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May 23, 2008 Volume 5, Issue 20
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Trissel's 2 Clinical Pharmaceutics Database from Compounding Today
Spectrum Pharmacy Products for USP <797> Compliance
  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: Made in the USA

Those words bring a sense of pride in the nation we live in! However, as mentioned in previous columns, fewer and fewer items of commerce are "Made in the USA"!

When we were kids, it was mostly toys that were labeled "Made in China." Today, most items of commerce are "Made in ?????" (not the USA). In fact, even a $100 million memorial that is largely being built with private donations by the Martin Luther King Jr. National Memorial Project Foundation, has selected a Chinese sculptor in China to create the monumental work of figures and other elements of the memorial in China.

Obviously, China has very talented and accomplished artists and workers. However, does this mean that in the U.S. there was not anyone capable of producing the $100 million memorial? I seriously doubt that! This means that a large amount of money is again leaving the U.S. that could have been used to employ numerous individuals in a worthy project.

This is only one additional example of the issue discussed two weeks ago in this newsletter. It seems fruitless to complain about unemployment, low wages, and high taxes, when we are sending so much money outside the country.

For most of us, we can realistically only affect our "little corner where we live." However, if we purchase items "Made in the USA" then we are supporting jobs (that pay taxes), keeping the unemployment low, helping to remove individuals from welfare to productive lives, and we all benefit.

What can be done to encourage the large pharmaceutical company executives that make millions of dollars (and are selling the U.S. out) to bring back home the complete production of drug products (from synthesis to final product manufacturing)? Incidentally, the oil companies should be doing the same thing! It was quite interesting to hear the oil companies testifying before Congress claim that they weren't actually making money with the high prices and exorbitant products; they said they were reinvesting it all.

We don't need to be isolationists; but we do need to be independent and be able to stand on our own two feet and depend upon ourselves.


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

Personal Note:

The editor and his family wish to express their sincere gratitude to the outpouring of expressions of sympathy from all over the world in the loss of one of our son-in-law and grandson. Your sympathies are deeply appreciated and will be long remembered.

Loyd and Margaret Allen

 
Other News

Protest Planned
Several healthcare groups are planning to stage coast-to-coast demonstrations on May 30. These groups are angry because an FDA Panel voted 17 to 0 to approve Provenge, but the FDA did not give the go-ahead for its release. As a result, the groups say 27,000 men have died from prostate cancer to date. The groups are seeking more transparency from the FDA.
http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=516955

Responsible DTC Advertising
Pharmaceutical companies need to be more responsible in touting their products to consumers or else face tighter controls from Congress, said the head of the U.S. House of Representatives Energy and Commerce investigative panel, Rep. Bart Stupak. A GAO report said that the FDA has made little or no progress in improving its oversight of direct-to-consumer advertising.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1777269&contentType=sentryarticle&channelID=33

Drugmakers Urged to Reduce Ads
Reps. Dingle and Stupak called on Pfizer, Johnson & Johnson, Merck & Co., and Schering-Plough Corp to voluntarily limit their DTC advertisements and hold off on marketing their products until certain studies are finalized, particularly for cholesterol drugs Lipitor and Vytorin.
http://news.yahoo.com/s/nm/20080520/hl_nm/congress_drugs_ads_dc

More than 11,000 Pharmacies to Close?
Medicaid cuts could force more than 11,000 pharmacies to close, according to an economic impact study of the Deficit Reduction Act of 2005, because of reductions in the Medicaid reimbursement rate which is well below the cost to fill prescriptions.
http://ncpa.yellowbrix.com/pages/ncpa/Story.nsp?story_id=117541688

More on "Preemption"
Committee on Oversight and Government Reform Chairman Henry Waxman (R-CA) pointed out that the FDA approval of drugs and high-risk medical devices before they are marketed does not necessarily guarantee safety. Any patient harmed by these products can seek compensation under state law for damages such as medical expenses and lost wages. The hearing, therefore, examined the implications of FDA's preemption of state liability laws. He called preemption a "radical legal doctrine being advocated by the pharmaceutical and device industries" and said the threat of liability itself is an incentive for safety.

The Supremacy Clause of the U.S. Constitution (Article VI, clause 2) establishes the legal basis for federal preemption of state law, including "express preemption" in which federal laws are explicitly precluding state and local regulations in a particular area as well as various.
http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=518102

McKesson Charged with Overpricing Drugs to the Poor
The city of San Francisco has filed suit against McKesson charging that it conspired with First DataBank to inflate prices of more than 400 drugs since 2001 in the cities health program for the poor.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/05/20/BUBB10PM81.DTL

 
Did You Know?

Cancer patients can fly free in the empty seats on corporate jets. Have your patients call the Corporate Angel Network at 914-328-1313

 
USP <797> Resource Directory: Compounding Aseptic Containment Isolators
CompanyWebsite
Gallipot, Inc.www.gallipot.com
ISO Tech Designwww.isotechdesign.com
MEDISCAwww.medisca.com
PCCAwww.pccarx.com
Spectrum Pharmacy Productswww.spectrumrx.com

IJPC supplies this list of providers of products required to remain USP Chapter <797> compliant as a service to our readers. We strongly urge you to support our current advertisers and supporters. In next week's newsletter, the resource directory will feature facility design.

Thus far, our newsletters have featured the following products:

Newsletter DateProduct Featured
January 25, 2008Sterile 70% isopropyl alcohol
February 1, 2008Sterile powder-free gloves
February 8, 2008Gowns, body coverings
February 15, 2008Shoe covering, hair coverings
February 22, 2008Face masks, eye shields
February 29, 2008Waterless alcohol-based surgical hand cleaner
March 7, 2008Lint-free wipes-nonshedding
March 14, 2008Cleaners/disinfectants
March 21, 2008Cleanroom mopping systems
March 28, 2008Tacky mats
April 4, 2008Temperature/humidity monitoring devices
April 11, 2008Microbial air sampling devices
April 18, 2008Air sampling devices
April 25, 2008Sterility testing kits
May 2, 2008Endotoxin testing kits
May 9, 2008Laminar airflow workbenches
 
Compounding Tip of the Week

Encapsulating Capsules
Two drugs with different characteristics can be placed into a "capsule within a capsule" surrounded by a media that can enhance their dissolution. As an example, an oil-soluble drug can be dissolved in oil and filled into a #3 or smaller capsule. This capsule can be placed inside a #1 or #0 capsule, and the second drug can be mixed with molten PEG 3350 and poured inside this second capsule. Upon cooling, the capsule can be locked and even sealed, if needed.

RxTriad - The most valuable marketing tool available for compounding pharmacist.
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