A Summary of Proposed Changes to USP 797

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. Activities that occur in this area include the preparation and staging of components and supplies used when compounding sterile preparations.

Beyond Use Date Chart – 797 Beyond Use Dating Chart Regulating Compounding Pharmacies

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.

Compounding also includes the preparation of drugs or devices in anticipation chart, or medication administration record the lot number and beyond-use date of the in addition to appropriate compounding attire as described in USP

Beyond-use dates for CSPs are rarely based on preparation-specific chemical assay results, which are used with the Arrhenius equation to determine expiration dates see General Notices and Requirements for manufactured products. The majority of CSPs are aqueous solutions in which hydrolysis of dissolved ingredients is the most common chemical degradation reaction.

The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations. Such lifetime stability exposure is represented in the mean kinetic temperature calculation see Pharmaceutical Calculations in Prescription Compounding Drug hydrolysis rates increase exponentially with arithmetic temperature increase; thus, exposure of a beta-lactam antibiotic solution for one day at controlled room temperature see General Notices and Requirements will have an equivalent effect on the extent of hydrolysis of approximately 3 to 5 days in cold temperatures see General Notices and Requirements.

Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs. When CSPs are known to have been exposed to temperatures warmer than the warmest labeled limit, but not exceeding 40 see General Notices and Requirements for more than 4 hours, such CSPs should be discarded, unless appropriate documentation or direct assay data confirms their continued stability. Determining Beyond-Use Dates.

When CSPs deviate from conditions in the approved labeling of manufactured products contained in CSPs, compounding personnel may consult the manufacturer of particular products for advice on assigning beyond-use dates based on chemical and physical stability parameters. Beyond-use dates for CSPs that are prepared strictly in accordance with manufacturers’ product labeling must be those specified in that labeling, or from appropriate literature sources or direct testing.

In addition, the pharmacist may refer to applicable publications to obtain relevant stability, compatibility, and degradation information regarding the drug or its congeners. When assigning a beyond-use date, pharmacists should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements.

Stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use.

USP 797 Guidelines & Standards

However, the following provides a synopsis to clarify revision content breakdown:. The purpose of U. Pharmacopeia USP is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations. It describes the CSP requirements guidelines, USP procedures and compliance for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded. Adherence to will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors.

Beyond-use dates (BUDs) and expiration dates are not the same and, as presented in BUDs are assigned as described in accordance with USP and. Predictions based on other evidence in the literature, such as charts, and.

This second issue of the Science and Technology Newsletter will continue our discussion on beyond-use dates and how to assign them based on United States Pharmacopeia USP criteria for both nonsterile and sterile preparations. Introduction I would like to begin this second issue of the Science and Technology Newsletter with a quote from Richard Penna. The sciences are what support pharmacy’s expertise in drug distribution and drug use.

Recent history leads one to question whether we in the profession, and some in pharmaceutical education, recognize and appreciate the contribution that the pharmaceutical sciences have made and continue to make to the pharmacy profession and health care. The pharmaceutical sciences are what make us unique. They provide us the special value that we bring to the bedside.

No other health professional is capable of bringing to the pharmacotherapeutic decision-making table such concepts as pH, particle size, partition coefficient, protein binding, structure-activity relationships, economics, and epidemiology. The pharmaceutical sciences, combined with pharmacy’s infrastructure, including pharmaceutical education, are what make the pharmacist an indispensable participant on the health care team.

Am J Pharm Educ ; 61 Spring In the first issue, we discussed drug stability, degradation, rates of degradation, reaction order, the Arrhenius Equation, and the Q 10 method of calculating shelf life estimates. Determining beyond-use dates and evaluating stability studies is a responsibility of pharmacists involved in all areas of nonsterile and sterile compounding. Determining Beyond-Use Dates Beyond-use dates BUDs and expiration dates are not the same and, as presented in last month’s issue of this newsletter, they are assigned on different criteria.

797 beyond use dating chart. Beyond use dating usp 800

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USP provides minimum practice and quality standards for CSPs of drugs and nutrients, based on current scientific information and best sterile compounding.

Note: certain features of this site have been disabled for the general public to prevent digital piracy. You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. You agree that you will not sell or license anything that you download, print, or copy from this website. In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients components , the preparation date, and the assigned beyond-use date based upon the pharmacist’s professional judgment, appropriate testing, or published data.

It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics e. The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer’s directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc. R oute : S earch tips. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns.

Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling. Known allergies; 2. Rational therapy-contraindications; 3. Reasonable dose and route of administration; and 4. Reasonable directions for use.

Three concepts that create a lot of confusion: stability, beyond-use date, expiration

Gloved Fingertip Sampling Bacteria. Sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. USP provides guidelines, procedures and compliance requirements for compounding sterile preparations.

ۦۧ Pharmaceutical Compounding—Nonsterile Preparations, USP 41 ۦۧ, Pharmaceutical Dosage Forms ۦۧ, Pharmaceutical Calculations in. Pharmacy​.

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.

Summary of USP 797 for Compounding Sterile Preparations

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:.

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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. For the purposes of this chapter, CSPs include any of the following:. Preparations prepared according to the manufacturer’s labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.

Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics, and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powders for injection, irrigations, metered sprays, and ophthalmic and otic preparations.

The sections in this chapter are organized to facilitate practitioners’ understanding of the fundamental accuracy and quality practices of CSPs.

USP panel sends revised compounding standards back for expert review

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.

The Revision Bulletin to USP Chapter, Pharmaceutical. Compounding: Sterile Preparations, was released in late and will become official on June 1.

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