Chapter 4729-16 Drug Compounding

4729-16-01 Definitions.

(A) As used in this chapter of the Administrative Code:

(1) "Compounding", except as provided in paragraph (A) of rule 4729-16-04 of the Administrative Code, means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance,

(2) "Cytotoxic" means a drug that has been shown to be carcinogenic or mutagenic to humans through active or passive exposure.

(3) "Drug" has the same meaning as division (E) of section 4729.01 of the Revised Code.

(4) "Drug shortage" means a drug on the United States food and drug administration's drug shortage list that is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer or wholesaler.

(5) "Fluid therapy pharmacy" means a pharmacy where the primary purpose is to compound and dispense parenteral compounded sterile product prescriptions.

(6) "Hazardous drugs" has the same meaning as defined in the United States pharmacopeia chapter chapter <800> USP 39 - NF 34, or any official supplement thereto (6/30/2016).

(7) "In-state health care facility" means any of the following that are licensed as a terminal distributor of dangerous drugs in the state of Ohio:

(a) A hospital registered with the department of health under section 3701.07 of the Revised Code;

(b) Ambulatory surgical facility as defined in section 3702.30 of the Revised Code; or

(c) Emergency medical service (EMS) organization as defined in section 4765.01 of the Revised Code.

(8) "In-state pharmacy" means any pharmacy, as defined in section 4729.01 of the Revised Code, located inside of Ohio that ships, mails, or delivers, in any manner, drugs at retail in or out of Ohio. An in-state pharmacy does not include a nuclear pharmacy as defined in rule 4729-15-01 of the Administrative Code.

(9) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as defined in division (I) of section 4729.01 of the Revised Code.

(10) "Medical director" means the physician who is responsible for managing and directing the provision of medical services at an in-state health care facility.

(11) "Non-resident pharmacy" means any pharmacy, as defined in section 4729.01 of the Revised Code, located outside of Ohio that ships, mails, or delivers, in any manner, drugs at retail into Ohio. A non-resident pharmacy does not include a nuclear pharmacy as defined in rule 4729-15-01 of the Administrative Code.

(12) "Non-sterile compounded drug" means a drug preparation intended to be non-sterile.

(13) "Outsourcing facility" means a facility at one geographic location or address that is engaged in anticipatory compounding of sterile drugs and complies with the United States food and drug administration section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

(14) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin.

(15) "Sterile" means a dosage form free of living microorganisms (aseptic)

(16) "Sterile compounded drug" means a preparation intended to be sterile.

(17) "Verified Pharmacy Program" means a program operated by the national association of boards of pharmacy that conducts inspections of pharmacies.

(18) "Licensed personnel approved by the responsible person" as used in paragraph (J) of rule 4729-16-04 and paragraph (G) of rules 4729-16-11 and 4729-16-13 of the Administrative Code means individuals licensed or registered pursuant to Chapters 4723., 4729., 4730., and 4731. of the Revised Code.

(19) "Beyond use date" means the date or time after which a compounded drug product shall not be administered, stored or transported. The date is determined from the date and time the preparation is compounded.

Effective: 4/1/2017
Five Year Review (FYR) Dates: 10/24/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.01
Prior Effective Dates: 10/24/2014, 5/1/15

4729-16-02 Sterile compounded drugs provided by an outsourcing facility.

(A) An entity may provide, without a patient specific prescription, a non-patient specific sterile compounded drug preparations , if the following conditions apply:

(1) The entity is registered with the United States food and drug administration as an outsourcing facility pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act ( 5/28/2015);

(2) The entity is licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification pursuant to section 4729.52 of the Revised Code. The entity must include a licensed pharmacist as the responsible person on the license; and

(B) This rule does not apply to pharmacies that compound drugs for direct administration by a prescriber pursuant to rule 4729-16-07 of the Administrative Code.

(C) The outsourcing facility shall comply with all labeling and recordkeeping requirements pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act ( 5/28/2015).

(D) If an entity licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification pursuant to paragraph (A) of this rule dispenses patient specific drugs, it must also register as a terminal distributor of dangerous drugs. All laws and rules applicable to the terminal distributor license shall apply to dispensing of patient specific drugs.

(E) The entity is licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification shall comply with all of the following:

All applicable federal, state, and local laws and regulations, including but not limited, to the following:

(1) Chapter 4729-9 of the Administrative Code;

(2) Section 503B of the Federal Food, Drug, and Cosmetic Act (5/28/2015); and

(3) Current good manufacturing practices pursuant to Section 501 of the Federal Food, Drug and Cosmetic Act (5/28/2015).

Effective: 1/15/2016
Five Year Review (FYR) Dates: 10/24/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.01, 4729.51, 4729.52, 4729.54, 4729.55, 4729.56
Prior Effective Dates: 10/24/2014

4729-16-03 Drugs compounded in a pharmacy.

(A) For all non-sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(B) For all sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(C) Comply with section 503A of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

(D) Only a pharmacist or pharmacy intern under the personal supervision of a pharmacist is permitted to engage in dispensing and compounding.

(E) A qualified pharmacy technician pursuant to section 4729.42 of the Revised Code may assist a pharmacist in the compounding and dispensing of drugs in accordance with section 4729.01 of the Revised Code and according to the following requirements:

(1) May not engage in any procedure requiring professional judgment. The pharmacist is responsible for the drug compounded or dispensed.

(2) The system of drug distribution must provide exact control and assign immediate responsibility only to a pharmacist accountable at every point in the system between receipt of the order for a drug and final delivery for administration or use by the patient.

(3) May not engage in any procedure contrary to the intent of the statutes and rules regulating the dispensing and compounding of drugs.

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

(G) For all compounded drug products, the pharmacist shall:

(1) Inspect and approve the compounding process;

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

(H) For all compounded drug products, the pharmacist shall be responsible for:

(1) All compounding records pursuant to rule 4729-16- 06 of the Administrative Code;

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

(I) 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.

(J) Except as otherwise provided in rules 4729-15-03, 4729-16-07, 4729-16-10 and 4729-16-12 of the Administrative Code, 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.

(K) The requirements for prescriptions received by a fluid therapy pharmacy are as specified in rule 4729-16-05 of the Administrative Code.

(L) A compounded drug product that is dispensed to an outpatient must be labeled according to rule 4729-5-16 of the Administrative Code. In addition, the label shall comply with paragraphs (N) and (A) or (B) of this rule. The statement "Compounded Drug Product" or other similar statement shall also be displayed prominently on the label.

(M) A compounded drug product that is dispensed to an inpatient must be labeled according to rule 4729-17-10 of the Administrative Code. In addition, the label shall comply with paragraphs (N) and (A) or (B) of this rule. The statement "Compounded Drug Product" or other similar statement shall also be displayed prominently on the label.

(N) The requirements for the labeling of sterile product prescriptions in a fluid therapy pharmacy are as specified in rule 4729-16- 05 of the Administrative Code.

(O) Labels for a compounded drug product 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 drug product;

(2) The identification of the repackager by name, by the final seven digits of its terminal distributor of dangerous drugs license number, or any other board approved identifier;

(3) Pharmacy control number;

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

(5) "Compounded Drug Product " or other similar statement.

(P) A sterile compounded drug product prepared in accordance with federal and state requirements that is for a schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the prescriber or the prescriber's agent to the dispensing pharmacy by facsimile or a board approved electronic prescription transmission system pursuant to rule 4729-5-30 of the Administrative Code. 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 the prescriber's office or the institutional facility where it was issued.

(Q) The pharmacy's responsible person shall ensure the environmental control of all products shipped to the patient.

(R) The pharmacy's responsible person shall ensure that there is a system for the disposal of cytotoxic and/or hazardous drug waste in a manner so as not to endanger the public health.

(S) A pharmacy that prepares hazardous and/or cytotoxic drugs shall do so in accordance with United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (09/10/2015).

(T) The pharmacy shall comply with the drug database reporting requirements for Chapter 4729-37 of the Administrative Code.

(U) This rule does not apply to nuclear pharmacies, unless the pharmacy meets the requirements in paragraph (A) of rule 4729-15-03 of the Administrative Code.

Effective: 2/15/2016
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3715.69, 3719.28
Rule Amplifies: 3715.521, 3715.63, 3715.64, 3719.05, 4729.28, 4729.55
Prior Effective Dates: 5/1/2015

4729-16-04 Drugs compounded by a prescriber.

(A) As used in this rule, "compounding" means the preparation of non-hazardous sterile and non-sterile compounded drugs but does not include any of the following when administered to an individual patient:

(1) The preparation of a drug device designated as such and approved by the United States food and drug administration strictly in accordance with the manufacturer's labeling for administration and beyond use dating. If no such beyond use date exists, the dangerous drug product may only be used for up to six hours following preparation. These devices shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids.

(2) The reconstitution or dilution of a conventionally manufactured nonsterile dangerous drug product with no intervening steps in accordance with the manufacturer's labeling for administration and beyond use dating. If no such beyond use date exists, the dangerous drug product may only be used for up to six hours following preparation. Any other reconstitution or dilution of a conventionally manufactured nonsterile product is considered compounding and shall be performed in accordance with United States Pharmacopeia Chapter <795> , USP 39-NF 34, or any official supplement thereto (6/30/2016).

(3) The reconstitution or dilution of a conventionally manufactured sterile dangerous drug product with no intervening steps in accordance with the manufacturer's labeling for administration and beyond use dating. If no such beyond use date exists, the dangerous drug product may only be used for up to six hours following preparation. These drug products shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. Any other reconstitution or dilution of a conventionally manufactured sterile product is considered compounding and shall be performed in accordance with this rule.

(B) A facility where a prescriber is compounding drugs shall be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.541 of the Revised Code. The responsible person on the license shall be an Ohio licensed prescriber as defined in section 4729.01 of the Revised Code and is responsible for all of the following:

(1) Developing and implementing appropriate procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with section 503A of the Federal Food, Drug, and Cosmetic Act (05/09/2015) and all other applicable federal and state laws and rules;

(4) Ensuring competency of personnel;

(5) Ensuring environmental control of the compounding areas;

(6) Ensuring compounded drug products maintain their quality and sterility until administered or personally furnished.

(C) As used in this rule, a low-risk sterile compounded drug means all of the following:

(1) Does not involve any hazardous drugs as defined in rule 4729-16-01 of the Administrative Code.

(2) The drug is compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices.

(3) The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package (e.g., bag, vial) of sterile product or administration container/device to prepare the compounded sterile product.

(4) Manipulations are limited to aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and personally furnishing.

(5) Administration of the drug shall commence within twelve hours of preparation or as recommended in the manufacturers' package insert, whichever is less.

(D) A prescriber who prepares low-risk sterile compounded drugs as defined in paragraph ( C) of this rule shall meet all of the following requirements:

(1) A policy and procedure manual shall be prepared, maintained, and reviewed regularly by the responsible person regarding the compounding, safe handling, personally furnishing, and administration of compounded drugs. The policy and procedure manual shall include a quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education. The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy designated agent.

(2) Physical requirements

(a) The facility shall have a designated area with access limited to authorized personnel for preparing low risk sterile compounded drugs. This area shall be isolated from other areas; including areas used to prepare hazardous compounded products, and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled area. It shall be used only for the preparations of low risk sterile compounded drugs and provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security. Cleaning and disinfecting of areas within the designated area including the primary engineering control device, counters, easily cleanable work surfaces and floors shall occur each business day. If compounding is done less frequently than each business day (e.g., once a week or once a month), cleaning shall occur before and after each compounding session. Cleaning and disinfection agents must be selected and used with careful consideration of compatibilities, effectiveness, and inappropriate or toxic residues.

(b) The facility shall have:

(i) Appropriate primary engineering control devices capable of maintaining an ISO class 5 environment in the work place where critical objects are exposed and critical activities are performed. These devices shall be capable of maintaining an ISO class 5 environment during normal activity. Examples of such devices include laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs).

(ii) Infusion devices and equipment, if appropriate.

(iii) Appropriate temperature controlled transport containers.

(c) The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(d) The facility shall have sufficient current reference materials related to sterile products to meet the needs of the facility staff.

(e) Low-risk sterile compounded drugs shall be prepared within an ISO class 5 environment and in accordance with all provisions of this rule except in an emergency situation when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized as documented in the patient's medical record.

(3) Patient training

(a) Whenever possible, a prescriber shall be involved in discussing with each patient receiving a low-risk sterile compounded product, or the caregiver of such individual, the following matters:

(i) Dosage form, dosage, route of administration, and duration of drug therapy;

(ii) Special directions and precautions for preparation and administration;

(iii) Stability or incompatibilities of the medication.

(4) Quality assurance

(a) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities. At a minimum, there shall be written quality assurance programs developed that address:

(i) Adequate training and continuing competency monitoring, including an initial skills assessment and examination as well as annual assessments of compounding personnel in all of the following areas:

(a) Personal cleansing including proficiency of proper hand hygiene;

(b) Proper attire;

(c) Aseptic technique;

(d) Proper clean room conduct; and

(e) Clean room disinfecting procedures.

(ii) Continued verification of compounding accuracy including physical inspection of end products.

(iii) Continued verification of automated compounding devices.

(iv) End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected.

(b) Instructors shall have the appropriate knowledge and experience necessary to conduct the training.

(c) All clean rooms and other primary engineering devices shall have environmental monitoring performed at least every six months to certify operational efficiency. There shall be a plan in place for immediate corrective action if operational efficiency is not certified. Records certifying operational efficiency shall be maintained for at least three years.

(5) Personal protective equipment (PPE)

(a) The following PPE is required for compounding sterile drug products:

(i) Sterile powder-free gloves;

(ii) Gowns, head, hair, and shoe covers.

(E) For non-sterile compounded drugs, the prescriber shall comply with the United States Pharmacopeia Chapter <795> , USP 39-NF 34, or any official supplement thereto (6/30/2016).

(F) For low-risk with greater than twelve hour beyond use date, allergen extracts, medium and high-risk sterile compounded drugs as defined in United States Pharmacopeia Chapter <797> , the prescriber shall comply with United States Pharmacopeia Chapter <797> , USP 38 - NF 33, or any official supplement thereto ( 6/30/2016). For immediate use compounded drugs, the prescriber shall comply with rule 4729-16-13 of the Administrative Code.

(G) For hazardous compounded drugs, the prescriber shall comply with rule 4729-16-11 of the Administrative Code.

(H) A prescriber may designate an appropriately trained agent to assist the prescriber in the compounding of drugs.

(I) For all compounded drugs prepared pursuant to this rule, the prescriber shall:

(1) Inspect and approve the compounding process.

(2) Perform the final check of the finished product

(J) Paragraph (I) of this rule does not apply if either:

(1) A compounded product is being administered to a patient in the facility by a licensed health professional in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, at least two licensed personnel approved by the responsible person to prepare or administer compounded drugs complies with the requirements in paragraph (K) of this rule; or

(2) a compounded drug product is being prepared and administered to a patient in the facility by a registered nurse in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, the same registered nurse complies with paragraph (K) of this rule.

(K) The following are required prior to the administration of a compounded drug product in accordance with paragraphs (J)(1) and (J)(2) of this rule:

(1) Verify patient identification using at least two identifiers (e.g., medical record number, DOB).

(2) Confirm with the patient his/her planned treatment, drug route, and symptom management.

(3) Verify the accuracy of:

(a) Drug name;

(b) Drug strength and dosage form ;

(c) Drug volume;

(d) Rate of administration;

(e) Route of administration;

(f) Expiration dates/times;

(g) Appearance and physical integrity of the drugs.

(4) Sign using positive identification pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code to indicate verification was completed;

(5) A licensed prescriber is on site and immediately available.

(L) For all compounded drug products, the prescriber shall be responsible for:

(1) All compounding records pursuant to rule 4729-16-06 of the Administrative Code, including positive identification requirements pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code;

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

(3) Ensuring aseptic technique for the preparation of all compounded drug products.

(M) A compounded drug that is personally furnished by a prescriber must be labeled according to rule 4729-5-17 of the Administrative Code and must include the appropriate beyond use date, in accordance with United States Pharmacopeia Chapter <797> or <795> and complete list of ingredients. The statement "Compounded Drug Product" or other similar statement shall also be displayed prominently on the label.

(N) A prescriber shall not compound drugs for anticipated needs or engage in compounding practices where multiple non-patient specific doses are produced in a single activity.

(O) The prescriber shall comply with the drug database reporting requirements for Chapter 4729-37 of the Administrative Code.

(P) This rule does not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of the Revised Code. If preparing or handling compounded hazardous drugs, a prescriber who is a veterinarian shall comply with rule 4729-16-11 of the Administrative Code.

Effective: 4/1/2017
Five Year Review (FYR) Dates: 05/01/2021
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.55, 4729.01, 4729.54, 4729.541
Prior Effective Dates: 5/1/2016

4729-16-05 Drugs compounded in a fluid therapy pharmacy.

(A) For all non-sterile compounded prescriptions, the fluid therapy pharmacy shall comply with the United States pharmacopeia chapter <795> (01/01/2014).

(B) For all sterile compounded prescriptions, the fluid therapy pharmacy shall comply with the United States pharmacopeia chapter <797> (08/01/2014).

(C) When prepared in a fluid therapy pharmacy, drugs shall be dispensed by a pharmacist pursuant to an original patient-specific order issued by a prescriber.

(D) All prescriptions shall be issued pursuant to rule 4729-5-30 of the Administrative Code.

(E) All prescriptions shall be processed pursuant to rule 4729-5-21 of the Administrative Code.

(F) All drug orders for patients of a fluid therapy pharmacy shall include, but are not limited to, at least the following:

(1) Name and address of the patient;

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

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

(4) Date prescribed;

(5) Prescriber's positive identification;

(6) Length of therapy or total quantity to be dispensed.

(G) When prepared in a fluid therapy pharmacy, no compounded parenteral product prescription may be dispensed unless a label is affixed to the container in which such drug is dispensed and such label includes:

(1) The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(2) The telephone number of the pharmacy;

(3) The full name of the patient for whom the drug is prescribed;

(4) The full name of the prescriber;

(5) Directions for use of the drug which must include route of administration;

(6) The date of dispensing;

(7) Any cautions which may be required by federal or state law;

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

(9) The name and volume of the parenteral solution;

(10) The quantity of drug dispensed, if appropriate;

(11) Beyond use date;

(12) Storage conditions.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.06, 3719.07, 4729.37

4729-16-06 Recordkeeping for compounding.

(A) This rule applies to all of the following:

(1) Drugs compounded in a pharmacy, including a fluid therapy pharmacy; and

(2) Drugs compounded by a prescriber pursuant to rule 4729-16-04 of the Administrative Code.

(B) The responsible pharmacist or prescriber shall maintain the following records:

(1) A record of all drugs purchased, the quantity received, and the name, address, and wholesale or terminal distributor of dangerous drugs license number of the person from whom the drugs were purchased.

(2) All drug orders and records, including logs, relating to the compounding of drugs. Such drug orders and records may be retained by any process providing an exact duplicate of the original order or prescription. In addition, if an alternate recordkeeping system is utilized, these records may be stored on any storage medium that meets industry standards for quality or any other mutually acceptable method and has stability for a period of at least three years. Records on an automated data processing system, or subsequent storage of such records, must be readily retrievable within seventy-two hours.

(3) Records of drugs dispensed or personally furnished shall include, but are not limited to:

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

(b) The date of dispensing or personally furnishing;

(c) The name of the patient to whom, or for whose use, the drug was dispensed or personally furnished;

(d) Positive identification pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code for all pharmacists or prescribers involved in each function of dispensing or personally furnishing; and

(e) Except as provided in paragraph (E) of this rule, disposal record of any unused drug(s).

(4) All other records relating to the compounding of drugs, other than dispensing or personally furnishing, shall include, but are not limited to:

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

(b) The activity performed;

(c) Documentation of all personnel involved in each function of the activity.

(5) A record of all drugs compounded which shall include at least the following:

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

(b) Quantity of drug(s) added to each container;

(c) Except as provided in paragraph (E) of this rule, disposition of unused drug(s) and amount;

(d) Manufacturer's lot number or distributors control number;

(e) Manufacturer's or distributor's name, if a generic drug is used and the record keeping system is capable of specifically tracking the manufacturer's or distributor's name as part of the documentation;

(f) Pharmacy control number, if prepared in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;

(g) Date of compounding;

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

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

(j) Positive identification of the registered pharmacist or prescriber responsible for the compounding or repackaging of each drug product.

(C) All records must provide accountability and ensure that patients do not receive more drugs than intended by the prescriber. All records shall be readily retrievable and uniformly maintained in an unalterable and secure manner for at least three years from the date of the last dispensing or personal furnishing.

(D) An outsourcing facility shall comply with recordkeeping requirements pursuant to rule 4729-16-02 of the Administrative Code.

(E) Paragraphs (B)(3)(e) and (B)(5)(c) of this rule do not apply to a hospital registered with the department of health under section 3701.07 of the Revised Code.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.541, 4729.55, 3719.07, 4729.37

4729-16-07 Drugs compounded for human use at an in-state pharmacy for direct administration by a prescriber.

(A) This rule applies to compounded drugs products for human use.

(B) The following requirements do not apply to:

(1) A nuclear pharmacy that compounds radiopharmaceuticals. A radiopharmaceutical must be prepared pursuant to Chapter 4729-15 of the Administrative Code.

(2) An outsourcing facility as defined in rule 4729-16-01 of the Administrative Code. An outsourcing facility must comply with the requirements of rule 4729-16-02 of the Administrative Code.

(3) A non-resident pharmacy as defined in rule 4729-16-01 of the Administrative Code. A nonresident pharmacy shall comply with the requirements of rule 4729-16-08 of the Administrative Code.

(4) An in-state pharmacy granted an exemption pursuant to rule 4729-16-10 of the Administrative Code.

(C) For all non-sterile compounded drug products, the in-state pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(D) For all sterile compounded drug products, the in-state pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(E) A pharmacist working at an in-state pharmacy as defined in rule 4729-16-01 of the Administrative Code licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific 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:

(1) 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.

(2) The in-state 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.

(F) The in-state pharmacy shall not supply more than a seventy-two hour supply of a non-patient specific compounded drug to a prescriber at a single location. A prescriber shall not have more than a seventy-two hour supply of a compounded drug at a single location 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 products for topical administration, pursuant to paragraphs ( E)(2)(b) and ( E)(2)(c) of this rule, shall be supplied to a prescriber in which the quantity does not exceed sixty grams or sixty milliliters at a single location. A prescriber shall not have more than sixty grams or sixty milliliters of a specific compounded drug at a single location at any given time; or

(2) Compounded non-sterile drug products intended to treat an emergency situation, pursuant to paragraph ( E)(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.

(G) The in-state pharmacy shall not sell a compounded drug to another pharmacy or wholesaler.

(H) Prescribers shall only administer a requested non-patient specific compounded drug directly to their own patients. Prescribers shall not:

(1) Dispense or personally furnish 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.

(I) The labeling of a compounded drug product 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;

(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;and

(11) The statement "Compounded Drug Product" or other similar statement.

(J) Compounded drug product containers that are too small to bear a complete label pursuant to paragraph ( I) 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), including all active ingredients;;

(5) The drug strength(s);

(6) The route of administration;

(7) The pharmacy control number;

(8) The pharmacy name.

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

(L) The sale of a compounded drug product 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.

(M) A pharmacy shall follow the compounding requirements pursuant to rules 4729-16-03 and 4729-16-06 of the Administrative Code current professional compounding standards, and all applicable federal and state laws, rules, and regulations.

(N) No in-state pharmacy shall sell any amount of non-patient specific prescriber administered compounds for human use in excess of five per cent of the total amount of compounded drug products sold and/or dispensed from their pharmacy. The five per cent limitation shall be calculated on an annual basis and shall reference the number of dosage units. If the five per cent limitation is exceeded, then the pharmacy must apply to become an outsourcing facility pursuant to rule 4729-16-02 of the Administrative Code.

Effective: 2/22/2016
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.01, 4729.54, 4729.55, 4729.541
Prior Effective Dates: 5/1/2015

4729-16-08 Drugs compounded by a nonresident pharmacy.

(A) For all non-sterile compounded drug products, the pharmacy shall comply with chapter <795> of the United States pharmacopeia, USP 38 - NF 33, or any official supplement thereto (09/01/2015).

(B) For all sterile compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (09/01/2015).

(C) A nonresident pharmacy may provide licensed veterinarians non-patient specific compounded drugs for animal use, pursuant to rule 4729-16-12 of the Administrative Code. Such compounding for office use shall comply with applicable federal laws and regulations.

(D) Except as provided in paragraph (C) of this rule, a nonresident pharmacy as defined in rule 4729-16-01 of the Administrative Code is prohibited from shipping compounded drugs into Ohio unless it is pursuant to a patient specific prescription.

(E) A nonresident pharmacy as defined in rule 4729-16-01 of the Administrative Code shall meet all of the following in order to ship, mail, or deliver, in any manner, compounded drugs into Ohio:

(1) Obtain licensure as a nonresident terminal distributor of dangerous drugs pursuant to Chapter 4729-10 of the Administrative Code.

(2) If the nonresident pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or their license has lapsed, they must provide one of the following, in a manner prescribed by the board, with their application:

(a) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule conducted by an agent of the regulatory or licensing agency in the pharmacy's resident jurisdiction or an agent of a regulatory or licensing agency from another licensing jurisdiction; or

(b) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule by the national association of boards of pharmacy's verified pharmacy program as defined in rule 4729-16-01 of the Administrative Code;

(c) The most recent inspection report that is less than two years old that demonstrates compliance with paragraphs (A) and (B) of this rule conducted by accreditation commission for health care inspection services (a.k.a. ACHC inspection services or AIS); or

(d) Proof of a current pharmacy compounding accreditation board (PCAB) accreditation provided by the accreditation commission for health care (ACHC).

(F) Notwithstanding submission of an inspection report from a source acceptable to the board, the board may deny an application or suspend a license on the grounds that the nonresident pharmacy failed to comply with applicable laws or regulations. The nonresident pharmacy would have the opportunity for a hearing before the board.

(G) The board may grant a one-year, one-time extension to nonresident pharmacies in the event an inspection report is not available at the time of application or renewal and documentation is presented verifying intent to comply with this rule.

(H) A nonresident pharmacy is required to report to the state board of pharmacy immediately upon discovery, by telephone and follow-up in writing within thirty days, any of the following:

(1) A violation of section 4729.16 of the Revised Code or any other violation of the Ohio Revised Code or Ohio Administrative Code that could potentially cause patient harm;

(2) A citation or violation against the nonresident pharmacy or the owner(s), responsible person, agent, employee or officer of the nonresident pharmacy by any pharmacy regulatory or licensing agency that results in any the following:

(a) Monetary penalty;

(b) Administrative hearing;

(c) Suspension or revocation of a license; or

(d) Violations of laws or regulations that could potentially cause patient harm.

(3) Any criminal conviction(s) of the owner(s), responsible person, agent, employee or officer of the nonresident pharmacy.

(4) Any adverse event related to improper compounding or product defect.

(I) Failure to report the required information in paragraph ( H) of this rule may result in a monetary penalty and/or the suspension, revocation, or refusal to grant or renew a license as a terminal distributor of dangerous drugs.

(J) This rule does not apply to a nuclear pharmacy that compounds radiopharmaceuticals pursuant to rule 4729-15-01 of the Administrative Code.

Effective: 2/15/2016
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.54, 4729.55, 4729.01
Prior Effective Dates: 5/1/2015

4729-16-09 Terminal distributor licenses for compounding drugs and ordering compounded drugs.

(A) Except as provided in paragraph (B) of this rule, a licensed wholesale distributor or terminal distributor of dangerous drugs is prohibited from selling, shipping, mailing, or delivering dangerous drugs that are compounded or used for the purpose of compounding to a location licensed in Ohio unless the location is licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

(B) Beginning April 1, 2015, a licensed wholesale distributor or terminal distributor of dangerous drugs is prohibited from selling, shipping, mailing, or delivering dangerous drugs that are compounded or used for the purpose of compounding to a business entity described in division (B)(1)(j) or (B)(1)(k) of section 4729.51 of the Revised Code unless that business entity is licensed as a terminal distributor of dangerous.

(C) Beginning April 1, 2015, a business entity described in division (B)(1)(j) or (B)(1)(k) of section 4729.51 of the Revised Code shall hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, and distribute dangerous drugs that are compounded or used for the purpose of compounding.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.541, 4729.55, 4729.54 , 4729-52, 4729.53

4729-16-10 In-state pharmacy compounding for drug shortages.

(A) In the event of a drug shortage as defined in rule 4729-16-01 of the Administrative Code, an in-state pharmacy may request an exemption from rule 4729-16-07 of the Administrative Code from the state board of pharmacy.

(B) Upon provision of an exemption, a pharmacist working at an in-state pharmacy, as defined in rule 4729-16-01 of the Administrative Code, licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific drug pursuant to a request made by a medical director of an in-state health care facility, as defined in rule 4729-16-01 of the Administrative Code, for a drug that is to be used by the facility for the purpose of direct administration to patients.

(C) In order to obtain an exemption, the responsible pharmacist for the in-state pharmacy and the medical director of an in-state health care facility or Ohio licensed pharmacist who is authorized by the in-state health care facility to act on behalf of the medical director must notify the executive director of the state board of pharmacy in a manner prescribed by the board.

(D) The executive director may, on behalf of the board, place restrictions on the exemption including, but not limited to, the following:

(1) A limit on the quantity of the drug(s) compounded without a patient specific prescription by the in-state pharmacy;

(2) A limit on the time the exemption shall be in effect;

(E) The board shall review each exemption notification provided to the executive director and may place restrictions on the exemption including, but not limited to, the following:

(1) A limit on the quantity of the drug(s) compounded without a patient specific prescription by the in-state pharmacy; and

(2) A limit on the time the exemption shall be in effect.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 3719.28
Rule Amplifies: 4729.01

4729-16-11 Hazardous drugs compounded by a prescriber.

(A) A facility where a prescriber is compounding or handling hazardous drugs shall be licensed as a terminal distributor of dangerous drugs. The responsible person on the license shall be an Ohio licensed prescriber as defined in section 4729.01 of the Revised Code and is responsible for all the following:

(1) Developing and implementing appropriate policies and procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with section 503A of the Federal Food, Drug, and Cosmetic Act (05/09/2015) and all other applicable federal and state laws and rules;

(4) Ensuring competency of personnel; and

(5) Assuring environmental control of the compounding areas.

(B) A prescriber who compounds or handles hazardous drugs as defined in rule 4729-16-01 of the Administrative Code shall meet all of the following requirements:

(1) Policy and procedures

(a) A policy and procedure manual shall be prepared, maintained, and reviewed regularly by the responsible person regarding the compounding, safe handling, personally furnishing, and administration of hazardous drugs. The policy and procedure manual shall include a quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education. The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy designated agent.

(2) Physical requirements

(a) Sterile compounded hazardous drugs shall be compounded within a containment primary engineering control (C-PEC) that meets all of the following requirements:

(i) Provides an ISO class 5 or better air quality, such as a class II or III biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). Class II BSC types B1 or B2 are acceptable.

(ii) Uses a high-efficiency particulate air filter (HEPA filter) for the exhaust from the control.

(iii) The C-PEC shall be externally vented in a manner where air is not pulled back into the facility by the heating, ventilating, and air conditioning (HVAC) systems or by the windows, doors, or other points of entry. Fans shall be placed downstream of the HEPA filter so that contaminated ducts are maintained under negative pressure.

(iv) Paragraph (B)(2)(a)(iii) of this rule is effective December 1, 2020 or upon any new construction or substantial modifications to the C-PEC or containment secondary engineering control (C-SEC), whichever is earlier. The board may grant a prescriber an extension of the external venting requirements if the board determines, upon petition by the prescriber, that the prescriber is unable to make any structural modifications due to an existing building lease agreement. Any prescriber granted an extension shall provide to the board documentation demonstrating how the prescriber will meet the external venting requirements of this rule by the extension date approved by the board.

(b) Nonsterile hazardous drugs shall be compounded in a C-PEC that is either an externally vented or a redundant-HEPA filtered in series. Nonsterile hazardous compounding must be performed in a C-PEC that provides personnel and environmental protection, such as a "Class I Biological Safety Cabinet (BSC)" or "Containment Ventilated Enclosure" (CVE). A class II BSC or a compounding aseptic containment isolator (CACI) may be also be used. For occasional nonsterile hazardous drug compounding, a C-PEC used for sterile compounding may be used but must be decontaminated, cleaned, and disinfected before resuming sterile compounding in that C-PEC. A C-PEC used only for nonsterile compounding does not need to have unidirectional airflow.

(c) C-PECs used for hazardous drug compounding shall be located in a containment secondary engineering control (C-SEC). The C-SEC shall be one of the following:

(i) For nonsterile hazardous drugs and sterile hazardous compounded drugs with a beyond use date that does not exceed twelve hours, a unclassified containment segregated compounding area (C-SCA) that meets all of the following:

(a) Isolated from other areas and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled area.

(b) Be of sufficient size to accommodate the containment primary engineering control and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

(c) If the C-PECs used for sterile and nonsterile compounding are placed in the C-SCA, they must be placed at least 3 feet apart and particle-generating activity must not be performed when sterile compounding is in process.

(d) Has a sink or wash station available for hand washing as well as emergency access to water for removal of hazardous substances from eyes and skin.

(ii) For sterile hazardous compounded drugs with a beyond use date that exceeds twelve hours, a containment secondary engineering control in accordance with the United States Pharmacopeia Chapter <797> USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(d) A C-PEC and C-SEC used for the preparation of hazardous drugs shall not be used for the preparation of a non-hazardous drug.

(e) The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(f) The facility shall have sufficient current reference materials related to sterile products to meet the needs of the facility staff.

(3) Environmental quality and control

(a) Environmental wipe sampling should be performed at least every six months. Common hazardous drug markers that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil and platinum-containing drugs.

(b) Surface wipe sampling should include:

(i) Interior of the C-PEC and equipment contained in it;

(ii) Staging or work areas near the C-PEC;

(iii) Areas adjacent to C-PECs (e.g., floors directly under staging and dispensing area);

(iv) Patient administration areas.

(c) If any measurable contamination is found, the responsible person shall identify, document, and contain the cause of contamination. The facility shall perform thorough deactivation (using an appropriate deactivating agent) decontamination and cleaning. The facility shall also consider the following steps to prevent further contamination:

(i) Reevaluating work practices;

(ii) Re-training personnel; and

(iii) Improving engineering controls.

(4) Personal protective equipment (PPE) and safety techniques

(a) PPE includes, but is not limited to, gloves, gowns, head covers, hair covers, shoe covers, eye/face protection.

(i) Gloves, gowns, head, hair, and shoe covers are required for compounding sterile and nonsterile hazardous drugs.

(ii) Chemotherapy gloves are required for compounding, handling and administering hazardous drugs. Sterile chemotherapy gloves are required for compounding of sterile hazardous drugs. Personnel should use double gloving for all activities involving hazardous drugs making sure that the outer glove extends over the cuff of the gown.

(iii) Gowns are required when compounding, handling and administering injectable antineoplastic hazardous drugs.

(iv) For all other activities, the facility's policy procedure manual must describe the appropriate PPE to be worn. The facility must develop policy and procedures for PPE based on the risk exposure and activities performed. Appropriate PPE must be worn handling hazardous drugs during the following:

(a) Receipt

(b) Storage

(c) Transport

(d) Compounding

(e) Administration

(f) Deactivation or decontamination, cleaning, and disinfecting

(g) Spill control

(v) Chemotherapy gloves must be tested to ASTM standard D6978 (or its successor) and must be powder-free. Gloves must be inspected for physical defects before use and must be changed every thirty minutes or when torn, punctured, or contaminated.

(b) All personnel handling hazardous drugs or hazardous drug waste shall wash hands with soap and water before donning protective gloves and immediately after removal.

(c) Disposable gowns shall be tested and shown to resist permeability by hazardous drugs. Gowns shall close in the back (i.e., no open front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns shall not have seams or closures that could allow hazardous drugs to pass through. Cloth laboratory coats, surgical scrubs, isolation gowns, or other absorbent materials shall not be worn as outerwear when handling hazardous drugs. Gowns shall be changed per the manufacturer's information for permeation of the gown. If no permeation information is available for the gowns used, they shall be changed every two to three hours or immediately after a spill or splash. Gowns worn in hazardous drug handling areas shall not be worn to other areas.

(d) Appropriate eye and face protection must be worn when there is a risk for spills or splashes of hazardous drugs or hazardous drug waste materials (examples include, but are not limited to: administration in a surgical suite, cleaning the C-PEC, working at or above eye level or cleaning a spill). A full-face piece respirator provides eye and face protection. Goggles shall be used when eye protection is needed. Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes. Face shields in combination with goggles provide a full range of protection against splashes to the face and eyes. Face shields alone do not provide full eye and face protection.

(e) When a hazardous drug preparation is completed, personnel shall:

(i) Seal the final product in a plastic bag or other sealed container for transport before taking it out of the C-PEC.

(ii) Seal and wipe all waste containers inside the C-PEC before removing them from the cabinet.

(f) When the dosage form allows, hazardous drugs shall be administered using a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside of the system.

(g) Hazardous drugs shall be administered safely using protective techniques, including the spiking or priming of IV tubing in the C-PEC and crushing hazardous tablets in plastic sleeves.

(5) Respiratory protection

Personnel shall use an appropriately fitted national institute for occupational safety approved N95 or equivalent respiratory protection during spill cleanup and whenever there is a significant risk of inhalation exposure to hazardous drug particulates. Surgical masks do not provide respiratory protection from drug exposure and shall not be used.

(6) Disposal of used personal protective equipment (PPE)

All personal protective equipment worn when handling hazardous drugs shall be placed in an appropriate waste container and further disposed of per local, state, and federal regulations. PPE used during compounding should be disposed of in the proper waste container before leaving the C-SEC. Gloves worn during compounding shall be carefully removed and discarded immediately in an approved hazardous waste container inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC. Potentially contaminated clothing shall not be taken home under any circumstances.

(7) Personnel training

(a) All personnel who handle hazardous drugs shall be fully trained based on their job functions (e.g., in the receipt, storage, handling, compounding, dispensing, and disposal of hazardous drugs). Training shall occur before the employee independently handles hazardous drugs. The effectiveness of training for hazardous drugs handling competencies must be demonstrated by each employee. Personnel competency must be reassessed at least every twelve months and when a new hazardous drug or new equipment is used or a new or significant change in process or standard operating procedure occurs. All training and competency assessment must be documented. The training must include at least the following:

(i) Review of the entity's policies and procedures related to handling of hazardous drugs;

(ii) Proper use of PPE;

(iii) Proper use of equipment and devices (e.g., engineering controls);

(iv) Spill management; and

(v) Response to known or suspected hazardous drug exposure.

(b) Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs.

(c) Personnel who handle hazardous drugs shall be reminded that they should undergo medical examinations annually to update their medical, reproductive, and exposure histories. The examinations should be complete, but the skin, mucous membranes, cardiopulmonary and lymphatic systems, and liver should be emphasized.

(8) Facilities

Access to areas where hazardous drugs are unpacked, stored and prepared shall be restricted to authorized staff to protect persons not involved in hazardous drug handling. The location of the hazardous drug compounding area shall be located away from break rooms and refreshment areas for staff, patients, or visitors to reduce risk of exposure. Signs designating the hazard shall be prominently displayed before entry into the hazardous drug area.

(9) Receipt of hazardous drugs

Appropriate PPE shall be used when unpacking hazardous drugs from their shipping containers.

(10) Storage of hazardous drugs

(a) Hazardous drugs shall be stored in a manner that prevents spillage or breakage if the container falls. Hazardous drugs shall not be stored on the floor.

(b) Hazardous drugs shall be stored separately from other inventory.

(c) Hazardous drugs shall be stored in a manner to prevent contamination and personnel exposure.

(11) Decontamination, deactivation, cleaning and disinfection

All areas where hazardous drugs are handled (including during receiving, storage, compounding, transport, administering, and disposal) and all reusable equipment and devices (e.g., C-PEC, carts, and trays) shall be routinely deactivated (using an appropriate deactivating agent for the type of hazardous drugs compounded), decontaminated and cleaned. Additionally, sterile compounding areas and devices must be subsequently disinfected. Equipment used to perform deactivation, cleaning, and disinfection shall not be used in areas where hazardous drugs are not handled. The facility shall establish written procedures for decontamination, deactivation, cleaning, and disinfection (for sterile compounding areas).

(12) Spill control

(a) All personnel who may be required to clean-up a spill of hazardous drugs shall receive proper training in spill management and the use of PPE. Spills shall be contained and cleaned immediately only by qualified personnel with appropriate PPE. Qualified personnel must be available at all times in facilities handling hazardous drugs. Signs must be available for restricting access to the spill area. Spill kits containing all of the materials needed to clean hazardous drug spills shall be readily available in all areas where hazardous drugs are routinely handled. If hazardous drugs are being prepared or administered in a non-routine healthcare area, a spill kit and respirator shall be available. All spill materials shall be disposed of as hazardous waste.

(b) Personnel who are potentially exposed during the spill or spill clean-up or who have direct skin or eye contact with hazardous drugs require immediate evaluation by a health care professional. Non-employees exposed to a hazardous drug spill should report to the designated emergency service for initial evaluation and also complete an incident report or exposure form.

(13) Disposal

(a) Disposal of all hazardous drug waste (including unused and unusable hazardous drugs) must comply with all applicable federal, state, and local regulations. All personnel who perform routine custodial waste removal and cleaning activities in hazardous drug handling areas must be trained in appropriate procedures to protect themselves and the environment to prevent hazardous drug contamination.

(b) All syringes and needles used in the course of preparation shall be placed in appropriate hazardous waste containers for hazardous disposal without being crushed or clipped.

(14) Maintenance personnel

Personnel that are charged with cleaning the facility shall wear the appropriate personal protective equipment, including appropriate use of gloves or gowns if they handle linens, feces or urine from patients who have received hazardous drugs within the last forty-eight hours. Appropriate eye and face protection shall be worn if splashing is possible.

(15) Patient training

Whenever possible, a prescriber shall be involved in discussing with each patient a hazardous compounded drug, or the caregiver of such individual, the following matters:

(a) Dosage form, dosage, route of administration, and duration of drug therapy;

(b) Special directions and precautions for preparation and administration;

(c) Stability or incompatibilities of the medication.

(16) Quality assurance

(a) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities. At a minimum, there shall be written quality assurance programs developed that address:

(i) Adequate training and continuing competency monitoring, including an initial skills assessment and examination as well as annual assessments, of compounding personnel in all of the following areas:

(a) Personal cleansing including proficiency of proper hand hygiene;

(b) Proper attire;

(c) Aseptic technique;

(d) Proper clean room conduct; and

(e) Clean room disinfecting procedures.

(ii) Continued verification of compounding accuracy including physical inspection of end products.

(iii) Continued verification of automated compounding devices.

(iv) End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected.

(b) Instructors shall have the appropriate knowledge and experience necessary to conduct the training.

(c) All clean rooms and other primary engineering devices shall have environmental monitoring performed at least every six months to certify operational efficiency. There shall be a plan in place for immediate corrective action if operational efficiency is not certified. Records certifying operational efficiency shall be maintained for at least three years.

(17) Packaging and transport

(a) Compounding personnel must select and use packaging containers and materials that will maintain physical integrity, stability, and sterility (if needed) of the hazardous drugs during transport. Packaging materials must protect the hazardous drug from damage, leakage, contamination, and degradation, while protecting healthcare workers who transport hazardous drugs. The entity shall have written standard operating procedures to describe appropriate shipping containers and insulating materials, based on information from product specifications, vendors, mode of transport, and experience of the compounding personnel.

(b) Hazardous drugs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. Hazardous drugs must be transported in containers that minimize the risk of breakage or leakage. Pneumatic tubes must not be used to transport any liquid or antineoplastic hazardous drugs because of the potential for breakage and contamination.

(C) Records of hazardous drug compounding shall be kept pursuant to rule 4729-16-06 of the Administrative Code.

(D) A hazardous compounded drug that is personally furnished by a prescriber must be labeled according to rule 4729-5-17 of the Administrative Code and must include the appropriate beyond use date, in accordance with United States Pharmacopeia Chapters <797> or <795> USP 38 - NF 33, or any official supplement thereto (9/10/2015) and complete list of ingredients. The statement "Hazardous Compounded Drug Product" shall also be displayed prominently on the label.

(E) A prescriber shall not compound hazardous drugs in anticipation of prescriptions based on routine prescribing patterns.

(F) A licensed prescriber is required to perform the final check of the finished hazardous compounded drug prior to it being personally furnished or administered to a patient.

(G) Paragraph (F) of this rule does not apply if a hazardous compounded drug is being administered to a patient in the facility by a licensed health professional in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, at least two licensed healthcare personnel approved by the responsible person to prepare or administer compounded drugs do all of the following:

(1) Verify patient identification using at least two identifiers (e.g., medical record number, DOB);

(2) Confirm with the patient his/her planned treatment, drug route, and symptom management;

(3) Verify the accuracy of the following:

(a) Drug name

(b) Drug dose

(c) Drug volume

(d) Rate of administration

(e) Route of administration

(f) Expiration dates/times

(g) Appearance and physical integrity of the drugs

(4) Sign using positive identification pursuant to rule 4729-5-01 of the Administrative Code to indicate verification was completed;

(5) Extravasation management procedures are defined;

(6) Antidote order sets and antidotes are accessible; and

(7) A licensed prescriber is on-site and immediately available.

(H) A prescriber may designate an appropriately trained agent to assist the prescriber in the compounding of hazardous drugs.

(I) For non-sterile hazardous compounded drugs, the prescriber shall also comply with the United States Pharmacopeia Chapter <795> USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(J) Sterile hazardous compounded drugs prepared with beyond use dates greater than 12 hours, shall comply with beyond use dating in accordance with the United States Pharmacopeia Chapter <797> USP 38 - NF 33, or any official supplement thereto (9/10/2015).

Effective: 5/1/2016
Five Year Review (FYR) Dates: 05/01/2021
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.55, 4729.01, 4729.54, 4729.541

4729-16-12 Drugs compounded by a pharmacy for use by a veterinarian.

(A) This rule only applies to compounded drugs intended for animal use by a licensed veterinarian.

(B) For all non-sterile compounded products, the pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(C) For all sterile compounded products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(D) In accordance with applicable federal laws and regulations, a pharmacist working at an pharmacy licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific drug pursuant to a request made by a veterinarian, or by an agent of the veterinarian, for a drug to be used by the veterinarian for the purpose of the direct administration to patients in the course of the veterinarian's practice pursuant to division (C)(5) of section 4729.01 of the Revised Code and the following:

(1) The pharmacy shall only provide compounded drug products that are not commercially available, as defined division (C)(5) of section 4729.01 of the Revised Code, to a veterinarian which are needed:

(a) To treat an emergency situation;

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

(c) For diagnostic purposes.

(2) A limited quantity of the drug is compounded and provided to the veterinarian. "Limited quantity" means a quantity of a compounded drug that meets the following:

(a) Is sufficient for that veterinarian's office use consistent with the beyond use date of the product;

(b) Is reasonable considering the intended use of the compounded medication and nature of the veterinarian's practice; and

(c) The pharmacist who provides the veterinarian with a compounded drug exercises their professional judgment as to whether the quantity of the drug is appropriate.

(E) A veterinarian may personally furnish up to a seven day supply of a compounded drug to a patient when, in their professional judgment, failure to provide the drug would result in potential harm to the patient.

(F) The pharmacy shall not sell a compounded drug to another pharmacy or wholesaler.

(G) Veterinarians shall not:

(1) Sell a compounded drug to another prescriber;

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

(3) Return a compounded drug to the supplying pharmacy, unless there is a documented error or recall.

(H) The labeling of a compounded drug product must contain the following:

(1) Proper storage conditions;

(2) Beyond use dates;

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

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

(5) The quantity of compounded drug provided;

(6) The route of administration;

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

(8) The pharmacy control number assigned to the compounded drug product.

(9) The statement "Compounded Drug Product" or other similar statement.

(I) Compounded drug product containers that are too small to bear a complete label pursuant to paragraph (H) of this rule must bear a label that contains at least the following information:

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

(2) The beyond use date;

(3) The drug name(s), including all active ingredients;

(4) The drug strength(s);

(5) The route of administration;

(6) The pharmacy control number;

(7) The pharmacy name.

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

(K) The sale of a compounded drug product 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.

(L) A pharmacy shall follow the compounding requirements pursuant to rules 4729-16-03 and 4729-16-06 of the Administrative Code, current professional compounding standards, and all applicable federal and state laws, rules, and regulations.

(M) No pharmacy shall sell any amount of non-patient specific veterinarian administered compounds in excess of five per cent of the total amount of drug products sold and/or dispensed from their pharmacy. The five per cent limitation shall be calculated on an annual basis and shall reference the number of dosage units. For non-resident pharmacies, the total amount sold and/or dispensed shall reference the pharmacy's total business within this state.

Effective: 2/22/2016
Five Year Review (FYR) Dates: 02/22/2021
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.55, 4729.01, 4729.54, 4729.541

4729-16-13 Immediate use non-hazardous sterile drugs compounded by a prescriber.

(A) A facility where a prescriber is compounding dangerous drugs for immediate use shall be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.541 of the Revised Code. The responsible person on the license shall be an Ohio licensed prescriber as defined in section 4729.01 of the Revised Code and is responsible for all of the following:

(1) Developing and implementing appropriate procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with section 503A of the Federal Food, Drug, and Cosmetic Act (05/09/2015) and all other applicable federal and state laws and rules;

(4) Ensuring competency of compounding personnel; and

(5) Ensuring that compounded drug products maintain their quality and sterility until administered.

(B) Immediate use sterile compounded drug products are exempt from the requirements in rule 4729-16-04 of the Administrative Code when all of the following criteria are met:

(1) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous drug products from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device.

(2) Personnel shall adhere to appropriate aseptic technique, including all of the following:

(a) Before beginning compounding activities, personnel shall perform a thorough hand-hygiene procedure; and

(b) Compounding personnel shall don powder free gloves prior to engaging in compounding activities.

(3) If not immediately administered, the finished drug product is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compounded drug products, and direct contact of outside surfaces.

(4) Notwithstanding paragraph (B)(1) of rule 4729-9-01 of the Administrative Code, the beyond-use date for an immediate use compounded drug product is no later than six hours following preparation of the drug.

(5) If administration has not begun within the beyond-use dating described in paragraph (B)(4) of this rule, the drug shall be promptly, properly, and safely discarded.

(6) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the compounded drug product shall bear a label listing the exact beyond-use date.

(7) Immediate-use compounded drug products are for administration only and shall not be personally furnished by a prescriber.

(8) For immediate-use compounded drug products administered via injection, a new sterile needle shall be used to administer the compounded drug product to the patient.

(C) Preparations that are medium-risk level and high-risk level compounded drug products as defined in United States Pharmacopeia Chapter <797>, USP 39 - NF 34, or any official supplement thereto (5/1/2016) shall not be prepared as immediate use. Preparations that cannot meet any of the requirements listed in paragraph (B) of this rule shall comply with the requirements in rule 4729-16-04 of the Administrative Code.

(D) Sterile compounded drug products for immediate use shall be prepared in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed. Cleaning and disinfecting of areas within the designated area including counters, easily cleanable work surfaces and floors shall occur each business day. If compounding is done less frequently than each business day (e.g., once a week or once a month), cleaning shall occur before and after each compounding session. Cleaning and disinfection agents must be selected and used with careful consideration of compatibilities, effectiveness, and inappropriate or toxic residues.

(E) A prescriber may designate an appropriately trained agent to assist the prescriber in the preparation of the sterile drug products.

(F) For all compounded drugs prepared pursuant to this rule, the prescriber shall:

(1) Inspect and approve the compounding process.

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

(G) Paragraph (F) of this rule does not apply if either:

(1) A compounded product is being administered to a patient in the facility by a licensed health professional in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, at least two licensed personnel approved by the responsible person to prepare or administer compounded drugs complies with the requirements in paragraph (H) of this rule.

(2) A compounded drug product is being prepared and administered to a patient in the facility by a registered nurse in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, the same registered nurse complies with paragraph (H) of this rule.

(H) The following are required prior to the administration of a compounded drug product in accordance with paragraphs (G)(1) and (G)(2) of this rule:

(1) Verify patient identification using at least two identifiers (e.g., medical record number, DOB).

(2) Confirm with the patient his/her planned treatment, drug route, and symptom management.

(3) Verify the accuracy of:

(a) Drug name;

(b) Drug strength and dosage form;

(c) Drug volume;

(d) Rate of administration;

(e) Route of administration;

(f) Expiration dates/times;

(g) Appearance and physical integrity of the drugs.

(4) Sign using positive identification pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code to indicate verification was completed;

(5) A licensed prescriber is on site and immediately available.

(6) For hazardous compounded drugs, the prescriber shall comply with rule 4729-16-11 of the Administrative Code.

(I) This rule does not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of the Revised Code. If preparing or handling compounded hazardous drugs, a prescriber who is a veterinarian shall comply with rule 4729-16-11 of the Administrative Code.

(J) Immediate-use compounded drug products shall be prepared in accordance with this rule except in an emergency situation, as documented in the medical record, when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized.

(K) A prescriber shall not compound drugs for anticipated needs or engage in compounding practices where multiple non-patient specific doses are produced in a single activity.

Effective: 4/1/2017
Five Year Review (FYR) Dates: 01/01/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.55, 4729.01, 4729.54, 4729.541