Editorial: "Compounding Around the World"

On October 11, 2008 in Tampa, Florida in conjunction with the NCPA Annual Meeting, the International Society of Pharmaceutical Compounding (headquartered in Madrid) will present its second "Compounding Around the World" program partially sponsored by IJPC. The first program was held in Salvatore Bahia Brazil last year in conjunction with the International Federation of Pharmacists meeting.

This year's program has outstanding speakers from Spain, Argentina, Puerto Rico, Portugal, Africa, Belgium, and Germany. The program is offered without charge to participants.

As will be evident, compounding differs from country to country and there is something to be learned from each speaker. This is also an opportunity to visit one-on-one with pharmacists from other parts of the world and discuss their problems and opportunities. Also, the organizations differ from country to country. Compounding differs as some countries are more limited and some are more open to various types of compounding. Some countries can do small scale manufacturing and some have unique arrangements with their physicians and patients.

Governmental control varies as well as the acceptance and utilization of compounding services in patient care. Financial aspects vary significantly between countries as well as methods of ownership of pharmacies.

Each speaker is being requested to address the following (1) Who regulates compounding in your country? (2) What are some difficulties you have with regulatory agencies regarding compounding? (3) What are you allowed to compound? (4) What are you not allowed to compound? (5) How would you describe your compounding pharmacy (with photos)? (6) What is some of the unique equipment you commonly use? (7) Can you compound or manufacture large quantities to provide to other pharmacies? (8) How do you assign beyond-use dates, or expiration dates, to your compounded preparations? (9) What do you think is unique about the way compounding is done in your country? (10) Do all pharmacists have the ability to compound? or does it take additional special training? (11) Are you allowed to compound nonprescription medications for sale? (12) What dosage forms do you normally compound? (13) What unique dosage forms do you compound? (14) Do you compound sterile dosage forms? If so, which ones? (15) For which therapeutic categories do you compound? (16) Is there any other information you would like to share with compounding pharmacists around the world about compounding in your country?

It will be a very educational and enjoyable program. Please plan to attend.

Loyd V. Allen, Jr., PhD, RPh

Faked Test Records by India's Ranbaxy Laboratories
An investigation is ongoing at Ranbaxy Laboratories by federal prosecutors for allegedly falsifying records that resulted in the production and sale of generic medicines in the U.S. that did not meet U.S. quality standards. Prosecutors allege that Ranbaxy officials fabricated test data and attempted to conceal the activity from FDA inspectors.
http://www.bloomberg.com/apps/news?pid=20601087&sid=aOHkSFq6r13s&refer=home

In a related story, Ranbaxy Laboratories is under federal investigation due to allegations they have been producing substandard generic medicines, including HIV drugs manufactured under the President's Emergency Plan for AIDS Relief that were distributed to patients in Africa.
http://online.wsj.com/article/SB121609257983253725.html?mod=dist_smartbrief

The American Psychiatric Association has been ordered to submit documents as part of an inquiry into whether financial ties with drugmakers have influenced the group's viewpoints and actions.
http://www.nytimes.com/2008/07/12/washington/12psych.html?_r=2&ref=health

A scientist at NIH has been criticized for not revealing a conflict of interest in a journal paper he wrote about such products being linked to a higher risk of heart attack and death. He also said he forgot that his name is on a pending patent for a technology that is developed to decrease the toxicity of blood substitutes.
http://online.wsj.com/article/SB121598988902149353.html?mod=dist_smartbrief

The Massachusetts House panel has removed from a bill the requirement banning gifts from drugmakers to physicians as well as requiring disclosure of consulting and speakers fees. They would, instead, require the companies to follow a voluntary code of conduct regarding these marketing practices. Fines were also dropped from the proposed bill. http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1810433&contentType=sentryarticle&channelID=33

We have added six new Standard Operating Procedures to www.CompoundingToday.com, as follows:

More to come next week.

Buy only 100% gasoline for better gas mileage
Renewable fuel standard requires that 36 billion gallons of biofuels be mixed into gasoline by 2022. However, if one monitors their miles per gallon when using 10% ethanol, you will note that you probably don't get the same miles per gallon as when using 100% gasoline. With the high cost of producing biofuels and its adverse impact on the price of food, this appears to be an ill-advised law that needs to be repealed. Why spend more to get less?