Chapter 4729-19 Sterile Product Prescriptions

4729-19-01 Definitions.

(A) As used in the Administrative Code:

(1) "Biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment according to "National Sanitation Foundation (NSF) Standard 49".

(2) "Class 100 environment" means an atmospheric environment which contains no more than one hundred particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E." A class 100 environment is equivalent to ISO class 5.

(3) "Compounding facility" means a site licensed as a terminal distributor of dangerous drugs where the compounding of sterile product prescriptions occurs.

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

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

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

(B) Compounded sterile product prescriptions include, but are not limited to, the following preparations:

(1) Total parenteral nutrition (TPN) solutions;

(2) Parenteral analgesic drugs;

(3) Parenteral antibiotics;

(4) Parenteral antineoplastic agents;

(5) Parenteral electrolytes;

(6) Parenteral vitamins;

(7) Irrigating fluids;

(8) Ophthalmic preparations.

(C) Sterile product prescriptions shall not include commercially manufactured products that do not require compounding prior to dispensing.

Eff 7-4-88; 7-1-93; 3-1-99; 2-1-05
Rule promulgated under: RC 119.03
Rule authorized by: RC 3719.28, 4729.26, 4729.66
Rule amplifies: RC 3719.01, 4729.01
R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

4729-19-02 Prescriptions for sterile products.

(A) Sterile product prescriptions must meet the requirements of rule 4729-5-30 of the Administrative Code, except that a sterile product prescription 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. 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.

(B) The requirements for sterile product prescriptions received by a fluid therapy pharmacy are as specified in rule 4729-31-02 of the Administrative Code.

Eff 11-25-94; 3-1-99; 1-1-04; 2-1-05
Rule promulgated under: RC 119.03
Rule authorized by: RC 3719.28, 4729.26, 4729.66
Rule amplifies: RC 3719.06, 3719.07, 4729.37
R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

4729-19-03 Labeling.

(A) No sterile product prescription may be dispensed to an outpatient unless the container in which such prescription is dispensed is labeled pursuant to rule 4729-5-16 of the Administrative Code nor to an inpatient unless the container in which such prescription is dispensed is labeled pursuant to rule 4729-17-10 of the Administrative Code. In addition, the label shall include the beyond-use date of the final preparation.

(B) The requirements for the labeling of sterile product prescriptions in a fluid therapy pharmacy are as specified in rule 4729-31-03 of the Administrative Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3715.69, 3719.28, 4729.26, 4729.66

Rule Amplifies: 3715.64, 3719.08

Prior Effective Dates: 07/04/88, 07/01/93

4729-19-04 Minimum standards for compounding parenteral or sterile product prescriptions.

(A) A compounding facility shall meet the minimum standards for institutional pharmacies pursuant to rule 4729-17-08 of the Administrative Code.

(B) A policy and procedure manual shall be prepared and maintained regarding the compounding, dispensing, and delivery of sterile product prescriptions. The policy and procedure manual shall include at a minimum:

(1) A quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education.

(2) Justification for the chosen beyond use dates of compounded products.

(3) Handling of cytotoxic waste, if applicable.

The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy designated agent.

(C) Physical requirements

(1) The facility shall have a designated area with access limited to authorized personnel for preparing parenteral and sterile products. This area shall be isolated from other areas 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 these specialty products, It shall be of sufficient size to accommodate a laminar airflow hood or other primary engineering control devices that provide a class 100 environment and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

(2) The facility compounding parenteral and sterile product prescriptions shall have:

(a) Appropriate primary engineering control devices capable of maintaining at least class 100 conditions in the work place where critical objects are exposed and critical activities are performed; furthermore, these devices are to be capable of maintaining class 100 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air;

(b) Appropriate disposal containers for used needles, syringes, etc. and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents;

(c) Appropriate environmental control including approved biohazard cabinetry when cytotoxic drug products are prepared;

(d) Infusion devices and equipment, if appropriate;

(e) Appropriate temperature controlled transport containers.

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

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

(5) The compounding of sterile products shall be done within a class 100 environment except in an emergency situation when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized.

(D) Delivery service

The responsible person shall assure the environmental control of all products shipped to the patient.

(E) Disposal of cytotoxic and/or hazardous waste

The responsible person shall assure that there is a system for the disposal of cytotoxic and/or hazardous waste in a manner so as not to endanger the public health.

(F) Cytotoxic drugs

The following requirements are necessary for those facilities that prepare cytotoxic drugs to ensure the protection of the personnel involved:

(1) All cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet or other appropriate Class II primary engineering control device.

(2) Protective apparel shall be worn by personnel compounding cytotoxic drugs. This shall include at least gloves and gowns with tight cuffs.

(3) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.

(4) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.

(5) Written procedures for handling both major and minor spills of cytotoxic agents shall be developed and shall be included in the policy and procedure manual.

(6) Prepared doses of cytotoxic drugs shall be dispensed, labeled with proper precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.

(G) Patient training

Whenever possible, a pharmacist shall be involved in discussing with each patient receiving an outpatient parenteral or sterile product prescription, or the caregiver of such individual, the following matters:

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

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

(3) Proper storage; and

(4) Stability or incompatibilities of the medication.

(H) Quality assurance

There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities.

(1) At a minimum, there shall be written quality assurance programs developed that address:

(a) Adequate training and continuing competency monitoring of all personnel in personal cleansing, proper attire, aseptic technique, proper clean room conduct, and clean room disinfecting procedures. Instructors shall have the appropriate knowledge and experience necessary to conduct the training;

(b) Continued verification of compounding accuracy including physical inspection of end products;

(c) Continued verification of automated compounding devices;

(d) Continued verification that appropriate beyond use dates are being assigned to compounded products;

(e) End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected. Additionally, if bulk compounding of parenteral or sterile products is being performed using nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.

(2) All clean rooms, laminar flow hoods, 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.

Effective: 01/01/2010
R.C. 119.032 review dates: 09/28/2009 and 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.55
Prior Effective Dates: 7/4/88, 7/1/93, 3/1/99, 2/1/05