Sterile Compounding Beyond Use Dating Materials

MASTERING STERILE COMPOUNDING: STABILITY, STERILITY, AND BEYOND-USE DATING

Faculty:

Liz Fredrickson, PharmD, BCPS

Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University (NEOMED) College of Pharmacy.

Pamela Sardo, PharmD, BS

Pamela Sardo is a freelance medical writer, pharmacist licensed in 2 states, and the founder/principal at Sardo Solutions. She received her BS from the University of Connecticut and a PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, pharmaceutical manufacturing, and managed healthcare across broad therapeutic classes and disease states.

Topic Overview:

Compounded sterile preparations (CSP) must be assigned a beyond-use date (BUD). Once this date has passed, the preparation is at risk of physical and chemical degradation and microbial contamination. While choosing a less conservative BUD or extending a BUD may be seen as convenient or a method by which to reduce waste, inappropriately assigning BUDs can lead to potential patient harm. This continuing education activity will assist pharmacists and pharmacy technicians in understanding the role of stability and sterility in determining BUDs for CSPs and provide recommendations for establishing BUDs for these preparations. Patient safety should always guide the general process of preparing sterile compounds, and this includes the assignment of BUDs.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is 

Pharmacist  0669-0000-25-029-H07-P

Pharmacy Technician  0669-0000-25-030-H07-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $6.99

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Course Test and course evaluation

Release Date: March 22, 2025 Expiration Date: March 22, 2028

Target Audience: This educational activity is for pharmacists and pharmacy technicians.

Secondary Audiences: Other healthcare professionals, such as nurses, physicians, or others who may be part of a healthcare team, may be interested in this educational topic. The healthcare team's approaches to patient care are discussed in this activity. No state board or professional organization has evaluated this activity to determine whether it meets the continuing education requirements of nurses, physicians, or other professions not listed under the “Target Audience” described above. Always verify with individual employers or supervisors whether they will accept this educational activity upon completion.

How to Earn Credit: From March 22, 2025, through March 22, 2028, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Describe factors that affect the stability of compounded sterile preparations

Describe factors that influence the sterility of compounded sterile preparations

Discuss how to evaluate stability and sterility to determine a beyond- use date

Assign appropriate beyond-use dates to compounded sterile preparations

Disclosures

The following individuals were involved in developing this activity: Liz Fredrickson, PharmD, BCPS, and Pamela Sardo, PharmD, BS. Liz Fredrickson, PharmD, BCPS, and Pamela Sardo have no conflicts of interest or financial relationships regarding the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

© RxCe.com LLC 2025: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Educational Activity

Mastering Sterile Compounding: Stability, Sterility, and Beyond-Use Dating

Introduction

Compounded sterile preparations (CSP) must be assigned a beyond-use date (BUD). Once this date has passed, the preparation is at risk of physical and chemical degradation and microbial contamination. While choosing a less conservative BUD or extending a BUD may be seen as convenient or a method by which to reduce waste, inappropriately assigning BUDs can lead to potential patient harm. This continuing education activity will assist pharmacists and pharmacy technicians in understanding the role of stability and sterility in determining BUDs for CSPs and provide recommendations for establishing BUDs for these preparations. Patient safety should always guide the general process of preparing sterile compounds, and this includes the assignment of BUDs.

Compounded Sterile Preparations Categories

In the previous version of USP <797> Pharmaceutical Compounding – Sterile Preparations, CSPs were categorized by a low, medium, or high risk level based on specified criteria and conditions for each level.1,2 Compounding personnel should now be familiar with the three numerical categories of CSPs: Category 1, Category 2, and Category 3.2 These categories differ based on three factors:

The environment in which they are compounded

The probability of microbial growth during the time they will be stored

The time within which they must be used

Category 1 CSPs are compounded under the least controlled environmental conditions and have the shortest BUDs of the three categories.2 Category 2 CSPs have stricter environmental controls and testing

requirements and may be assigned longer BUDs than Category 1 CSPs. Category 3 CSPs have requirements for personnel qualifications, garbing, sporicidal disinfectants, environmental monitoring, and stability determination.6 When applicable requirements are met, Category 3 CSPs are assigned the longest BUDs of the three categories.2

Comparing CSP Categories

Table 1 provides a comparison of the three CSP categories.2

Table 1 Comparison of CSP Categories2

Immediate-use CSPs

Immediate-use CSPs are intended to be administered to a patient directly and immediately.2 Category 1, 2, and 3 CSPs requirements are not applicable when the following criteria are met:

Aseptic techniques, processes, and procedures are followed, and written SOPs are in place to minimize the potential for contact with nonsterile surfaces, the introduction of particulate matter or biological fluids, and mix-ups with other conventionally manufactured products or CSPs.

Personnel are trained and demonstrate competency in aseptic processes as they relate to assigned tasks and the facility's SOPs.

The preparation is performed in accordance with evidence-based information for the physical and chemical compatibility of the drugs (e.g., approved labeling, stability, and compatibility studies).

The preparation involves no more than three different sterile products.

Any unused starting component from a single-dose container must be discarded after preparation is complete. Single-dose containers must not be used for more than one patient.

Administration begins within 4 hours following the start of preparation. If administration has not begun within 4 hours following the start of preparation, it must be promptly, appropriately, and safely discarded.

Unless directly administered by the person who prepared it or the administration is witnessed by the preparer, the CSP must be labeled with the names and amounts of all active ingredients, the name or initials of the person who prepared the preparation, and the 4-hour time period within which administration must begin.

Beyond-Use Date Basics

Definition

A BUD is defined as the date (or hour and date) after which a CSP cannot be used and must be discarded.2 Once the BUD has passed, the preparation is at risk for physical and chemical degradation and microbial contamination.1

Per USP <797>, a BUD should be determined from the date and time the preparation of the CSP is started.2 However, it is not intended to limit the time of infusion for the CSP.2 Infusion time is defined as the time a product or preparation is being administered to a patient.3 In-use time is the time from when a product or preparation is opened or punctured until the point it can no longer be used.3

Before learning more about what a BUD is, it can be helpful to understand what it is not. The most important distinction is recognizing the differences between a BUD and an expiration date. These terms are compared in Table 2. An expiration date is defined as the time during which a conventionally manufactured product, active pharmaceutical ingredient (API), or added substance can be expected to meet the requirements of a compendial monograph or maintain expected quality if it is kept under the prescribed storage conditions.2 An expiration date limits the time during which manufactured products can be dispensed or used.1,2 Beyond-use dates are typically much shorter than expiration dates and do not require the extensive testing required for expiration dating.1

Table 2

Comparison of Beyond-Use Dates and Expiration Dates1,2

Regulatory Requirements

Various regulatory organizations provide oversight for CSP beyond-use dating. Among these, the United States Pharmacopeial Convention is the most influential.1 USP standards are divided into chapters, and the purpose of USP Chapter <797> is to prevent patient harm from exposure to CSP contamination.1 These standards are considered minimum practice guidelines when compounding sterile preparations.3 Notably, guidance from USP is descriptive rather than prescriptive or exhaustive; thus, it is up to compounding personnel to implement these measures using the utmost professional judgment.1 USP Chapter <797> is considered an enforceable chapter, and such enforcement is the responsibility of state boards of pharmacy who may choose to require even more stringent beyond-use dating requirements. Compounding personnel should always refer to and follow compliance requirements of their specific state board of pharmacy or the board of pharmacy for states in which they are licensed.

Parameters for Establishing Beyond-Use Dates

Beyond-use dates for CSPs must be established conservatively to ensure the preparation retains its essential characteristics, such as stability and sterility, throughout its intended use.2 In determining an appropriate BUD, compounding personnel need to evaluate factors that influence the preparation's quality.2 These include the chemical and physical stability of the drug or its formulation, as well as the compatibility and material composition of the container closure system, considering potential interactions, adsorption, and storage conditions.2

Beyond-use dates are influenced by parameters affecting the maintenance of sterility.2 Key considerations include the preparation environment, aseptic processing and sterilization methods, the use of sterile versus nonsterile starting components, the performance of sterility testing, and storage conditions, such as packaging and temperature control.2 Careful assessment of these factors ensures that CSPs remain safe and effective for

patients within their assigned BUD.2 These factors will be discussed in more detail below (Table 3).3

Table 3

Factors Affecting CSP Beyond-Use Dates3

Sterility Considerations

Sterility is defined as being free from viable microorganisms.8 Compounding personnel should note sterility is an absolute term. This means a CSP cannot be partially sterile—it either is or is not sterile. If not sterile, it is contaminated.8 Any preparation given via a route that bypasses the body’s natural defenses must be sterile.14 It is extremely important for compounding personnel to prevent loss of sterility, as this exacerbates risk of patient harm and possible death. In the evaluation of CSP sterility, compounding personnel should consider that preparation’s potential to support microbial growth.10

Sterilization Methods and Aseptic Processing

Compounded sterile preparations can be sterilized using terminal sterilization methods or aseptic processing.2 Terminal sterilization involves using sterile or nonsterile starting ingredients followed by a validated

sterilization process, such as steam, dry heat, or irradiation, to achieve a probability of a nonsterile unit (PNSU) of 10⁻⁶.2 In contrast, aseptic processing includes either compounding with only sterile starting ingredients or compounding with nonsterile ingredients, followed by filtration sterilization.2 Filtration sterilization is not considered a form of terminal sterilization.2 Terminal sterilization is preferred whenever feasible, as it provides greater assurance of sterility and allows for longer BUDs compared to aseptic processing, as outlined in the standards.2

Starting Components

The choice of starting components significantly impacts the risk profile and allowable BUD for a CSP.1,2 Using nonsterile starting components introduces a higher contamination risk compared to using conventionally manufactured sterile components.1,2 Consequently, CSPs made with sterile starting ingredients and processed aseptically are permitted longer BUDs than those prepared with one or more nonsterile starting components.1,2

Sterility Testing

Sterility testing of CSPs is valuable for confirming the absence of contamination but does not guarantee sterility across an entire batch due to the potential for uneven contamination distribution.1,2 CSPs that pass sterility testing within acceptable limits are permitted longer BUDs.1,2 However, the batch size for CSPs requiring sterility testing is limited to a maximum of 250 units to maintain control over quality assurance.1,2

Compounding Personnel

The role of compounding personnel is critical in maintaining the sterility of CSPs.1 As the primary influencers of sterility, personnel must undergo rigorous training to ensure a comprehensive understanding of aseptic techniques and protocols.1 Adherence to these techniques is essential for preventing touch contamination, which is the most common cause of microbial contamination during the compounding process.1 Effective training programs

should focus on proper hand hygiene, gowning procedures, and the use of sterile equipment to minimize the risk of introducing contaminants into the preparation environment.1,2

Environment

The sterility of CSPs is also heavily influenced by the air quality within the compounding area.1,2 To maintain an environment that minimizes contamination risk, compounding must be performed in ISO Class 5 conditions.2 Proper airflow management, routine environmental monitoring, and regular cleaning protocols are important for maintaining these conditions and reducing the likelihood of airborne contaminants.1,2

Multiple-Dose Vials

Using multiple-dose vials introduces a significant risk of contamination due to repeated entry of a needle into the vial.1,2 Each entry increases the potential for microbial introduction, which can compromise the sterility of the remaining contents.1,2 To mitigate this risk, strict handling protocols must be followed, which include using new sterile syringes and needles for each entry and adherence to the manufacturer's guidelines for storage and usage.1,2

Open Systems

Open systems, such as ampules, present an elevated risk of contamination because they expose the contents to air upon opening.1,2 This air contact increases the likelihood of microbial introduction, especially if aseptic techniques are not strictly followed.1 When working with open systems, it is essential to use them in a controlled environment and to minimize the time the contents are exposed to air.1 Discarding any unused portions immediately after opening further ensures that sterility is maintained throughout the compounding process.1

Storage Conditions

Storage temperature strongly impacts the stability and sterility of CSPs. Storing CSPs in colder environments, such as refrigerators or freezers, slows microbial growth, which can extend their BUDs.2 However, the chemical and physical stability of the CSP must also be evaluated, as some formulations may precipitate or degrade when frozen or refrigerated.2 Container closure systems used for frozen CSPs must be able to withstand the stresses of freezing without cracking.2 Proper thawing techniques, such as gradual warming, are important to preserve the preparation's integrity. Once thawed, CSPs must not be refrozen.2

Importantly, CSPs may undergo multiple storage conditions during their lifespan (e.g., freezing, thawing, and refrigeration), but the total storage time must not exceed the original BUD assigned for the preparation.2 Beyond-use dates are not additive, meaning CSPs cannot be stored sequentially across multiple conditions to extend their overall shelf life.2 For example, a CSP stored for 45 days in a freezer, then 4 days in refrigeration, and finally 24 hours at room temperature must adhere to the shortest BUD allowed for its final storage condition.2 Adhering to these storage guidelines ensures the safety and efficacy of the CSPs throughout their use.2

Stability Considerations

Stability refers to "the extent to which a product retains, within specified limits and throughout its storage and use, the properties and characteristics it possessed at the time of manufacture."2 Instability, which is a change in or degradation of active ingredients within a CSP, can lead to reduced therapeutic efficacy and the formation of harmful substances.1 Several factors may affect the stability of a CSP. These can be grouped into two categories: intrinsic and extrinsic factors.8 Intrinsic factors are those related to the chemical structure of the active pharmaceutical ingredient (API), while extrinsic factors involve the environment to which the product is exposed. Intrinsic factors include the chemical structure of the active ingredient, its crystallization properties, solubility, and melting point.1 For example, drugs with labile functional groups,

such as esters, are more prone to hydrolysis.1 Extrinsic factors include environmental conditions such as temperature, pH, and light exposure.1

Temperature

Temperature is one of the most critical factors affecting drug stability.1 Increases in temperature accelerate chemical degradation processes, potentially rendering drugs ineffective or unsafe.1 For example, ampicillin degradation significantly increases when exposed to heat1. While it may seem intuitive to refrigerate or freeze medications to ensure stability, this is not always the case.

Freezing can potentially damage proteins, cause precipitation, or result in physical instability, as seen with heparin.1 Temperature excursions that are deviations from the manufacturer’s labeled storage conditions are especially concerning.1 USP <797> states that when it is known that a CSP has been exposed to temperatures either below or above the storage temperature limits for the CSP, the designated person must determine whether the CSP is expected to retain its integrity or quality. If this cannot be determined, it must be discarded.1 Proper monitoring and adherence to recommended storage conditions are essential to maintaining drug stability and ensuring patient safety.1

pH, Concentration, and Light

Alterations in pH during compounding can significantly impact drug solubility and stability.1 For example, a decrease in pH during the preparation of phenytoin solutions can result in precipitation, reducing the drug’s efficacy.1 A drug solution that has been stable for weeks can rapidly degrade when mixed with a liquid that changes its pH.7 The Handbook on Injectable Drugs or similar drug information resources can be consulted when mixing solutions to ensure there are no issues regarding pH.

When the concentration of a drug is increased, its rate of degradation increases due to an increase in the availability of ingredients able to react.8 Concentration plays an important role when compounding products for infant patients. These types of CSPs often involve small volumes compared to adult preparations, and this can lead to precipitation.8 Precipitation can also occur when drugs are not adequately diluted.10 Concentration issues may also come into play when preparing a drug in a syringe.8

Photodegradation is a process whereby some medications either lose potency or form a secondary degradation product in the presence of light.8 The more intense the light source or, the closer the proximity of a photolabile drug to a light source, the greater the rate of photodegradation.10 Sodium nitroprusside provides a notable example of this process. While normally brown or light orange in color, sodium nitroprusside becomes dark brown or blue once exposed to light.8 Once a light-sensitive CSP has been compounded, it should be placed in a protective sleeve; these are commonly black, green, or brown in color.

Establishing Beyond-Use Dates

The process of assigning BUDs was significantly revised within the newest version of the standards.2 The USP Compounding Expert Committee utilized the previously published chapter and stakeholder input to revise the BUD limits.4 Due to the challenge of predicting stability and sterility concerns for all sterile products, these limits were created using a risk-based approach.4

Beyond-use date limits are determined based on the risk of microbial contamination or the inability to maintain sterility despite adherence to established requirements.2 Additionally, the CSP formulation must remain chemically and physically stable, with packaging integrity maintained for the entirety of the BUD.2

The BUD must not exceed the shortest remaining expiration date of any commercially available starting component used in the preparation.2 For CSPs made with compounded components, the assigned BUD generally cannot exceed the shortest BUD of the individual components.2 However, exceptions may apply in specific cases, such as when pH-altering solutions are involved. In these instances, the physical, chemical, and microbiological quality of the final CSP must remain uncompromised if the final CSP’s BUD exceeds that of its individual compounded components.2 This ensures the overall safety and efficacy of the preparation.2

The dates specified with <797> represent the maximum allowable BUDs for CSPs.3 In practice, other factors may necessitate shorter timeframes.3 Additionally, if a state board of pharmacy requires more stringent regulations. Ideally, each institution should utilize a standardized, guideline-driven approach and have established policies and procedures for assigning beyond- use dates.

Hospitals and other institutions may consider creating sterile compounding committees to standardize beyond-use dates and develop a systematic approach for assigning BUD via creating SOPs. Tables 4, 5, and 6 detail the BUD limits for Category 1, Category 2, and Category 3 CSPs, respectively.2

Table 4

BUD Limits for Category 1 CSPs6

Table 5

Beyond-Use Date Limits for Category 2 CSPs6

Table 6

Beyond-Use Date Limits for Category 3 CSPs6

Increasing the storage time of a CSP introduces additional risks for chemical degradation, physical incompatibilities, the compromising of the container closure system, and microbial proliferation.1 Category 3 CSPs may be assigned longer BUD than those in Category 1 or Category 2, given additional requirements are met but cannot exceed the limits within the standards.1 There are additional requirements for the facility and compounding personnel for Category 3 CSPs.5 These include the following:

Category 3 personnel competency requirements apply to personnel who participate in or oversee the compounding of Category 3 CSPs

Category 3 garbing requirements apply to all personnel entering the classified areas where Category 3 CSPs are compounded and always apply regardless of whether Category 3 CSPs are being compounded on a given day

Increased environmental monitoring requirements apply to all classified areas where Category 3 CSPs are compounded and always apply regardless of whether Category 3 CSPs are being compounded on a given day

The frequency of application of sporicidal disinfectants applies to all classified areas where Category 3 CSPs are compounded and always applies regardless of whether Category 3 CSPs are being compounded on a given day

These products must undergo sterility testing as well as endotoxin testing when applicable.5 There are also additional stability data requirements. Per USP Chapter <797>, the BUD assigned to a Category 3 CSP must be supported by stability data using a method that distinguishes the active ingredient from its degradants and impurities and quantifies the amount of the active ingredient.5 These CSPs must be prepared using the exact formulation from which stability data are derived. 5 They must also be packaged and stored in the same container closure used in the study.5 The analytical method must be validated based on characteristics such as those described in Chapter <1225>.5

Finally, the facility must have documentation of the stability study, including a description of the methodology (e.g., number of samples taken, storage conditions), validation of the method, the stability-indicating analytical method, and results of the study.5

Other requirements include the following:5,16

Sterile injectable preparations made from one or more nonsterile components must have endotoxin testing

Strict garbing practices must be followed

Skin cannot be exposed in the buffer room

Disposable garb must be discarded after exiting the classified area

Direct compounding area gloved fingertip and surface sampling are required every 3 months

Use of Conventionally Manufactured Products as Components

Conventionally manufactured single-dose containers are sterile systems designed for parenteral administration, which are not required to meet antimicrobial effectiveness testing.2 If used in an ISO Class 5 or cleaner air environment, these containers may remain usable for up to 12 hours after initial entry or puncture, provided storage conditions meet labeled requirements.2 However, single-dose ampules cannot be stored once opened. Multiple-dose containers, intended to hold more than one dose, must not be used for more than 28 days after initial entry unless the manufacturer specifies otherwise.2 Pharmacy bulk packages, designed for preparing multiple sterile doses in a pharmacy admixture program, must be handled according to manufacturer instructions and punctured only within an ISO Class 5 primary engineering control to maintain sterility.2 These changes are compared to the previous guidelines in Table 7 below.2

Table 7

Other Beyond Use Dates2

Sterility Testing

Sterility testing requirements vary depending on the CSP category. Category 1 CSPs do not require sterility testing. Some Category 2 CSPs may be assigned a BUD that requires sterility testing.6 All Category 3 CSPs require testing to be performed according to <71> or a validated alternative method that is not inferior to <71>.2,5 For CSPs that undergo sterility testing, USP

<71> specifies the minimum quantity of each container to be tested.5 The maximum batch size for all CSPs requiring sterility testing is limited to 250 final yield units.

If the number of CSPs compounded in a single batch is less than the number of CSPs needed for testing as specified in Table 3 in USP <71>, additional units must be compounded.2,5 When 1 to 39 CSPs are compounded in a single batch, sterility testing must be performed on an additional number of units equal to 10% of the CSPs prepared, rounded up to the next whole number.2,5 For example, if a single CSP is compounded, 10% of 1 is 0.1, which rounds up to 1, meaning one additional CSP must be prepared for testing. Similarly, if 39 CSPs are compounded, 10% of 39 is 3.9, which rounds up to

4 additional CSPs required for testing. However, if more than 40 CSPs are prepared in a single batch, the sample sizes specified in <71> must be used.2,5

Endotoxins Testing

Requirements for endotoxin testing also depend on the category of CSPs. Category 1 CSPs do not require testing for bacterial endotoxins.2 Category 2 CSPs compounded from one or more nonsterile component(s) should be tested for bacterial endotoxins.6 Category 3 CSPs compounded from one or more nonsterile component(s) also must undergo this testing to ensure that they do not contain excessive bacterial endotoxins.2 If an official USP–NF monograph or other CSP formula source does not specify an endotoxin limit, the CSP must not exceed the endotoxin limit calculated as described in Chapter <1085> for the appropriate route of administration for humans.2,6

Beyond-use Date Labeling and Documentation

Labeling

Labeling must comply with laws and regulations pertinent to the applicable regulatory jurisdiction. Per USP, the term label designates the part of the labeling that is on the immediate container.5 The BUD is considered a minimum requirement of the CSP label and should be displayed prominently and legibly.5 Beyond-use dates should be listed on CSP labels as the date or hour and date beyond which the product should not be used.5 Per USP Chapter

<797>, Category 1, Category 2, and Category 3 CSPs must be appropriately labeled in order to identify pertinent information and prevent errors during the storage, dispensing, and use of these products.5 The BUD should relate to a storage condition. The following phrases can be used when noting a BUD:

“Do not use after:         ”

“Use before:           ”

Documentation

The process of preparing CSPs requires stringent documentation, including the completion of a compounding record.5 A record must be created for any Category 1, Category 2, Category 3, and immediate-use CSPs prepared for more than one patient and for any CSPs prepared from nonsterile ingredients.5

Beyond-use Dates: Dos and Do Nots

Do:

Assign the more conservative date when there is conflicting information between regulatory agencies

Maintain written policies and procedures to ensure standard BUD assignment for each CSP

Keep patient safety at the forefront of BUD assignment

Do Not:

Establish a BUD without considering both stability and sterility

Exceed the manufacturer expiration date of any ingredient in the CSP

Summary

Compounded sterile preparations require an assigned BUD to ensure their safety and efficacy. After this date, the preparation is at an increased risk of physical and chemical degradation and microbial contamination, which can pose significant risks to patients. Pharmacists and pharmacy technicians involved in sterile compounding must understand the critical role of stability and sterility in determining BUDs.

Course Test

Which of the following is an intrinsic factor that can significantly affect the stability of a CSP?

Temperature

Light exposure during preparation

The chemical structure of the active ingredient

Duration of administration

What is the impact of temperature on the stability of CSPs?

Temperature does not affect chemical stability

Increasing temperature slows down chemical degradation

Rising temperatures accelerate chemical degradation processes

Freezing CSPs enhances chemical stability

What should be done to protect light-sensitive CSPs?

Store in transparent containers

Use amber containers or opaque coverings

Expose them briefly to natural light

Use UV lights to prevent degradation

Why are open systems like ampules more prone to contamination?

They expose the contents to air upon opening

They are made of fragile materials

They are not sterilized

They are stored at room temperature

How should multiple-dose vials be managed to reduce contamination risks?

Always use the same vial until all doses are depleted

Store in ISO Class 8 environments

Avoid the use of multiple-dose vials

Use new sterile needles and syringes for each entry

Sterility testing of compounded sterile preparations (CSPs) is valuable for confirming the absence of contamination. Which of the following statements about sterility testing of CSPs is correct?

Sterility testing guarantees sterility across an entire batch because all batches are evenly contaminated

CSPs that pass sterility testing within acceptable limits may be permitted longer beyond-use dates

Aseptic processing is considered a form of terminal sterilization

There is no limit to the batch size of CSPs requiring sterility testing.

What is the ultimate goal of determining a BUD?

To ensure that CSPs remain safe and effective for patients

To enforce the manufacturer's guidelines

To maximize storage room capacity

To control the cost of compounded preparations

What happens if a CSP's stability is shorter than the maximum allowable BUD?

The BUD is extended to the maximum time

The shorter BUD must be assigned

The CSP is discarded immediately

The preparation is re-evaluated for new testing

Which of the following is the BUD limit for a Category 1 CSP stored at refrigerated conditions?

≤6 hours

≤12 hours

≤48 hours

≤24 hours

Which of the following is the BUD limit for a Category 2 CSP stored at controlled room temperature that was aseptically processed, did not pass sterility testing, and was prepared from one or more nonsterile starting component(s)?

1 day

4 days

35 day

90 days

References

Ochoa P and Vega J. Concepts in sterile preparations and aseptic technique. Jones and Barnett Learning. 2015.

General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; September 2023.

Kienle P. The Chapter <797> Answer Book. ASHP. 2023.

Commentary. USP-NF. Accessed January 16, 2025. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf- commentary/797-commentary-20221101.pdf.

U.S. Pharmacopeia. 2018. USP<71>Sterility tests, p 5984–5991. In 2018 United States Pharmacopeia and National Formulary. USP 41-NF 36 U.S. Pharmacopeial Convention, Rockville, MD.

General Chapter: USP. Guidelines on Endotoxin Testing <1085>. In: USP-NF. Rockville, MD: USP; September 2020.

DISCLAIMER

The information provided in this course is general in nature, and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment, and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

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© RxCe.com LLC 2025: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.