Compounding This Week Newsletter from www.CompoundingToday.com
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October 7, 2011 Volume 8, Issue 40
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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: More on the United States Pharmacopeia General Notices, Part V

Section 4 of the United States Pharmacopeia (USP) General Notices discusses Monographs and General Chapters

4.10Monographs
4.10.10Applicability of Test Procedures
4.10.20Acceptance Criteria
4.20General Chapters

USP monographs are "where it's at" for specifications of what is acceptable for substances and products/preparations. Monographs include the article's name, definition, specifications, and other requirements regarding packaging, storage, and labeling. The "specification" component consists of tests, procedures, and acceptance criteria to aid in ensuring the identity, strength, quality, and purity of the article. Each article may not have all the characteristics that are available to be done on a specific article so to ensure interchangeability in these cases, users may decide to determine functional equivalence or determine which characteristics to use, as appropriate.

One monograph may include numerous tests, procedures, and acceptance criteria that are developed to reflect the articles attributes. Alternatives may be presented for different polymorphic forms, impurities, hydrates, and dissolution situations. Sometimes a test may present numerous procedures to ensure the availability of a procedure for different products.

Acceptance criteria are developed to allow for analytical error, unavoidable variations in manufacturing and compounding, and for deterioration of the article to an acceptable extent under appropriate conditions. Official manufactured products are formulated to provide 100 percent of the quantity of each individual ingredient. Official compounded preparations have acceptance criteria based on quality attributes that are expected to characterize a compounded preparation from suitable ingredients and using procedures described in the USP.

General Chapters contain the following types of information:

  1. Test descriptions and procedures used in individual monographs
  2. Pharmaceutical compounding standards and practices
  3. Information for interpreting compendial requirements
  4. Official substance and official product guidance to manufacturers

Next week we will look at the different components of a USP monograph.


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

 
Other News

Drug Resellers Marking up Short-supply Medications 80-fold Being Probed
With the number of drug shortages tripling in the past five years, gray-market companies that buy up critical drugs in short supply and resell them to hospitals and pharmacies at a markup of as much as 80 times their price are under investigation.

Representative Elijah Cummings (Democrat, Maryland) has launched the investigation as the U.S. faces record drug shortages. Some hospitals have changed medical practices and in some cases, use less-effective medicines. Cummings said one reseller charged a hospital 80 times the typical price for cytarabine.

"Price gouging for drugs that treat cancer in children is simply unconscionable," said Cummings; "We want to know where these companies are getting these drugs, and how much they are making in profits."
http://www.bloomberg.com/news/2011-10-05/drug-resellers-probed-by-lawmaker-for-80-fold-markup-on-scarce-medicines.html

FDA Okays Novel Gel to Curb Bleeding During Surgery
A gel called LeGoo that temporarily stops blood flow during surgery has been approved by the FDA. It is indicated for use in blood vessels (below the neck) that are 4 mm or less in diameter. It stops blood from filling a surgical area without causing damage to the vessel, which often happens when clamps or elastic loops are used.

LeGoo is a temperature sensitive product; it is liquid at room temperature and solid at a higher temperature. The gel plugs the vessel for up to 15 minutes, after which it dissolves. The formed plug can also be dissolved faster by cooling the vessel with an ice pack or cold saline.
http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/28879

(Editor's Note: The website of the company is: http://www.pluromed.com/index.htm. It appears this is a Pluronic gel.)

PHARMA Spent $4.7M on Lobbying in Second Quarter 2011
PHARMA lobbied on implementation of aspects of the 2010 healthcare overhaul, including prices and rebates for drugs purchased through the Medicare program, strengthening Medicare anti-fraud measures, and eliminating an independent payment advisory board meant to hold down Medicare spending. The amount is an increase over the $4.65 million it spent a year earlier and the $4.54 million it spent in this year's first quarter.

PHARMA's efforts are on legislation that would bar the marketing of authorized generic drugs, which allow makers of brand-name drugs to partner with a generic company to retain more revenue after their patents expire. Also the target of their lobbying activities are reforms concerning patent lawsuits and on other patent rules, and for the protection of intellectual property in foreign countries.
http://news.yahoo.com/drug-industry-group-spent-4-7m-lobbying-2q-231944814.html

Last Tax Holiday Shows U.S. Firms Cut Thousands of Jobs
As many of the large corporations push for a tax holiday on more than one trillion dollars of overseas profits, a new survey has revealed that the last time such a measure was tried it ended in the loss of hundreds of thousands of jobs.

The group has employed over 160 lobbyists to push its agenda, claiming that the companies will use the tax break to bring back money overseas and invest it in building new facilities and creating jobs.

However, a report that studied the last time such a move was carried out, which was in 2004, allowed 843 firms to cut their tax rate on repatriating overseas profits from 35% to 5%. These firms brought home $312 billion dollars and avoided paying $92 billion dollars in government taxes in return for a promise to create jobs. The measure was called the American Job Creation Act.
http://www.guardian.co.uk/world/2011/oct/04/us-tax-holiday-job-cuts

 
Did You Know...

�that Columbus Day, which is annually on the second Monday of October, celebrates Christopher Columbus' arrival to the Americas on October 12, 1492? In some towns and cities, special church services, parades, and large events are held with most celebrations concentrated around the Italian-American community. Columbus Day originated as a celebration of Italian-American heritage and was first celebrated in San Francisco in 1869; New York and San Francisco have celebrations that are particularly noteworthy. In Hawaii Columbus Day is also known as Landing Day or Discoverer's Day. Although not observed in all states, it is a public holiday in many parts of the U.S. Government offices and schools are generally closed, but businesses may be open and the flag of the U.S. is displayed on government buildings.

 
Correction

In last week's "Did you Know..." section, we miss-spelled the web address for one of our valued supporters. B&B Pharmaceuticals has a new and improved web site that can be seen at www.bbpharm.net. We apologize for the inconvenience this has caused.

 
Compounding Tip of the Week

Halloween
Halloween decorations can be easily put together for your pharmacy using dry ice, water and some laboratory/compounding equipment. This can often open up opportunities for communication with some of your younger patients.

 
Meetings and Events

Second Annual Compounding Competition Announced
MEDISCA and the University of Florida College of Pharmacy announce the launch of the 2nd annual Student Pharmacist Compounding Competition (SPCC). This nation-wide event provides an educational experience for the student pharmacist and increases their exposure to the pharmacy compounding industry overall.

Its mission is to bring excellence and expertise to the compounding pharmacy community by embracing the student pharmacist and asking them to step forward and participate in this initiative. In doing so, the pharmacy student can bring forth a sense of pride and prestige to themselves and their college. The SPCC is also charged with the task of enriching the pharmacy student with a rewarding and positive experience in pharmacy compounding; to have pharmacy students ascribe to a higher standard of continuous quality improvement; and to strengthen the integrity of compounding by conveying a message of excellence.

Local competitions will be held from October 2011 through January 2012, and the National Championships are scheduled for March 17-18, 2012 at the University of Florida College of Pharmacy, Gainesville, Florida.

Are you a compounding pharmacist? Do you have an association with a local college of pharmacy? Do you support the college from which you graduated? If yes, then forward this correspondence to a colleague or faculty member and spread the word. For more information regarding this event and to ensure your college is well represented, send a correspondence e-mail to spcc@medisca.com.

Contact: Darian Zaccardo VP, Business Development & Marketing Toll-Free: 1.800.665.6334 Ext. 1233 Toll-Free: 1.800.932.1039 Ext. 1233 E-mail: dzaccardo@medisca.com; Website: www.medisca.com

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