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

Chapter 4729:7-3 | Prescriber Compounding

 
 
 
Rule
Rule 4729:7-3-01 | Definitions - prescriber compounding.
 

As used in Chapter 4729:7-3 of the Administrative Code:

(A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms.

(B) "Beyond-use date" or "beyond-use dating" means either the date or time after which a compounded drug preparation must not be used, or administration must not begin, and must be discarded. The beyond-use date is determined from the date/time that preparation of the compounded drug is initiated.

(C) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(D) "Compounding" 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.

(E) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(F) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(G) "Dilution" means a process of reducing the concentration of a solute in solution, usually by mixing with a solvent.

(H) "Hazardous drug" means any antineoplastic drug listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code.

(I) "Immediate use" or "immediate use drug" means the immediate preparation of a sterile non-hazardous compounded drug preparation in accordance with rule 4729:7-3-04 of the Administrative Code.

(J) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(K) "Non-sterile compounded drug" means a dangerous drug preparation intended to be non-sterile. Non-sterile compounded drugs include, but are not limited to, the preparation of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

(L) "Outsourcing facility" means a facility that is engaged in the compounding and sale of sterile drugs, is registered as an outsourcing facility with the United States food and drug administration, and is licensed in accordance with section 4729.52 of the Revised Code.

(M) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting.

(N)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(O) "Preparation" means a drug compounded in a licensed pharmacy or other healthcare-related facility. Preparations may include the compounding of one or more drug products.

(P) "Product" means a drug in a commercially manufactured pharmaceutical dosage form that has been evaluated for safety and efficacy by the United States food and drug administration. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer's labeling or product package insert.

(Q) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(R) "Reconstitution" means the process of adding a diluent to a powdered drug to prepare a solution or suspension.

(S) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

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

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

(V) "United States Pharmacopeia Chapter <795>" or "USP <795>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(W) "United States Pharmacopeia Chapter <797>" or "USP <797>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(X) "United States Pharmacopeia Chapter <800>" or "USP <800>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.51, 4729.53, 4729.54, 4729.541, 4729.55
Five Year Review Date: 3/31/2026
Rule 4729:7-3-02 | Exemptions.
 

(A) Licensing exemptions.

Persons listed in divisions (A)(1) to (A)(3) of section 4729.541 of the Revised Code shall be exempted from licensure as a terminal distributor of dangerous drugs as required in division (D)(1) of section 4729.541 of the Revised Code for any of the following:

(1) The preparation of a device, as defined in Title 21 U.S. Code section 321 (12/13/2016), containing dangerous drugs strictly in accordance with the manufacturer's labeling for administration and beyond-use dating.

(2) The preparation or reconstitution of non-hazardous, conventionally manufactured sterile dangerous drug products for direct administration with no intervening steps in accordance with the manufacturer's labeling for preparation, administration and beyond-use dating.

(3) The compounding, preparation, dilution or reconstitution of non-hazardous, non-sterile dangerous drug preparations.

(4) The possession of compounded dangerous drug preparations provided by an outsourcing facility.

(5) The dilution of non-hazardous, conventionally manufactured sterile dangerous drug products (e.g., diluting or mixing into a syringe to administer directly to the patient).

(B) Exemptions from the requirements of this chapter.

The following non-hazardous devices and drugs prepared by a licensed terminal distributor of dangerous drugs are exempted from the requirements of this chapter:

(1) The preparation of a device, as defined in Title 21 U.S. Code section 321 (12/13/2016), containing dangerous drugs strictly in accordance with the manufacturer's labeling for administration and beyond-use dating. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the device. 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. Unless administered immediately, the drug device described in this paragraph shall bear a label listing the name of the device (if not legible), date, and time prepared.

(2) The reconstitution of a conventionally manufactured sterile dangerous drug product with no intervening steps in accordance with the manufacturer's labeling for administration, and the beyond-use dating indicated on the manufacturer's labeling. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the drug product. If no such beyond use date or timeframe 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. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible), date, and time prepared.

(3) The preparation, 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. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the drug product. If no such beyond-use date exists, the dangerous drug product shall be assigned a beyond-use date in accordance with USP <795>. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible), date, and time prepared.

(4) The dilution of a conventionally manufactured sterile dangerous drug product (e.g., diluting or mixing into a syringe to administer directly to the patient). The drug product 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. The dangerous drug product may only be used for up to six hours following preparation. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug, date, and time prepared.

Last updated April 16, 2021 at 8:24 AM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.51, 4729.53, 4729.54, 4729.541 and 4729.55
Five Year Review Date: 4/16/2026
Rule 4729:7-3-03 | Non-Hazardous Drugs Compounded by a Prescriber.
 

(A) Except as provided in paragraph (L) of this rule, all non-hazardous, non-sterile compounded drug preparations shall be prepared in accordance with United States pharmacopeia chapter <795>.

(B) Except as provided in paragraph (C) of this rule, all non-hazardous, sterile compounded drug preparations, shall be prepared in accordance with United States pharmacopeia chapter <797>.

(C) For all immediate-use, non-hazardous sterile compounded drug preparations, a prescriber shall comply with either:

(1) Rule 4729:7-3-04 of the Administrative Code; or

(2) United States pharmacopeia chapter <797>.

(D) For all hazardous non-sterile and sterile compounded drug preparations, a prescriber shall comply with rule 4729:7-3-05 of the Administrative Code.

(E) The responsible person of a facility where a prescriber is engaged in the compounding of dangerous drugs shall be responsible for all of the following:

(1) Developing and implementing appropriate compounding procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S. Code section 353a (November 27, 2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring documented training and competency of compounding personnel;

(5) Ensuring environmental control of the compounding areas;

(6) Ensuring compounded drug preparations maintain quality and sterility until administered or personally furnished;

(7) Maintaining drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code.

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

(9) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(F) A prescriber may designate an appropriately trained agent to prepare compounded drug preparations.

(G) For all compounded drugs prepared pursuant to this rule, a prescriber shall:

(1) Inspect and approve the compounding process; and

(2) Except as provided in paragraph (H) of this rule, perform medication validation ("final check") prior to the medication being administered.

(H) The requirements of paragraph (G)(2) of this rule do not apply to either of the following:

(1) A compounded drug preparation is being administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, at least two nurses that are approved by the responsible person to prepare or administer compounded drugs comply with the requirements in paragraph (I) of this rule; or

(2) A compounded drug preparation is prepared and administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, the same nurse complies with paragraph (I) of this rule.

(I) All the following are required to administer a compounded drug preparation in accordance with paragraphs (H)(1) and (H)(2) of this rule:

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

(2) Confirm with the patient the patient's 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) Indicate in the compounding record verification was completed;

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

(J) A prescriber shall not compound drug preparations unless a specific patient need exists. Compounding for anticipated needs or engaging in compounding practices where multiple non-patient specific doses are produced in a single activity is prohibited.

(K) A prescriber shall comply with the drug database reporting requirements for personally furnishing drugs pursuant to section 4729.79 of the Revised Code.

(L)

(1) Except as provided for in paragraph (L)(2) of this rule, the requirements of this rule do 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 4729:7-3-05 of the Administrative Code.

(2) A veterinarian engaged in the compounding of sterile and non-sterile drug preparations shall comply with the following:

(a) Unless administered immediately, the compounded drug preparation shall bear a label listing all of the following:

(i) Patient identification information, including the full name of the owner, if applicable, and the name or identification of the animal;

(ii) The name and quantity of each ingredient;

(iii) The date and time prepared;

(iv) The name or initials of the person who prepared the compounded drug preparation.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.51, 4729.53, 4729.54, 4729.541 and 4729.55
Five Year Review Date: 3/31/2026
Prior Effective Dates: 5/1/2016, 4/1/2017
Rule 4729:7-3-04 | Immediate-Use, Sterile Non-Hazardous Drugs Compounded by a Prescriber.
 

(A) The responsible person of a facility where a prescriber is engaged in the compounding of immediate-use, sterile non-hazardous dangerous drug preparations in accordance with paragraph (B) of this rule shall be responsible for all the following:

(1) Developing and implementing appropriate compounding procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S.C. section 353a (11/27/2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring training and competency of compounding personnel;

(5) Ensuring that compounded drug preparations maintain quality and sterility until administered;

(6) Maintaining drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code;

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

(8) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(B) Immediate-use, sterile compounded drug preparations are exempt from the requirements in rule 4729:7-3-03 of the Administrative Code if all the following criteria are met:

(1) The compounding process involves the simple transfer of not more than three commercially manufactured packages of sterile, non-hazardous drugs 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 the following:

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

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

(3) If not immediately administered, the finished compounded drug preparation shall be regularly monitored by compounding personnel to minimize the potential for contact with non-sterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compounded drug preparations, and direct contact of outside surfaces.

(4) The beyond-use date for an immediate-use compounded drug preparation is as follows:

(a) Except as provided in paragraph (B)(4)(b) of this rule, no later than six-hours following preparation of the drug.

(b) For preparations of buffered lidocaine containing antimicrobial preservatives, no later than twelve-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 disposed. Records of disposal shall be maintained in accordance with rule 4729:7-3-06 of the Administrative Code.

(6) Unless administered immediately, the compounded drug preparation shall bear a label listing all the following:

(a) Except for preparations compounded in accordance with paragraph (G)(2) of this rule, patient identification information, including the patient's first and last name;

(b) The name and quantity of each ingredient;

(c) The beyond-use date and time prepared; and

(d) The name or initials of the person who prepared the compounded drug preparation.

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

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

(C) Unless administered within one-hour of preparation, sterile compounded drug preparations for immediate-use shall be prepared in a designated clean medication area that is not adjacent to areas where potentially contaminated or hazardous items are placed. Such an area shall be limited to compounding personnel and shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to construction sites, warehouses, or food preparation. Cleaning and disinfection agents must be selected and used with careful consideration of compatibility, effectiveness, and inappropriate or toxic residues. Cleaning and disinfecting shall occur before compounding is performed. This shall be followed by wiping with a residue-free disinfecting agent, such as sterile seventy per cent isopropyl alcohol, which is allowed to dry before compounding begins.

(D) Preparations that are deemed category two, medium-risk level, or high-risk level compounded drug preparations as defined in United States pharmacopeia chapter <797> shall not be prepared as immediate-use.

(E) Preparations that do not meet all the requirements listed in paragraph (B) of this rule shall comply with the requirements in rule 4729:7-3-03 of the Administrative Code.

(F) Immediate-use compounded drug preparations shall be prepared in accordance with this rule except in an emergency, 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.

(G)

(1) Except as provided in paragraph (G)(2) of this rule, compounding for anticipated needs or engaging in compounding practices where multiple non-patient specific doses are produced in a single activity is prohibited.

(2) A prescriber may compound preparations of buffered lidocaine containing antimicrobial preservatives for anticipated needs where multiple non-patient specific doses are produced in a single activity.

(H) Records of drug compounding shall be maintained pursuant to rule 4729:7-3-06 of the Administrative Code.

(I)

(1) Except as provided for in paragraph (I)(2) of this rule, this rule does not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of the Revised Code. If preparing or handling hazardous drug preparations, a prescriber who is a veterinarian shall comply with rule 4729:7-3-05 of the Administrative Code.

(2) A veterinarian engaged in the compounding of immediate-use sterile drug preparations shall comply with the following:

(a) Unless administered immediately, the compounded drug preparation shall bear a label listing all of the following:

(i) Patient identification information, including the full name of the owner, if applicable, and the name or identification of the animal;

(ii) The name and quantity of each ingredient;

(iii) The date and time prepared; and

(iv) The name or initials of the person who prepared the compounded drug preparation.

(J) For hazardous compounded drugs, the prescriber shall comply with rule 4729:7-3-05 of the Administrative Code.

(K) A prescriber may designate an appropriately trained agent to prepare compounded drug preparations.

(L) For all compounded drugs prepared pursuant to this rule, a prescriber shall:

(1) Inspect and approve the compounding process; and

(2) Except as provided in paragraph (M) of this rule, perform medication validation ("final check") prior to the medication being administered.

(M) The requirements of paragraph (M)(2) of this rule do not apply to either of the following:

(1) A compounded drug preparation is being administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, at least two nurses that are approved by the responsible person to prepare or administer compounded drugs comply with the requirements in paragraph (N) of this rule; or

(2) A compounded drug preparation is prepared and administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, the same nurse complies with paragraph (N) of this rule.

(N) All the following are required to administer a compounded drug preparation in accordance with paragraphs (M)(1) and (M)(2) of this rule:

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

(2) Confirm with the patient the patient's 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) Indicate in the compounding record verification was completed.

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

Last updated April 8, 2021 at 1:19 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.51, 4729.54, 4729.55
Five Year Review Date: 4/2/2026
Prior Effective Dates: 4/1/2017
Rule 4729:7-3-05 | Hazardous drugs compounded by a prescriber.
 

(A) The responsible person of a facility where a prescriber is engaged in the compounding or handling of hazardous dangerous drugs shall be responsible for all of the following:

(1) Developing and implementing appropriate compounding policies and procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S. Code section 353a (November 27, 2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring training and competency of compounding personnel;

(5) Ensuring environmental control of the compounding areas;

(6) Ensuring that compounded drug preparations maintain quality and sterility until administered or personally furnished;

(7) Ensuring appropriate equipment cleaning and disposal of all hazardous drug waste;

(8) All drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code;

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

(10) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(B) A prescriber who compounds or handles hazardous drugs as defined in rule 4729:7-3-01 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 an agent of the state board of pharmacy.

(2) Physical requirements

(a) Sterile compounded hazardous drug preparations 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 A2, 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) Non-sterile hazardous drug preparations shall be compounded in a C-PEC that is either externally vented or has redundant-HEPA filters 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 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 non-sterile hazardous drugs and sterile hazardous compounded drugs with a beyond-use date that does not exceed twelve hours, an 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 three 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 <800>.

(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 preparations to meet the needs of the facility staff.

(3) Environmental quality and control

(a) Environmental wipe sampling to detect hazardous drug surface residue should be performed routinely (e.g., initially as a benchmark and at least every six months, or more often as needed, to verify containment). 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;

(v) Counters where finished preparations are placed.

(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, at a minimum, 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 (or dedicated shoes) 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 and procedure manual must describe the appropriate PPE to be worn. The facility must develop policies 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; and

(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); and

(iv) Spill management.

(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.

(c) An eyewash station and other emergency or safety precautions that meet applicable laws and regulations must be readily available.

(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 licensed health care provider shall be involved in discussing with each patient receiving 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; and

(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 preparations, 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 and shall be readily retrievable.

(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 maintained pursuant to rule 4729:7-3-06 of the Administrative Code.

(D) A hazardous compounded drug that is personally furnished by a prescriber must be labeled according to rule 4729:5-19-02 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 "Hazardous Compounded Drug" 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 prescriber is required to perform medication validation ("final check") of the finished hazardous compounded drug preparation prior to it being 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 nurse licensed under Chapter 4723. of the Revised Code in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, at least two nurses that are approved by the responsible person to prepare or administer compounded drugs comply with the following:

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

(2) Confirm with the patient the patient's 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; and

(g) Appearance and physical integrity of the drugs.

(4) Indicate in the compounding record verification was completed.

(5) Extravasation management procedures are defined.

(6) Antidote order sets and antidotes are accessible.

(7) A 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 United States Pharmacopeia Chapter <795>.

(J) Sterile hazardous compounded drugs prepared with beyond-use dates greater than twelve hours, shall comply with beyond-use dating requirements in accordance with United States Pharmacopeia Chapter <797>.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.54, 4729.541, 4729.55
Five Year Review Date: 3/31/2026
Rule 4729:7-3-06 | Record Keeping.
 

(A) The responsible person shall maintain the following records relating to the compounding of dangerous drugs:

(1) 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.

(2) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(a) Complies with the requirements of this rule;

(b) All paper records shall be scanned in full color via technology designed to capture information and reproduce it in an electronic medium presentable and usable to an end user;

(c) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(d) Contains daily back-up functionality to protect against record loss.

(3) Records of each drug compounded shall, at a minimum, include all the following:

(a) The full name of the patient, unless compounded in accordance with paragraph (G)(2) of rule 4729:7-3-04 of the Administrative Code;

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

(c) Name and quantity of each ingredient;

(d) If a controlled substance, the disposition of unused drug(s) and amount;

(e) Date and time of preparation;

(f) Beyond-use date of the compounded drug;

(g) The positive identification of the personnel responsible for compounding the drug;

(h) The positive identification of either of the following:

(i) Person or persons performing medication validation prior to the compounded drug being administered; or

(ii) The prescriber personally furnishing the compounded drug.

(B) Records of disposal of compounded drugs, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, the identification of the licensed health care professional that performed the disposal.

(C) Records of the disposal of compounded drugs containing controlled substances shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of a compounded drug containing a controlled substance is performed on-site, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a compounded drug containing a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal.

(3) A veterinarian may use an animal aide, as defined in section 4741.01 of the Revised Code, in lieu of one of the licensed or registered healthcare professionals required to witness and conduct the disposal of controlled substances pursuant to paragraphs (C)(1) and (C)(2) of this rule. Records kept in accordance with paragraphs (C)(1) and (C)(2) of this rule shall include the positive identification of the animal aide witnessing the disposal.

(D) Drug compounding records which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this rule.

(E) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01, 4729.51, 4729.53, 4729.54, 4729.541 and 4729.55
Five Year Review Date: 3/31/2026