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Editorial: United States Pharmacopeia 101, Part V

This is the fifth in the series on the United States Pharmacopeia (USP). In this part, we will continue with a discussion on the publications of the USP. This week we will look at the FCC, DSC, and the USAN.

1. The Food Chemicals Codex (FCC): This publication is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features approximately 1,100 monographs, including food-grade chemicals, processing aids, foods (e.g., vegetable oils, fructose, whey, amino acids), flavoring agents, vitamins, and functional food ingredients (e.g., lycopene, olestra, short chain fructooligosaccharides). The FCC also supports ingredients such as sucrose and essential oils that are not commonly found in other food additive standards resources.

   The FCC has been published since 1966 and plays a key role in safeguarding commerce and public health by providing essential criteria and analytical methods to authenticate and determine the quality of food ingredients. FCC standards are beneficial to all players in the food industry.

2. The Dietary Supplements Compendium (DSC): In 2009, the USP introduced the USP Dietary Supplements Compendium (DSC)—an industry-directed resource featuring relevant documentary standards previously only accessible through the United States Pharmacopeia-National Formulary (USP-NF) and FCC compendia, along with industry and regulatory guidance documents, supplemental information, and reference tools. The USP updates and publishes the DSC every two years.

   The DSC offers the dietary supplement community a comprehensive resource for finding suitable, unbiased, and scientifically sound specifications for their products, associated analytical methodology for ingredients they buy, and for products common to many manufacturers.

3. The USP Dictionary of United States Adopted Names (USAN) and International Drug Names is the leading reference for nonproprietary drug names and chemical structures. In addition to USAN, the USP Dictionary provides International Nonproprietary Names (INNs), British Approved Names, Japanese Accepted Names, brand names, Unique Ingredient Identifier (UNII) codes, manufacturers, official USP-NF names, molecular weights, graphic formulas, pharmacologic and/or therapeutic categories, and pronunciations.

Next week we will look at the composition and organization of the USP 35-NF 30, which becomes official May 1, 2012.


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

Prempro Decision Orders Pfizer to Pay $4 Million in Damages to One Woman
Pfizer must pay at least $4 million in damages to a woman who developed breast cancer after taking Prempro, a jury in Connecticut ruled. Jurors ruled that Pfizer's Wyeth unit was liable for causing Margaret Fraser's cancer and that Prempro was an "unreasonably dangerous product." The panel also found Wyeth should pay punitive damages over its handling of the drug. The jury concluded that Wyeth's handling of the drug "was reckless and they had misrepresented the risks and benefits of its drug to patients and doctors." A federal judge will decide later how much in punitive damages Pfizer must pay. Pfizer's Wyeth and Upjohn units have now lost 11 of 20 Prempro cases decided by juries since trials began in 2006.
http://www.bloomberg.com/news/2012-04-20/pfizer-ordered-to-pay-4-million-in-damages-in-prempro-case-1-.html

56 More Doctors Alerted On Counterfeit Avastin
The FDA has warned more than 50 doctors and medical practices in the U.S. that they may have bought a fake version of Avastin. The FDA asked doctors and medical practices in 13 states from Alabama to Washington to avoid using the fake drugs, as they may cause harm to patients because they may be unsafe or ineffective," said the letters.

This batch of letters follows previous dispatches to 20 doctors and clinics about the counterfeit drug. The FDA said it has tracked a batch sold under Avastin's Turkish brand name, Altuzan. In both of these cases, the counterfeits contain no active ingredient. The fakes have been tracked to the Middle East and beyond, traveling through U.S. and Europe along the way.
http://online.wsj.com/article/SB10001424052702304331204577356231660528806.html

45 People Detained and 9 Arrested in China Related to Contaminated Capsules
Chinese police have detained 45 people, arrested nine, and seized more than 77 million chromium-tainted capsules in China's latest product safety scandal. This latest ordeal has aroused widespread public concern despite repeated pledges to get tough. The government said the companies involved sold gelatin capsules made with industrial gelatin, which contains a far higher chromium content than the edible gelatin they should have used. The Ministry of Public Security said they have closed 80 illegal production lines after a week of inspections centered on Zhejiang, Hebei, and Jiangxi provinces. The ministry did not provide details on who it had detained or arrested, nor what charges they might face.
http://www.reuters.com/article/2012/04/23/china-capsules-idUSL3E8FN0SY20120423

Nanotech May Need Extra Safety Tests Says FDA
The FDA has said that consumer products using nanotechnology may have unknown effects on the human body; and they advised food and cosmetic companies to further study the safety of these tiny particles. The FDA has rejected a consumer group's petition from 2006 that urged a separate category of regulation for nanotechnology due to its "unique human health and environmental risks."

Nanotechnology is used in hundreds of products in areas ranging from stain-resistant clothing and cosmetics to food additives, but the health effects of nanoparticles are still poorly understood. Nanoparticles may be able to penetrate the skin, or move between organs, with undefined health effects.
http://articles.chicagotribune.com/2012-04-20/lifestyle/sns-rt-us-fda-nanotechbre83j1b1-20120420_1_fda-commissioner-margaret-hamburg-food-additives-pew-health-group

Future Technology: Sonic Screwdriver May have Multiple Uses
From Doctor Who to today, a team of physicists at the University of Dundee have taken equipment designed for MRI-guided focused ultrasound surgery and demonstrated a real Sonic Screwdriver—lifting and spinning a free-floating 10-cm diameter rubber disk with an ultrasound beam. The physicists used a targeted ultrasound beam to lift and spin a 90-gram, 10-centimeter rubber disk. By shaping the beam like a helix, the researchers were able to rotate the disk using only the energy of an ultrasound array. The vortex-shaped beam allows for angular momentum and the application of torque to an object without actually touching it.This may potentially have applications in the future for pharmacy. The Sonic Screwdriver can be viewed at:
www.youtube.com/watch?v=SeB69CcLEI8
http://www.fiercedrugdelivery.com/press-releases/sonic-screwdriver-tightens-fundamental-physics?utm_medium=nl&utm_source=internal#ixzz1tArQHNyL

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�that the next RxTriad will be titled, "Discontinued Drugs-Still Available!"? The focus is to inform physicians that in many cases compounding pharmacists can prepare drugs that have been discontinued. See the RxTriad website and call Deb at 1-800-757-4572 to place your order.

Reach Out with the RxTriad
The RxTriad is a great marketing tool to inform your prescribers of capabilities of which they might not be aware. For example, they may not be aware that you can compound many drugs that are discontinued as well as those in short supply.

Said Farmer Brown,
Who's bald on top,
Wished I could
Rotate the crop!
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

RX3 Compounding Pharmacy, Chester, Virginia; Chris Currin, RPh; ckcurrin@yahoo.com: Reaccreditation for Sterile and Nonsterile Compounding

Fresenius Medical Care Pharmacy Services, Inc., St. Petersburg, Florida; Pauline Laurendeau, CPhT, Pharmacy Supervisor; Pauline.Laurendeau@fmc-na.com: Initial Accreditation Sterile Only

Please join us in congratulating these outstanding pharmacies on their achievement.

2012 USP <797> Compliance Study

The 2012 USP <797> Compliance Study has started. This Study was first conducted in 2011. The information and insights gained will be very valuable. These results assist in benchmarking progress and to identify where additional resources and focus are required to continue to improve sterile compounding practice and patient safety.

The 2012 USP <797> Compliance Study uses a sophisticated web-based <797> Gap Analysis Tool that is being made available at no charge to all study participants. It should be noted that ALL INDIVIDUAL FACILITY RESULTS ARE CONFIDENTIAL—ONLY AGGREGATE DATA WILL BE USED IN THE STUDY REPORT.

In return for your participation, you will receive a highly detailed Action Plan that is automatically generated based on your answers to the survey. This Action Plan provides documentation that can be used to begin or continue sterile compounding practice improvements at your location. The survey takes 60 to 90 minutes to complete but does not need to be completed at one sitting. This year, the study team has also provided a pdf document of all the questions to facilitate data collection offline for those who might find this useful.

Please register for the Study today:  www.797study.com. Use Survey Code B797I.