When performing Gap Analysis surveys for compliance with USP <795> and <797> as well as in many presentations/lectures, I usually try to remember to explain that disposable plastic syringes are for measuring a quantity of finished medication for administration. Disposable plastic syringes were never designed for compounding purposes. However, they are used for that purpose but caution must be observed. Let's first look at some new documentation concerning their use.

In a new study, Erstad et al [AJHP 63 (Apr 15, 2006), 748-750] studied the accuracy and reproducibility of small-volume injections from various-sized syringes. They used thirty each of polypropylene syringes, including 1 mL, 3 mL and 5 mL volumes. An analytical balance was used to determine the weights of distilled water drawn into the syringes. 0.5 mL was used for all syringes and allowance made for the "dead space" and the weight of the syringe. The accuracy and reproducibility of the delivered dose was reduced as syringe size increased.

The mean percent error drawing up 0.5 mL was 0.81% for the 1 mL syringe, 4.70% for the 3 mL syringe and 16.8% for the 5 mL syringe. This study concluded that the size syringe closest to the quantity being measured should be selected

In addition to the study conclusions, it is also recommended each new lot of syringes received in the pharmacy be checked for accuracy. For example, tare one of the new syringes on an electronic balance; fill the syringe to a designated mark with water, and weigh to determine the weight of the volume of water. Assuming a specific gravity of 1.0 for water, the volume should be represented in grams. For example, if using a 3 mL syringe filled to the 3.0 mL mark, it should weigh 3.0 grams. This is a quick and easy check for the accuracy of the plastic disposable syringes. If a typical error of 5% is acceptable as in the case of weighing, then the weight of the water should be between 2.85 g and 3.15 g. If outside this range, that specific lot of syringes should not be used in compounding.

To summarize, use the size syringe closest to the volume to be measured and check each new lot of syringes for accuracy prior to using them.

Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years of age because of the potential for fatal respiratory depression.

See www.fda.gov/cder/drug/InfoSheets/HCP/promethazineHCP.htm for more information.

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This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

Senator Kennedy Explores New Compounding Legislation
On March 3rd, a healthcare policy newsletter, Washington Drug Letter, reported that the office of Senator Edward Kennedy is "exploring" legislation that would re-establish several elements of section 503(a) of the FDA Modernization Act (FDAMA). FDAMA Section 503(a) (the section regulating compounding that was ruled unconstitutional by the Supreme Court) was deeply flawed and, for a number of reasons, IACP believes that new legislation could have many adverse and unintended consequences on our profession and, as importantly, on our patients. IACP members are encouraged to contact their Senators regarding the new legislation. IACP provides an issue brief and a template letter at its new advocacy center - www.iacprx.org/GetActive (please sign in to the member center to view all action alerts).

IACP Issues Guidelines for Labeling of Compounded Medications
In January, IACP issued guidelines for the labeling of compounded medications. These guidelines are intended to provide patients with the most complete information available about how to use and care for their compounded prescriptions. The guidelines will promote best practices and standardized labeling across all 50 states. An added benefit, by taking this step proactively we will demonstrate to policymakers, opinion leaders and the public that our profession's top priority is patient safety. These guidelines will not only generate recognition of the profession's responsibility, but they will also raise awareness among patients that customized, compounded medications offer a unique value that off-the-shelf pharmaceuticals do not provide. IACP is currently working with software vendors to incorporate suggested language into current labeling programs. To review the complete guidelines, visit www.iacprx.org/Labeling.

Drying Equipment
Need to dry some equipment quickly? You have a number of options. First, keep an oven at a temperature of about 110�C. If the equipment can withstand the temperature, place the equipment in the oven for a few minutes and it will be ready to use (after cooling down). Or, a dedicated laboratory drier (hair drier) can be used for drying equipment that may not be suitable for placement in an oven. Last, and this method should be used with caution, after thoroughly rinsing the equipment with purified water USP, rinse it with acetone NF (in a well-ventilated area). The acetone is miscible with the water and dries very rapidly. Acetone also works very well when the equipment has tiny cracks and crevices that are very slow to dry.