cause a reconciliation of the automated storage system to be conducted which must include at least the following:

(a) A physical count and reconciliation of the controlled substances to ensure the accountability of all doses,

(b) An inspection of the packaging to ensure its integrity,

(c) The positive identification of the persons conducting the reconciliation, and

(d) The immediate reporting of any unresolved discrepancy to the appropriate people within the institution. A pharmacist at the pharmacy department responsible for the terminal distributor of dangerous drugs license must be one of those notified;

(5) Access to all controlled substances stored in the automated storage system shall be limited to one drug and strength at a time;

(6) All controlled substances stored in the automated storage system shall be packaged in tamper-evident containers, unless the system only allows access to one dose at a time.

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 , 4729.37 , 4729.55
Prior Effective Dates: 2/1/98, 3/1/99

4729-17-08 Minimum standards for an institutional 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) Drug inventory, fixtures, and space

(1) The inventory of drugs and equipment shall be commensurate with the scope of pharmacy services provided, and housed in suitable, well-lighted and well-ventilated room(s), in a clean and sanitary area.

(2) All areas where drugs are stored shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing or administration as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(3) All areas where drugs are stored shall provide adequate physical security to deter and detect their diversion and/or adulteration.

(C) 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.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.55
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/90, 1/10/96, 3/1/99, 1/1/06, 1/1/09

4729-17-09 Drug orders for patients of an institutional facility.

(A) Drugs shall be dispensed by a pharmacist for inpatients pursuant to an original patient specific order issued by a prescriber.

(1) Oral orders issued by a prescriber for inpatients of an institutional facility may be transmitted to a pharmacist by personnel authorized by, and in accordance with, written policies and procedures of the facility. Such orders shall be recorded by the pharmacist, noting the full name(s) of the authorized personnel transmitting the order. Oral orders issued by a prescriber and transmitted by authorized personnel shall be verified by the prescriber using positive identification within a reasonable time and as required by the written policies and procedures of the facility.

(2) Drug orders for inpatients of an institutional facility transmitted to a pharmacist by use of a facsimile machine to facsimile machine transfer shall be transmitted by personnel authorized by, and in accordance with, written policies and procedures of the facility. The pharmacist receiving the facsimile shall have in place written policies and procedures allowing only authorized personnel access to the drug order facsimile. The pharmacist shall maintain the facsimile showing the origin of the order as a part of the drug order record. This facsimile must be maintained if it is the only record showing the pharmacist responsible for dispensing the drug.

(3) Drug orders for inpatients of an institutional facility transmitted to a pharmacist by use of an electronic drug record keeping system may be considered an original order for the dispensing of drugs. Access to such system for entering and transmitting original orders shall be restricted to licensed health care professionals using positive identification. If the licensed health care professional entering the order into the system is not the prescriber, there shall be a system in place requiring the positive identification of the prescriber for each order within a reasonable period of time which shall be available in a readily retrievable fashion.

(B) All orders for drugs for inpatients shall include, but are not limited to, at least the following:

(1) Name of patient;

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

(3) Directions for use, including route of administration ;

(4) Date prescribed; and

(5) Prescriber's positive identification.

(C) Drugs shall be dispensed for outpatients pursuant to an original order of a prescriber.

All orders for the dispensing of drugs to outpatients shall, at a minimum, conform to rule 4729-5-30 of the Administrative Code, shall be labeled in accordance with rule 4729-5-16 of the Administrative Code, and the records shall be maintained in accordance with rule 4729-5-27 of the Administrative Code.

(D) An original signed prescription for a schedule II controlled substance prepared in accordance with federal and state requirements and issued for a resident in a long term care facility may be transmitted by the prescriber or the prescriber's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be received and maintained pursuant to rules 4729-5-21 and 4729-5-30 of the Administrative Code. The original signed prescription must remain with the patient's records at either the prescriber's office or the long term care facility.

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 , 3719.06 , 3719.07 , 4729.28 , 4729.37 , 4729.55
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/90, 7/1/91, 11/25/94, 1/10/96, 2/1/98, 3/1/99, 2/1/05, 1/1/06

4729-17-10 Labeling of prescriptions for patients of an institutional facility.

(A) All dangerous drugs dispensed for use by inpatients in an institutional facility, whereby the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements:

(1) The label of a single unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

(a) The non-proprietary or proprietary name of the drug;

(b) The route of administration, if other than oral;

(c) The strength and volume, where appropriate, expressed in the metric system whenever possible;

(d) The control number and expiration date;

(e) Identification of the manufacturer, packer or distributor, or if the repackager is the dispensing pharmacy identification of the repackager, shall be by name or by the final seven digits of their terminal distributor of dangerous drugs license number, and such identification shall be clearly distinguishable from the rest of the label;

(f) Special storage conditions, if required.

(2) When a multiple-dose drug distribution system is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information:

(a) Identification of the dispensing pharmacy;

(b) The patient's full name;

(c) The date of dispensing;

(d) The non-proprietary and/or proprietary name of the drug;

(e) The strength, expressed in the metric system whenever possible.

(3) 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 may not be returned to stock or redispensed when returned to the pharmacy for any reason.

(f) When the drugs are not in the possession of the ultimate user and any one drug within each individual package has been discontinued, all drugs in the individual package are deemed adulterated and they may not be administered unless otherwise approved by the board of pharmacy.

(g) The packaging is tamper-evident.

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

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

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

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

(iv) The drug products require special packaging.

(4) At least the name of the patient must be placed on all medication containers too small to bear a complete label and dispensed in a container bearing a complete label.

(B) All drugs dispensed to inpatients for self-administration shall be labeled in accordance with paragraphs (A), (B), and (C) of rule 4729-5-16 of the Administrative Code.

(C) Whenever any drugs are added to parenteral solutions, such admixtures shall bear a distinctive label indicating:

(1) The patient's full name;

(2) The name and amount of the parenteral solution;

(3) The name and amount of the drug(s) added;

(4) The expiration date or beyond-use date;

(5) The name and address of the institutional facility pharmacy;

(6) Cautionary statements, if required.

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: 3715.64 , 3719.08
Prior Effective Dates: 9/1/85, 7/1/91, 1/10/96, 3/1/99, 1/1/09, 1/1/10

4729-17-11 Labeling of prescriptions for outpatients.

All drugs dispensed for use by outpatients of an institutional facility shall be labeled in accordance with paragraphs (A), (B), and (C) of rule 4729-5-16 of the Administrative Code except as noted in paragraph (A) of rule 4729-17-10 of the Administrative Code.

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: 3715.64 , 3719.08 , 4729.37 , 4729.55
Prior Effective Dates: 9/1/85, 7/1/91, 1/10/96

4729-17-13 D.E.A. numbers for hospital employed prescribers.

(A) A person authorized to write prescriptions pursuant to rule 4729-5-15 of the Administrative Code who is employed as a staff prescriber of a hospital, is not individually registered under the provisions of the controlled substances act and, therefore, does not possess a"Drug Enforcement Administration" (D.E.A.) number, may administer, dispense, and prescribe controlled substances under the registration of the hospital.

(B) A person pursuing an approved training program within the jurisdiction of the hospital and authorized to write prescriptions pursuant to paragraph (B) of rule 4729-5-15 of the Administrative Code may administer, dispense, or prescribe controlled substances under the registration of the hospital. Persons pursuing such approved training programs may function in sites outside the physical confines of the hospital only if such sites are part of the training program and the persons are under the employment and jurisdiction of the hospital administering the approved program. While functioning in the outside sites, such persons may continue to use the internal code assigned by the hospital administering the approved program, upon mutual agreement of the hospital and the outside site.

(C) The administering, dispensing, or prescribing must be done in the usual course of his/her professional practice and only within the scope of his/her employment.

(D) Each person so authorized must be assigned a specific internal code number by the hospital which will be used as a suffix to the hospital D.E.A. registration number. Such internal code number shall consist of numbers, letters, or a combination thereof and shall be preceded by a hyphen. A list of the internal codes and the corresponding individual prescribers must be kept by the hospital and made available at all times to other registrants, state board of pharmacy designated agents, investigators of the state medical board, and federal, state, county, or municipal law enforcement agencies for verification.

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: 3719.06 , 4729.51
Prior Effective Dates: 7/1/91, 11/25/94, 3/1/99, 1/1/06