Editorial: Revised USP Chapter <797>...Now Available

After a long wait, USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations was released on Monday of this week. This work, by the USP Pharmacy Compounding Expert Committee-Sterile Compounding, represents the conclusion of an heroic effort to evaluate and consider over 500 comments for changes in the chapter.

The chapter has grown in length to 61 pages printed out from the website (www.usp.org). I recommend that you go to the website and download your personal copy.

Some of the major changes deal with training of personnel in the areas of garbing, techniques, and media fills. Along with the three previous risk levels, are additions: "Low-Risk Level CSPs with 12-Hour or Less BUD," and provisions for "Immediate-Use CSPs."

There are clarifications on standards for Primary Engineering Controls (laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators) and Secondary Engineering Controls (cleanrooms, buffer areas, ante-rooms).

A section on definitions helps to understand the content of the chapter. Also included are new sections covering hazardous drugs, radiopharmaceuticals, and allergen extracts. New standards for surface and air sampling are presented, as well as new information on cleaning and disinfecting along with recommended action levels. Garbing order and gloved fingertip sampling standards are emphasized as well as the use of sterile 70% isopropyl alcohol in all processes.

In summary, the chapter is written with the safety of the patient as the primary consideration. It was a little overwhelming the first time I read it. However, in most documents of this type, the second time through made it much easier and simpler to understand. It will require some changes in many pharmacies; however, improved standards and safety do come with a cost. It really hits home when an accident or mishap affects one of your own family.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

In the November 20 issue of White Coat Notes, news from the Boston-area medical community (Blog), there is a report that hospitals in Massachusetts have agreed not to charge patients for costs resulting from nine types of medical errors, as follows:

1. Surgery on the wrong body part
2. Surgery on the wrong patient
3. Wrong surgical procedure
4. Foreign object left inside the body
5. Patient death or serious disability associated with an air embolism
6. Patient death or serious disability associated with a medication error
7. Patient death or serious disability associated with a reaction to the administration of incompatible blood or blood products
8. Artificial insemination with the wrong donor sperm or wrong egg
9. Infant discharged to the wrong family

While we applaud their decision, it is actually incredible that they would have ever charged for these mistakes in the first place!

Tablet and Capsule Machine Instrumentation
Watt PC, Armstrong NA, eds.
Chicago, IL: Pharmaceutical Press; 2007 (www.pharmpress.com)

In order to produce a satisfactory tablet or capsule, there is a process necessary to do just this. By involving specific techniques outlined in this text, pharmaceutical research, along with developmental and manufacturing problems, will be more clearly understood. The principles involved with generating data by instrumental machines are crucial to the application of those techniques. The topics in Tablet and Capsule Machine Instrumentation include:

• The measurement of force
• The installation of strain gauges
• The measurement of displacement
• Power supplies and data acquisition
• Instrumented tablet presses
• Calibration of transducer systems
• Data handling
• Applications of tablet press instrumentation
• The instrumentation of capsule filling machinery
• Automatic control of tablet presses in a production environment

The tableting and capsule filling process requires accurate measurements. This being considered, this text is an exceptional guide that can be used practically by pharmacists and scientists in the ever-changing field of pharmacy.

Thank the Veterans!
As this is Pearl Harbor Day, express a word of appreciation to all the veterans that come into your facility. We owe a lot to them!