163 Questions
What are the two very important records that each compounded product must have?
Master formula record and compounding record
What is the purpose of the compounding log?
To provide detailed documentation for replication, evaluation, and traceability
What initial steps are similar for most formulations when preparing to compound?
Calibrating equipment and weighing ingredients
What must the pharmacy keep records of related to the compounded product?
Equipment cleaning, calibration, maintenance, temperature logs, and chemical records
What is the purpose of using a powder sieve?
To ensure uniform particle size
What is the range of particle size after grinding the powder?
0.1 - 10 microns
What is levigation in the context of comminution?
Incorporating a small amount of liquid to aid grinding
What does trituration primarily involve?
Grinding tablets with a mortar and pestle
What is the main goal when making a compound with dry ingredients?
To make an evenly-distributed mixture with fine powder
What is the sieve number based on?
The number of holes per inch
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
Comminution
What is the purpose of levigating agent in levigation and spatulation?
To aid the grinding process
What type of calculations are often required for compounding?
Percentage and ratio strengths
What is the recommended personal protective equipment (PPE) for compounding non-sterile, non-hazardous preparations?
Clean lab coat and gloves
Where should the preparation of non-sterile hazardous drugs (HDs) ideally be done?
Containment primary engineering control (C-PEC)
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
Dedicated equipment
What is the primary purpose of Safety Data Sheets (SDS) for compounding?
Determine safety procedures and recommended PPE
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
Placing into unit-dose sealed packaging
What is the recommended primary engineering control for preparing non-sterile hazardous drugs (HDs)?
Containment primary engineering control (C-PEC)
What is the primary technique recommended for most formulations when preparing to compound?
Trituration
What is the primary goal of completing compounding steps?
Packaging the product
What is the primary aspect of quality control for compounded products?
Validating weight
What is the primary part of the compounding record related to patient care?
Counseling the patient
What is the recommended practice for compounding non-sterile hazardous drugs (HDs) into final formulations?
Placing into unit-dose sealed packaging
True or false: The compounding log must be detailed enough that another trained person can replicate the steps involved in the preparation.
True
True or false: The main goal when making a compound with dry ingredients is to reduce particle size by grinding, crushing, milling, or vibrating.
True
True or false: The pharmacy must keep records of steps and processes that relate to the compounded product, such as equipment cleaning, calibration and maintenance.
True
True or false: The initial steps for most formulations when ready to compound, include calibrating equipment and weighing ingredients.
True
Comminution involves reducing particle size by grinding, crushing, milling, vibrating, or other processes.
True
The size of particles after grinding the powder ranges from 0.1 - 10 microns.
True
A sieve with a high mesh size has many wires that make many holes, allowing only a fine powder to get through the mesh.
True
Trituration is a general term used to mean 'mix thoroughly' and is commonly associated with grinding tablets with a mortar and pestle until a fine powder is achieved.
True
Levigation involves triturating the powder with a mortar and pestle and incorporating a small amount of liquid, called a levigating agent, to help with the grinding process.
True
Sieves, which are sifters, are used to ensure that the particle size is uniform by sifting the powder through the mesh.
True
The number of holes per inch determines the sieve number, e.g., a #100 sieve has 100 openings per inch.
True
The primary goal when making a compound with dry ingredients is to make an evenly-distributed mixture with fine powder.
True
Compounding of non-sterile, non-hazardous preparations does not require any personal protective equipment (PPE).
False
Safety Data Sheets (SDS) provide information on recommended personal protective equipment (PPE) for specific compounds, such as benzalkonium chloride.
True
Compounding Record includes the drug name, strength, quantity, ingredients, compounding directions, and procedures.
True
Techniques to reduce exposure for non-sterile hazardous drugs (HDs) include using shared equipment and placing final formulations into bulk packaging.
False
Common techniques for most formulations include trituration, emulsification, and geometric dilution.
False
Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and temperature.
False
Calculations for compounding often require unit conversions, percentage and ratio strengths, basic geometry, and changing concentrations.
False
Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) whenever possible.
True
Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
True
Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
True
Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
True
Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal personal protective equipment (PPE).
False
What is the primary purpose of using a powder sieve in compounding?
To ensure uniform particle size by sifting the powder through the mesh
What is the range of particle size after grinding the powder for most formulations in compounding?
0.1 - 10 microns
What is the recommended osmolarity for sterile preparations, including intravenous (IV) solutions and ophthalmic products, to prevent fluid transfer across biological semipermeable membranes?
Approximately -285 mOsm/L
What is the primary technique recommended for most formulations when preparing to compound?
Trituration, emulsification, and geometric dilution
Which type of bag should be used for IV medications with leaching or sorption issues?
Non-PVC bags
What should be done to equalize pressure when drawing up liquid from vials?
Injecting a volume of air equal to the volume of drug withdrawn
What is the primary purpose of lyophilized or freeze-dried powder in vials?
To enable reconstitution before use
What is the volume range for Small Volume Parenteral (SVP) bags?
50 - 100 ml
What is the primary characteristic of Large Volume Parenteral (LVP) containers?
Contain more than 100 ml of fluids
What is the risk level of Ready-to-use medications in terms of Compounded Sterile Preparations (CSP)?
No risk level
What is involved in the workflow for CSP preparation?
Disposal of syringes and needles
What is the primary requirement for sterile compounding space?
Proper ventilation
What is the recommended practice for Ready-to-use vial/bag systems?
Attach vials to bags at the patient's bedside
What is the primary containment equipment recommended for reducing exposure to non-sterile hazardous drugs (HDs)?
Glove box
What is the primary technique for reducing exposure to non-sterile hazardous drugs (HDs)?
Using closed-system transfer devices (CSTDs)
What is the primary aspect of quality control for compounded products?
Visual appearance
What determines the Beyond-Use Date (BUD) for compounded sterile preparations (CSPs)?
The stability of individual ingredients and USP 797 standards
Which CSPs require sterilization before use?
High-risk CSPs
What is the primary purpose of immediate-use compounded sterile preparations (CSPs)?
Emergency administration
What is the required sterility testing for certain high-risk CSPs and those beyond recommended BUD?
Tryptic soy broth or fluid thioglycollate medium
Which CSPs have the shortest Beyond-Use Date (BUD)?
Immediate-use CSPs
What type of CSPs are commonly prepared by pharmacy staff and use 1 to 3 sterile components?
Low-risk CSPs
What determines the BUDs for Single-Dose Containers and Multi-Dose Containers?
Type of container and the environment in which they are opened
What must every facility preparing CSPs have in place to evaluate and improve the quality processes?
Quality assurance plan
What is the primary requirement for immediate-use CSPs?
Emergency administration within 1 hour
What do BUDs for room temperature and refrigerated CSPs vary based on?
Risk level of the CSP
What are medium-risk CSPs examples of?
Parenteral nutrition preparations
What are high-risk CSPs characterized by?
Use of non-sterile ingredients and equipment
What is the primary purpose of the carbonic acid-bicarbonate buffer system in the body?
To resist changes in pH in the body
What is the potential consequence of administering lower osmolarity saline solutions alone?
RBCs absorb fluid and burst
Why should hypertonic saline concentrations be restricted to specific areas in the hospital?
To avoid adverse outcomes
What is the primary reason for administering solutions with high osmolarity via a central line?
To avoid vein damage
What is the potential consequence of administering hypertonic saline into a peripheral vein?
RBCs become shriveled and dysfunctional
What is the classification for a recall that is not likely to cause adverse health consequences?
Class III
What is the primary purpose of Root cause analysis for medication errors or safety issues?
To identify problems with new procedures
What is the primary function of the Standard Operating Procedures (SOPs) in pharmaceutical quality assurance?
To follow and periodically review for necessary revisions
What must High-risk level Compounded Sterile Preparations (CSPs) have in place for daily observation of test specimens?
Immediate recall if evidence of microbial growth is found
What are the primary components that a QA plan must include?
All of the above
What is the primary role of failure mode and effects analysis in pharmaceutical quality assurance?
To help identify problems with new procedures
What is the primary reason for developing, following, and periodically reviewing Standard Operating Procedures (SOPs)?
To ensure adherence to established processes
What is the recommended technique for handling closed-system transfer devices (CSTDs) when compounding?
Handling at a 45-degree angle
What is the primary purpose of using a filter straw or needle when withdrawing fluid from glass ampules?
To avoid glass particles
What is the primary purpose of using a negative-pressure technique for hazardous drugs?
To prevent spraying and contamination
What is the recommended method for sterilizing heat-sensitive drugs?
Filtration with a 0.22-micron filter
What must labels for compounded sterile preparations (CSPs) include?
Ingredient names, concentrations, total volume, BUD, route of administration, storage requirements, and hazardous warnings
What is the primary purpose of auxiliary labels for compounded sterile preparations (CSPs)?
To indicate special handling requirements
What is the primary goal of terminal sterilization methods for compounded products?
To ensure sterility
What is the primary purpose of visual inspection for rubber coring when using multi-dose vials?
To check for contamination
What is the recommended practice for changing the needle before injecting into an IV bag?
To prevent glass or particles from entering the bag
What is the primary purpose of testing certain compounded sterile preparations (CSPs) for endotoxins?
To ensure safety and quality
What is the primary purpose of rinsing glassware and utensils with sterile water and depyrogenating them?
To avoid contamination
What is the primary purpose of inverting multi-dose vials after withdrawal?
To ensure proper mixing
What is the osmotic pressure of human blood and body tissues equivalent to?
False
All hazardous drugs (HDs) should be labeled appropriately.
True
Is the osmolarity of most sterile preparations, including intravenous (IV) solutions and ophthalmic products, approximately -285 mOsm/L?
True
The pharmacist is not required to counsel the patient or caregiver about the proper use of a compounded product.
False
Closed-system transfer devices (CSTDs) equalize vial pressure and eliminate the need to inject air.
True
Multi-dose vials should be visually inspected for rubber coring after withdrawal.
True
Glass ampules should be opened towards the user to avoid contamination.
False
The needle must be changed after injecting into an IV bag to prevent glass particles from entering the bag.
True
Heat-sensitive drugs can be sterilized using filtration with a 0.22-micron filter without the need for a bubble-point test.
False
Labels for CSPs must include the total weight, BUD, and potential adverse reactions.
False
Low-risk sterile drugs have the lowest contamination risk and the shortest BUD.
False
Auxiliary labels should be used for CSPs requiring special handling, and high-alert medications do not need appropriate auxiliary labels.
False
Certain CSPs must be tested for endotoxins, and glassware and utensils should be rinsed with regular water to avoid contamination.
False
Terminal sterilization methods include steam, dry-heat, gas sterilization, ionizing radiation, and bidirectional aseptic processing.
False
The negative-pressure technique should be used for non-hazardous drugs to prevent spraying and contamination.
False
Sterile compounding space must have a temperature of 25°C and humidity of 60%.
False
Which technique should be used to prevent contamination when withdrawing fluid from glass ampules?
Using a filter straw or needle to withdraw fluid
What must be done before injecting into an IV bag to prevent contamination?
Changing the needle
Low-risk CSPs use 1 to 3 sterile components and are commonly prepared by pharmacy staff.
True
High-risk CSPs are uncommon and use non-sterile ingredients and equipment, requiring sterilization before use.
True
What is the primary purpose of using a 0.22-micron filter in sterilizing heat-sensitive drugs?
To prevent spraying and contamination
What information must be included in labels for Compounded Sterile Preparations (CSPs)?
Ingredient names and concentrations
Sterility testing using tryptic soy broth or fluid thioglycollate medium is required for certain high-risk CSPs and those beyond recommended BUD.
True
What is the recommended containment equipment for reducing exposure to non-sterile hazardous drugs (HDs)?
Containment primary engineering control (C-PEC)
BUDs for Single-Dose Containers and Multi-Dose Containers depend on the type of container and the environment in which they are opened.
True
Immediate-use CSPs are intended for emergency administration and have specific requirements for administration within 1 hour.
True
What is the recommended method for terminal sterilization of Compounded Sterile Preparations (CSPs)?
Ionizing radiation
What is the primary aspect of quality control for compounded products?
Checking for mixing adequacy
BUD is determined by USP 797 standards and the stability of individual ingredients, with shorter BUD for higher risk levels.
True
Room temperature and refrigerated BUDs vary based on CSP risk level, with longer BUD for low-risk CSPs and immediate-use.
True
What is the recommended personal protective equipment (PPE) for compounding non-sterile hazardous drugs (HDs)?
Clean lab coat and gloves
Immediate-use CSPs, prepared in emergency situations, have the shortest Beyond-Use Date (BUD).
True
What is the purpose of using a levigating agent in levigation and spatulation?
To help with the grinding process
Every facility preparing CSPs must have a quality assurance plan to evaluate and improve the quality processes.
True
What must the pharmacy keep records of related to the compounded product?
Equipment cleaning and maintenance
What is the recommended practice for packaging final formulations of non-sterile hazardous drugs (HDs)?
Applying container labels
Low-risk, medium-risk, and high-risk CSPs have specific area requirements based on the number of sterile ingredients and complexity of manipulations.
True
Medium-risk CSPs include parenteral nutrition preparations and compounding a batch of drugs like IV bags for surgeries.
True
What is the term used to describe reducing particle size by grinding, crushing, milling, or vibrating?
Trituration
Non-PVC bags should be used for IV medications with leaching or sorption issues
True
Ampules are small, sealed glass containers with a long neck containing liquid medication; breaking the ampule can introduce glass particles into the drug solution
True
Small volume parenteral (SVP) bags contain 100 ml or less of fluid and can be sent to the patient care area for floor stock
True
Ready-to-use medications do not have a CSP risk level and have an expiration date provided by the manufacturer
True
Large volume parenteral (LVP) containers contain more than 100 ml of fluids, including NS, DSW, DSNS, and others
True
Ready-to-use vial/bag systems involve attaching vials to bags at the bedside or in the pharmacy cleanroom
True
Lyophilized or freeze-dried powder in vials needs reconstitution by adding sterile water for injection, bacteriostatic water for injection, or a diluent supplied by the manufacturer
True
Vials containing liquids require drawing up the drug in a syringe and injecting a volume of air equal to the volume of drug withdrawn to equalize pressure
True
SVPs can contain plain fluid, drugs with or without a diluent, and can be piggybacked onto a large volume parenteral (LVP)
True
pH of sterile preparations should be close to neutral (pH of 7); blood is slightly alkaline at a pH of 7.35 - 7.45
True
Workflow for CSP preparation involves pharmacist review, gathering and inspecting materials, aseptic preparation, disposal of syringes and needles, and visual inspection of finished CSPs
True
Space requirements for sterile compounding are discussed in detail, including the placement of items in the sterile hood and the transfer of solutions into IV bags
True
Osmolarity and tonicity are unrelated terms used to express solute concentration in solutions.
False
Hypertonic saline concentrations can be administered into a peripheral vein without causing adverse effects.
False
Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone.
True
The carbonic acid-bicarbonate buffer system is the only buffer system used by the body to resist changes in pH.
False
Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage.
True
QA plan for pharmaceuticals must include environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
True
Root cause analysis should not be initiated for medication errors or safety issues.
False
Standard Operating Procedures (SOPs) should not be developed, followed, and periodically reviewed for necessary revisions.
False
Recalls are classified as Class I (temporary or reversible adverse health consequences), Class II (serious adverse health consequences or death), and Class III (not likely to cause adverse health consequences).
False
High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
True
Solutions with high osmolarity should be administered via a central line to avoid vein damage.
True
pH changes in body tissues are not resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
False
Study Notes
Compounding Formulation and Safety Procedures
- Always review Safety Data Sheets (SDS) for each bulk ingredient to determine safety procedures for compounding and recommended personal protective equipment (PPE).
- Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
- Compounding Record includes drug name, strength, quantity, ingredients, compounding directions, and procedures.
- Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) when possible.
- Techniques to reduce exposure for non-sterile HDs include using dedicated equipment and placing final formulations into unit-dose sealed packaging.
- Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal PPE.
- Safety Data Sheets provide information on additional PPE needed for specific compounds, such as benzalkonium chloride.
- Calculations for compounding often require unit conversions, percentage and ratio strengths, basic algebra, and changing concentrations.
- Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
- Common techniques for most formulations include trituration, levigation, and geometric dilution.
- Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and pH.
- Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Compounding Formulation and Safety Procedures
- Always review Safety Data Sheets (SDS) for each bulk ingredient to determine safety procedures for compounding and recommended personal protective equipment (PPE).
- Master Formula #3755 for Ibuprofen 200mg Suppositories includes ingredients, quantities, and preparation steps.
- Compounding Record includes drug name, strength, quantity, ingredients, compounding directions, and procedures.
- Preparation of non-sterile hazardous drugs (HDs) should be done in a containment primary engineering control (C-PEC) when possible.
- Techniques to reduce exposure for non-sterile HDs include using dedicated equipment and placing final formulations into unit-dose sealed packaging.
- Compounding of non-sterile, non-hazardous preparations requires a clean lab coat and gloves as minimal PPE.
- Safety Data Sheets provide information on additional PPE needed for specific compounds, such as benzalkonium chloride.
- Calculations for compounding often require unit conversions, percentage and ratio strengths, basic algebra, and changing concentrations.
- Completion steps for compounding include packaging the product, performing quality control, and applying container labels.
- Common techniques for most formulations include trituration, levigation, and geometric dilution.
- Quality control for compounded products involves validating weight, checking for mixing adequacy, color, clarity, odor, consistency, and pH.
- Counseling the patient and documenting any subsequent adverse drug reactions (ADRs) are part of the compounding record.
Pharmaceutical Quality Assurance and Osmolarity in Intravenous Drugs
- QA plan must include personnel training, environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
- Root cause analysis should be initiated for medication errors or safety issues, and failure mode and effects analysis can help identify problems with new procedures.
- Standard Operating Procedures (SOPs) should be developed, followed, and periodically reviewed for necessary revisions.
- High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
- Recalls are classified as Class I (serious adverse health consequences or death), Class II (temporary or reversible adverse health consequences), and Class III (not likely to cause adverse health consequences).
- Osmolarity and tonicity are related terms used to express solute concentration in solutions, and hypertonic saline concentrations should be restricted to specific areas in the hospital to avoid adverse outcomes.
- Hypertonic saline administered into a peripheral vein can cause RBCs to become shriveled and dysfunctional, while solutions with high osmolarity should be administered via a central line to avoid vein damage.
- Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone, and pH changes in body tissues are resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
- The carbonic acid-bicarbonate buffer system is used by the body to resist changes in pH, with two other buffer systems also playing a role in pH regulation.
- Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage and provide stability for the drug in the solution.
Sterile Compounding Best Practices
- Closed-system transfer devices (CSTDs) or the negative-pressure technique should be used to prevent contamination.
- CSTDs equalize vial pressure, eliminating the need to inject air, and should be handled at a 45-degree angle.
- Multi-dose vials should be inverted after withdrawal, and visual inspection for rubber coring is crucial.
- Glass ampules should be opened away from the user, and a filter straw or needle should be used to withdraw fluid to avoid glass particles.
- The needle must be changed before injecting into an IV bag to prevent glass or particles from entering the bag.
- Negative-pressure technique should be used for hazardous drugs to prevent spraying and contamination.
- Terminal sterilization methods include steam, dry-heat, gas sterilization, ionizing radiation, and unidirectional aseptic processing.
- Heat-sensitive drugs can be sterilized using filtration with a 0.22-micron filter, with a bubble-point test to test filter integrity.
- Labels for CSPs must include ingredient names, concentrations, total volume, BUD, route of administration, storage requirements, and hazardous warnings.
- Low-risk sterile drugs have the lowest contamination risk and the longest BUD.
- Auxiliary labels should be used for CSPs requiring special handling, and high-alert medications need appropriate auxiliary labels.
- Certain CSPs must be tested for endotoxins, and glassware and utensils should be rinsed with sterile water and depyrogenated to avoid contamination.
Pharmaceutical Quality Assurance and Osmolarity in Intravenous Drugs
- QA plan must include personnel training, environmental monitoring, equipment calibration, and maintenance, with documented follow-up actions and assigned personnel.
- Root cause analysis should be initiated for medication errors or safety issues, and failure mode and effects analysis can help identify problems with new procedures.
- Standard Operating Procedures (SOPs) should be developed, followed, and periodically reviewed for necessary revisions.
- High-risk level Compounded Sterile Preparations (CSPs) must have a written procedure for daily observation of incubating test specimens and immediate recall if evidence of microbial growth is found.
- Recalls are classified as Class I (serious adverse health consequences or death), Class II (temporary or reversible adverse health consequences), and Class III (not likely to cause adverse health consequences).
- Osmolarity and tonicity are related terms used to express solute concentration in solutions, and hypertonic saline concentrations should be restricted to specific areas in the hospital to avoid adverse outcomes.
- Hypertonic saline administered into a peripheral vein can cause RBCs to become shriveled and dysfunctional, while solutions with high osmolarity should be administered via a central line to avoid vein damage.
- Lower osmolarity saline solutions can cause RBCs to absorb fluid and burst if administered alone, and pH changes in body tissues are resisted by buffer systems to maintain a narrow pH range in sensitive tissues.
- The carbonic acid-bicarbonate buffer system is used by the body to resist changes in pH, with two other buffer systems also playing a role in pH regulation.
- Preparations administered in sensitive tissues must be formulated to keep the pH within a narrow range to avoid tissue damage and provide stability for the drug in the solution.
Test your knowledge of compounding formulation and safety procedures with this quiz. Covering topics such as Safety Data Sheets, master formulas, compounding records, PPE, hazardous drugs, calculations, quality control, and common techniques, this quiz will help reinforce essential concepts for pharmaceutical compounding.
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