10
Extemporaneous,
Nonsterile
Compounding
Learning Objectives
1 Define the terms compounding, extemporaneous, nonsterile, sterile, and anticipatory, compounding.
2 Understand the distinction between a manufactured drug product and a compounded nonsterile preparation, and preparation and the purpose of Chapter <795>. (Section 10.1)
3 Understand the role and training requirements of pharmacy technicians in nonsterile compounding.
4 Explain the contemporary demands for nonsterile compounding and and the process for accreditation of specialty compounded pharmacies.
5 Describe the distinct purposes of the master formulation record and the compounding record.
6 Understand nonsterile compounding hand hygiene and garbing requirements.
7 Identify and describe the functions and limitations of the equipment used for the weighing, measuring, and compounding, and the proper techniques for using them.
8 Define the term percentage of error and its function.
9 Discuss the types of compounding ingredients and how to determine their quality and safety, and store them.
10 Define the various methods for the comminution and blending of ingredients.
11 Explain the differing techniques by which solutions, suspensions, ointments, creams, powders, suppositories, rapid dissolving tablets, troches, and capsules are prepared.
12 Understand the final compounding steps including calculating beyond-use-dating, labeling, offering patient education, and doing cleaning-up and equipment maintenance.
ASHP/ACPE Accreditation Standards
To view the ASHP/ACPE Accreditation Standards addressed in this chapter, refer to Appendix B.
Though most medications are manufactured in a drug production facility, the practice of compounding in the pharmacy is on the upswing. Today, approximately 40–120 million prescriptions are compounded in the United States each year, which is estimated to be 1%–3% of prescriptions dispensed (according to the International Academy of Compounding Pharmacists). General community and hospital pharmacies and their pharmacy personnel often do some simple compounding and even a little moderately complex compounding, but most complex nonsterile compounding occurs at dedicated pharmacies.
Nonsterile pharmaceutical compounding is both a necessary pharmacy skill and, on the complex end, a pharmacy specialty. It comes with a unique set of supplies, techniques, terminology, calculations, and decisions to be made. In addition, like other areas of pharmacy practice, nonsterile pharmaceutical compounding is governed by specific federal and state laws, regulations, and standards.
Because many high-volume chain pharmacies (and even most independent pharmacies) do not have the time, space, equipment, or expertise for complex compounding, specially trained community pharmacists and their technicians are increasingly being called upon to prepare a recipe or compound a preparation in individualized doses or strengths for human or veterinary use. To engage in this practice, pharmacy technicians must have advanced training and experience and devote the majority of their workday to performing precise calculations and mixing ingredients rather than dispensing prescriptions, billing insurance companies, or communicating with patients.
Even if you will not be doing this work intensely in the first years of being a technician, it is important to be able to do simple compounding in case you are called upon to do so. It is also helpful to have an understanding of what is involved to see if this may be a specialty you may someday want to pursue.