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Editorial: First Meeting of the USP Compounding Committees in the 2005-2010 Cycle

To foster greater communication between the activities of the USP compounding committees and compounding pharmacists, I thought it would be of interest to provide information in the public domain related to the two committees, namely the USP Pharmacy Compounding Expert Committee and the Sterile Compounding Expert Committee. The USP strives to be a transparent organization and a lot of effort is expended to educate and inform stakeholders of its activities and decisions.

The committees met in joint session on July 7 and individually on July 8 in Rockville, Maryland. The Compounding Pharmacy Expert Committee consists of the following individuals:

• Loyd V. Allen, Jr., Ph.D., Chair
• Judith E. Thompson, R.Ph., Vice-Chair
• Lisa D. Ashworth, B.S.
• Robin H. Bogner, Ph.D.
• Gigi S. Davidson, R.Ph.
• Deborah R. Holy, Ph.D.
• Mary Ann F. Kirkpatrick Ph.D.
• Mark G. Klang, M.S.
• Lawson G. Kloesel, B.S.
• Lawrence A. Trissel, B.S.
• Samia M. Nasr, M.S., FDA Observer

The Sterile Compounding Expert Committee consists of the following individuals:

• David W. Newton, Ph.D., Chair
• Lawrence A. Trissel, B.S., Vice-Chair
• Samuel C. Augustine, Pharm.D.
• Mary B. Baker, Pharm.D.
• James F. Cooper, Pharm.D.
• Donald J. Filibeck, Pharm.D.
• Larry W. Griffin
• Kenneth L. Hughes, B.S.
• Eric S. Kastango, M.B.A.
• Keith H. St. John, M.S.
• Laura A. Thoma, Pharm.D.
• James Wagner
• Kathleen R. Anderson, FDA Observer

Many USP staff participated in the meetings over the two-day period for this initial meeting of the two committees. The joint meeting consisted of an orientation of the committee members to the governance, programs and strategic directions of the USP. There was a review of the Constitution and Bylaws and the Rules and Procedures. The topics of confidentiality and conflict of interest was explained in detail. Next the topics of monograph development and revision and the services provided by the USP Volunteer Support and Services group were explained. Following this, there was a discussion of the roles and responsibilities of the chairs, expert committee members and scientific liaisons. The day concluded with a tour of the USP facilities.

The second day the two committees met individually to begin their work for this five-year cycle. The work generally includes the revision and development of new General Chapters; revision activities may involve (795> Pharmaceutical Compounding-Nonsterile Preparations, <797> Pharmaceutical Compounding-Sterile Preparations, <1075> Good Compounding Practices and <1160> Pharmaceutical Calculations in Prescription Compounding. Other activities include the preparation of new compounding monographs with associated stability studies conducted by the USP Research and Development Laboratories. Among other topics to be considered include revisions and updates of the new USP-Pharmacists' Pharmacopeia, evaluation of all the USP General Chapters for their impact on compounding pharmacy, and activities related to veterinary compounding and compounding materials resources.

All in all, this 5-year cycle is shaping up to be very active and productive.

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

• 882 Formulas
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Pharmacists from around the world talked on the International Journal of Pharmaceutical Compounding's network this week about the following topics:

• Rapid dissolving tablet formulations
• Locating compounding pharmacists in the UK, South Africa, and Portugal for patients going to those countries.
• The difference and benefits between and EMP and an Ointment Mill.

Join the this network today! It's FREE and a great source of information. Click here to start receiving Network emails http://compoundingtoday.com/CNL/.

Doing sterile compounding? Sign up for the free online or print publication "Cleanrooms" at www.cleanrooms.com. Although the primary emphasis is industry, there is a lot of valuable information for compounding pharmacists.

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

Motions for Reconsideration and Replies Filed with Kentucky Federal Court
In April, Judge Forester of the Kentucky federal court case involving BET Pharm, LLC announced that the March 23rd decision on BET's motion to dismiss a FDA complaint against the pharmacy would be reconsidered. The decision in question, which denied BET's motion to dismiss, reflected significant confusion on law and policy applicable to compounding, as it repeatedly cited FDAMA Section 503(A) as if that section of law were current and applicable. In June, both the government and BET filed motions for reconsideration with the court. On July 11, the parties filed respective response briefs. The court can be expected to issue a revised decision on BET's motion to dismiss shortly. View copies of the briefs here.

Senate Announces Floor Vote on Crawford Nomination
In mid-February, Acting FDA Commissioner Lester Crawford was nominated to permanently fill the post of FDA Commissioner. The confirmation process for this nomination has been ongoing and has encountered several delays. On July 13, Senate leadership announced their intention to hold a full Senate vote on Crawford's nomination before Congress' August recess; however further delays in the confirmation are possible.

Flow Sciences, Inc. (FSI) has been awarded a patent for its innovative invention of the Lateral Flow Robotic Enclosure for enclosing automated instrumentation. The lateral flow biohazard safety enclosure is a totally enclosed workstation in which HEPA filtered air enters the chamber, and is drawn horizontally across the work area and through another HEPA filter at the other end of the chamber wall.

"Today's pharmaceutical laboratories have changed significantly. We can't emphasize enough the importance of effective vendor/client communication in delivering task-specific, process-driven, containment solutions for modern pharmaceutical laboratories." stated Dr. Doug Walters, an independent consultant specializing in Laboratory Health and Safety and Laboratory Ventilation.

Flow Sciences, Inc. (FSI) designs and manufactures containment solutions for Research and Development Laboratories, Pilot Plants, and Laboratory Automation Equipment and Robotics where toxic or noxious potent powders, fluids, aerosols, and gases require safe handling while weighing, handling, mixing, and manufacturing.

For more information please visit www.flowsciences.com or call Steve Janz at 910.763.1717.

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