USP-Part 3: Resolutions of the 2005 USP Convention

There were 13 resolutions that were passed at the recent USP Convention. These will be presented this week and over the next two weeks to provide everyone with information concerning some of the activities of the USP over this next 2005-2010 cycle. It is important to understand the USP and its procedures since pharmacy practice is becoming a more significant part of USP life.

RESOLUTION: PUBLIC MONOGRAPHS AND REFERENCE MATERIALS
USP resolves to work with appropriate stakeholders to contribute to the public health and patient care by eliminating barriers to expanding and updating public monographs in USP-NF and, if needed, developing reference materials for all legally marketed therapeutic products in the U.S.
This resolution is aimed at increasing the number of monographs contained in the USP. Even though USP 28 NF 23 has over 4,000 monographs, there are still about 2,000 monographs that need to be developed and about 800-1000 of the current monographs need to be updated for currently marketed manufactured drug products.

RESOLUTION; INTEGRITY AND SAFETY OF THERAPEUTIC PRODUCTS
USP resolves to work with stakeholders to continue to develop packaging, shipping, distribution, and storage standards and practices that ensure the integrity and safety of all therapeutic products through the distribution and dispensing system. USP further resolves to support educational and allied activities at all levels of distribution, dispensing, and administration (manufacturer through patient) concerning the integrity and safety of therapeutic products.
Although much has been accomplished during the past 10 years in packaging, shipping, distribution and storage, much work remains to be done to shore up the general chapters and allied monographs to ensure the quality standards of drugs throughout the drug distribution channel.

RESOLUTION: NEW SCIENCE AND TECHNOLOGY
USP resolves to work with appropriate stakeholders to track emerging sciences and technologies, and when appropriate, to develop information, best practices, and standards that have direct applications to the public health and patient care.
The development of new technologies is accelerating and they are having an impact on the healthcare industry as well as on patients and regulatory agencies. These technologies include new analytical and bioanalytical techniques, process analytical technologies, gene and cell therapy and tissue engineering, biotechnology, genomics, proteomics and metabolomics and nanotechnology. Monitoring these new technologies and their impact on USP standards is important in the standards-setting responsibility of the USP.

RESOLUTION: COMPOUNDING STANDARDS AND EDUCATION
USP resolves to expand its work with appropriate parties involved in compounding, including practitioners, FDA, state boards of pharmacy, and other regulatory authorities, to support and disseminate information about science-based compounding practice.
This resolution involves an expansion of the standards setting responsibility of the USP in the compounding area. Potential efforts may include (1) standards for compounding procedures, processes and documentation, (2) monographs for compounded preparations, including standards for analysis, and (3) educational resources for practitioners, schools of medicine, pharmacy, and veterinary medicine in the area of compounding. The work of USP will be done in conjunction with the PCAB, NABP, Colleges of Pharmacy and State Pharmacy Associations to further advance standards for compounded preparations.

Next week, we will continue with a presentation of the USP Resolutions.

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

Compoundingtoday.com is equipping the compounding pharmacists with Standard Operating Procedures. We're the only source of compounding SOPs that can be downloaded and customized for your pharmacy needs. Ten new ones were added to the 245 SOPs already available at CT.com. The new ones include:

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There are several places you can obtain drug shortage information on the Internet but here is a quick and easy reference of the most recent drugs posted in the short supply category.

For more information and an extensive list of every drug in short supply, see:
http://www.fda.gov/cder/drug/shortages/default.htm#Current
http://www.ashp.org/shortage/index.cfm

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• Apfel CC, Korttila K, Abdalla M et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 2004p 350(24): 2441-2451.
• Bergasa NV. Treatment of the pruritus of cholestasis. Curr Treat Options Gastroenterol 2004; 7(6): 501-508.
• Candelli M, Nista EC, Carloni E et al. Treatment of H. pylori infection: A review. Curr Med Chem 2005; 12(4): 375-384.
• Greaves MW, Khalifa N. Itch: More than skin deep. Int Arch Allergy Immunol 2004; 35(2): 166-172.
• Howden CW. Management of acid-related disorders in patients with dysphagia. Am J Med 2004; 117(Suppl 5A): 44S-48S.

Here is what compounders discussed this week on the International Journal of Pharmaceutical Compounding's Network:

• I have a patient who is allergic to NSAIDS. What other transdermal medications are you all using for arthritis other than NSAIDS?
• Discussion of the pH and stability of procainamide solution in different vehicles.
• The availability of methotrexate powder and the injectable commercial product.

The International Academy of Compounding Pharmacists provided this regulatory update

USP Updates Chapter <1160>
This week, the United States Pharmacopeia (USP) published revisions to Chapter <1160>, "Pharmaceutical Calculations in Prescription Compounding." The revisions were published in PF 31(3). USP will be accepting comments on the proposed revisions. Please contact Jennifer at IACP if you are interested in reviewing and providing feedback on the proposed revisions.

Featuring comprehensive review of compounding, General Chapter <797> Pharmaceutical Compounding Sterile Preparation and more...
Co-sponsored by the University of Wisconsin, a USP Pharmacy Continuing Education Program

May 19-20, 2005 Workshop
Hilton Charleston Harbor Resort & Marina
Charleston, SC
Registration Deadline: May 11, 2005
For more information, visit http://www.usp.org/education/workshops/pharmacy.html

Lois A. Witkop
Director, Program Marketing
US Pharmacopeia
301.816.8228
301.816.8236 (fax)
law@usp.org