Last updated: May 31, 2019
For FAQs on USP Compounding Standards, please see below:
Introduction and Scope
For the purposes of General Chapter <797>, sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication. However, administration and preparation per approved labeling are out of the scope of the chapter as described in 1.2 Administration and 1.4 Preparation Per Approved Labeling, respectively.
This chapter applies to all persons who prepare CSPs and all places where CSPs are prepared for human patients. This includes, but is not limited to, pharmacists, technicians, nurses, physicians, dentists, naturopaths, and chiropractors in all places including, but not limited to, hospitals and other healthcare institutions, medical and surgical patient treatment sites, infusion facilities, pharmacies, and physicians’ practice sites.
Please note, compounding of sterile hazardous drugs (HDs) must additionally comply with General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
The intent of the chapter is to establish minimum standards to help ensure quality of CSPs, whether the CSP is for human or animal patients. USP has no role in the enforcement of compounding chapters. Pursuant to General Notices, 2.30 Legal Recognition, ensuring compliance with USP standards is the responsibility of regulatory bodies. Regulators may choose to enforce the requirements of <797> with respect to veterinary compounding.
Generally, requirements in a General Chapter are conveyed by use of the terms "must" or "shall". Recommendations are conveyed by use of the terms "should" and "may".
The USP "official date" indicates the date by which affected users are expected to meet the requirements of a particular standard. Ensuring compliance with the requirements of these standards is the responsibility of regulators such as the FDA, states, and other government authorities. USP has no role in enforcement.
All text in the United States Pharmacopeia (USP) or National Formulary (NF) that has reached its official date is "official text." Although all text of the USP–NF that has reached its official date is "official text," not all official text states requirements with which compendial users must comply. Some official text is intended to assist or guide compendial users or to serve informational purposes.
The revision of <797> published on June 1, 2019 will become "official" on December 1, 2019. The "official date" indicates the date by which affected users are expected to meet the requirements of a particular standard. However, ensuring compliance with the requirements of these standards is the responsibility of regulators such as the FDA, states, and other government authorities. Regulatory bodies such as state boards of pharmacy may have a different official date. USP has no role in enforcement.
Unless otherwise specified, all temperatures in the USP-NF are expressed in degrees centigrade (Celsius) (see also General Notices 8.180 Temperatures).
No. The term "API" refers to a bulk drug substances (pure chemical substances), usually in powder or liquid form, which is intended to be used in compounding as opposed to a finished dosage forms.
The designated person is one or more individuals assigned by the facility to be responsible and accountable for the performance and operation of the facility and personnel for the preparation of compounded sterile preparations (CSPs). Facilities must determine whether they have one or more designated person, select the designed person, and determine how to allocate responsibility if there is more than one designated person.
No. Docking and activation of proprietary bag and vial systems in accordance with the manufacturer’s labeling for immediate administration to an individual patient is not required to meet the standards in this chapter.
Docking proprietary bag and vial systems for future activation and administration is considered compounding and must be performed in accordance with this chapter.
Yes, repackaging of a sterile product or preparation from its original container into another container must be performed in accordance with the requirements in this chapter.
Yes. The intent of the chapter is to establish minimum standards for practitioners when preparing CSPs in order to minimize harm, including death, to human and animal patients. The scope of the chapter is intended to be limited to compounding and the standards are designed to help ensure a CSP maintains its integrity up until the time when administration begins. Standard precautions such as the Centers for Disease Control and Prevention’s (CDC’s) safe injection practices apply to administration (see 1.2 Administration).
No. When all of the conditions in 1.4 Preparation Per Approved Labeling are met, the storage information in the manufacturer’s approved labeling may be followed.
Preparation of a single dose of a conventionally manufactured sterile product in accordance with the approved labeling that includes information about the diluent to be used, the resultant strength, storage time, and container closure system is not considered compounding. Compounding for immediate use involves mixing up to three different sterile products to make a CSP. Immediate use CSPs must be used within 4 hours following the start of preparation (see 1.3 Immediate Use CSPs).
No, withdrawing a dose from a container of a conventionally manufactured sterile product without any further manipulation is considered administration and is out of the scope of <797>.
The immediate use CSPs provision states that the preparation must not involve more than 3 different sterile products. Two or more of the same sterile product may be used as long as there are not more than three different sterile products. For example, two vials of drug are reconstituted using two vials of sterile water for injection and added to an intravenous bag may be considered immediate use as long as the criteria listed in 1.3 Immediate Use CSPs are met. As another example, when the CSP requires combining 4 vials of the same component into a single bag of diluent, only 2 different sterile products are used to prepare the CSP.
No. One of the conditions of the immediate use CSP provision specifies that any unused starting components 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 1 patient when used for preparing immediate use CSPs.
The immediate use CSPs provision was revised to allow up to 4 hours for beginning administration based on the lag phase of microbial growth, during which potential bacterial cells are adjusting to their environment and change very little, and they do not immediately start reproducing. On average, exponential reproduction may not start for 4 to 6 hours.1 In the event bacterial cells were inadvertently introduced into a CSP, it would not immediately start replicating, and therefore there is a window of time in which a CSP can be held prior to administration.
Daquigan N et al. Early recovery of Salmonella from food using a 6-hour non-selective pre-enrichment and reformulation of tetrathionate broth. Front Microbiol. 2016;7:2103.
Jarvis, Basil. Statistical Aspects of the Microbiological Examination of Foods, Third Edition. Academic Press, 2016.
Ryan, Kenneth et al. Sherris Medical Microbiology, Sixth Edition. McGraw-Hill Education, 2014.
Wang J et al. A novel approach to predict the growth of Staphylococcus aureus on rice care. Front Microbiol. 2017;8:1140.
Yes. Any compounding (e.g., mixing, reconstituting) that is not performed according to the manufacturer’s approved labeling is considered sterile compounding and is subject to the requirements in the chapter.
No. Radiopharmaceuticals are not subject to the requirements in <797> but are subject to the requirements in General Chapter <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging.
Personnel Training and Evaluation
It is the responsibility of the facility to determine who is the designated person(s). The designated person is one or more individuals assigned by the facility to be responsible and accountable for the performance and operation of the facility and personnel for the preparation of CSPs. Facilities must determine whether they have one or more designated person, select the designated person, and determine how to allocate responsibility if there is more than one designated person.
No. All results of the evaluations must be documented and maintained to provide a record and long-term assessment of personnel competency. Documentation must at a minimum include the name of the person evaluated, evaluation date/time, media and components used including the manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.
Environmental air and surface samples and gloved fingertip and thumb samples are incubated at a high temperature and then a low temperature. Incubation at a lower temperature first may compromise recovery of gram-positive cocci which are often associated with humans. The incubation conditions are consistent with General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. Media-fill test samples are incubated at a low temperature and then a high temperature to detect a broad spectrum of microorganisms. The incubation time and temperatures for media-fill test samples are consistent with FDA Guidance for Sterile Drug Products Produced by Aseptic Processing ‒ Current Good Manufacturing Practices.
Personal Hygiene and Garbing
General Chapter <797> does not specify an order of garbing. Garb must be donned and doffed in an order that reduces the risk of contamination. The order of garbing and location where garbing occurs would depend on the type of garbing used (e.g., sterile gowns) and the placement of the sink (e.g., if the sink is located inside or outside of the ante-room). The order of garbing must be determined by the facility and documented in the facility’s SOP.
The chapter recommends (but does not require) that donning and doffing not occur in the ante-room or the segregated compounding area (SCA) at the same time. Personnel must be aware of activity in the room to ensure that the integrity of garb is not compromised. For example, if one person is performing hand hygiene while another is donning a gown, personnel must consider the risk of contaminating the gown (e.g., from potential splashing).
Examples of jewelry that cannot be removed are dermal piercings (also known as a microdermal piercing), which is a piercing that is held in place with a dermal anchor that is installed underneath the skin. Facilities must determine the appropriate method for covering dermal piercings to minimize the risk of contaminating the CSP and the environment. For example, depending on the location of the piercing, an adhesive bandage or head cover may be used to cover the jewelry.
The chapter requires removing all hand jewelry that could interfere with the effectiveness of garbing or otherwise increase the risk of contamination of the CSP. Wedding rings may potentially compromise the integrity of the glove (e.g., tearing).
If using a CAI or CACI, the chapter recommends disposable gloves to be worn inside gloves attached to the restricted-access barrier system (RABS) sleeves. However, the chapter requires sterile gloves to be worn over the gloves attached to the RABS sleeves. The use of disposable gloves inside of gloves attached to the RABS sleeve is intended to maintain the cleanliness of the gloves attached to the RABS sleeve which may collect sweat or other touch contaminants. Sterile gloves outside of the gauntlet gloves help minimize the risk of contamination to the environment and the CSP.
Yes. Minimum garbing requirements are not stratified based on facility design. The chapter lists the minimum garbing requirements to protect the CSP and the environment. Sterile gloves are required for preparing CSPs inside an ISO Class 5 PEC.
Yes. Gowns may be re-used within the same shift if the gown is maintained in a classified area or inside the perimeter of an SCA. Garb must be replaced immediately if it becomes visibly soiled or if its integrity is compromised. Additionally, gowns and other garb must be stored in a manner that minimizes contamination (e.g., away from sinks to avoid splashing).
Facilities and Engineering Controls
Placement of HEPA filters in the ceiling eliminates the potential for post-filtration contamination of the air-stream. Air distribution systems with duct-mounted HEPA filters are susceptible to introduction of unfiltered air into the airstream after the air is filtered. HEPA filter placement in the ventilation duct is difficult to leak test and susceptible to contamination, especially in the event of water leakage or other breaches. Ceiling mounted filters help facilitate testing and servicing.
The PEC must be located in a controlled environment for preparing Category 2 CSPs to minimize the risk of contamination. Movement of materials in and out of the RABS (e.g., CAI or CACI) in unclassified air carries a higher risk of contamination. Placement of the RABS in a classified area mitigates the risk of inadvertent contamination of CSPs with the longer BUDs that are permitted for Category 2 CSPs.
The chapter requires "full coverage of HEPA filters above the work surface" but does not specify 100% coverage. HEPA filters must cover the entire area above the work tables. However, even if HEPA filters cover the entire ceiling above the table of an IVLFZ, there may be less than 100% coverage.
Returns must be positioned where they create the best "pull" of air across the work surface. Returns may be on the wall behind the table at a height where the return straddles the table. A portion of the air is drawn into the section of return above the table and a portion of the air is drawn around the front of the table to the area of the return below the table. If the returns are only located under the table, the table should be positioned in such a way to allow air to pass between the wall and the table to the return. The chapter does note that dynamic airflow smoke pattern tests have shown that it is difficult to achieve this type of design and also achieve and maintain unidirectional airflow under dynamic operating conditions.
Presterilization procedures must be performed in a single-use containment glove bag, CVE, BSC, or CACI to minimize the risk of airborne contamination.
The chapter recommends that pass-through doors be interlocking. However, if a pass-through is used, both doors must never be opened at the same time.
A visual smoke study uses a visible source of smoke, which is neutrally buoyant, to verify an absence of stagnant airflow where particulates can accumulate.
Unlike RABS, pharmaceutical isolators are different in that they contain 4 major elements: controlled workspace, transfer device, access device, and a decontamination system. A pharmaceutical isolator is equipped with a generator that distributes a sporicidal agent throughout the chamber.
If the isolator is used to prepare Category 2 CSPs, it must be placed in an ISO Class 8 or better positive pressure room. In contrast, if the CAI or CACI is used to prepare Category 2 CSPs, the CAI or CACI must be placed in a cleanroom suite with an ISO Class 7 or better positive pressure buffer room with an ISO Class 8 or better positive pressure ante-room.
Yes, magnehelic gauges may be used to monitor pressure. The quantitative results from the pressure monitoring device must be reviewed and documented at least daily on the days when compounding is occurring. Users should note that magnehelic gauges do not warn or alert personnel to events where there is a loss of pressure whereas there other pressure monitoring systems may have audible or visible alarms.
Surface sampling was previously required "periodically" which was interpreted differently by users (e.g., monthly, quarterly, or biannually). The change to monthly surface sampling is intended to provide an additional measure of control and monitoring in between viable air monitoring and certification requirements every 6 months. Monthly surface sampling provides additional data for trending and allow for monitoring of contamination risks.
In facilities with cleanroom suites, the sink used for hand hygiene may be placed either inside or outside of the ante-room. If the sink is located outside of the ante-room, it must be located in a clean space to minimize the risk of bringing in contaminants into the ante-room. Sinks are permitted outside of the ante-room to offer more flexibility to the cleanroom design and help minimize the risk of contamination from water sources to the classified areas.
In facilities preparing HDs in a cleanroom suite, General Chapter <800> requires the sink to be placed in the ante-room at least 1 meter away from the entrance of the HD buffer room to avoid contamination migration into the negative pressure HD buffer room. There are no conflicts for the sink placement in <797> and <800>. Facilities compounding sterile HDs must meet the requirements in both <797> and <800>.
No. An SCA is defined as a designated, unclassified space, area, or room with a defined perimeter that contains a PEC and is suitable for preparation of Category 1 CSPs only.
No, facilities may use the CETA certification guide or an equivalent guideline. Facilities must determine the appropriate certification guide to use for certifying their compounding area.
Microbiological Air and Surface Monitoring
Microbiological air and surface monitoring must be conducted in all classified areas to confirm that the required environment quality is maintained. The microbiological air and surface sampling must be facility specific and must be described in the facility’s Standard Operating Procedures (SOPs). The chapter does not specify a minimum number of samples based on the size of the room. Facilities must determine the appropriate number of locations and select the locations of sampling based on their relationship to the activities performed in the area.
No, an attempt must be made to identify any microorganisms recovered to the genus level if the levels measured during sampling exceed the action levels in the chapter.
In some instances, microorganisms cannot be identified to the genus level because the microorganism is no longer viable or the mold may not be producing the reproductive structures necessary for identification. In these instances, the genus may not be identified, but the chapter does require than an attempt be made to identify the microorganism to the genus level.
Cleaning, Disinfecting, and Applying Sporicidal Agents in Compounding Areas
Cleaning is the process of removing residues (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces. Disinfecting is the process of destroying fungi, viruses, and bacteria on inanimate surfaces and objects. Applying a sporicidal agent is used to destroy bacterial and fungal spores and is expected to kill all vegetative microorganisms.
A one-step disinfectant cleaner is a product with an EPA-registered (or equivalent) claim that it can clean and disinfect a non-porous surface in the presence of light to moderate organic soiling without a separate cleaning step. It is important to note that sterile isopropyl alcohol (IPA) is not a one-step disinfectant cleaner.
USP cannot endorse particular products. Users may research one-step disinfectant cleaners or contact cleaning/disinfecting agent manufacturers to get more information on available products.
The minimum frequencies in Table 8 apply to all surfaces within the perimeter of the SCA. These include the PEC(s), walls, floors, ceilings, work surfaces, equipment, and storage shelving and bins located within the perimeter of the SCA.
Yes, the chapter requires equipment inside of the PEC to be cleaned, disinfected, and a sporicidal agent applied (see Table 8).
No, cleaning tools are not required to be sterile. The chapter does state that all cleaning supplies (e.g., wipers, sponges, and mop heads) with the exception of tool handles and holders must be low-lint. Further, the chapter recommends that wipes, sponges, and mop heads be disposable.
No, cleaning agents are not required to be sterile.
Users should refer to the manufacturer’s directions or published data for the minimum contact time for the agent used. The minimum contact time may differ based on the intended purpose. For example, an agent may have a 1-minute contact time to be bactericidal and a 3-minute contact time to be sporicidal.
The chapter requires cleaning and disinfecting of the compounding areas. These steps can be combined if an EPA-registered one-step disinfectant is used. One-step disinfectants have been formulated to be effective in the presence of light to moderate soiling without a separate cleaning step. Sporicidal agents must be used at least monthly. Some EPA-registered disinfectant cleaners may also have sporicidal properties. If the sporicidal agent is an EPA-registered (or equivalent) one-step disinfectant sporicidal cleaner, separate cleaning and disinfecting steps are not required.
No. CAIs, CACIs, and some LAFWs have removable work trays.
Equipment, Supplies, and Components
The Federal Food Drug and Cosmetic Act requires compounded preparations to be prepared from bulk drug substances that are obtained from FDA-registered facilities. The Expert Committee recognizes that there may be some components other than APIs that cannot be obtained from an FDA-registered facility, thus, it is a recommendation that these components be obtained from an FDA-registered facility.
Sterilization and Depyrogenation
Aseptic processing includes either 1) compounding with only sterile starting ingredient(s), or 2) compounding with nonsterile ingredient(s) followed by sterilization by filtration. Aseptic processing is not terminal sterilization.
Terminal sterilization includes compounding with sterile and/or nonsterile starting ingredient(s) and subsequent sterilization with a process intended to achieve a probability of a nonsterile unit (PNSU) of 10−6 (e.g., dry heat, steam, irradiation).
Sealed containers must be able to generate steam internally to be sterilized by steam heat. Stoppered and crimped empty vials must contain a small amount of sterile water to generate steam (see also <1229> Sterilization of Compendial Articles).
A prefiltration step with a filter of a pore size of 1.2 µm removes particulate matter in the solution before sterilization.
A PNSU value cannot be applied to CSPs that are sterilized by filtration because sterilization by filtration is not terminal sterilization.
Yes, the effectiveness of the steam and dry heat sterilization method must be verified and documented with each run or load using an appropriate biological indicator.
Release Inspections and Testing
All CSPs must be visually inspected to determine whether the physical appearance of the CSP is as expected. Visible quality characteristics (e.g., discoloration, visible particulates, cloudiness) may be documented. Results of visual inspection of the container-closure system (e.g. checking for leakage, cracks in the container, or improper seals) may be documented.
CSPs delivered by implanted pumps may be administered over a long period of time and may be compounded from nonsterile components. Bacterial endotoxin testing helps ensure that CSP do not contain excessive bacterial endotoxins. Although <797> refers to General Chapter <85> Bacterial Endotoxins Test for calculating endotoxin limits for the appropriate route of administration, <85> does not address products administered epidurally or administered directly into the central nervous system. Compounders should be aware that endotoxin testing is also important for CSPs administered epidurally.
Establishing Beyond-Use Dates
The BUD is the date or the hour and date after which the CSP must not be used. BUDs applies to CSPs and are not intended to limit the time during which a CSP is administered (e.g., infused). "Hang time" is often used to refer to the amount of time during which a CSP or conventionally manufactured product (e.g. pre-mix, large volume parenteral solution) may be infused before which either the tubing or the medication must be changed. General Chapter <797> does not address administration time (e.g., hang time).
Generally, longer BUDs are permitted for CSPs stored in colder conditions than for CSPs stored at controlled room temperature as colder temperatures have been shown to slow the growth of most microorganisms.
No, BUDs must not be additive. The storage time of a CSP must not exceed the original BUD placed on the CSP for its labeled storage condition. For example, a CSP that is assigned a BUD based on storage at room temperature cannot subsequently be refrigerated or frozen in order to extend the original BUD assigned. Likewise, the BUD of a frozen CSP must not be extended based on storage at room temperature when it is thawed.
The chapter states that BUDs for Category 2 CSPs must be established in accordance with Table 11. However, if there is a compounded preparation monograph for a particular CSP formulation, that BUD may be assigned if the CSP is prepared according to the monograph and all monograph requirements are met (e.g., Specific Tests). General Notices 3.10 states that where the requirements of a monograph differ from the requirements in an applicable general chapter, the monograph requirements apply and supersede the general chapter. In the absence of a compounded preparation monograph, the chapter does not allow for extension of BUDs beyond those in Table 11. BUDs must be assigned conservatively and must take into account factors such as validated stability-indicating assays and testing for sterility, endotoxins, container-closure integrity, and particulate matter.
The previous version of <797> specified a storage time of 48 hours and 30 hours at controlled room temperature for low- and medium-risk level CSPs, respectively. The longer BUD in the revised chapter is based on a risk based approach to balance the need for quality CSPs and to facilitate patient access. Further, the revised chapter contains additional requirements (e.g., facility and engineering controls and surface sampling) to help mitigate risks of inadvertent contamination.
Use of Conventionally Manufactured Products as Components
No, opened or punctured conventionally manufactured single-dose containers may be stored outside of an ISO Class 5 PEC. However, the chapter does require that the conventionally manufactured single-dose container be entered or punctured inside of an ISO Class 5 PEC. These containers may be used up to 12 hours after initial entry or puncture provided that the storage requirements (e.g., controlled room temperature, cold temperature) are maintained. Opened single-dose ampules must not be stored for any period of time.
No, <659> Packaging and Storage Requirements defines multiple-dose containers as a container–closure system that holds a sterile medication for parenteral administration (injection or infusion) that has met antimicrobial effectiveness testing requirements, or is excluded from such testing requirements by FDA regulation. Therefore, the requirement that multiple-dose containers not be used for more than 28 days unless otherwise specified on the labeling does not apply to conventionally manufactured sterile topical products.
Users should carefully review the manufacturer’s approved labeling for pharmacy bulk packages. Some approved labeling may provide a storage time based on stability (e.g., 14 days) as well as a shorter time (e.g., 4 hours) based on the risk of microbial contamination. Users must use the shorter storage time specified in the manufacturer’s approved labeling. The pharmacy bulk package must be used according to the manufacturer’s approved labeling.
Use of CSPs as Components
The BUD of a CSP prepared from one or more compounded components may not exceed the shortest BUD of any of the individual starting components. If a nonsterile pH solution is compounded and used within 6 hours for a single CSP or a single batch, the pH solution would not be assigned a BUD, and therefore would not affect the BUD assigned to the final CSP. The nonsterile pH solution is considered to be part of the compounding process. However, if a pH solution is prepared and stored, it must be sterilized within 6 hours and must be treated as a compounded stock solution. Sterilized and stored pH solutions must be assigned a BUD and the BUD must be taken into account when assigning a BUD to the final CSP.
A compounder wants to reconstitute a conventionally manufactured sterile product and further dilute it to prepare a subsequent CSP (see 16.2 Use of Compounded Single-Dose CSPs and CSP Stock Solutions).
- Day 1: a 2 gram single-dose conventionally manufactured container of powder for solution is reconstituted with 8 mL of a conventionally manufactured diluent, yielding 10 mL of 200 mg/mL of drug (CSP-A, original CSP). CSP-A is assigned a BUD of 10 days because it is aseptically processed, has not passed sterility testing, was prepared from only sterile starting components, and will be stored in a refrigerator (see Table 11).
- Day 3: CSP-A is entered or punctured in ISO Class 5 PEC, where 10 mL of CSP-A solution is further diluted with 40 mL of diluent, yielding 50 mL solution of 40 mg/mL of drug (CSP-B, a finished CSP). CSP-B is aseptically processed, has not passed sterility testing, was prepared from only sterile starting components, and will be stored in a refrigerator. The BUD of a CSP prepared from one or more compounded components may not exceed the shortest BUD of any of the individual starting components. Therefore, the assigned BUD for CSP-B will be 7 days (10 days minus the 3 lapsed days of CSP-A), because that is the shortest BUD of all of its individual components.
- Additionally, CSP-A must be used within 12 hours of initial entry/puncture or its originally assigned BUD, whichever is shorter, and the remainder must be discarded.
Compounding Allergenic Extracts
Allergenic extracts are biological substances used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis, allergic sinusitis, allergic conjunctivitis, bee venom allergy, and food allergy. Allergenic extract prescription sets are combinations of licensed allergenic extracts which would be mixed and diluted to provide subcutaneous immunotherapy to an individual patient, even though these allergenic extract combinations are not specified in the approved Biological License Application (BLA) for the licensed biological products.
Yes, the provisions in 21. Compounding Allergenic Extracts apply regardless of where the allergenic extract is compounded when:
- The compounding process involves transfer via sterile needles and syringes of conventionally manufactured sterile allergen products and appropriate conventionally manufactured sterile added substances, and
- Manipulations are limited to penetrating stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile vials.
Because of certain characteristics of allergenic extracts and allergy practice (e.g., preservative systems and risk of anaphylaxis), preparation of allergenic extract prescription sets is not subject to the requirements in this chapter that are applicable to other sterile CSPs. Further, FDA provides additional guidance for preparation of allergenic extracts in the FDA Guidance for Mixing, Diluting, or Repackaging Biological Products Outside of the Scope of an Approved Biologics License Application.