CHAPTER 17 STERILE PRODUCT COMPOUNDING - College Of
CHAPTER 17STERILE PRODUCT COMPOUNDING17-1
Sterile Product CompoundingReference:1) United States Pharmacopeia chapter 797 (USP 797 )2) CMS: §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicalsmust be under the supervision of a pharmacist and performed consistent with State andFederal laws.Interpretive Guidelines §482.25(b)(1)All compounding, packaging, and dispensing of drugs and biologicals must be conducted by aregistered pharmacist or under the supervision of a registered pharmacist and performedconsistent with State and Federal laws.Medications must be prepared safely. Safe preparation procedures could include: Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, orother drugs except in emergencies or when not feasible (for example, when the product’s stabilityis short).Whenever medications are prepared, staff uses safety materials and equipment while preparinghazardous medications.Wherever medications are prepared, staff uses techniques to assure accuracy in medicationpreparation.Whenever medications are prepared, staff uses appropriate techniques to avoid contaminationduring medication preparation, which include but are not limited to the following: Using clean or sterile technique as appropriate; Maintaining clean, uncluttered, and functionally separate areas for product preparation tominimize the possibility of contamination; Using a laminar airflow hood or other appropriate environment while preparing anyintravenous (IV) admixture in the pharmacy, any sterile product made from non-sterileingredients, or any sterile product that will not be used with 24 hours; and Visually inspecting the integrity of the medications.3) Joint commission standards – prepared in pharmacy using aseptic technique unlessemergency or short stability4) Florida Regulations (64B16-27.797 Standards of Practice for Compounding SterilePreparations (CSPs).Health care institutionsPharmaciesPhysician officesFacilities where compounded sterile preparations are prepared, stored & dispensedApplies to Facilities that: Prepare sterile products according to manufacturer recommendations wheremanipulations are performed during the compounding Compounding using devices or non-sterile ingredients Includes baths & soaks for live organs and tissues, implants, inhalations, injections,irrigations, metered sprays, ophthalmic and otic preparations.17.2
Enforceable by FDAJoint CommissionFL Board of PharmacyISO Classification of Particulate Matter in Room AirISO 5Class 100Air quality inside a laminar air flow hoodISO 7Class 10,000Buffer area – preparation area where hoods are locatedISO 8Class 100,000 Ante area – where hand hygiene, garbing, staging forcompounding and labeling occursLaminarAirFlow Hood with HEPA (high efficiency particle air) filter. Air Flow either horizontal or verticalBiological safety cabinet for hazardous drug preparations (vertical)Barrier Isolator or Glove boxREQUIRES KNOWLEDGE of RISK LEVEL for COMPOUNDING STERILEPRODUCTSLow Risk: ISO Class 5 or better air quality using only sterile ingredients, transferringdrugs from the manufacturer’s original packaging (e.g., vials or ampules), and no morethan 3 products and entries into one container to compound sterile products.Examples: 20 mEq KCl to liter 0.9% sodium chloride; cefazolin 1 gm to 50 ml D5WBeyond Use Dating for Low Risk compounds prior to administration cannot exceed thefollowing unless sterility testing is performed:48 hours room temperature14 days cold temperature45 days solid frozen at –25 to -10 C17.3
Low Risk with 12 hour or less Beyond Use Dating:ISO Class 5 or better air quality NOT located in ISO 7 buffer areaFollow requirements for garbing, cleaning, personnel training, microbiological monitoring,etc.Only used for compounding low risk and non-hazardous sterile products.Use within 12 hours of preparation or as recommended by manufacturer (whichever isless).Medium Risk: Multiple individual or small doses of sterile products are compounded orpooled to prepare a sterile product that will be administered either to multiple patients orto one patient on multiple occasions (i.e. prepare a batch), or there are complex asepticmanipulations, or the dissolution or mixing takes a long duration and the compoundedsterile products do not contain a broad spectrum bacteriostatic substance and areadministered over several days.Beyond Use Dating for Medium Risk compounds prior to administration can not exceedthe following unless sterility testing is performed:30 hours room temperature9 days cold temperature45 days solid frozen at –25 to -10 CExamples:TPN using manual or automated devicesFilling reservoirs of infusion devices with multiple sterile drug products where the air isremoved from the device or the solution is administered over several days at ambienttemperatures between 25-40 degrees C.Transferring multiple vials or ampules into the final product.High Risk: Using non-sterile ingredients that will be terminally sterilized.Beyond Use Dating for High Risk compounds prior to administration can not exceed thefollowing unless sterility testing is performed:24 hours room temperature3 days cold temperature45 days solid frozen at –25 to -10 CExamples:Dissolving non-sterile powder to make solution that will be terminally sterilizedIngredients, devices or components stored or exposed to air quality with less than ISOClass 5Using non-sterile devices before sterilization is performedSterilization methods are defined in the standards (filtration, steam, dry heat)17.4
Immediate Use Compounding:Low risk compounding used within 1 hour of preparation is exempt from requirements.Beyond Use Dating:1. Single Dose containers (vials, bags) opened in ISO 5 must be used within 1 hourand remaining contents are discarded.2. Single Dose containers opened in ISO 5 or better quality air may be used up to 6hours.3. Ampuls are not stored for any period of time4. Multi-dose vials (contains a preservative) may be used up to 28 days unlessotherwise specified by the manufacturer.5. Based on the compound’s risk level (described above).Personnel TrainingTraining prior to beginning to prepare productsPerform didactic review, written testing and the following suggested training, competencyand process validation methods:1.2.3.4.5.6.Cleansing and garbing competencyAseptic work practice assessment with glove fingertip samplingAseptic manipulation competency with media fill test proceduresSurface cleaning and disinfection sampling assessmentCleaning and disinfecting competency evaluationSuggested standard operating procedures (SOPs) defined in the standardsClean roomsHoods are located in rooms with smooth walls & floors without cracks, non-shedding, andresistant to sanitizing chemicals.Positive pressure exists between buffer and ante area and ante area and the generalenvironment that is measured and documented each work shift (at least daily). At least 30air changes per hour.No cardboard boxes to minimize air particles.Gowning and Personal Protective Equipment (PPE)1. Artificial nails are prohibited2. Staff with sunburn, rashes, conjunctivitis, and upper respiratory infections cannotprepare sterile compounds3. Remove lab coat, make-up, hand and wrist jewelry and visible piercings that mayinterfere with PPE4. Apply shoe covers5. Apply head and facial hair covers6. Apply face mask17.5
7. Wash hands and forearms for 30 seconds and dry with hand dryer or non-sheddingtowels8. Put on non-shedding gown closed at neck and snug at wrists9. Enter buffer area and use waterless alcohol-based surgical hand scrub. Allow todry10. Put on sterile powder-free gloves11. Disinfect sterile gloves with Sterile 70% Isopropyl Alcohol after touching non-sterilesurfaces during compoundingCleaning and sanitizing the work spaceHoodCounters and FloorsWalls, ceiling, shelvesBeginning of each shift, before each batch, every 30minutes during compounding, after spill orcontaminationDailyMonthlyCleaning and disinfection agentsSanitation with Sterile 70% Isopropyl AlcoholEnvironmental MonitoringIncludes monitoring for airborne microorganisms and determining air particulate counts.Hoods are certified every 6 months.Validation of automated compounding devices for nutrition compoundingValidate accuracy & precisionHazardous Drugs/ChemotherapyStorage is in negative pressure room ( 0.01 inch water column negative pressure toadjacent positive pressure), at least 12 air changes per hour, and 100% vented and HEPAfiltered to the outside air or barrier isolator.Hazardous drug preparation training is required.Compounding personnel of reproductive capability “shall confirm in writing that theyunderstand the risks of handling hazardousHospitals (Institutional II pharmacydrugs”.permits) may outsource patientspecific compounding using facility OSHA guidelineswith Special Parenteral/Enteral NIOSH recommendationsExtended Scope permit. Hospital Material Safety Data Sheets (MSDS)maintains responsibility forreviewing for appropriateness,Radiopharmaceutical and Allergen Extractsmedication profile, DUE, etc.The Joint Commission expects that in housecompounding is under the supervision of an appropriately trained pharmacist or physician(MM.05.01.07).17.6
Examples of PreparationsLarge volume parenterals 250ml, 500ml, 1000ml. Usually continuous infusions IV infusion pump guidelinesHospital may purchase pre-madecompounded products (notpatient specific) frommanufacturing facility such asPharMediumIV piggy back (IVPB) Usually intermittent infusions over 30-60 minutes 50ml – 100ml volume (adults)Pharmacy is responsible for IVcompounding throughout thehospital. Preparation by nonpharmacy personnel should beminimized and restricted toemergencies.Pediatric patients Special dilutions Syringe pumpsQuality Assurance Based on Risk level Problems identified Microbiologic/ pyrogen testing Refractive indexTraining: The Joint Commission (HR 01.02.01 EP 19) If blood transfusions and IVmedications are administered by staff other than physicians, staff have special training anddocumentation of competency is maintained.Resources:1. United States Pharmacopeia, Chapter 797 – Pharmaceutical Compounding – SterilePreparations, the Second Supplement to USP31-NF26 (official on June 1, 2008)2. “ASHP Guidelines of Quality Assurance for Pharmacy-Prepared Sterile tion/prep GdlQualAssurSterile.pdf3. “ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs”17.7
www.ashp.org/bestpractices/drugdistribution/prep TAB Cytotoxic.pdf4. Hazardous Drugs: OSHA Standards www.osha.gov5. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and otherHazardous Drugs in Healthcare Settings, DHHS (NIOSH) Publication No. 2004-165(2004) www.cdc.gov/niosh/topics/hazdrug/6. ASHP Links: Manufacturers, Products, and ServicesCompounding Courses Pharmaceutics Laboratory, UNCCHCompounding-Related Journals A2C2 Cleanroom.com International Journal of Pharmaceutical Compounding Pharmacy Purchasing & Products MagazineOnline Engineering Control Manufacturers (Laminar Airflow Workbenches andBarrier Isolators) The Baker Company Containment Technologies Group Germfree LaboratoriesClosed System Transfer Devices Baxa CorporationQuality Control Kits Valiteq Q. I. MedicalCulture Media Hardy Diagnostics7. ASHP Products (www.ashp.org) ASHP's 797 Compliance Advisor Basics of Aseptic Compounding Technique Video Training Program Safe Handling of Hazardous Drugs Video Training Program Compounding Sterile Preparations, 2nd ed. (formerly titled Principles of SterileProduct Preparation, revised 1st ed.) Compounding Sterile Preparations Video Training Program (formerly titled QualityAssurance for Pharmacy-Prepared Sterile Products Videotape & Workbook)17.8
Compounding Sterile Preparations 2.0: A Multimedia Learning ProgramCompetence Assessment Tools for Health-System Pharmacies, 2nd ed.Handbook on Injectable Drugs, 14th ed.Extended Stability for Parenteral Drugs, 3rd ed.Children's Hospital of Philadelphia Extemporaneous Formulations64B16-27.797 Standards of Practice for Compounding Sterile Preparations (CSPs).The purpose of this section is to assure positive patient outcomes through the provision of standards for 1)pharmaceutical care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuantto or in anticipation of a prescription drug order, and 3) product quality and characteristics. These standards areintended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital,nursing home, hospice, doctor’s office).(1) Definitions:(a) “Anteroom” means an area where personnel perform hand hygiene and garbing procedures, staging ofcomponents, order entry, CSP labeling, and other high-particulate generating activities. It is also a transition areathat provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirtyareas. The Anteroom area is to be maintained within ISO Class 8 level of particulate contamination.(b) “Antineoplastic” means a pharmaceutical agent that has the intent of causing cell death targeted to cancercells, metastatic cells, or other cells involved in a severe inflammatory or autoimmune response.(c) “Beyond-use-date” means the date after which a compounded preparation should not be used and isdetermined from the date the preparation was compounded.(d) “Biological safety cabinet” means a containment unit suitable for the preparation of low, moderate, and highrisk agents where there is a need for protection of the product, personnel, and environment.(e) “Bulk Compounding” means the compounding of CSPs in increments of twenty-five (25) or more dosesfrom a single source.(f) “Buffer area” (Clean room) is an area where the activities of CSP take place; it shall not contain sinks ordrains. In High-Risk compounding this must be a separate room. The Buffer area is to be maintained within ISOClass 7 level of particulate contamination.(g) “Class 100 environment” means an atmospheric environment which contains no more than one hundredparticles of 0.5 microns in diameter or larger per cubic foot of air. A class 100 environment is equivalent to ISOClass 5 level of particulate contamination.(h) “Compounding Aseptic Isolator” (CAI) – is a form of barrier isolator specifically designed for compoundingpharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment withinthe isolator throughout the compounding and material transfer process. Air exchange into the isolator from thesurrounding environment should not occur unless it is first passed through a microbially retentive filter (HEPAminimum 0.2 microns).(i) “High-Risk Level CSPs” – are products compounded under any of the following conditions are either nonsterile or at high risk to become non-sterile with infectious microorganisms.1. Non-sterile ingredients, including manufactured products for routes of administration other than sterileparenteral administration are incorporated or a non-sterile device is employed before terminal sterilization.2. Sterile contents of commercially manufactured products, CSP that lack effective antimicrobial preservatives,sterile surfaces of devices and containers for the preparation, transfer, sterilization, and packaging of CSPs areexposed to air quality worse than ISO Class 5 for more than one (1) hour.3. Before sterilization, non-sterile procedures such as weighing and mixing are conducted in air quality worsethan ISO Class 7, compounding personnel are improperly garbed and gloved, or water-containing preparations arestored for more than 6 hours.4. For properly stored sterilized high-risk preparation, in the absence of passing a sterility test, the storageperiods cannot exceed the following time periods: before administration, the CSPs are properly stored and exposedfor not more than 24 hours at controlled room temperature, and for not more than 3 days at a cold temperature (2-817.9
degrees Celsius) and for not more than 45 days in solid frozen state at -20 degrees celsius or colder.5. Examples of high-risk compounding include: (1) dissolving non-sterile bulk drug and nutrient powders tomake solutions, which will be terminally sterilized; (2) exposing the sterile ingredients and components used toprepare and package CSPs to room air quality worse than ISO Class 5 for more than one (1) hour; (3) measuring andmixing sterile ingredients in non-sterile devices before sterilization is performed; (4) assuming, without appropriateevidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their activechemical moiety and have not been contaminated or adulterated between uses.6. All high risk category products must be rendered sterile by heat sterilization, gas sterilization, or filtrationsterilization in order to become a CSP.7. Quality assurance practices for high-risk level CSPs include all those for low-risk level CSPs. In addition,each person authorized to compound high-risk level CSPs demonstrates competency by completing a media-filledtest that represents high-level compounding semiannually.(j) Immediate Use CSPs:1. Requires only simple aseptic measuring and transfer manipulations are performed with not more than three(3) sterile non-hazardous drug or diagnostic radiopharmaceutical drug preparations, including an infusion or dilutionsolution.2. The preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour.3. At no point during preparation and prior to administration are critical surfaces and ingredients of the CSPdirectly exposed to contact contamination such as human touch, cosmetic flakes or particulates, blood, human bodysubstances (excretions and secretions, e.g., nasal or oral) and non-sterile inanimate sources.4. Administration begins not later than one (1) hour following the start of preparing the CSP.5. When the CSP is not administered by the person who prepared it, or its administration is not witnessed by theperson who prepared it, the CSP container shall bear a label listing patient identification information (name,identification numbers), and the names and amounts of all active ingredients, and the name or identifiable initials ofthe person who prepared the CSP, and one (1) hour beyond-use time and date.6. If administration has not begun within one (1) hour following the start of preparing the CSP, the CSP ispromptly and safely discarded. Immediate use CSPs shall not be stored for later use.(k) ISO Class 5 guidelines are met when particulate contamination is measured at “not more than 3,520 particles0.5 micron size or larger per cubic meter of air for any lamiar airflow workbench (LAWF), BSC, or CAI. (Alsoreferred to as a “Class 100 environment.”)(l) ISO Class 7 guidelines are met when particulate contamination is measured at “not more than 352,000particles 0.5 micron size or larger per cubic meter of air for any buffer area (room).”(m) ISO Class 8 guidelines are met when particulate contamination is measured at “not more than 3,520,000particles 0.5 micron size or larger per cubic meter of air for any anteroom (area).”(n) Low-Risk Level CSPs compounded under all of the following are at a low risk of contamination:1. The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 (class 100) or better airquality using only sterile ingredients, products, components, and devices.2. The compounding involves only transfer, measuring, and mixing manipulations using no more than threecommercially manufactured sterile products and entries into one container (e.g., bag, vial) of sterile product to makethe CSP.3. Manipulations are limited to aseptically opening ampoules, penetrating sterile stoppers on vials with sterileneedles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, packagecontainers for storage and dispensing. The contents of ampoules shall be passed through a sterile filter to removeany particles.4. For low-risk preparation, in the absence of passing a sterility test or a documented validated process, thestorage periods cannot exceed the following time periods; before administration, the CSPs are properly stored andexposed for not more than 48 hours at controlled room temperature, and for not more than 14 days at a coldtemperature (2-8 degrees celsius) and for 45 days in solid frozen state at -20 degrees celsius or colder.5. Quality Assurance practices include, but are not limited to, the following: (1) routine disinfection and air17.10
quality testing of the direct compounding environment to minimize microbial surface contamination and maintainISO Class 5 air quality; (2) Visual confirmation that compounding personnel are properly donning and wearingappropriate items and types of protective garments; (3) Review of all orders and packages of ingredients to ensurethat the correct identity and amounts of ingredients were compounded; (4) Visual inspection of CSPs to ensure theabsence of particulate matter in solutions, the absence of leakage from vials and bags, and accuracy andthoroughness of labeling.6. All compounding personnel are required to demonstrate competency by completing a media-filled test thatrepresents low-level compounding annually. A media-filled test is a commercially available sterile fluid culturemedia that shall be able to promote exponential colonization of bacteria that are both likely to be transmitted to CSPfrom the compounding personnel and environment. Media filled vials are incubated at 25-35 degrees celsius for 14days. Failure is indicated by visible turbidity in the medium on or before 14 days.(o) Medium-Risk Level CSPs – When CSPs are compounded aseptically under Low-Risk Conditions, and oneor more of the following conditions exist, such CSPs are at a medium risk of contamination:1. CSPs containing more than three (3) commercial sterile drug products and those requiring complexmanipulations and/or preparation methods.2. Multiple individual or small doses of sterile products are combined or pooled to prepare a CSP that will beadministered either to multiple patients or to one patient on multiple occasions.3. The compounding process requires unusually long duration, such as that required to complete dissolution orhomogeneous mixing.4. For Medium-risk preparation, in the absence of passing a sterility test or a documented validated process, thestorage periods cannot exceed the following time periods; before administration, the CSPs are properly stored andexposed for not more than 30 hours at controlled room temperature, and for not more than 9 days at a coldtemperature and for 45 days in solid frozen state at -20 degrees celsius or colder.5. These include compounding of total parenteral nutrition (TPN) using either manual or automated devicesduring which there are multiple injections, detachments, and attachments of nutrient source products to the device ormachine to deliver all nutritional components to a final sterile container.6. Filling of reservoirs of injection and infusion devices with more than three (3) sterile drug products andevacuation of air from those reservoirs before the filled devices are dispensed.7. Transfer of volumes from multiple ampules or vials into one or more final sterile containers.8. Quality assurance practices for medium-risk level CSPs include all those for low-risk level CSPs.9. Demonstrates competency by completing a media-filled test that represents medium-level compoundingannually.(p) Parenteral means a sterile preparation of drugs for injection through one or more layers of the skin.(q) Risk level of the sterile preparation means the level assigned to a sterile product by a pharmacist thatrepresents the probability that the sterile product will be contaminated with microbial organisms, spores, endotoxins,foreign chemicals or other physical matter.(r) Sterile preparation means any dosage form devoid of viable microorganisms, including but not limited to,parenterals, injectables, ophthalmics, and aqueous inhalant solutions for respiratory treatments.(2) Compounded sterile preparations include, but are not limited, to the following:(a) Total Parenteral Nutrition (TPN) solutions;(b) Parenteral analgesic drugs;(c) Parenteral antibiotics;(d) Parenteral antineoplastic agents;(e) Parenteral electrolytes;(f) Parenteral vitamins;(g) Irrigating fluids;(h) Ophthalmic preparations; and(i) Aqueous inhalant solutions for respiratory treatments.(3) Sterile preparations shall not include commercially manufactured products that do not require compounding17.11
prior to dispensing.(4) Policy & Procedure Manual. A policy and procedure manual shall be prepared and maintained for thecompounding, dispensing, and delivery of sterile preparation prescriptions. The policy and procedure manual shallbe available for inspection by the Department and include at a minimum:(a) Use of single dose and multiple dose containers not to exceed United States Pharmacopeia 797 guidelines.(b) Verification of compounding accuracy and sterility.(c) Personnel training and evaluation in aseptic manipulation skills.(d) Environmental quality and control:1. Air particle monitoring for hoods (or Barrier Isolator), clean room and buffer area (or anteroom) whenapplicable;2. Unidirectional airflow (pressure differential monitoring);3. Cleaning and disinfecting the sterile compounding areas;4. Personnel cleansing and garbing;5. Environmental monitoring (air and surfaces).(e) Personnel monitoring and validation.(f) Finished product checks and tests.(g) Method to identify and verify ingredients used in compounding.(h) Labeling requirements for bulk compounded products:1. Contents;2. Beyond-Use-Date; and3. Storage requirements.(i) Packing, storage, and transportation conditions.(5) Physical Requirements.(a) The pharmacy shall have a designated area with entry restricted to designated personnel for preparingparenteral products. This area shall have a specified ante area and buffer area; in high risk compounding, this shallbe separate rooms. This area shall be structurally isolated from other areas with restricted entry or access, and mustbe designed to avoid unnecessary traffic and interference with unidirectional airflow. It shall be used only for thepreparation of these sterile preparations. It shall be of sufficient size to accommodate a laminar airflow hood and toprovide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture,sanitation, ventilation, and security.(b) The pharmacy compounding parenteral and sterile preparation shall have the following:1. Appropriate environmental control devices capable of maintaining at least class 100 conditions in the workplace where critical objects are exposed and critical activities are performed; furthermore, these devices must becapable of maintaining class 100 conditions during normal activity. Examples of appropriate devices include laminarairflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air;2. Appropriate disposal containers for used needles, syringes, and if applicable, for antineoplastic waste fromthe preparation of chemotherapy agents;3. Appropriate environmental control including approved biohazard cabinetry when antineoplastic drugproducts are prepared;4. Appropriate temperature and transport containers;5. Infusion devices and equipment, if appropriate.(c) The pharmacy shall maintain and use supplies adequate to preserve an environment suitable for the asepticpreparation of sterile preparations, such as:1. Gloves, masks, shoe covers, head and facial hair covers, and non-shedding gowns;2. Needles and syringes of various standard sizes;3. Disinfectant cleaning agents;4. Clean towels;5. Hand washing materials with bactericidal properties;6. Vacuum containers and various transfer sets;17.12
7. “Spill kits” for antineoplastic agent spills.(d) The pharmacy should have current reference material in hard copy or readily available on line:1. USP Pharmacist Pharmacopeia (optional) or Handbook of Injectable Drugs by American Society of HospitalPharmacists; or other nationally recognized standard reference; and2. “Practice Guidelines for Personnel Dealing with Cytotoxic Drugs,” or other nationally recognized standardcytotoxic reference if applicable.(e) Barrier isolator is exempt from all physical requirements subject to manufacturer guidelines for properplacement.(6) Antineoplastic Drugs. The following requirements are necessary for those pharmacies that prepareantineoplastic drugs to ensure the protection of the personnel involved:(a) All antineoplastic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet placed innegative pressure room unless using barrier isolators. Other preparations shall not be compounded in this cabinet.(b) Protective apparel shall be worn by personnel compounding antineoplastic drugs. This shall include at leastgloves and gowns with tight cuffs.(c) Appropriate safety and containment techniques for compounding antineoplastic drugs shall be used inconjunction with the aseptic techniques required for preparing sterile products.(d) Disposal of antineoplastic waste shall comply with all applicable local, state, and federal requirements.(e) Written procedures for handling both major and minor spills of antineoplastic agents shall be developed andshall be included in the policy and procedure manual.(f) Prepared doses of antineoplastic drugs shall be dispensed, labeled with proper precautions inside andoutside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.(7) Quality Assurance:(a) There shall be a documented, ongoing quality assurance control program that monitors personnelperformance,
Product Preparation, revised 1st ed.) Compounding Sterile Preparations Video Training Program (formerly titled Quality Assurance for Pharmacy-Prepared Sterile Products Videotape & Workbook) .
Assistant Professor of Pharmacy Practice Northeast Ohio Medical University Sterile compounding is a unique and critical skill of both pharmacists and pharmacy technicians. In order to become proficient in such skills, it is crucial to have a thorough understanding of the supplies and materials utilized when compounding sterile products.
Part One: Heir of Ash Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Chapter 13 Chapter 14 Chapter 15 Chapter 16 Chapter 17 Chapter 18 Chapter 19 Chapter 20 Chapter 21 Chapter 22 Chapter 23 Chapter 24 Chapter 25 Chapter 26 Chapter 27 Chapter 28 Chapter 29 Chapter 30 .
of traditional pharmacy practice. In 1938, the USP had already been providing compounding instructions for 118 years. Compounding occupied such an important role in U.S. pharmacy practice in the early 20th century that a number of state pharmacy practice acts not only regu-lated compounding but specifically included the term compounding.
WHAT SECTIONS ARE NOT HARMONIZED There are two conflicts that exist between the current 797 2008 and 800 Segregated Compounding Area (SCA) USP 797 only allows low risk, NONHAZARDOUS CSPs with 12 hour BUD USP 800 allows for HD compounding in a Containment-Segregated Compounding Area Low Volume HD Compounding USP 797 allows "low volume" HD compounding with two tiers of .
TO KILL A MOCKINGBIRD. Contents Dedication Epigraph Part One Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Part Two Chapter 12 Chapter 13 Chapter 14 Chapter 15 Chapter 16 Chapter 17 Chapter 18. Chapter 19 Chapter 20 Chapter 21 Chapter 22 Chapter 23 Chapter 24 Chapter 25 Chapter 26
10/28/2017 1 The Inspection Process for Pharmacies Compounding Sterile Preparations (CSPs) Timeline of the Regulation of CSPs in Texas 11/9/2013 1982 First mention of “IV Admixtures” in the Texas Pharmacy Act 1991 Requirements for the preparation of sterile ph
6 2. Disinfection / sterilization and storage of instruments and equipment a) Use pre-packaged, disposable sterile acupuncture needles whenever possible. b) Check the expiry dates of sterile items before use and make sure the packages are intact. c) Package should be opened just before use to prevent contamination. d) Unopened sterile items, e.g. alcohol pads, sterile needles, sterile cotton
Safety Code for Elevators and Escalators, ASME A17.1-2013, as amended in this ordinance and Appendices A through D, F through J, L, M and P through V. Exceptions: 1.1. ASME A17.1 Sections 5.4, 5.5, 5.10 ((and)) , 5.11, and 5.12 are not adopted. 1.2. ASME A17.1 Section 1.2.1, Purpose, is not adopted. 2015 SEATTLE BUILDING CODE 639 . ELEVATORS AND CONVEYING SYSTEMS . 2. Safety Standard for .
