Compounding

The proposed chapter was open to public comments until November 30, , and is expected to become official on December 1, The proposed revision differs from the current chapter in both its structure and its content. Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate. Here is a summary of some of the changes. The current chapter classifies compounded sterile preparations CSPs as low-, medium-, or high-risk level CSPs based on the sterility of the starting components and the number and types of compounding manipulations. The proposed chapter, however, eliminates this system of classifications and instead classifies sterile preparations as either a category 1 or category 2 CSP based on the conditions under which the product was prepared. The proposed chapter also changes the system for assigning beyond-use dates to CSPs. Instead of assigning a maximum allowable BUD based on the risk level of the preparation, the proposed chapter follows a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility. The proposed guidelines allow a longer BUD for category 2 CSPs, especially those that are terminally sterilized, prepared using only sterile components, tested for sterility, or stored in refrigerated or frozen storage conditions.

32 General Principles of Sterile Dosage Form Preparation

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, Public comments on these changes are no longer heard, but we can still take a look at some of the most significant changes that will take effect in less than a year.

If no such beyond use date exists, the dangerous drug product may only be used for (D) A prescriber who prepares low-risk sterile compounded drugs as defined in twelve hour beyond use date, allergen extracts, medium and high-​risk sterile comply with United States Pharmacopeia Chapter , USP 38 – NF

This article is intended to provide a broad overview of sterile and nonsterile Compounding. This article will cover the following knowledge areas:. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines.

USP – USP Chapter , Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals. USP Chapter describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

USP – USP Chapter , Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state. Trituration is achieved by firmly holding the pestle and exerting a downward pressure with it while moving it in successively larger circles starting at the center of the mortar, moving outward to the side of the mortar, then back again toward the center.

With this method there is no particle size reduction, so the powders to be mixed must be fine and of uniform size.

Summary of USP 797 for Compounding Sterile Preparations

Potential sources of contamination include, but are not limited to, solid and liquid matter from compounding personnel and objects; non-sterile components employed and incorporated before terminal sterilization; and inappropriate conditions within the restricted compounding environment. It is determined from the date or time the preparation is compounded. No sterile compounding is inherently “low risk” and preparation of all CSPs must be done carefully.

Categories were renamed neutrally and are distinguished primarily by the conditions under which they are made. References 1.

“Beyond-use date” refers to the date placed on preparation label that is intended to indicate to Preparations should be compounded according to USP Chapter preparations must not be medium risk level or high risk level compounded.

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A Summary of Proposed Changes to USP 797

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Usp medium risk beyond use dating. Since january 1, and effective july Why is a csp shall comply with the fda cites the usp a breakdown of.

The compounding of medications is a fundamental part of pharmacy practice. All compounding personnel, mainly pharmacists and pharmacy technicians, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity freedom from physical contaminants, such as precipitates, 1 and chemical contaminants , strength including stability 2 and compatibility , and sterility and for dispensing them in appropriate containers that are labeled accurately and appropriately for the end user.

In contemporary health care organizations, patients receive compounded sterile preparations CSPs that are stored for extended periods before use. It has long been recognized that extended storage of CSPs may allow for the growth of a pathological bioburden of microorganisms 3 and that patient morbidity and mortality can result from contaminated or incorrectly compounded sterile preparations. Most users should sign in with their email address. If you originally registered with a username please use that to sign in.

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USP Risk Level

Contaminated CSPs are potentially most hazardous to patients when administered into body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues. When CSPs contain excessive bacterial endotoxins see Bacterial Endotoxins Test 85 , they are potentially most hazardous to patients when administered into the central nervous system.

Despite the extensive attention in this chapter to the provision, maintenance, and evaluation of air quality, the avoidance of direct or physical contact contamination is paramount. It is generally acknowledged that direct or physical contact of critical sites of CSPs with contaminants, especially microbial sources, poses the greatest probability of risk to patients.

Table 1: USP Risk Levels. Type of Compounding, Definition, Requirements, Beyond use dating: Room Temperature, Refrigerated. Low-risk Medium-risk, · Multiple additives and/or small volumes · Batch preparations.

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. As was described in Chapter 12 of this book, the USP is a private, nonprofit organization recognized by the federal government as the official group responsible for setting national standards for drug purity and safety. Most recently, the USP has become involved with issuing standards on the pharmaceutical compounding of sterile preparations.

Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures

Compounding has been a fundamental aspect of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.

Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.

Sterile preparations typically include injections, infusions, and some irrigation, ophthalmic, and inhalation preparations. Nonsterile preparations typically include oral suspensions, topical solutions, topical suspensions, topical gels, powders, ointments, creams, emulsions, suppositories, and others.

Patient-specific. − On-demand. − Products made ahead with USP Chapter beyond-use dating (BUD). − Low, medium, and high risk.

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.

The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination nonsterility , excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs. The quality control and testing for CSPs in this chapter are appropriate and necessary. The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.

USP Finalizes Revisions to Sterile Compounding Standards

Pharmacies Compounding Sterile Preparations. Pharmacies compounding sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. For example: A ISO Class 5 formerly Class is an atmospheric environment that contains less than 3, particles 0.

office use (restricted to Ohio pharmacies If no such beyond use date exists, the Medium or high-risk must adhere to USP. ▫ Similar to immediate-use.

Potential sources of contamination include, but are not limited to, solid and liquid matter from compounding personnel and objects; non-sterile components employed and incorporated before terminal sterilization; and inappropriate conditions within the restricted compounding environment. It is determined from the date or time the preparation is compounded. No sterile compounding is inherently “low risk” and preparation of all CSPs must be done carefully.

Categories were renamed neutrally and are distinguished primarily by the conditions under which they are made. References 1. Product News FAQ.

USP 797 Guidelines & Standards

The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS.

In USP chapter, compounding personnel are required to be adequately skilled, compounded sterile products (low, medium, or high-risk) prior to beyond-use date as determined by the pharmacist in compliance.

The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. Significant changes include:. In light of the new standards, pharmacies should evaluate the physical capabilities of their compounding facilities to ensure they can meet the demands of the revised requirements.

With states increasingly requiring that licensees adhere to the USP standards, state Boards of Pharmacy are likely to adopt these or similar changes in the near future. In addition, providers may need to train employees to work within a controlled environment that conforms to the new USP standards. The revised chapter instead focuses on standards aimed at ensuring the integrity of CSPs.

Current Developments

A As used in this rule, “compounding” means the preparation of non-hazardous sterile and non-sterile compounded drugs but does not include any of the following when administered to an individual patient: 1 The preparation of a drug device designated as such and approved by the United States food and drug administration strictly in accordance with the manufacturer’s labeling for administration and beyond use dating. If no such beyond use date exists, the dangerous drug product may only be used for up to six hours following preparation.

These devices shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. These drug products shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. Any other reconstitution or dilution of a conventionally manufactured sterile product is considered compounding and shall be performed in accordance with this rule.

B A facility where a prescriber is compounding drugs shall be licensed as a terminal distributor of dangerous drugs pursuant to section

The subject of “beyond use dating” for compounded sterile preparations published in USP-NF USP-NF 27 is concerned with two issues, risk of microbiological Examples of Medium-Risk Compounding, item number 3 provides for a.

To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources. In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements.

To meet the operational demands of a pharmacy, institutions employ a referenced guideline approach to guide decision making for safe sterile admixing. Often these guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. In an effort to improve sterile compounding across a multihospital system, we developed and implemented beyond use dating guidelines to improve consistency and patient safety while meeting regulatory concerns.

Beyond use date BUD is the date after which a compounded preparation shall not be used, and it is set based on the date on which the preparation was compounded. To support compounding of products that are both sterile and chemically stable, beyond use dating of sterile compounded admixtures must include a thorough evaluation of appropriate resources. Prior to admixing, literature should be evaluated to determine the chemical stability of each medication at a referenced concentration range, within a specified diluent, and stored at appropriate temperature within an appropriate container.

The chemical stability must also be cross-referenced with current US Pharmacopeial Convention standards to ensure that sterility is maintained throughout the storage period. It is important to note that BUDs and expiration dates are not the same.

Recommendations for USP 797 Updates


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