USP’s New Requirements for Nonsterile Compounding

October 2011 : Cleanrooms & Compounding - Vol. 8 No. 10 - Page #20

Q & A with Patricia Kienle, RPh, MPA, FASHP
Director, Accreditation and Medication Safety
Quality Services

Cardinal Health Pharmacy Solutions


Pharmacy Purchasing & Products: How do the recent changes to USP Chapter <795> affect compounding policies and procedures? 
Patricia Kienle: While most of us are familiar with USP Chapter <797> and its focus on sterile compounding, recent revisions to Chapter <795> addressing nonsterile compounding became official in May of this year. There are many new elements that deserve pharmacy’s attention. 

For those practitioners not familiar with USP’s nonsterile compounding content, the chapter should be reviewed in its entirety. Beyond that, the sections of most urgent interest to practitioners are those covering compounding documentation, beyond-use dating, and stability criteria. Certainly there other important topics—such as equipment, facilities, processes, and quality control—but these are the ones that need the most immediate attention 

PP&P: What are the first steps to ensure proper nonsterile compounding techniques are performed?
Kienle: Start by identifying all nonsterile compounding done in the pharmacy. It is important to remember that even simple processes, such as reconstituting an antibiotic suspension, signify compounding and thus, are covered by this chapter. 

Next, review existing policies and procedures for nonsterile compounding, including any records that have been kept to date. Many pharmacists keep recipe files—informal notes and directions for compounding nonsterile products. While these often can serve as the basis of the formal compounding documents, they are likely not in the format necessary to meet the criteria of this chapter. Finally, pharmacy graduates are generally presumed to be competent in compounding tenets, but regardless, new (and even seasoned) practitioners often require a refresher on basic technique, as well as a review of formal policies and procedures. Pharmacy directors and managers must never forget that observation of technique is the gold standard for determining competence. 

PP&P: How can staff assessments be incorporated to ensure competency?
Kienle: Most hospital pharmacist job descriptions, and many technician job descriptions, rightfully include references to compounding performance. Accordingly, compounding proficiency should be a basic element of competency assessments for pharmacists and pharmacy technicians. Such assessments can kind be guided by the three types of compounding that are defined in USP Chapter <795>:

Simple compounding includes the reconstitution or manipulation of a commercial product (such as adding water or another ingredient to a product as directed by the manufacturer), or use of a USP Compounding Monograph that includes specific information on all components, compounding procedures, and stability data.

Moderate compounding involves preparations that require special calculations or procedures to determine—such as quantities of components or individualized dosage units—or compounding a preparation for which stability information is not available. 

Complex compounding includes specialized drug manipulations that require specific training, equipment, facilities, etc. This includes institutions making transdermal dosage forms or modified release preparations—activities generally outside the scope of most hospital pharmacy operations. 

As hospital pharmacies tend to compound in the simple through moderate range, any attendant activities need to be included in the practitioner’s job description as well as the assessment of competence.

The revisions to Chapter <795> are now official, underscoring the importance of standardization for nonsterile compounding. Activities associated with nonsterile compounding should be assessed during a new employee’s probationary period. Following this, periodic assessments should occur when any new procedures are enacted or a review of overall compounding practices is performed. Although there are no specific tests for <795> competency, such as those that exist for Chapter <797>, applying standardization to staff assessments of compounding practices is always a good idea. 

PP&P: What elements of the revised Chapter <795> tend to differ from common hospital pharmacy practice for compounding nonsterile preparations?
Kienle: Other than the competency issues outlined above, there are three primary areas where there is likely to be a discrepancy between <795> and common practice. While pharmacies typically designate a functionally separate area for compounding operations, often this space is not recognized as conforming to its true function, especially if it is not physically defined by walls or partitions. For example, it is not unusual to find coffee cups in the sink or food on the counter intended for nonsterile compounding operations. Accordingly, pharmacy leadership needs to ensure that areas intended for compounding are kept neat, clean, uncluttered, and are truly reserved for nonsterile compounding activities. 

The second common discrepancy involves the water used in compounding. Water intended for this purpose needs to be purified. In most hospitals, pharmacy is reconstituting products using readily available sterile water, which is fine because it is purified. However, pharmacists and technicians may not be rinsing compounding equipment in purified or sterile water, and <795> recommends the rinsing of compounding equipment in purified water as well. 

The third area involves record keeping. Often pharmacies have hand written recipe files, notebooks, or 3x5 card collections that may have been in existence for a number of years. For example, there are several products being compounded in hospitals—such as alprazolam suspensions, captopril solutions, or morphine suppositories—that are made following such recipe guidelines when, in fact, there are over 100 official formulations with specific directions and requirements, outlined in the USP. For documentation, two records are required by USP Chapter <795>. One is the Master Formulation Record, which essentially details each step that needs to occur for every nonsterile compounded formula. This record should include the compounded product name, the ingredients list, calculations, and processes for mixing, labeling, and packaging the product. These elements provide standardization, ensuring that regardless of who prepares it, the compounds are codified. The other record is the Compounding Record, or perhaps more appropriate, the Dispensing Record, as it is meant to identify the name of the preparation—referencing the Master Formulation Record name or number—the lot numbers, the sources of the preparation’s components, how much was compounded, and who performed the compounding. The details required for each of these documents can be found in the revised USP Chapter <795>. 

PP&P: How are beyond-use dates determined?
Kienle: Chapter <795> defines the three parts of a nonsterile compound as the active pharmaceutical ingredient (API), inactive ingredients, and the diluent or vehicle. Accordingly, the beyond-use date (BUD) of the final product cannot exceed the expiration date of any of its individual components. In addition to this, <795> provides guidance for determining beyond-use dates if that information is not available in a compounding monograph or peer-reviewed journal (see Figure 1). 

These guidelines may introduce a very different approach because beyond-use dates often are based on historical information found on recipe cards and not, in fact, on any scientific evidence. 

PP&P: What risks are associated with nonsterile compounding?
Kienle: Chapter <795> emphasizes accuracy and safety as the tenets of any compounding procedure. Patient safety is paramount, so ensuring appropriate dosage forms and drug efficacy is vital. Simultaneously, the safety of pharmacy personnel must receive equal concern. With nonsterile compounding, safety risks are coming to light that have not historically been considered. In some cases, nonsterile compounding may involve raw chemicals and hazardous drugs. Some practitioners think of hazardous drugs as being limited to injectable cytotoxic drugs such as chemotherapy, but there are a large number of additional drugs that have been defined as hazardous, which may be compounded or packaged or pulverized for use in a nonsterile compound. In this case, the drugs would be hazardous to both the pharmacist and the patient. If a patient cannot swallow an oral drug that is defined as hazardous, it needs to be put it into a capsule or some other stable dosage form, and the pharmacist or technician performing this task is handling a hazardous drug that is no longer in final form. Some hazardous tablets, such as those that require splitting, need to be handled within the appropriate engineering control; some tablets should not be touched by pregnant women or women looking to become pregnant. These activities may fall under nonsterile compounding activities, but offer very real risks. 

PP&P: Beyond USP, what other regulations come into play for nonsterile preparations?
Kienle: Determining individual state board of pharmacy regulations is probably the biggest issue. It is key for each hospital to identify any requisite conditions or restrictions for compounding established by their state board of pharmacy. For example, there may be restrictions that assign certain procedures to a pharmacist only and these vary by state. Different states take different approaches with requirements of the US Pharmacopeia. Many states automatically adopt anything in the USP as official regulation in their state; others make different arrangements. It will prove very beneficial to be thoroughly familiar with your state regulations on nonsterile compounding.

The Joint Commission (TJC), Det Norske Veritas (DNV), and the Healthcare Facilities Accreditation Program (HFAP) expect facilities to follow any applicable state or federal regulations. This includes USP and the respective state board requirements. This being said, it is unlikely that an accrediting surveyor would ask pointed questions about nonsterile compounding operations, but the subject could arise if other deficiencies in pharmacy operations, particularly with sterile compounding, are detected during a survey.

Disclaimer: Ms. Kienle is a member of the USP Compounding Expert Committee, but the views and opinions presented herein are entirely her own. They do not necessarily reflect the views of USP, nor should they be construed as an official explanation or interpretation of USP General Chapter <795>.

Patricia C. Kienle received her MPA in health service administration from Marywood College in Scranton, Pennsylvania, a BS in pharmacy from Philadelphia College of Pharmacy and Science, and has completed an executive fellowship in patient safety from Virginia Commonwealth University.


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