A Summary of Proposed Changes to USP 797

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USP Finalizes Revisions to Sterile Compounding Standards

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.

Beyond-Use Date is the date and time after which a CSP shall not be stored or 45 days. Medium. One: Many or Many: One. 30 hours. 9 days. High The proposed USP revisions collapsed CSP microbial risk.

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.

The U. The new revision will likely take several years to complete and thus is not the focus of this CE program. For the convenience of those studying this program, the numerous acronyms used are compiled in Table 1. Sterile compounding evolved primarily in hospitals in the s and s. It involves preparations that are made in sterile environments aseptically by mixing, diluting, repackaging, or manipulating injectable products. The injections and infusions compounded in hospitals and other health systems include large-volume parenterals LVPs and small-volume parenterals SVPs.

Beginning with pharmacist-prepared, centralized IV admixtures in the s, hospitals have provided aseptic environments within which to compound sterile products and prevent microbial contamination, including the use of laminar airflow rooms and hoods with high-efficiency particulate air HEPA filters, IV compounding rooms, and work practices to support aseptic compounding. Even with these precautions, however, there have been many sterility challenges and patient morbidity and mortality issues secondary to contaminated compounded parenteral medicines.

Compounding

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. It is also a transition area that: A provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and B reduces the need for the heating, ventilating and air conditioning HVAC control system to respond to large disturbances.

The beyond-use date is determined from the date or time the preparation is compounded.

This “beyond use date” of the compounded drug product preparation least once every six months for low and medium risk-level compounding and USP or the practice of pharmacy and would have substantial adverse.

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.

Table 12 from the proposed chapter summarizes these requirements. As indicated in the table above, CSPs that are sterilized in their final container-closure systems terminal sterilization are permitted longer BUDs than CSPs that are sterilized via filtration.

USP 797 Guidelines & Standards

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.

PCCA Blog – – USP Revisions Summary – Main Image png as low-​, medium-, or high-risk level CSPs based on the sterility of the starting Instead of assigning a maximum allowable beyond-use date (BUD).

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. Unique Consumables CultureCoin. Formulation and Filling Filling Line Isolator. For more information contact us at: mail tapestlerx. Esco Group of Companies. IVF Medtech. Division of Esco Group of Companies. Bioprocessing Tools. Life Science Investment Arm.

Microbial Contamination Risk Levels and Beyond-Use Dating

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.

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

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.

beyond use date. • Identify important remaining USP Pharmaceutical Compounding – Sterile Preparations Factors affecting risk of contaminants ‐ Personnel. Personnel •low, medium, high revised to. •Category 1.

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. For more information contact us at: mail tapestlerx. Esco Group of Companies. IVF Medtech. Division of Esco Group of Companies. Bioprocessing Tools. Life Science Investment Arm.

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Sterile IV Compounding Laminar Flow Hood Cleaning USP 797