Over the next few weeks, we will be discussing quality assurance standards in pharmaceutical compounding. Many methods can be used by a compounding pharmacy for checking the quality of what has been compounded. In the Compounding Record section of USP Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations, it states "For all compounded preparations, results of quality-control procedures are to be recorded�"

There are numerous tests that can be conducted in-house for documentation of quality, including weight, volume, pH, color, particle size, specific gravity, sterility, and endotoxins. Other tests that can be done with a small investment and in certain circumstances include osmolality, refractive index, and melting point. Tests that generally are outsourced include UV/Vis/IR spectroscopy, spectrophotofluorometry, HPLC, and GC; however, with newer technology, some can be done in-house.

Starting next week in this newsletter, we will begin briefly covering these topics in short narratives to assist in setting up and expanding rapid quality-control procedures.


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

These CDs contain each issue of the Journal published during the respective calendar year. Visit the IJPC store and order yours today at www.ijpc.com/Products/Index.cfm#LibCD

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

A well-attended Hill Briefing "Pharmacy Compounding: Treating the Forgotten Patient" was held on Monday, March 12, 2007 in the Russell building with speakers:

• Tony Lee, Esq., Director of Public Policy of the National Community Pharmacists Association
• Kristina Lunner, Director of Legislative Affairs of the American Pharmacists Association
• Loyd V. Allen, Jr., PhD, RPh, FIACP, Editor-in-Chief for the International Journal of Pharmaceutical Compounding
• Robert Hilsenroth, DVM, Executive Director of the American Association of Zoo Veterinarians
• Ken Baker, Executive Director of the Pharmacy Compounding Accreditation Board
• L.D. King, Excutive Director IACP

To read more about the proposed bill and hill activities go to www.iacprx.org or www.iacprx.org/site/PageServer?pagename=Press_Releases#030707

Start Quality Testing
Quality testing is not difficult! Simply implement one new method every month, every other month, or every quarter, and soon you will be documenting your processes and preparations without a strain on the budget or in the time required.