STERILE COMPOUNDING 101: STABILITY, STERILITY, AND BEYOND-USE DATING
LIZ FREDRICKSON, PharmD, BCPS
Liz Fredrickson is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University College of Pharmacy. She serves as the Director of Instructional Labs and is course director for the Basic Pharmaceutics Lab and Parenteral Products and Parenteral Products Lab courses.
Compounded sterile preparations (CSP) should be assigned a beyond-use date (BUD). The BUD is the date or time after which a CSP must not be stored or transported. Once this date has passed, the product is at risk of physical and chemical degradation as well as microbial contamination, thus placing a patient who may receive the product at risk. This course will assist pharmacists and pharmacy technicians in understanding the role stability and sterility play in the determination of beyond-use dates for CSPs and will provide recommendations for establishing BUD for these types of compounded preparations. Assignment of BUDs utilizing proposed United States Pharmacopeia (USP) Chapter <797> guidelines will be reviewed.
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
Pharmacy Technician 0669-0000-22-059-H07-T
Credits: 1 hour of continuing education credit
Type of Activity: Knowledge
Media: Internet Fee Information: $4.99
Estimated time to complete activity: 1 hour, including Course Test and course evaluation
Release Date: November 1, 2022 Expiration Date: November 1, 2025
Target Audience: This educational activity is for pharmacists.
How to Earn Credit: From November 1, 2022, through November 1, 2025, participants must:
Read the “learning objectives” and “author and planning team disclosures;”
Study the section entitled “educational activity;” and
Complete the Post-test and Evaluation form. The Post-test will be graded automatically. Following successful completion of the Post-test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
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
The following individuals were involved in the development of this activity: Liz Fredrickson, PharmD, BDPS, and Susan DePasquale, MSN, PMHNP-BC. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.
ⓒ RxCe.com LLC 2022: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.
Compounded sterile preparations (CSPs) should be assigned a beyond- use date (BUD). Pharmacists and pharmacy technicians involved in sterile compounding should have a good understanding of how to assign beyond-use dates. Compounding personnel are awaiting revisions to the United States Pharmacopeia (USP) Chapter <797> “Pharmaceutical Compounding—Sterile Preparations,” which includes expanded guidance for assigning beyond-use dates. This course will assist pharmacists and pharmacy technicians in understanding the roles stability and sterility play in determining beyond-use dates for CSPs and will provide recommendations for establishing appropriate beyond-use dates for these types of preparations. USP Chapter <797> guidelines will also be reviewed.
A Brief Overview of Sterile Compounding
Compounded sterile preparations (CSPs) should be assigned a beyond- use date (BUD). The BUD is the date or time after which a CSP must not be stored or transported, and this valuable information notifies healthcare workers as to the date after which the CSP must not be used.1,2 Once the BUD has passed, the product is at risk of physical and chemical degradation, reduced integrity of the container-closure system, and microbial contamination.2 Patient safety should always be at the forefront of the sterile compounding process, including the assignment of beyond-use dates. While choosing a less conservative BUD or extending a BUD may seem convenient or be seen as a method by which to reduce waste, inappropriately assigning BUDs can lead to potential patient harm.
Compounding personnel are awaiting revisions to the United States Pharmacopeia (USP) Chapter <797> “Pharmaceutical Compounding—Sterile Preparations,” which includes expanded guidance for assigning beyond-use dates.3,5 The comment period closed in March of 2022. The newest revisions are set to be published on November 1, 2022. These revised guidelines will include stakeholder input and scientific and technological advances, and they have the potential to impact personnel involved in sterile compounding
significantly. In a survey of 227 pharmacies, sixteen percent voiced concern regarding implementing a methodology for extending BUD because of the proposed USP revisions. 4
To set the stage for beyond-use dating, it can be helpful to identify acronyms that are used when discussing sterile compounding. They include the following:
BUD = beyond-use date
CSP = compounded sterile preparation
ISO = International Organization for Standardization
MDV = multiple-dose vial
PI = package insert
SDV = single dose vial
USP = United States Pharmacopeia
To set the stage for beyond-use dating, it can be helpful to distinguish between what is and is not considered sterile compounding. Per USP, the following products must be sterile:3,5
Injections (including infusions)
Irrigations for internal body cavities
Ophthalmic dosage forms
Aqueous preparations for pulmonary inhalation
Baths and soaks for live organs and tissues
Proposed USP Chapter <797> revisions state sterile compounding is not mixing, reconstituting, or completing similar acts per manufacturer directions.5 Preparing these types of products is considered out of the scope of the guidelines if:5
The product is prepared as a single dose for an individual patient
The labeling includes information for the diluent, strength, container closure system, and storage time.
The proposed revisions also state activating a proprietary bag and vial system following manufacturer instructions and immediately administering this product to an individual patient is not considered compounding.5 However, if these products are instead docked for future activation and administration, this is considered compounding, and USP Chapter <797> guidance should be followed.5
Beyond-Use Date Basics
A BUD can be thought of as a risk assignment determined by using the most current and evidence-based information available.1 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.3 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.6 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.6 Compliance should be maintained with current USP Chapter <797> guidelines until further notice. 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.6
Stability and Sterility
Beyond-use dating should always be done in a conservative manner to minimize patient risk, and many factors must be considered to establish the
most accurate BUD for a CSP. Two key determinants that must be assessed are stability and sterility. These concepts are discussed in detail below.
Stability is defined as the extent to which a product retains—within specified limits and throughout its period of storage and use—the same properties and characteristics that it possessed at the time it was manufactured.7 Conversely, instability is a change in or degradation of active ingredients within a CSP.8 USP recognizes five types of stability, including chemical, physical, toxicological, microbiological, and therapeutic stability.7 The stability of a CSP pertains not only to the active ingredients but also to the diluent and excipients.7 Additionally, the compatibility of the container closure system should be considered with respect to the potential for leaching, interactions, and adsorption.9,10 Storage conditions also need to be considered.
A multitude of factors may affect the stability of a CSP. These can be grouped into two broad categories of 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.8 Table 1 lists extrinsic factors that can affect CSP stability, and these are described further below.
Table 1. Extrinsic Factors that May Affect CSP Stability
Temperature can have a significant impact on the stability of CSP, and deviations in temperature from the permissible storage conditions should be noted by compounding personnel. CSPs may become discolored, or impurities can occur if stored at improper temperatures.8 Many products are temperature sensitive, and pharmacists and pharmacy technicians should be aware of medications that are sensitive to hot and cold temperatures. When a medication is kept at a temperature exceeding the allotted range, chemical degradation can be accelerated in an exponential fashion. 8 This can possibly occur during the infusion of a medication, during which products that may require refrigeration are exposed to ambient temperatures.10 While it may seem intuitive to refrigerate or freeze medications to ensure stability, this is not always the case. In fact, improper storage of certain medications in the refrigerator can lead to unwanted changes, including precipitation and crystallization.10 Metronidazole is an example of a medication that should not be refrigerated.11 Freezing certain medications can result in the inactivation of the active ingredient or denaturing of the product.10 Heparin is one example of a medication that cannot be frozen.12
To ensure stability, pharmacists and pharmacy technicians should store all products according to manufacturer instructions. Additionally, temperatures of compounding and storage facilities should be regularly monitored and documented. Proposed USP Chapter <797> revisions state that when a CSP has been exposed to temperatures below or above the storage limits for the CSP, a designated person must determine whether the CSP is expected to retain its integrity or quality, which can be done via testing or consulting primary literature. 5 The CSP should be discarded if it cannot be determined.
Changes in pH
Like temperature, changes in pH can affect drug stability. The pH of diluent solutions impacts the solubility of drugs that are either weak acids or weak bases.10 When the pH is altered, this can result in changes to the
solubility and rate of degradation of the product.8 Subsequently, compounding personnel should be cautious when mixing two solutions when one solution has the potential to affect the final pH.8 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.13
Medication Concentration Levels
The third factor to consider when compounding sterile products is the concentration of the medications involved. 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.
Time is another extrinsic factor that may impact stability. The longer a product is stored, the greater the chance for instability to result.8 Thus, it is recommended that pharmacists dispense the oldest stock first.8 Additionally, expired products should be removed on a regular basis.
Sorption is the loss of a drug due to adsorption to the surface or absorption to a container material or administration set.10 The more time the drug spends in contact with the matrix, the more sorption occurs. This leads to a decrease in the availability of the product.10 Diazepam is an example of a drug that has sorptive properties.10
Sterility is defined as being free from viable microorganisms.8 Compounding personnel should note that 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 the risk of patient harm and possible death. In the evaluation of CSP sterility, compounding personnel should consider the preparation’s potential to support microbial growth.10
As with stability, many factors may affect the sterility of a CSP. These are noted in Table 2 below.
Table 2. Factors that May Affect the Achievement and Maintenance of Sterility
|Open and closed systems
|Aseptic Processing and Sterilization Methods+
Among all factors that impact sterility, personnel present the greatest risk to CSPs. In fact, touch contamination is considered the largest source of CSP contamination.8 To mitigate these risks, compounding personnel should adhere to strict measures, including appropriately garbing, gloving, and washing hands and utilizing appropriate aseptic techniques when compounding CSPs.3 Further, personnel should never eat, drink, chew gum, cough, or sneeze in the cleanroom.
Per USP Chapter <797>, “sterile compounding facilities must be designed to minimize the risk of airborne contamination of the area in which sterile compounding occurs. Proper design and controls are required to minimize the risk of exposure of CSPs to airborne contaminants.”5 The air quality of the environment in which a CSP is prepared will affect its sterility. CSPs should ideally be prepared in an ISO Class 5 environment, which signifies
a low particle count and high air quality. However, products are sometimes prepared at a patient’s bedside, such as during an emergency, and in these cases, there is a much greater risk of contamination.8
Multidose Vials (MDV)
Unlike single-dose vials, which are discarded after one-time use, MDV are entered multiple times and stored between uses.8 This presents an increased risk of contamination. MDV should be stored appropriately in between uses, and those that are used in a patient care area should be immediately discarded after use.8,10
Ampules are open systems that become exposed to air after being accessed. Unlike vials, ampules are more prone to contamination due to this contact with air and thus present a greater risk of sterility concerns.8 They should not be stored for any period.3,5
Aseptic Processing and Sterilization Methods
Proposed USP Chapter <797> guidelines state CSPs can be prepared using either of the following methods. Terminal sterilization is preferred unless the CSP or container system cannot tolerate this method.5
Aseptic processing, which includes compounding with only sterile starting ingredient(s) or compounding with nonsterile ingredient(s) followed by sterilization by filtration.
Terminal sterilization, which includes compounding with sterile and/or nonsterile starting ingredient(s) and subsequent sterilization with a
process intended to achieve a PNSU of 10!".
Using one or more nonsterile starting components in the sterile compounding process introduces the risk of contamination to the preparation.5
By sterility testing a CSP, compounding personnel can provide additional assurance that there is no product contamination.5 It is important to note if a unit passes a sterility test, this in and of itself does not guarantee the sterility of the entire batch.5 The maximum batch size for all CSPs that require sterility testing must be limited to 250 final yield units per USP <797>.5
Keeping CSPs in cold storage conditions, such as in a refrigerator or freezer, often assists with the slowing of microbial growth.5 However, as noted above, not all CSPs can be stored under these conditions.
Assigning Beyond-Use Dates
The ultimate responsibility for assigning beyond-use dates falls to the designated person or persons.5 These individuals are deemed responsible by their institution and must use professional judgment when determining beyond-use dates.5 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 standard operating procedures (SOP).15 As an example, Wake Forest Baptist Health has such a committee.15 Part of their work included building beyond-use dates into the electronic health record.15
Many terms are related to the preparation and administration of CSPs. It is important to understand this terminology and differentiate BUD from similar terms. “In use time” is defined as the timeframe starting when a product is opened until the product is discarded.1 “Infusion time” is the time during which a CSP is administered to a patient.1 A common source of confusion stems from differentiating a BUD from an expiration date. Table 3 details the differences between these two terms.3 Pharmacists should never label a CSP with the phrase “expiration date” or any similar term.5
Table 3. Comparing BUD and Expiration Dates
|The date or time after which a CSP may not be stored or transported
|Compounder/ Designated person
|The time after which the product should not be used (regardless of whether the product was opened or unopened) because the strength, quality, and purity of the shelf-life can no longer be guaranteed
|All conventionally manufactured products and APIs
Process for Assigning Beyond-use Dates
Beyond-use dates should be established in a conservative manner to help ensure the CSP maintains its required characteristics—both stability and sterility—until its BUD.5
Evidence of Stability
Both the chemical and physical stability of a CSP are important considerations when assigning a BUD.14 In determining a BUD compounding, personnel should consider the following relevant factors:3
Nature of the drug and its degradation mechanisms
Environment in which it is compounded
Container in which it is packaged
Expected storage conditions
Intended duration of therapy
the length of time within which the CSP must be used.5 A longer BUD is permitted if sterility testing results fall within acceptable limits. The maximum batch size for all CSPs requiring sterility testing must be limited to 250 final yield units. 5
CSP Category 1
These preparations are compounded under the least controlled environmental conditions among the three categories.5 They are prepared in a segregated compounding area (SGA) or cleanroom suite. 5 They have shorter beyond-use dates compared to Category 2 and Category 3 CSPs. These products do not require sterility testing or testing for bacterial endotoxins.5
Table 4. BUD Limits for Category 1 CSPs
|Controlled Room Temperature (20-25°C)
|Refrigerator (2-8° C)
CSP Category 2
These preparations require more environmental controls and testing compared to Category 1 CSPs.5 They should be prepared in an ISO 5 primary engineering control located in a classified clean room environment.5 If they are compounded from one or more nonsterile ingredients and assigned a BUD that requires sterility testing (per Table 5 below), they must be tested to ensure there are not excessive bacterial endotoxins present within the compound.5 If they are compounded from one or more nonsterile ingredients and assigned a BUD that does not require sterility testing, they should also be tested for bacterial endotoxins.6 Category 2 CSPs have longer beyond-use dates than Category 1 CSPs. USP Chapter <797> allows for longer BUDs for terminally sterilized CSPs than for aseptically processed CSPs because terminal sterilization provides assurance a CSP will be sterile, as long as a verified method is utilized. 5,17
Table 5. BUD Limits for Category 2 CSPs
|Compoundin g Method
|Sterility Testing Performe d and Passed
|Controlled Room Temperature (20 to 25 °C)
|Refrigerator (2-8 °C)
(-25 to -10 °C)
|Aseptically processed CSPs
|Prepared from one or more nonsterile starting component(s): 1 day
|Prepared from one or more nonsterile starting component (s): 4 days
Prepared from one or more
nonsterile starting component(s): 45 days
Prepared from only sterile
: 4 days
Prepared from only sterile
starting component s: 10 days
|Prepared from only sterile starting compone nts: 45 days
|Terminally sterilized CSPs
CSP Category 3
Increasing the storage time of a CSP introduces additional risk for chemical degradation, physical incompatibilities, the compromising of the container closure system, and microbial proliferation.5 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 guidelines. 5 There are additional requirements for both the facility and compounding personnel for Category 3 CSPs.5 These include:
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 date 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 also must be packaged and stored in the same container closure as that used in the study.5 The analytical method must be validated based on characteristics such as those described in 〈1225).5 Finally, a 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: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
Table 6. BUD Limits for Category 3 CSPs
|Controlled Room Temperature (20-25°C)
(-25 to -10°C)
Aseptically processed, sterility tested, and passing all applicable tests for Category
Terminally sterilized, sterility tested, and passing all applicable tests for Category
CSPs that are compounded and intended for direct, immediate administration are not subject to the requirements of Category 1, Category 2, or Category 3 CSPs per USP, given that the following criteria are met:5
Aseptic techniques, processes, and procedures must be followed.
Written SOPS must be 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 must be 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
The preparation involves not more than 3 different sterile products.
Any unused starting component from a single-dose container must be discarded after preparation for the individual patient is complete. Single- dose containers must not be used for more than one patient.
Administration begins within 4 h following the start of preparation. If the administration has not begun within 4 h following the start of preparation, it must be promptly, appropriately, and safely discarded.
Unless administered by the person who prepared it or administration is witnessed by the preparer, the CSP must be labeled with the names and amounts of all active ingredients, the name, or initials
Other Important Beyond-use Dates
Pharmacists and pharmacy technicians should note the following BUD for various products. Previous and proposed USP Chapter <797> guidelines are compared.3,5
Table 7. Other Beyond-use Dates
|Single Dose Vials
|Multiple Dose Vials
6 hours if opened in an ISO 5 or cleaner air
12 hours if opened or punctured in ISO 5 or cleaner
28 days unless otherwise stated by the
28 days unless otherwise stated by the
Per manufacturer instructions
Per manufacturer instructions
Do not store for any amount of time (immediate
Do not store for any amount of time (immediate
“Do not use after: ”
“Use before: ”
The process of preparing CSPs requires stringent documentation, including completion of a compounding record.5 Proposed USP Chapter <797> revisions state such a record must be created for any Category 1, Category 2, Category 3, and immediate-use CSPs prepared for more than one patient and any CSPs prepared from nonsterile ingredients.5
Beyond-use Dates: Dos and Do Nots
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
Establish a BUD without considering both stability and sterility
Exceed the manufacturer expiration date of any ingredient in the CSP
Frequently Asked Questions
What should be done if the stability and sterility of a CSP cannot be adequately determined?
In those instances, pharmacies should create a BUD standard operating procedure that outlines a formal risk assessment procedure comparing the clinical benefit of the proposed CSP and the compounding risks.15 Such risk assessments should be reviewed by the System Medication Safety Pharmacy and Therapeutics Subcommittee or a similar committee.15
Can CSPs be stored under different storage conditions before use?
The proposed USP revisions suggest that they can.5 For example, a CSP could be frozen, thawed in the refrigerator, and then kept at a controlled room temperature before being administered to a patient. Notably, the storage time of a CSP should not exceed the original BUD for the labeled storage condition, and the BUDs cannot be additive.5 USP <797> provides the following example. A CSP could not be stored in the freezer for 45 days and then stored in the refrigerator for 4 days, and then stored at control room temperature for 1 day, yielding a combined BUD of 50 days.5 A CSP that is stored under a new condition requiring a shorter BUD (like from refrigerator to controlled room temperature) must be used within the most restrictive period.5
Compounding personnel should recognize the importance of and be knowledgeable regarding the assignment of appropriate beyond-use dates to compounded sterile preparations. Numerous factors must be considered when assigning a beyond-use date, with the stability and sterility of the preparation requiring specific consideration. A variety of factors have the potential to impact the stability and sterility of CSPs, and compounding personnel should understand these factors and their ramifications. Pharmacists and pharmacy technicians should adhere to USP Chapter <797> guidelines. All compounding personnel should refer to their state boards of pharmacy for guidance regarding beyond-use dating.
Which of the following is true regarding the impact of temperature on the stability of a compounded sterile preparation (CSP)?
Storage temperature has a minimal effect on the stability of a CSP
All CSPs can be stored in the freezer to extend their stability
The impact of temperature on stability is not a consideration during the infusion of a CSP
Proposed USP <797> revisions suggest if a CSP has been exposed to temperatures outside its storage limits, a designated person must determine whether the CSP is expected to retain its integrity or quality
Which of the following is true regarding extrinsic factors that may impact the stability of a compounded sterile preparation (CSP)?
Photolabile preparations should be covered with a black, green, or brown protective sleeve
The newest stock should always be dispensed first
Increased concentration can decrease the rate of degradation of CSPs
pH rarely impacts the solubility of sterile preparations
Which of the following factors is considered the greatest source of contamination during the compounding sterile process?
Use of multiple-dose vials
Use of open systems
Which of the following is the preferred method of obtaining stability information for a compounded sterile preparation (CSP)?
When determining a beyond-use date, the compounder should take which of the following into consideration? Select all that apply.
Nature of the drug and Container in which it is packaged
Expected storage conditions of the CSP
Intended length of therapy
All of the above
Per the proposed USP <797> revisions, a Category 1 CSP stored at refrigerated temperature should be assigned which of the following beyond-use dates?
≤ 6 hours
≤ 12 hours
≤ 24 hours
Per the proposed USP <797> revisions, a Category 2 CSP that was aseptically processed, passed sterility testing, and is stored in the freezer should be assigned which of the following beyond-use dates?
Per the proposed USP <797> guidelines, a single-dose vial opened in an ISO 5 environment can be assigned which of the following beyond-use dates?
The USP <797> proposed guidelines provide that an ampule opened in an ISO 5 environment can be assigned a/an
Which of the following would place a CSP at greatly risk of contamination?
Terminally sterilizing the product
Compounding the product in an ISO Class 5 environment
Compounding with nonsterile starting ingredients
Compounding the product using a single-dose vial
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USP Compounding Standards and Beyond-Use Dates (BUDs). USP. 2019. https://www.usp.org/sites/default/files/usp/document/our- work/compounding/usp-bud-factsheet.pdf. Accessed September 25, 2022.
General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; May 2020.
Lambert A. The USP revision schedule tightens—pharmacies should not wait to implement change. Wolters Kluwer. June 16 2022. https://www.wolterskluwer.com/en/expert-insights/usp-revisions- schedule-tightens-pharmacies-should-not-wait-to-implement-change.
General Chapter: USP. Pharmaceutical Compounding-Sterile Preparations <797>. In: USP-NF. Rockville, MD: USP; September 2021.
Martin M. Criteria for Determining Beyond-Use Dating. IJPC. 2018; 22:4.
General Chapter: USP. Stability Considerations in Dispensing Practice
<1191>. In: USP-NF. Rockville, MD: USP; May 2018.
Ochoa P and Vega J. Concepts in Sterile Preparations and Aseptic Technique. Jones and Barnett Learning. 2015. Burlington MA.
Understanding Container Closure Integrity Testing. American Pharmaceutical Review. 2016. https://www.americanpharmaceuticalreview.com/Featured- Articles/239498-Understanding-Container-Closure-Integrity-Testing/. Accessed September 2022.
Buchanan E and Schneider P. Compounding Sterile Preparations. ASHP. 2005.
Flagyl (Metronidazole hydrochloride) package insert. 2013. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s0 26lbl.pdf. Accessed September 25, 2022.
Heparin sodium package insert. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017029s1 40lbl.pdf. Accessed September 25, 2022.
Trissel L. Handbook on Injectable Drugs. ASHP.
Trissel L. Overview of beyond-use dating for compounded sterile preparations. IJPC. 2008; 12(6).
Wolf M and Lux A. Standardizing the Approach to BUD Assignment.
Pharmacy Purchasing and Products. 2022; 19(4).
changes-to-usp-797. Accessed September 28, 2022.
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