NMBOP:16.19.36 COMPOUNDED STERILE PREPARATIONS Flashcards
1
Q
Q: What does “Air changes per hour” (ACPH) mean?
A
A: “Air changes per hour” (ACPH) means the number of times a volume of air equivalent to the room passes through the room each hour.
2
Q
Q: What is an “Anteroom”?
A
A: An “Anteroom” means an ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed. It is also a transition area that:
(1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and
(2) contains a line of demarcation which is a visible line on the floor that separates the clean and dirty sides of the anteroom.
3
Q
Q: What does “Aseptic processing” refer to?
A
A: “Aseptic processing” refers to a method by which separate, sterile components (e.g., drugs, containers, or closures) are brought together under conditions that maintain their sterility. The components can either be purchased as sterile or, when starting with nonsterile components, can be separately sterilized prior to combining (e.g., by membrane filtration or by autoclave).
4
Q
Q: What is meant by “Aseptic technique”?
A
A: “Aseptic technique” means proper manipulation of preparations to maintain sterility.
5
Q
Q: Define “Batch” in the context of CSPs.
A
A: “Batch” refers to more than one CSP prepared as described in the MFR in a single, discrete process, and expected to have uniform character and quality, within specified limits.
6
Q
Q: What is a “Beyond-use date” (BUD)?
A
A: A “Beyond-use date” (BUD) means the date, or as appropriate, date and time, after which a compounded preparation is not to be used and is determined from the date and time the preparation is compounded.
7
Q
Q: What is a “Biological safety cabinet (BSC), Class II”?
A
A: A “Biological safety cabinet (BSC), Class II” is a ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. A BSC used to prepare a CSP must be capable of providing an ISO Class 5 or better environment for preparation of the CSPs.
8
Q
Q: What does “Biological safety cabinet” (BSC) refer to?
A
A: “Biological safety cabinet” (BSC) is a ventilated cabinet that may be used for compounding. These cabinets are divided into three general classes (Class I, Class II, and Class III). Class II BSCs are further divided into types (Type A1, Type A2, Type B1, Type B2, and Type C1).
9
Q
Q: Define “Buffer room”.
A
A: A “Buffer room” is an ISO Class 7 or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class 5 environment are physically located. The buffer room may only be accessed through the anteroom or another buffer room.
10
Q
Q: Define “Category 2 CSP”.
A
A: A “Category 2 CSP” is a CSP that may be assigned a BUD of greater than 12 h at controlled room temperature or greater than 24 h refrigerated that is compounded in accordance with all applicable requirements for Category 2 CSPs in USP/NF <797>.
10
Q
Q: What is a “Category 3 CSP”?
A
Q: What is a “Category 3 CSP”?
A: A “Category 3 CSP” is a CSP that may be assigned a BUD exceeding the limits in for Category 2 CSPs and is compounded in accordance with all applicable requirements for Category 3 CSPs in USP/NF <797>.
11
Q
Q: What does “Certification” mean in this context?
A
A: “Certification” means independent third party documentation declaring that the specific requirements of USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) have been met.
11
Q
Q: What is a “Category 1 CSP”?
A
A: A “Category 1 CSP” is a CSP that is assigned a BUD of 12 h or less at controlled room temperature or 24 h or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in USP/NF <797>.
12
Q
Q: What is a “Cleaning agent”?
A
A: A “Cleaning agent” is an agent, usually containing a surfactant, used for the removal of substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.
13
Q
Q: Define “Cleaning”.
A
A: “Cleaning” is the process of removing substances (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.
14
Q
Q: What does “Cleanroom suite” refer to?
A
A: A “Cleanroom suite” is a classified area that consists of both an anteroom and buffer room.
15
Q
Q: What is a “Closed system vial-transfer device”?
A
A: A “Closed system vial-transfer device” is a vial-transfer system that allows no venting or exposure of substances to the environment.
16
Q
Q: Define “Component” in the context of compounding.
A
A: A “Component” is any ingredient used in the compounding of a preparation, including any active ingredient, added substance, or conventionally manufactured product.
17
Q
Q: What are “Compounded sterile preparations” (CSPs)?
A
A: “Compounded sterile preparations” (CSPs) include, but are not limited to, the following dosage forms which must be sterile when administered to patients:
(1) parenteral preparations;
(2) aqueous bronchial and nasal inhalations;
(3) baths and soaks for live organs and tissues;
(4) injections (e.g. colloidal dispersions, emulsions, solutions, suspensions);
(5) irrigations for wounds and internal body cavities;
(6) ophthalmic drops and ointments; and
(7) implants.
18
Q
Q: What is a “Compounding aseptic containment isolator” (CACI)?
A
A: A “Compounding aseptic containment isolator” (CACI) is a type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for the compounding of sterile HDs.
19
Q
Q: Define “Compounding record” (CR).
A
A: A “Compounding record” (CR) documents the compounding of each CSP.
19
Q
Q: What is a “Compounding aseptic isolator” (CAI)?
A
A: A “Compounding aseptic isolator” (CAI) is a type of RABS that uses HEPA filtration to provide an ISO Class 5 unidirectional air environment designed for compounding of sterile non-HDs.
20
Q
Q: What is a “Container closure system”?
A
A: A “Container closure system” is packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection.
21
Q
Q: What is a “Containment ventilated enclosure” (CVE)?
A
A: A “Containment ventilated enclosure” (CVE) is a non-ISO classified full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through HEPA filtration and prevent their release into the work environment.
22
**Q: What is a "Critical area"?**
**A:** A "Critical area" means an ISO Class 5 environment.
23
**Q: Who is a "Designated person"?**
**A:** A "Designated person" is an individual assigned to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of CSPs. For pharmacies, the designated person must be the pharmacist-in-charge. For clinic facilities, the designated person must be the consultant pharmacist.
23
**Q: Define "Critical site".**
**A:** A "Critical site" means a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination.
24
**Q: What is a "Direct compounding area" (DCA)?**
**A:** A "Direct compounding area" (DCA) means a critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.
24
**Q: What does "Disinfectant" mean?**
**A:** A "Disinfectant" is a chemical or physical agent used on inanimate surfaces and objects to destroy fungi, viruses, and bacteria. Sporicidal disinfectants are considered a special class of disinfectants that also are effective against bacterial and fungal spores.
24
**Q: Define "Dynamic operating conditions".**
**A:** "Dynamic operating conditions" are conditions in the compounding area in which operating personnel are present and simulating or performing compounding. The conditions should reflect the largest number of personnel and highest complexity of compounding expected during routine operations as determined by the designated person(s).
24
**Q: What is a "Dynamic airflow smoke pattern test"?**
**A:** A "Dynamic airflow smoke pattern test
" is a PEC test in which a visible source of smoke, which is neutrally buoyant, is used to observe air patterns within the unidirectional space (i.e., the DCA) under dynamic operating conditions (see the entry for Dynamic operating conditions). This test is not appropriate for ISO Class 7 or ISO Class 8 cleanrooms that do not have unidirectional airflow (see the entry for Visual smoke study).
25
**Q: What is "Home care"?**
**A:** "Home care" means health care provided in the patient’s home (not a hospital or skilled nursing facility) by either licensed health professionals or trained caregivers. It may include hospice care.
25
**Q: What does "Garb" include?**
**A:** "Garb" includes items such as gloves, garments (e.g., gowns), shoe covers, head and facial hair covers, masks, and other items designed to reduce particle-shedding from personnel and minimize the risk of contamination of CSP(s).
25
**Q: What is a "Hazardous drug" (HD)?**
**A:** A "Hazardous drug" (HD) is any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing HDs in structure or toxicity. (Reference current NIOSH publications).
25
**Q: What does "High-efficiency particulate air (HEPA) filtration" refer to?**
**A:** "High-efficiency particulate air (HEPA) filtration" refers to being, using, or containing a filter designed to remove ninety-nine and ninety-seven one-hundredths percent of airborne particles measuring zero and three-micron or greater in diameter passing through it.
26
**Q: What does "ISO class" refer to?**
**A:** "ISO class" refers to an air-quality classification from the International Organization for Standardization.
26
**Q: What does "Laminar airflow" mean?**
**A:** "Laminar airflow" means a non-turbulent, non-mixing streamline flow of air in parallel layers.
26
**Q: What is an "Integrated vertical laminar flow zone" (IVLFZ)?**
**A:** An "Integrated vertical laminar flow zone" (IVLFZ) is a designated ISO Class 5 area serving as the PEC within an ISO Class 7 or cleaner buffer room. In the IVLFZ, unidirectional airflow is created by placing HEPA filters over the entire surface of the worktables and by effective placement of air returns.
26
**Q: What is a "Laminar airflow system" (LAFS)?**
**A:** A "Laminar airflow system" (LAFS) is a device or zone within a buffer room that provides an ISO Class 5 or better air quality environment for sterile compounding. The system provides a unidirectional HEPA filtered airflow.
27
**Q: Define "Laminar airflow workbench" (LAFW).**
**A:** A "Laminar airflow workbench" (LAFW) is a device that is a type of LAFS that provides an ISO Class 5 or better air quality environment for sterile compounding. The device provides a unidirectional HEPA-filtered airflow.
28
**Q: What is a "Line of demarcation"?**
**A:** A "Line of demarcation" is a visible line on the floor that separates the clean and dirty sides of the anteroom.
29
**Q: What is a "Master formulation record" (MFR)?**
**A:** A "Master formulation record" (MFR) is a detailed record of procedures that describes how the CSP is to be prepared.
30
**Q: What is a "Media-fill test"?**
**A:** A "Media-fill test" is a simulation used to qualify processes and personnel engaged in sterile compounding to ensure that the processes and personnel are able to prepare CSPs without contamination.
30
**Q: Define "Multiple-dose container".**
**A:** A "Multiple-dose container" is a multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. Once opened or entered, a multiple-dose container with antimicrobial preservative has a BUD of 28 days unless otherwise specified by the manufacturer.
31
**Q: What is a "One-step disinfectant cleaner"?**
**A:** A "One-step disinfectant cleaner" is a product with an EPA-registered (or equivalent) claim that it can clean and disinfect a nonporous surface in the presence of light to moderate organic soiling without a separate cleaning step
31
**Q: What is a "Negative pressure room"?**
**A:** A "Negative pressure room" is a room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.
32
**Q: Define "Parenteral product".**
**A:** A "Parenteral product" is any preparation administered by injection through one or more layers of skin tissue.
33
**Q: What is a "Pass-through chamber"?**
**A:** A "Pass-through chamber" is an enclosure with sealed doors on both sides that should be interlocked. The pass-through chamber is positioned between two spaces for the purpose of minimizing particulate transfer while moving materials from one space to another.
34
**Q: What is "Personal protective equipment" (PPE)?**
**A:** "Personal protective equipment" (PPE) includes items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.
35
**Q: Define "Pharmacy bulk packages".**
**A:** "Pharmacy bulk packages" are containers of a sterile preparation for parenteral use that contain many single doses. Contents are intended for use in a pharmacy admixture program and are restricted to use in a suitable ISO Class 5 environment.
36
**Q: What is a "Plan of care"?**
**A:** A "Plan of care" is an individualized care plan for each patient receiving parenteral products in a home setting to include the following:
(1) description of actual or potential drug therapy problems and their proposed solutions;
(2) a description of desired outcomes of drug therapy provided;
(3) a proposal for patient education and counseling; and
(4) a plan specifying proactive objective and subjective monitoring (e.g., vital signs, laboratory tests, physical findings, patient response, toxicity, adverse reactions, and noncompliance) and the frequency with which monitoring is to occur.
37
**Q: What is a "Positive pressure room"?**
**A:** A "Positive pressure room" is a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.
38
**Q: Define "Primary engineering control" (PEC).**
**A:** A "Primary engineering control" (PEC) is a device or zone that provides an ISO Class 5 air quality environment for sterile compounding.
39
**Q: What is "Process validation"?**
**Q: What is "Process validation"?**
**A:** "Process validation" means documented evidence providing a high degree of assurance that a specific process will consistently produce a preparation meeting its predetermined specifications and quality attributes.
40
**Q: What does "Product" mean in this context?**
**A:** "Product" means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert.
41
**Q: What is "Quality assurance"?**
**Q: What is "Quality assurance"?**
**A:** "Quality assurance" means a program for the systematic monitoring and evaluation of the various aspects of a service or facility to ensure that standards of quality are being met.
42
**Q: Define "Quality control".**
**A:** "Quality control" means a system for verifying and maintaining a desired level of quality in a preparation or process, as by planning, continued inspection, and corrective action as required.
42
**Q: What is "Reconstitution"?**
**A:** "Reconstitution" is the process of adding a diluent to a conventionally manufactured product to prepare a sterile solution or suspension.
43
**Q: What does "Repackaging" involve?**
**A:** "Repackaging" involves removing a sterile product or preparation from its original primary container and placing it into another primary container, usually of smaller size without further manipulation.
44
**Q: Define "Segregated compounding area" (SCA).**
**A:** A "Segregated compounding area" (SCA) is a designated space, area, or room that is not required to be classified and is defined with a visible perimeter. The SCA must contain a PEC and is suitable for preparation of Category 1 CSPs only.
44
**Q: What is a "Secondary engineering control"?**
**A:** A "Secondary engineering control" is the area where the PEC is placed (e.g., a cleanroom suite or an SCA). It incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area.
45
**Q: Define "Restricted-access barrier system" (RABS).**
**A:** A "Restricted-access barrier system" (RABS) is an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. Examples of RABS include CAIs and CACIs.
46
**Q: What is "Terminal sterilization"?**
**A:** "Terminal sterilization" is the application of a lethal process (e.g., steam, dry heat, irradiation) to sealed containers for the purpose of achieving a predetermined sterility assurance level of usually less than 10−6, or a probability of less than one in one million of a non-sterile unit.
46
**Q: What is a "Single-dose container"?**
**A:** A "Single-dose container" is a single-dose, or a single-unit, container for articles or preparations intended for parenteral administration only. It is intended for a single use. Examples include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
47
**Q: What does "Sterile Compounding" involve?**
**A:** "Sterile Compounding" involves the process of combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.
47
**Q: What is a "Sporicidal disinfectant"?**
**A:** A "Sporicidal disinfectant" is a chemical or physical agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.
47
**Q: What is "Sterility"?**
**A:** "Sterility" is the absence of viable microorganisms.
47
**Q: Define "Stability" in the context of pharmaceuticals.**
**A:** "Stability" is the extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or BUD.
47
**Q: What is a "Standard operating procedure" (SOP)?**
**A:** A "Standard operating procedure" (SOP) is a written protocol detailing the required standards for performance of tasks and operations within a facility.
47
**Q: Define "Sterilization by filtration".**
**A:** "Sterilization by filtration" means the passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent.
48
**Q: Define "Unidirectional airflow".**
**A:** "Unidirectional airflow" refers to air within a PEC moving in a single direction in a uniform manner and at sufficient velocity to sweep particles away from the DCA.
48
**Q: What is a "Sterilizing grade filter"?**
**A:** A "Sterilizing grade filter" refers to filter membranes that are documented to retain one hundred percent of a culture of 107 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta per square centimeter of membrane surface under a pressure of not less than 30 psi. Such filter membranes are nominally at zero and twenty-two mm or zero and two mm pore size.
49
**Q: What does "USP" stand for?**
**A:** "USP" stands for United States Pharmacopeia.
50
**Q: What is a "Visual smoke study"?**
**A:** A "Visual smoke study" is a test used in ISO Class 7 and ISO Class 8 rooms that do not have unidirectional airflow, in which a visible source of smoke, which is neutrally buoyant, is used to verify an absence of stagnant airflow. This test does not need to be performed under dynamic operating conditions and is not appropriate for PECs.
51
**Q: What is a "Workflow management system"?**
**A:** A "Workflow management system" is technology comprised of hardware and/or software that allows for automation to assist in the verification of components of, and preparation of, CSPs and to document components and processes.
52
**Q: What is required for a facility compounding sterile preparations in terms of designating personnel?**
A: All facilities compounding sterile preparations must designate a pharmacist in charge of operations who is licensed as a pharmacist in the state of residence of the facility.
53
**Q: What are the responsibilities of the pharmacist-in-charge or consultant pharmacist in an in-state clinic?**
A: The pharmacist-in-charge (or consultant pharmacist, for in-state clinics) is responsible for:
1. The development, implementation, and continuing review and maintenance of written policies, procedures, and SOPs which comply with USP/NF standards.
2. Providing a pharmacist who is available for 24-hour, seven-day-a-week services.
3. Establishing a system to ensure that the CSPs (Compounded Sterile Preparations) prepared by compounding personnel are administered by licensed personnel or properly trained and instructed patients.
4. Establishing a system to ensure that CSPs prepared by compounding personnel are prepared in compliance with USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) standards.
5. Ensuring facility personnel comply with written policies, procedures, and SOPs.
6. Developing an appropriate and individualized plan of care in collaboration with the patient or caregiver and other healthcare providers for each patient receiving parenteral preparations in a home setting.
54
**Q: What must the pharmacist-in-charge develop, implement, and maintain?**
A: The pharmacist-in-charge must develop, implement, and maintain written policies, procedures, and SOPs which comply with USP/NF standards.
55
**Q: What type of service must the pharmacist provide?**
A: The pharmacist must be available for 24-hour, seven-day-a-week services.
55
**Q: How should CSPs be administered according to the pharmacist-in-charge's responsibilities?**
A: The pharmacist-in-charge must establish a system to ensure that CSPs prepared by compounding personnel are administered by licensed personnel or properly trained and instructed patients.
56
**Q: What compliance standard must be followed for CSP preparation?**
A: CSPs must be prepared in compliance with USP/NF <797> standards (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations).
56
**Q: How should facility personnel adhere to written procedures?**
A: The pharmacist-in-charge must ensure that facility personnel comply with written policies, procedures, and SOPs.
57
**Q: What is involved in developing a plan of care for patients receiving parenteral preparations in a home setting?**
A: The pharmacist-in-charge must develop an appropriate and individualized plan of care in collaboration with the patient or caregiver and other healthcare providers.
58
**Q: What design and environmental control requirements must the room or area where compounded sterile preparations (CSPs) are prepared meet?**
A: The room or area must be physically designed and environmentally controlled to meet the standards of compliance as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations).
59
**Q: How often must the room or area where CSPs are prepared be monitored and tested?**
A: The room or area must be periodically monitored, evaluated, tested, and certified by environmental sampling testing (including both viable and nonviable particle sampling) as required by USP/NF <797>. Documentation of this testing must be retained for three years.
60
**Q: What is the minimum square footage required for compounding sterile preparations?**
A: The room or area must have a minimum of 100 square feet dedicated to compounding sterile preparations.
61
**Q: What are the specific square footage requirements for a retail pharmacy with sterile product preparation capabilities?**
A:
1. The minimum size of a retail pharmacy must be 240 square feet.
2. A retail pharmacy with preparation of sterile products capabilities must have 340 square feet, with 100 square feet exclusive to compounding sterile preparations.
62
**Q: What are the square footage requirements for a stand-alone CSP facility?**
A: A stand-alone CSP facility must have a minimum of 240 square feet with 100 square feet exclusive to compounding sterile preparations.
63
**Q: What are the environmental conditions required in the room or area where CSPs are prepared?**
A: The room or area must be clean, lighted, and maintained at an average of 80-150 foot candles. It must also minimize particle generating activities.
64
**Q: What type of sink is required in the room or area where CSPs are prepared?**
A: The room or area must have a sink of sufficient size for compounding personnel to adequately wash hands and forearms up to the elbows with soap and water.
65
**Q: What is required for adding a compounding sterile preparations area to existing pharmacies?**
A: The addition of a compounding sterile preparations area in existing pharmacies will require the submission of plans for remodeling to the board office for approval and inspection prior to licensure.
66
**Q: How must equipment be maintained in facilities compounding sterile preparations?**
A: All equipment must be cleaned, maintained, monitored, calibrated, tested, and certified as appropriate to ensure proper function and operation, with documentation retained for three years.
66
**Q: What are the general equipment requirements for facilities compounding sterile preparations?**
A: Each facility compounding sterile preparations shall have sufficient equipment for the safe and appropriate storage, compounding, packaging, labeling, dispensing, and preparation of compounded sterile preparations and parenteral preparations. This equipment must be appropriate to the scope of pharmaceutical services provided and as specified in USP/NF <797>.
66
**Q: How often must primary and secondary engineering controls used to provide an aseptic environment be tested and certified?**
A: Primary and secondary engineering controls must be tested in the course of normal operation by an independent qualified contractor and certified as meeting USP/NF <797> requirements at least every six months and when relocated. Certification records must be maintained for three years.
67
**Q: What are the requirements for automated compounding devices in terms of accuracy verification?**
A: Automated compounding devices must:
1. Have accuracy verified on a routine basis at least every 30 days per manufacturer's specifications.
2. Be observed every 30 days by the operator during the mixing process to ensure proper operation.
3. Have data entry verified by a pharmacist prior to compounding or have accurate final documentation of compounded preparations to allow for verification of ingredients by a pharmacist prior to dispensing.
4. Have the accuracy of delivery of the end product verified according to written policies and procedures.
****
68
**Q: What types of references must be available in a facility compounding sterile preparations?**
A: A library of current references (hard copy or electronic) must include:
1. All USP/NF chapters applicable to the facility’s sterile compounding practice.
2. New Mexico pharmacy laws, rules, and regulations.
3. Specialty references such as stability and incompatibility references, sterilization and preservation references, pediatric dosing, and drug monograph references as appropriate for the scope of services provided.
69
**Q: What are the requirements for written policies, procedures, and SOPs in facilities compounding sterile preparations?**
A: Written policies, procedures, and SOPs consistent with USP/NF <797> standards must be established, implemented, followed by facility personnel, and available for inspection and review by authorized agents of the board of pharmacy. All personnel who perform or oversee sterile compounding must be trained in these policies, procedures, and SOPs.
69
**Q: When must written policies and procedures be submitted to the state board of pharmacy?**
A: Written policies and procedures must be submitted to the state board of pharmacy prior to the issuance of any license.
70
**Q: What specific areas must written policies and procedures cover for submission to the state board of pharmacy?**
A: The policies and procedures must include, but are not limited to:
1. Cleaning, disinfection, evaluation, validation, testing, certification, and maintenance of the sterile compounding area.
2. Personnel qualifications, training, assessment, and performance validation.
3. Operation, maintenance, validation, testing, and certification of facility and equipment.
4. SOPs for compounding, storing, handling, and dispensing of all components used and all compounded sterile preparations.
5. SOPs for proper disposal of physical, chemical, and infectious waste.
6. Quality control guidelines and standards.
7. Quality assurance guidelines and standards.
8. SOPs for determination of stability, incompatibilities, and drug interactions.
9. Error prevention and incident reporting policies and procedures as per 16.19.25 NMAC.
71
**Q: How long must records required by this part be kept, and how should they be made available?**
A: All records required by this part must be kept by the facility for at least three years and shall be readily available for inspection by the board or the board’s agent
72
**Q: What records are required for patients in a compounded sterile preparations facility?**
A: The facility must maintain the following patient records:
1. Prescription records or provider orders, including the original prescription or provider order, refill authorization, alterations in the prescription or provider order, and interruptions in therapy due to hospitalization.
2. Patient’s history, including pertinent information regarding allergies or adverse drug reactions experienced by the patient.
3. For patients receiving parenteral preparations in a home setting, documentation of contact frequency appropriate to the complexity of the patient’s health problems and drug therapy, as documented on the patient-specific plan of care and with each new prescription, change in therapy, or condition.
4. Documentation that the patient or the agent has received a written copy of the plan of care and training in the safe administration of the medication.
72
**Q: What training is required for all personnel involved in compounding sterile preparations?**
A: All personnel, including pharmacists, pharmacists who supervise compounding personnel, pharmacist interns, and pharmacy technicians, must complete didactic and experiential training with competency evaluation through demonstration and testing (written or practical) as required by USP/NF <797> and as outlined by the pharmacist-in-charge and described in the site policy and procedures or training manual, prior to compounding sterile preparations.
73
**Q: What instructional topics should be covered in the training for compounding sterile preparations?**
A: Instructional topics shall include:
1. Aseptic technique.
2. Achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile components).
3. Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class five area.
4. Environmental monitoring.
5. Proper use of primary engineering controls (PECs).
6. Equipment and supplies.
7. Sterile pharmaceutical calculations, measuring, mixing, and terminology.
8. Documentation of the compounding process (MFR and CR).
9. Quality assurance procedures.
10. Hand hygiene.
11. Proper gowning and gloving technique.
12. The handling of cytotoxic and hazardous drugs (if applicable).
13. Principles of movement of materials and personnel within the compounding area.
14. Cleaning and disinfection.
74
**Q: What are the specific training requirements for pharmacy technicians in compounded sterile preparations?**
A: Pharmacy technicians must complete 100 hours of documented experiential training in compounded sterile preparations in accordance with Section 61-11-11.1 of the Pharmacy Act NMSA 1978 prior to compounding sterile preparations. Documentation of experiential training is transferable to another practice site.
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**Q: How should training for compounding sterile preparations be structured?**
A: Training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program, which is not transferable to another practice site.
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**Q: What is the frequency of training and assessment required for compounding personnel?**
A: Frequency of training and assessment shall include:
1. Initial training before compounding sterile preparations.
2. Annual refresher training and assessment in didactic topics.
3. Garbing competency and aseptic manipulation competency evaluations every 6 months for personnel compounding Category 1 and Category 2 CSPs.
4. Garbing competency and aseptic manipulation competency evaluations every 3 months for personnel compounding Category 3 CSPs.
5. Personnel who have direct oversight of compounding personnel must complete garbing competency and aseptic manipulation competency evaluations annually (unless a more frequent requirement applies).
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**Q: What should experiential training for compounding sterile preparations include?**
A: Experiential training shall include areas outlined in USP <797>, with appropriate observational assessment and testing of performance, including garbing competency and aseptic manipulation competency evaluations.
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**Q: What is a requirement for facilities regarding patient support in the home setting?**
A: The facility must provide a 24-hour toll-free telephone number for use by patients of the pharmacy.
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**Q: What additional training is required for handling sterile hazardous drugs?**
A: All personnel compounding sterile hazardous drugs, including pharmacists, supervising pharmacists, pharmacy interns, and pharmacy technicians, must complete didactic and experiential training with competency evaluation through demonstration and written or practical testing as required by USP/NF <800> in addition to training in sterile non-hazardous preparations. Training must be conducted as outlined by the pharmacist-in-charge and described in the site policy and procedures or training manual, and must be completed prior to compounding sterile hazardous preparations.
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**Q: What documentation is required for training in compounding sterile preparations?**
A: Written documentation of initial and in-service training, the results of written or practical testing, and process validation must be retained for three years and must include:
1. Name of person receiving the training or completing the testing or process validation.
2. Date(s) of the training, testing, or process validation.
3. General description of the topics covered in the training or testing or of the process validated.
4. Name of the person supervising the training, testing, or process validation.
5. Signature of the person receiving the training or completing the testing or process validation and the designated person or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel.
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**Q: What must a documented, ongoing quality assurance program include for patient care and pharmaceutical care outcomes?**
A: The quality assurance program must include:
1. Routine performance of prospective drug use review and patient monitoring functions by a pharmacist.
2. Patient monitoring plans that include written outcome measures and systems for routine patient assessment.
3. Documentation of patient training.
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**Q: What should a documented, ongoing performance improvement control program monitor?**
A: The program should monitor personnel performance, equipment, and facilities, addressing:
1. All aspects of sterile product preparation, storage, and distribution, including cleaning materials and disinfectants and monitoring equipment accuracy.
2. Non-sterile to sterile bulk compounding of more than 25 units, including end product testing for particulate matter and pyrogens.
3. Quality assurance audits at regular intervals, including infection control and sterile technique audits, with a corrective action plan and periodic evaluation of quality assurance activities.
4. Batch labels of sterile compounded products, including detailed information like drug product names, identification numbers, concentrations, beyond use dates, and other relevant details.
5. Patient-specific labels for CSPs, including patient name, ingredient names and amounts, beyond use date, dosage form, and other necessary information.
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**Q: What information must be included on the batch label of a sterile compounded product?**
A: The batch label must include:
1. Drug product name(s), diluent name(s), and amount(s).
2. Assigned internal identification number (e.g., barcode, prescription, order, or lot number).
3. Final concentration(s) and volume when appropriate, solution ingredient names and amounts.
4. Beyond use date and time when applicable.
5. Dosage form.
6. Route of administration when applicable.
7. Date of preparation.
8. Name or initials of the person preparing the product and the pharmacist completing the final check.
9. Ancillary instructions such as storage instructions or cautionary systems.
10. Device instructions when needed.
11. Statement if it is a single-dose or multiple-dose container.
12. Compounding facility name and contact information if sent outside the facility.
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**Q: What must be included on the patient-specific label of a compounded sterile preparation (CSP)?**
A: The patient-specific label must include:
1. Patient name.
2. Solution, ingredient names, amounts.
3. Beyond use date and time when applicable.
4. Dosage form.
5. Route of administration.
6. Directions for use, including infusion rates and specific times scheduled.
7. Identifier of the person preparing the product and the pharmacist completing the final check.
8. Ancillary instructions such as storage instructions or cautionary systems.
9. Device instructions when needed.
10. Assigned internal identification number.
11. Statement if it is a single-dose or multiple-dose container.
12. If dispensed for other than inpatient use, all other required information.
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**Q: What records are required for compounded sterile preparations (CSPs)?**: MASTER FORMULATION RECORD
A: Records include:
1. **Master Formulation Record (MFR)** for all CSPs prepared from non-sterile ingredients, including:
- Name, strength, dosage form, and final volume.
- Ingredients and quantities, relevant characteristics of components.
- Complete preparation instructions.
- Other details for repeatability (e.g., pH adjustments, sterilization methods).
- Beyond use dating and storage requirements.
- Information for proper labeling.
- Container closure system types and sizes.
- Physical description of the final CSP.
- Quality control procedures.
- Reference source for CSP stability.
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**Q: What records are required for compounded sterile preparations (CSPs)?**: COMPOUNDING RECORD
2. **Compounding Record (CR)** for all Category 1, Category 2, and Category 3 CSPs, and for immediate-use CSPs prepared for more than one patient, including:
- Reference to the MFR.
- Details of each component (name, strength, lot number, expiration date).
- Name, strength, dosage form, and volume of the finished CSP.
- Reconciliation of actual yield with anticipated yield.
- Identifier of the person preparing and final checking the product.
- Date and time of preparation.
- Assigned internal identification number.
- Beyond use date, time, and storage requirements.
- Results of applicable quality control procedures.
- Calculations for determining and verifying quantities and/or concentrations of components.
