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May 11, 2012 Volume 9, Issue 19
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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: United States Pharmacopeia 101, Part VII

This is the seventh in the series on the United States Pharmacopeia, actually the United States Pharmacopeia-National Formulary. In this part, we will begin our discussion of the National Formulary.

The name of the "First Issue" of the National Formulary was "The National Formulary of Unofficinal Preparations," and it was published by the authority of the American Pharmaceutical Association (APhA), in 1888. (Yes, the word is "Unofficinal.") The Preface contains the following:

It is well known that the remedies for which the Pharmacopoeia prescribes definite standards, constitute only a limited portion of the resources of the medical profession in the treatment of the sick. Without referring to the more ephemeral preparations, or to such as are of a proprietary character, or are used by the public for self-medication, there are a large number of others, which are more or less frequently prescribed by physicians, or demanded by the public, but which are not recognized by the Pharmacopoeia, either because they were not deemed by the revisers to be of sufficient importance to be included in the official work, or because they originated subsequently to the appearance of the work, or for other reasons. Owing to the absence of an authoritative standard, many of these unofficial preparations have been, and are being made, after different formulae and in varying strength, so that the pharmacists, particularly in the larger cities, are compelled to procure and keep on hand a variety of brands of what is intended to be one and the same preparation, to satisfy the demands of their patrons, professional or otherwise. The evils arising from this condition of things are so well known and so far-reaching in their results, that there is no need of any argument in favor of a plan which may palliate the existing evil, chiefly caused by a lack of uniformity, or the want of a common standard.

At the Annual Meeting, in Pittsburgh, in 1885, a Committee representing the College of Pharmacy of the City of New York, the Kings County Pharmaceutical Society of Brooklyn, and the German Apothecaries' Society of the City of New York presented a book of formulas they had published a few years earlier. This book had been widely accepted and used and was provided to the APhA as a nucleus for the construction of a National Formulary. At the next Annual Meeting in Providence in 1886, a "Preliminary Draft of a National Formulary" was presented and the committee was expanded to include the addition of one member from every State Pharmaceutical Association in the U.S. and Canada. Despite the difficulties of travel, terminology, professional considerations, metrology, etc., they completed the difficult task with the publication of the National Formulary in 1888. They stated that their work is turned over to the public and expressed the hope that it will be accepted as a standard and guide and would be made more perfect and complete in future revisions and that changes be sent to the Secretary of the American Pharmaceutical Association, or to any Formulary Committee that may be later appointed.

Next week, we will continue with our discussion of the National Formulary.


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

 
News

Testosterone Hormone Replacement Therapy May Help Male Weight Loss
Older obese men could shift excess weight by taking testosterone supplements, suggest findings announced at the European Congress on Obesity. A study reported that hormone-deficient men who were given testosterone supplements in a similar way to hormone replacement therapy for older women lost an average of 16 kg over five years when testosterone levels were increased back to normal. Experts warn that supplements may not be the answer because of the possibility of prostate cancer and heart disease. The study also suggested that increasing testosterone levels could reduce waist circumference and blood pressure.
http://www.bbc.co.uk/news/health-17992440

Doxil Rationing Program Expanding
J&J will soon be allowing new patients to enroll in a rationing program to receive the cancer drug Doxil; this is because some of the limited, remaining supply has been freed up. About 1,000 patients are now receiving Doxil. The Doxil shortage was caused by problems at the Ohio plant of a contract manufacturer, Boehringer Ingelheim GmbH's Ben Venue Laboratories unit, which makes Doxil for J&J.
http://www.foxbusiness.com/news/2012/05/09/jj-opens-doxil-rationing-program-to-new-patients/

Drug Regulator in India Accused of Corruption and Collusion
The Central Drugs Standard Control Organization which oversees clinical trials and India's 10,000 manufacturers, approved medicines from companies including Novartis AG , GlaxoSmithKline, and Mumbai-based Cipla without the required appropriate clinical trials. Drugs were also found that were banned in the U.S., Europe, and most developed countries because of their adverse side effects but had been approved for sale in India.
http://www.bloomberg.com/news/2012-05-10/indian-drug-regulator-accused-of-corruption-and-collusion.html

Nanoparticle Drug Delivery Shows Potential to Revive Abandoned Cancer Drug
A nanoparticle formulation of wortmannin has shown to have decreased toxicity and increased stability, solubility, and effectiveness of the drug in the treatment of cancer. Additionally, nanoparticle wortmannin can improve the efficacy of radiotherapy dramatically and is more effective than the most commonly utilized chemotherapeutics. Wortmannin is a highly promising cancer drug, but its successful preclinical studies did not translate into clinical efficacy because of challenges such as high toxicity, low stability, and low solubility (unable to be dissolved in blood).
http://www.fiercedrugdelivery.com/press-releases/unc-study-shows-potential-revive-abandoned-cancer-drug-nanoparticle-drug-de?utm_medium=nl&utm_source=internal

"Pink Slime" Crusade Forces Beef Plant Closures
Beef Products Inc will close plants on May 25 in Amarillo, Texas; Garden City, Kansas; and Waterloo, Iowa. About 650 people will lose their jobs when the plants close. This is a direct result of all the misinformation about our lean beef. Iowa Governor Terry Branstad on Monday called the closings a "sad day for the state of Iowa." "The fact that a false, misleading smear campaign can destroy a company's reputation overnight should disturb us all," Branstad said in a statement. The beef product was considered safe by the FDA.
http://www.cnbc.com/id/47331619

17 Studies Say Zinc May Shorten Common Colds in Adults
Data was analyzed from 17 studies, involving 2,121 people who had been randomly assigned to take zinc or a placebo within three days of coming down with a cold. Medication was taken either as a lozenge, as a tablet or in syrup form. On average, cold symptoms disappeared about three days sooner among adults who took zinc than they did for those taking the placebo, especially when higher doses of zinc were taken.
http://www.washingtonpost.com/national/health-science/zinc-may-shorten-common-colds-in-adults-a-review-of-17-studies-finds/2012/05/04/gIQAcmYA8T_story.html

Bayer Challenges Nexavar Generic License Order in India
Bayer states it has challenged an Indian patent office order that allowed domestic rival Natco Pharma to sell a cheap generic version of the German firm's liver and kidney cancer drug Nexavar in India. The patents office stripped Bayer of its exclusive rights to sell Nexavar, saying most Indians could not afford it. The decision stated it told Natco Pharma to sell the generic drug significantly more cheaply and pay Bayer a 6 percent royalty on sales.
http://www.reuters.com/article/2012/05/05/india-bayer-idUSL4E8G505A20120505

 
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Did You Know ...

�that Sunday is Mother's Day�?

 
Compounding Tip of the Week

Remember Moms
Don't forget to remember your mother, grandmother, great grandmother, and even your daughter(s) and granddaughter(s) that may be mothers also!

 
Looking Back

Within this vale
Of toil and sin,
Your head grows bald
But not your chin�
      Burma Shave

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