Editorial: Quality Assurance in Compounding, Part 3

United States Pharmacopeia (USP) Chapter <905> Uniformity of Dosage Units

A couple of weeks ago, a discussion was held on a simple weighing method for quality assurance consisting of establishing upper and lower boundaries and weighing each dosage unit to confirm its "fit" into the weight range for which it was prepared. This was not really a USP method, however. To put things in context, the USP method that is used in the pharmaceutical industry should be discussed.

USP Chapter <905> Uniformity of Dosage Units is a different type of testing procedure that does not really lend itself to a compounding pharmacy unless large quantities of dosage forms are compounded and it becomes economically feasible to do the test. USP Chapter <905> consists of two different types of tests for uniformity from dosage unit to dosage unit; Weight Variation (WV) and Content Uniformity (CU).

WV and CU tests are designed for industry and differ as follows. The procedure starts with 30 dosage units, of which ten are used initially.

WV Test: The USP assay is performed according to the monograph on the finished dosage units to determine the quantity of drug per dosage unit of average weight. Then, the individual dosage units are weighed and the quantity of drug, based on their weights, is calculated.

CU Test: Each dosage unit is individually assayed and the individual results compared to the others in the sample. This is a much more rigorous and lengthy test.

If an average assay for a single dosage unit is approximately $150, then it is easy to see, starting with ten units for the CU test, that the costs would be $1,500 for this test. Consequently, this is not a reasonable test for the vast majority of compounders to have performed. It may be appropriate if thousands of dosage units are compounded as a single batch. The WV test would be less expensive, but it is not designed for as many different types of dosage units as is the CU test.

So, what should compounders do? When compounding small quantities, compounders meet "the spirit" of USP Chapter <795> by documenting weights as discussed in Part 2 of this series. If you compound thousands in a batch, then either the WV or CU test may be appropriate and can be performed by a quality laboratory well versed in USP methods. The decision is yours.


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

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

Senate is in recess this week�.
Contact your congressional representative while they are at home regarding the Kennedy, Burr, Roberts proposed legislation to give the FDA control of compounding. For more information www.iacprx.convio.net/site/MessageViewer?em_id=2821.0

Funding Available for Compounded Medication Studies
The International Academy of Compounding Pharmacists Foundation is accepting applications for several types of studies involving compounded medications. If you are interested, please contact Lizzie Dragon at the IACP Foundation office 281-704-5090 for an application.

To learn more about the IACP Foundation please visit their webpage at http://www.iacprx.org/site/PageServer?pagename=Foundation_about

Check out the dermatomes chart available to help treat pain patients at http://www.ijpc.com/Products/ProductDescription.cfm?PID=2466

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