Editorial: Contemporary Topics in Pharmaceutical Compounding

Sometimes it's interesting to just sit back and think of all the factors that affect pharmaceutical compounding and what some of the hot topics are. I thought I would just list a few and then we can address some of them over the next several months as time and space allows. Some of these topics will be addressed by the USP committees on compounding. The first meeting of the new committees occurs this week (Thursday and Friday, July 7 and 8, 2005). Through this column, we will also try to keep everyone informed of the activities of the committees. Now, back to some of the topics that are often brought up at meetings involving compounding pharmacists.

• Accreditation
• Beyond-Use dates
• Bioavailability/Bioequivalence
• Bulk drug substances
• Categories of pharmaceutical compounding
• Certification
• Compliance policy guidelines-FDA
• Compounding vs manufacturing: not crossing the line
• Discontinued drugs: a compounding opportunity
• Drug shortages
• Education and training
• Endotoxin testing
• Expiration dates on chemicals
• Evidenced based clinical reports using compounded preparations
• Formulations for compounding
• Good compounding practices
• Label and Off-label use of medications
• Laboratories, analytical
• Mail order compounding pharmacies
• Nonprescription drug compounding
• Nonsterile vs sterile preparations compounding
• Office use compounding
• Patents and patenting
• Pharmacogenomics
• Quality assurance: How much is enough?
• Reimbursement
• Reporting adverse drug events
• Reporting codes
• Safety comparison of commercial products and compounded preparations
• Sourcing drugs/chemicals used in compounding
• Stability issues regarding compounding
• Standard Operating Procedures
• State to state variability in pharmacy regulations
• Sterility testing
• Technicians
• Testing
• USP-Pharmacists' Pharmacopeia

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

Rockville, Md., July 5, 2005 - The U.S. Pharmacopeia (USP) released today the USP Pharmacists' Pharmacopeia for practicing pharmacists. Adapted from the U.S. Pharmacopeia-National Formulary (USP-NF), the USP Pharmacists' Pharmacopeia contains monographs and general chapters as well as references for compounding specifications and general legal information that meets the unique needs of practicing pharmacists.

"The USP Pharmacists' Pharmacopeia is reminiscent of the original text of the USP-NF, which consisted essentially of a compendium of recipes for drugs," said Roger L. Williams, M.D., USP executive vice president and chief executive officer. "Pharmacists play a critical role in ensuring the safety of medicines, and this publication is intended to better serve the interests and needs of practicing pharmacists."

Leading pharmacy experts contributed to the comprehensive and critical information contained in the 2005 edition of the USP Pharmacists' Pharmacopeia. Contents include:

• Extracts from USP 28-NF 23, including General Chapter <797> Pharmaceutical Compounding - Sterile Preparations;
• Official standards and guidelines on compounding, packaging, and storage of pharmaceutical preparations;
• Official monographs from USP 28-NF 23, abridged for pharmacy practitioners;
• Comprehensive information on compounding from pharmacy experts;
• Information and resources to help reduce medication errors and enhance patient safety,
• Legal statutes and regulatory information; and,
• Other reference information relevant to pharmacy practice.

"The USP Pharmacists' Pharmacopeia will provide compounding pharmacists with a needed and useful reference designed specifically for their practice," said Kenneth R. Baker, R.Ph., J.D., executive director, Pharmacy Compounding Accreditation Board. "It is likely to become one of the premier publications in every pharmacy."

The publication was formally unveiled at the International Association of Compounding Pharmacists (IACP) Conference June 5-7 in Washington, D.C., and at the American Society of Health-System Pharmacists (ASHP) Summer Meeting in Boston June 11-15.

There will be three supplements for the first edition of the USP Pharmacists' Pharmacopeia, to be published on Nov. 1, 2005 (official on Jan. 1, 2006); Feb. 1, 2006 (official on April 1, 2006); and June 1, 2006 (official on Aug. 1, 2006). The next edition will be released on Nov. 1, 2006, and will become official on Jan. 1, 2007. Updates to USP-NF will automatically transfer to the USP Pharmacists' Pharmacopeia in subsequent supplements and editions.

An online version of the publication will be available in November 2005. Pharmacists and others will be able to order the publication through USP customer service at 1-800-227-8772 as well as from numerous partners via the Web, including the American Society of Healthsystem Pharmacists at www.ashp.org, the American Pharmacists Association at www.pharmacist.com, and the National Home Infusion Association at www.nhianet.org

CONTACT: Sherrie Borden
301/816-8268; slb@usp.org

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

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