sterile / non sterile

Question 1

It is the age-old practice of combining medications, also referred to as active ingredients, with inactive ingredients to create personalized medications that can be adapted to the needs of each individual.

Answer 1

Pharmaceutical compounding

Question 2

two overarching types of compounding, which vary depending on the product being made.

Answer 2

sterile and non-sterile

Question 3

It is most commonly used in the preparation of medications that require sterility due to the risk of infection.

Answer 3

Sterile compounding

Question 4

Sterile compounding is most commonly used in the preparation of medications that require sterility due to the risk of infection.

This risk is tied to their route of administration and includes things like eye drops, injections, and intravenous
medications.

These types of products can have a negative impact on patients’ lives if there is even a trace of bacteria present in preparation.

Question 5

It is by far the more common of the two and can be slightly misleading in its name.

Answer 5

Non-sterile compounding

Question 6

While these products are not compounded in an entirely sterile environment which consists of a separate clean room, non-sterile compounding must follow its own set of strict guidelines.

Question 7

It must ensure and maintain active ingredient purity and potency, guarantee accurate mixing, packaging, labeling, and storage of the final product, and must keep all surfaces, materials, and equipment as clean as possible.

Answer 7

Non-sterile compounding

Question 8

It is a fundamental part of pharmacy practice.

Answer 8

compounding of medications

Question 9

All compounding personnel, mainly
___ and ___, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity (freedom
from physical contaminants, such as precipitates, and chemical contaminants), strength (including stability and compatibility), and sterility and for dispensing them in
appropriate containers that are labeled accurately and appropriately for the end user.

Answer 9

pharmacists
pharmacy technicians

Question 10

It means any dosage form of a drug,
including parenteral products free of viable microorganisms, made using currently accepted aseptic compounding techniques under acceptable compounding conditions.

Answer 10

Sterile preparation

Question 11

It is further defined by USP to include any manipulation of a sterile or non-sterile product intended to produce a sterile final product. The ____
recognizes compounding as a part of pharmacy practice, which does not fall within the agency’s authority.

Answer 11

Sterile compounding

Food and Drug Administration (FDA)

Question 12

It involves creating a medication in an environment free from viruses, bacteria, or any other potentially infectious microorganisms. This type of
compounding is used for medications that will be administered either through an IV, injection, or directly into the eyes.

Answer 12

Sterile compounding

Question 13

Administering medications through IV, Injection, or Directly into the eyes all have a very high risk of causing infection, so using sterile compounding techniques will help to significantly reduce these risks.

Question 14

There are certain procedures and techniques that must be followed during sterile compounding to ensure that a
medication does not get contaminated with infectious microorganisms. These procedures and techniques include:

Answer 14

 Wear proper personal protective equipment (PPE), which includes gloves, goggles, masks, and hair coverings

 Use a compounding hood, which is a piece of equipment that prevents potentially infectious microorganisms from entering a work area.

 Sterilize all equipment, such as flasks, beakers, spatulas, and syringes; equipment sterilization can be
accomplished using an autoclave, which sterilizes equipment using very high heat.

 Compounding surfaces must be deactivated using an oxidizing material, cleaned with a germicidal material,
and disinfected with a substance containing alcohol

Question 15

Pharmacy ensures that sterile preparations meet the clinical needs of
patients, satisfying quality, safety, and environmental control requirements in all phases of preparation, storage,
transportation, and administration in compliance with established standards, regulations, and professional best
practices.

Answer 15

Compounded Sterile Preparations

Question 16

Includes Compounded biologics, diagnostic, drugs, nutrients, and
radiopharmaceuticals, including but not limited to the following dosage forms that must be sterile when they are
administered to patients; aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues,
injections (e.g. colloidal dispersions, emulsions, solutions, suspensions), irrigations for wounds and body cavities,
ophthalmic drops and ointments, and tissue implants.

Answer 16

Compounded Sterile Preparations (CSP)

Question 17

It is a treatment modality that should only be employed when enteral nutrition is not plausible.

Answer 17

Total Parenteral Nutrition

Question 18

It must supply all necessary nutrients for synthesis of lean body mass, wound healing, and maintenance of immune functions.

 It supplies all daily nutritional requirements of a patient.

Answer 18

Total Parenteral Nutrition

Question 19

Nutrition Support Team (NST) Is usually composed of the:

Answer 19

Gastroenterologist
Primary Care Physician
Pharmacist
Nurse
Dietician

Question 20

It is the head of the NST and responsible for the entire team duties and responsibilities

Answer 20

Physician

Question 21

It has the responsibility of preparing the
sterile TPN solution.

Answer 21

Pharmacist

Question 22

The key figure in the NST, being in constant contact with the patient.

Answer 22

Nurse

Question 23

It is the resulting combination when one or more sterile products are added to an IV fluid for administration.

Answer 23

Intravenous admixture

Question 24

In designing an IV admixture system, the pharmacist will have to consider typical process flow, stability, sterility, incompatibility information, type of IV fluid containers, compounding procedures, solubility, and proper labeling.

Question 25

It refers to the preparation of the solution with additives by individuals other than those who will administer them or who will assume responsibility for monitoring the effects on the patient once the administration has been initiated.

Answer 25

Intravenous admixture services

Question 26

 IV Fluids with or without additives intended to be administered by intravenous infusion. These consist of
single-dose injections having a volume of 100 mL to 1000 mL.

Answer 26

Large Volume Parenterals (LVP)

Question 27

Resulting intravenous preparations are packaged in containers having a capacity of ____.

Answer 27

100 mL to 1000 mL

Question 28

The commonly used mini-type infusion containers are ____ and ____ partial fills for solutions of drugs intended for “piggyback” technique.

Answer 28

250 mL capacity and 100 mL

Question 29

Consist of single-dose IV injections having a volume of less than 100 mL.

These includes 50 mL partial fills for solutions of drugs used in“piggyback” infusion and IV push preparations which are being administered over a short
period of time.

Answer 29

Small Volume Parenterals

Question 30

Consist of parenteral preparations in single dose, ready-to-administer aspirated syringes.

Answer 30

Unit Dose Injections

Question 31

Small Volume Parenterals (SVP) consist of single-dose IV injections having a volume of less than __. These includes ___ partial fills for solutions of drugs used in“piggyback” infusion and IV push
preparations which are being administered over a short period of time.

Answer 31

100 mL

50 mL

Question 32

It is a critical measure that is affected by
facility design.

Answer 32

International Organization for Standardization (ISO) air cleanliness classification of the compounding
environment

Question 33

PHYSICAL FACILITIES AND EQUIPMENT
Design and Functionality Requirements

Answer 33

• Primary Engineering Controls (PECs)
• Architecture
• Buffer Areas
• Air Supply
• Surfaces

Question 34

 To meet requirements for sterile compounding, many facilities choose to renovate existing space rather than
construct new facilities.

Answer 34

Renovation

Question 35

 Whether designing a new area or retrofitting one, the specific types (e.g., hazardous or nonhazardous) and risk
levels of CSPs that will be prepared in the area should guide the facility design and construction.

 A plan for how operations will continue without interruption should be devised prior to construction.

Answer 35

Renovation

Question 36

 The facility’s emergency management plan should include steps to meet patient-care needs during time of utility
interruptions, including the need for CSPs. In some cases, immediate-use procedures may be safely implemented to meet some needs.

Answer 36

Power and Other Utility Interruptions

Question 37

Methods to identify and safely meet interim compounding needs or address patient-care needs with non compounded alternatives should be developed, put into standard operating
procedures (SOPs), in-serviced to staff, and tested as part of the organization’s emergency planning process.

Answer 37

Power and Other Utility Interruptions

Question 38

These are utilized to increase efficiency while decreasing the potential for human error.

Devices that do not create their own ISO Class 5 environment must be located within an ISO Class 5 PEC and adhere to
applicable standards for accuracy and precision.

Answer 38

Pharmacy compounding devices

Question 39

 All compounding devices must be monitored and validated for accuracy consistent with device manufacturer specifications.

Answer 39

Pharmacy Compounding Devices

Question 40

Cleaning with a germicidal detergent and water will remove visible solids or soiling before disinfecting. Disinfecting
removes microbial contamination.
 It is critical that an appropriate germicidal detergent and water be used to clean all surfaces of the buffer and ante areas in addition to all of the PECs.

Answer 40

Cleaning and Disinfecting

Question 41

It requires viable and nonviable airborne particle testing, pressure differential
or displacement airflow measurement, temperature monitoring, and surface disinfection sampling and assessment.

Answer 41

Ensuring a safe compounding environment

Question 42

PHYSICAL FACILITIES AND EQUIPMENT
Environmental Monitoring

Answer 42

 Temperature Monitoring
 Pressure Differential or Air Displacement
 Nonviable Airborne Particle Testing Program
 Viable Airborne Particle Testing Program
 Surface Disinfection Sampling and Assessment

Question 43

It refers to any individual involved in compounding sterile preparations, regardless of profession.

Answer 43

Compounding Personnel

Question 44

They are responsible for ensuring that
CSPs are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged,
sealed, labeled, stored, dispensed, distributed, and disposed of if not used.

Answer 44

Compounding Personnel

Question 45

Proper preparation for sterile, nonhazardous drug compounding

Answer 45

Hygiene and Garbing

Question 46

To minimize the number of particles introduced into the sterile compounding area and to minimize the risk of bacteria, all outer jackets and sweaters, visible jewelry, and cosmetics must be removed prior to initiating the hand washing and garbing processes.

Personal electronic devices (e.g., cell phones, MP3 players) and any associated attachments must be removed prior to hand hygiene and garbing and should not be used within the sterile compounding area.

Answer 46

Hygiene and Garbing

Question 47

 Compounding personnel must understand the purposes of and relationships between ante, buffer, segregated, and storage areas.
 A systematic process of entering and exiting the various areas is necessary to minimize contamination. Food, drinks, and gum are prohibited in all of these areas.

Answer 47

Compounding Areas

Question 48

 Packaging and subsequent labeling are critical to patient safety. Packaging must be appropriate to preserve both sterility and stability until the ___.

Answer 48

BUD

Question 49

Proper labeling requires an understanding of compounding risk levels and how to determine BUDs
based on both stability and sterility.

Answer 49

Packaging and Labeling

Question 50

Labels for single compounded preparations must, at a minimum, include the following:

Answer 50

 Names of active ingredients
 Amounts or concentrations of active ingredients
 BUD and time
 Storage requirements
 Identification of responsible compounding personnel

Question 51

Labels for batch-prepared CSPs must also include:

Answer 51

 Control or lot number
 Appropriate auxiliary labeling (including precautions)
 Device-specific instructions (when appropriate)

Question 52

Temperatures of areas used for storage on patient-care and procedural units, including room temperature and in
refrigerators, freezers, and warmers, must be monitored and recorded daily.

Answer 52

Storage

Question 53

On at least a ___ basis, compounding personnel or designated pharmacy personnel should evaluate storage areas for appropriate secure conditions, separation of drugs and food, and proper use and disposal of single-and multiple-dose vials.

Answer 53

monthly

Question 54

 All personnel involved in the handling, transport, or storage
of CSPs, whether they are compounding personnel or not, must be properly trained to complete these tasks, and the
performance of all personnel, including contractors, must be monitored for compliance with facility policies.

 Transportation methods for CSPs should be evaluated, as some forms of transportation, such as pneumatic tube
systems, may adversely affect stability or integrity.

Answer 54

Transporting

Question 55

It allows pharmacist and doctor to
work together to create medication that is tailored to specific needs. Compounded medications require a prescription from physician, just like any other prescription medication.

Answer 55

Non-sterile compounding

Question 56

Advantages of Non Sterile Compounding

Answer 56

• Custom-made strength or dosage
• Addition of flavoring
• Removal of unwanted inactive
ingredients

Question 57

Commercially available products come in a set range of doses, meaning you may be getting more or less of the medication than your body needs.

Customizing the strength or dosage
allows you to receive the amount you need, while potentially avoiding some unwanted side effects.

Answer 57

Custom-made strength or dosage

Question 58

Flavoring can be added to many
medications to make them more palatable without altering their efficacy.

This can be especially useful for children or animals who are not able to swallow pills and/or do not like the taste of a certain medication.

Answer 58

Addition of flavoring

Question 59

Compounding allows the physician and
pharmacist to reformulated products in order to remove unwanted inactive agents, such as lactose, dyes, or gluten that may lead to sensitivities for certain patients.

Answer 59

Removal of unwanted inactive ingredients

Question 60

These are another way non-sterile
compounding can create a more personalized approach to treatment.

Answer 60

Alternate formulations

Question 61

Some products can be prepared using alternate formulations to provide patients with other ways of taking
their medication, including:

Answer 61

 Sustained-release oral products
 Liquids preparations
 Topical gels, lotions, ointments, creams, and foams
 Medicated shampoos
 Medicated lip balms
 Dissolving troches and lollipops

Question 62

All personnel are responsible for knowing and performing their roles and responsibilities in accordance with these
Model Standards and the requirements of the applicable pharmacy regulatory authority.

Compounding Personnel:

Answer 62

 Pharmacy Manager, Pharmacy Department Head
 Non-sterile compounding Supervisor (Pharmacist or Pharmacy Technician)
 Regulated Pharmacy Personnel (Pharmacist or Pharmacy Technician)
 Non-regulated Pharmacy Personnel

Question 63

 Must be clear and provide detailed descriptions of all activities, including cleaning.
 Must be reviewed at least every ____, or more frequently if there is a change in practice or standards.
 Must be updated promptly when there is a change affecting practice.
 Additional procedures must be developed if staff are also handling hazardous products.

Answer 63

Policies and procedures

3 years

Question 64

 Must be determined by regulated pharmacy personnel with adequate experience and broad scientific knowledge.
 Must be assigned after consulting the manufacturer’s documentation and literature on the stability, compatibility
and degradation of ingredients

 Compounded preparations must be monitored for signs of instability and/or degradation.

Answer 64

BUD and Dating Methods

Question 65

 Must be performed at each stage of the compounding process.
 ____ must take place before the preparation is dispensed.

Answer 65

Verification

Final verification

Question 66

 Must be kept (in paper-based or electronic form) for each individual prescription and for non-sterile preparations made in batches.

Answer 66

Compounding Record

Question 67

 Must be developed for each non-sterile compound by regulated pharmacy personnel with adequate experience and broad scientific knowledge.
 Must include all necessary information to compound the non-sterile preparation.
 Must contain supporting rationale and references.
 Must be kept in a format that is readily accessible to compounding personnel.

Answer 67

Master Formulation Record

Question 68

 Must be pure and of good quality.
 Purified water or water of equivalent or superior quality must be used
whenever the formula specifies water as an ingredient.
 Must be obtained from recognized and reliable sources.

Answer 68

Ingredients Used for Compounding

Question 69

 Must be cleaned regularly, as recommended by the manufacturer.
 A log must be kept recording each cleaning session.

Answer 69

Specialized Equipment

Question 70

 Must be routinely inspected and calibrated, if applicable, at appropriate intervals, as recommended by the manufacturer, or at least once a year if there are no manufacturer recommendations.

Answer 70

Equipment

Question 71

 Must be appropriate for the type of preparations to be compounded.
 Must not negatively affect the purity or quality of the preparation being compounded.
 Must be cleaned well after each use.

Answer 71

Equipment