Editorial: Quality Improvement in Pharmaceutical Compounding

One does not have to look very far to see the improvements that have occurred related to quality in pharmaceutical compounding over the past 20 years. In fact, the improvement and enhanced standards have come about much more rapidly than they did in pharmaceutical manufacturing in the mid-1900s! Let's briefly look at some of the improvements that have been made.

First, the United States Pharmacopeial Convention (USP) has been at work in setting standards for compounding. Currently, there are three primary chapters in the United States Pharmacopeia (USP) that specifically address compounding standards and about fifty others that contain standards that can apply to compounding in some form. The three primary chapters are:

USP <795> Pharmaceutical Compounding-Nonsterile Preparations
USP <797> Pharmaceutical Compounding-Sterile Preparations
USP <1163> Quality Assurance in Pharmaceutical Compounding

In addition, the USP Pharmacists' Pharmacopeia is preparing for its third edition.

Second, most individual state Boards of Pharmacy are either incorporating USP by reference, rewriting their pharmacy practice laws to address pharmacy compounding, or considering other options related to compounding.

Third, the Pharmacy Compounding Accreditation Board (PCAB) is becoming more firmly established as an accrediting body for those pharmacies that seek accreditation of their compounding pharmacy practice.

Fourth, the International Journal of Pharmaceutical Compounding, Inc. was established in 1997 for the purpose of enhancing quality pharmaceutical compounding through their publication, the International Journal of Pharmaceutical Compounding (IJPC). Now in its 14th year of publication and distribution throughout the world, it now has the largest documented database of compounding information that is accessible to compounding pharmacists worldwide.

Fifth, numerous other journals publish articles, including stability studies, etc., that are valuable in ensuring quality compounding.

Sixth, there are numerous pharmacy compounding support companies of all types whose goal is to provide information, equipment, supplies, training, etc. to compounding pharmacists.

Seventh, there are a number of high-quality analytical laboratories that provide services to compounding pharmacists for potency, sterility, endotoxin, and stability testing. More and more pharmacists are having their compounded preparations tested routinely.

Eighth, a number of stability studies have been accomplished by the USP, individual pharmacists, pharmacy groups, and independent laboratories, where the information is used in establishing valid beyond-use-dates for compounded medications.

Ninth, there are pharmaceutical organizations supporting quality pharmaceutical compounding by offering seminars, training sessions, books, and other materials for training purposes.

Yes, the past 20 years have seen tremendous growth in resolving quality concerns in pharmaceutical compounding. We will continue to see growth in this area, as the goal of compounding pharmacists is to do a quality job in providing medications to individual patients.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Foreign Firms Take Slight Collective Lead for Second Straight Year Despite Substantial Individual Gains by U.S. Firms in Number of Patents Issued
Foreign companies collectively captured a slight majority of new U.S. patents awarded to corporations by the U.S. Patent and Trademark Office for the second straight year. According to an annual corporate ranking, U.S. corporations garnered 49 percent of all U.S. utility patents issued in 2009 with the remainder going to foreign firms. This is only the second time that foreign companies collectively received more U.S. patents than U.S.-based firms. Innovation in American firms is far from declining, however, because many firms had impressive gains and several posted record numbers of total new patents. Overall, U.S. companies received approximately 7 percent more utility patents in 2009 than in 2008, compared to 6.5 percent by foreign companies. The U.S. also received more than twice as many corporate patents than Japan (23%) which was the country with the second most U.S. patents issued in 2009. This was followed by South Korea (5.6%) in third place displacing Germany (5.2%) for the first time. http://www.ificlaims.com

Foreign Manufacturers Inspections Could Rise by 50%
The number of inspections of foreign manufacturers carried out by the FDA this year could rise by 50%. This year, the Agency is expected to visit more facilities, particularly in China, India, and Mexico.

Considerable resources have been spent into opening offices abroad over the past two years after a Government Accountability Office (GAO) report revealed, in January 2008, that the agency had inspected relatively few foreign manufacturers; the least inspected major country was China.

The GAO report set into motion events at FDA leading to opening 10 international offices, the first of which was in China, followed by offices in India and Europe. Most recently, on December 15 2009, the FDA opened an office in Mexico City.
http://www.clinica.co.uk/policyregulation/regulation/FDA-foreign-inspections-may-go-up-by-50-this-year-187527

Traditional Medicine
Kayne SB, ed.
London, UK: Pharmaceutical Press; 2010
Paperback; 320 pages; $59.99

This is a very interesting book to read! Much of this book can be used to better understand why the majority of people living in "developing countries" continue to use traditional medicine. With immigration into the U.S., it means that health professionals may come into contact with the patients involved. This book covers (1) traditional European folk medicine, (2) Aboriginal/traditional medicine in North America, (3) traditional medicine in the Colombian Amazon Tropical forest, (4) traditional medical practice in Africa, (5) traditional Chinese medicine, (6) Indian Ayurvedic medicine, (7) traditional medicines in the Pacific, and (8) traditional Jewish medicine. Each section provides information on the history, philosophy, methods of practice, safety issues, evidence, and examples of the medicines. A "must read" for those practitioners working in a multicultural society involving patients using traditional medicines.

USP General Chapter <1163> Quality Assurance in Pharmaceutical Compounding is posted for public comment on the USP website. Go to www.usp.org/USPNF/pf/1163comments.html to review this chapter. This new chapter has been stated to be one of USP's greatest contributions of the past decade.

Baby, It's Cold Outside

Don't forget the weather extremes (very cold temperatures) when shipping prescriptions to your patients. This is especially important for liquids (suspensions, emulsions, etc.) as some of them should not be allowed to freeze.