The U. Pharmacopeia Appeals Panel sent two revised compounding chapters back to an expert committee for review March The two revised chapters are USP chapter , which regulates nonsterile compounding, and USP chapter , which regulates sterile compounding. The panel made its decision to address “issues raised concerning the beyond-use date provisions. Last year, the USP postponed the dates these updated chapters were slated to go into effect because of appeals filed against them. Appeals were also filed against USP chapter , which deals with radiopharmaceuticals. While the panel sent chapter and back for review, it denied the appeal for chapter March 12, asking the appellant to submit a narrower request. The panel’s decision will delay the date the revised version of chapter will be enforced as well as the date for general chapter , which deals with hazardous drugs.
USP 797 Guidelines & Standards
The chapter is not yet enforceable as it will become official in USP on December 1st, In the current and soon to be former Chapter sterile preparations were divided into Low, Medium, and High Risk Preparations. Category 1 CSPs do not require sterility testing while Category 2 CSPs may require a sterility test depending on the beyond use date assigned.
The Beyond Use Dates BUDs allowed for Category 2 CSPs are dictated by the method of sterilization, whether or not a sterility test is performed, passed, and the storage temperature of the preparation. Table 11 of the new Chapter 1 provides the following maximum BUDs:.
I can use the full beyond-use dates in USP Chapter if I have a glove box outside a cleanroom. Not true. Compounding aseptic isolators .
Considerations for CSP. Verification of Compounding Accuracy and Sterility. Environmental Quality and Control. Suggested Standard Operating Procedures. Finished Preparation Release Checks and Tests. Storage and Beyond-Use Dating. Patient or Caregiver Training. Patient Monitoring and Adverse Events Reporting. Quality Assurance Program. A primary responsibility of the pharmacist is to ensure safe sterile dosage form preparation.
Compounding an accurate formulation free of microbial and particulate matter is an essential component of this process.
USP panel sends revised compounding standards back for expert review
One definition of sterile preparations is that they are anything that is not a nonsterile preparation. Although the statement may be true, it is not very helpful. A sterile preparation is one that does not have any microbial contamination. However, the only absolute method to prove that a preparation has no microbial contamination is to submit the entire preparation to a sterility test, thereby consuming it. Sterility in a practical sense must provide a means to statistically ascertain that the preparation is not likely to carry enough of a microbial burden to cause patient harm.
These guidelines were difficult to formulate and slow to be accepted.
USP General Chapter Update: A Guide to Sterile Compounding for Pharmacy Personnel. INTRODUCTION. Note to users: At the time this monograph.
Chapter in Pharmaceutical Compounding — Sterile Preparations issued by the US Pharmacopeia describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. The clean room must include an attached anteroom at the same air quality level ISO Class 8 for movement of personnel and materials in and out of the clean room. Building and operating a clean room can be an expensive and time-consuming proposition.
Fortunately, pharmacies can also comply with requirements using a barrier isolator, also known as a glovebox. A glovebox isolator or barrier isolator provides a physical barrier between pharmacy personnel and the compounding activity. Traditional clean benches and biosafety cabinets have an open front access area, where there is the possibility that disruptions in the room airflow or poor aseptic technique by the operator will introduce contaminants to the work area.
A glove box provides an additional level of protection, as the sterile product is never exposed to the room environment or to compounding personnel directly. When using a glovebox, materials are passed into the main working chamber through an enclosed pass-thru chamber, and accessed through glove ports to perform aseptic manipulations. Clean air is supplied to the work area through a HEPA filter, providing better than ISO Class 5 conditions under positive pressure within the glovebox.
Gloveboxes offer the same or better air quality as a clean bench or biosafety cabinet located within a clean room, plus their design offers some significant advantages in both initial investment and ongoing operating expenses. USP Chapter speaks to aseptic conditions for compounded sterile preparations; however the chapter does not cover in detail the risks to pharmacy personnel associated with handling cytotoxic or other hazardous drugs.
For these special cases of CSPs, a negative pressure glovebox should be used to provide ISO Class 5 conditions while also protecting personnel from exposure.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
This chapter provides procedures and requirements for compounding sterile preparations. Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices. Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.
In essence, a CSP that is an official USP/NF compounding monograph that non-sterile to sterile compounding should have its own chapter.
Usp chapter provides guidelines beyond use date. One 1: matches and. Based on a. Medication procedures to usp general notices and usp chapter , new revisions as of. Name according to usp extended beyond use date is compounded. Based on high risk and closures. First official january 1. That most significant upcoming changes to a pharmacy personnel. Equipment, new beyond use dating for compounding. For compounding generally.
Usp 797 guidelines beyond use dating
The USP has recently published a revised version of general chapter Pharmacy Compounding. -Sterile Preparations addressing sterile compounding.
D uring the s, the practice of pharmacy began growing and evolving. In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety. For the next 30 years, various pharmacy organizations published documents in an effort to establish a standard for the practice of compounding sterile preparations CSPs. However, none of the documents were successful in providing a professional mandate and the handling of sterile product preparation by licensed pharmacies varied nationally through the s.
In , The U. The law introduced limits on pharmacy compounding and attempted to protect patients from unnecessary use of compounded drugs. Supreme Court in , and so the efforts to improve the quality of pharmacy-prepared CSPs continued. The United States Pharmacopeia USP drafted a revision of the general information chapter , which was proposed as a guideline and detailed the procedures for preparing sterile drugs intended for home use. The FDA committee wanted an enforceable entity and, by changing chapter to chapter and moving it into the General Tests and Assays portion of the USP, they established a legal base by which the FDA could determine whether a drug has been adulterated.
The revision of the chapter ensures that medications are compounded accurately and appropriately, protecting patients from microbially contaminated preparations.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
These revisions differ from the existing chapter in some significant ways — both structure and content. These changes, at least some of them, will undoubtedly require the pharmacy system and processes to undergo some significant adjustments. Although, many of the variations will be easier to implement. The changes are set to become official and take effect on December 1,
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Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.
All CSPs are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter. A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and pH; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.
The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed. Qualified licensed health care professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved.
This chapter emphasizes the need to maintain high standards for the quality and control of processes, components, and environments; and for the skill and knowledge of personnel who prepare CSPs. The rigor of in-process quality-control checks and of postcompounding quality inspection and testing increases corresponding to the potential hazard of the route of administration. For example, nonsterility, excessive bacterial endotoxin contamination, large errors in strength of correct ingredients, and incorrect ingredients in CSPs are potentially more dangerous to patients when the CSPs are administered into the vascular and central nervous systems than when administered by most other routes.