Brought to you by the International Journal of Pharmaceutical Compounding
September 1, 2006 Volume 3, Issue 35
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Quality Assurance Seminar
  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editorial: Federation of International Pharmacists (FIP) and the International Society of Pharmacy Compounding (ISPhC) Meetings in Brazil

With participants from more than 15 different countries, the meetings in Salvador, Bahia, Brazil were great. The first meeting was a full-house, pre-FIP meeting and was cosponsored by Anfarmag, the professional association of pharmacists in Brazil. The program discussed pharmaceutical compounding (nonsterile and sterile), pediatric, dermatological, odontological, podiatric and diabetic foot compounding, compounding with opioids, and quality assurance.

The session at the FIP meeting in the Community Pharmacy Section, sponsored with Fagron, located in Europe, discussed compounding around the world and included topics on the role of compounded medicines in therapy, and compounding in Brazil, in the US, in Portugal, in Argentina, in Spain, in Belgium, and other countries. The sessions were scheduled to end at 5:00 P.M., but there were so many questions that we were there until 6:30 P.M. It was a great time of sharing about compounding.

Many topics, which can have a direct impact on compounding in the US, were covered and many opportunities presented that can be incorporated into compounding in the US. More on some of these later.

It was also interesting that many of the concerns in other countries are the same as in the US, including reimbursement issues, governmental control, quality assurance, manufacturers' intrusion into the compounding relationship between physician, patient and pharmacist, and official formularies.

There was a surprise visit by Dr. Roger Williams, CEO and Executive Vice President of the United States Pharmacopeia (USP), who attended our session for a couple of hours. Dr. Williams is very well versed in compounding, and, after he was introduced, fielded many questions and made a number of very positive, supportive statements concerning USP and compounding throughout the world.

Although the FIP meeting had a full schedule, this editor had the opportunity to visit a couple of compounding-only Brazilian pharmacies that are state-of-the-art pharmacies that compound approximately 500 to 1,000 prescriptions per day, with associated documentation, etc. The pharmacies are computer-based, extremely attractive, and, as indicated, are very busy.

Salvador, Bahia, Brazil is a great tourist site with very white, sandy beaches and great, year-round weather of 70 to 80 during the day and 60 to 70 at night.

It was a great trip for compounding pharmacists from around the world and a good look toward the future. FIP will be in Beijing, China next year, and, in 2008, will be in Basel, Switzerland. The US had a large number of participants in the meeting, and you might want to think about a travel opportunity combined with professional continuing education for the future. I generally learn enough from each of these trips to pay for the trip and enjoy doing it at the same time.

Compounding pharmacy is truly a world-wide profession, and we can all learn from each other to make our practices better.


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

 
Regulatory Update

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

Compounding Victory: Federal Court Issues Written Ruling that Compounded Medicines are Legal!
Consistent with his oral ruling in May, U.S. District Court Judge Robert Junell issued a written order yesterday stating that compounding is legal. He went further to rule that the Food and Drug Administration does not have authority to inspect a pharmacy's records if that pharmacy complies with applicable state laws and operates as a retail pharmacy. He also ruled in our favor that it is legal to compound from bulk pharmaceutical ingredients for nonfood animals. This is a tremendous victory for patients, prescribers, and our profession!

We owe the Midland Coalition a debt of gratitude for fighting this fight. Their dedication and Hance Scarborough's winning strategy carried the day.

Whether the next forum is in the appellate court or the halls of Congress, we will continue to fight for your right to compound.


Sincerely,
International Academy of Compounding Pharmacists (IACP)

Click here to view IACP's press release about the decision.
Click here to view a copy of the court's decision.

 
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Upcoming Issues of International Journal of Pharmaceutical Compounding

Approximately 24 million individuals in the US alone are affected by migraines. To assist migraine sufferers in their efforts to find relief from the pain and reduce the occurrence of migraines, compounding pharmacists should be aware of the clinical features of migraine and the treatment options that can be offered to the sufferers. IJPC's September/October 2006 (Pages 344 through 351) issue includes an article titled "Migraine: A General Approach to Prevention and Treatment." The article contains important facts about migraine, provides common side effects of various migraine treatment options and selected compounded treatment options for migraine, and is accompanied by a case report containing a suggested formula.

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

 
Press Release

Two-Day Seminar Helping You Develop A Quality Compounding Practice That Meets and Exceeds USP Standards

When: September 16 & 17, 2006
Where: PHF Conference Center, 655 Research Parkway, Oklahoma City, Oklahoma 73104
Featured Speakers: Thomas Kupiec, PhD; Loyd V. Allen, Jr., PhD, RPh; and Kenneth R. Baker, RPh, JD

Click Here for more Information: www.spectrumrx.com/SpectrumRx/events/QAseminar.asp

 
Compounding Tip of the Week

Maximum Security for your Computer
Well, it's here. The latest wireless technology allows you to prevent anyone from using your computer except you. The latest issue of PC Magazine (September 5, 2006: 95-99) describes how you can modify a MicroSoft Natural Elite keyboard, install a USB hub inside the keyboard along with a Radio Frequency Identification reader and you are all set. Well, not quite. The next step is to prepare a small RFID implant containing a very simple EM4102 125 kHz tag with a unique ID. This is encased in a small glass cylinder 13 mm long by 3 mm in diameter or smaller. It is sterilized in disinfectant and then can be implanted by a surgeon just beneath the skin (usually in the hand). After a device driver is installed and the system started and installed, then you bring your RFID-tagged hand to within 4 inches of the reader and you are authenticated and can use the computer.

Believe it or not, this is a "do-it-yourself" system�for now. May not be long until it is standard. Remind you of anything?

RxTriad
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