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September 2, 2011 Volume 8, Issue 35
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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 I

As we introduced last week, the United States Pharmacopeia (USP) General Notices and Requirements presents the basic assumptions, definitions, and default conditions for the interpretation and application of the USP and National Formulary (NF). Requirements in this section apply to all articles recognized in the USP–NF and to all general chapters unless specifically stated otherwise. The exceptions would be if different information is specifically explained and stated in the General Chapter or the Monographs.

There are ten sections in the General Notices:

  1. Title and Revision
  2. Official Status and Legal Recognition
  3. Conformance and Standards
  4. Monographs and General Chapters
  5. Monograph Components
  6. Testing Practices and Procedures
  7. Test Results
  8. Terms and Definitions
  9. Prescribing and Dispensing
  10. Preservation, Packaging, Storage and Labeling

As some of this information is not covered in college curricula, pharmacy continuing education programs, or via other means, over the next few weeks we will briefly look at these sections and how they impact pharmacy practice. The current General Notices of USP 34–NF 29 became official May 1, 2011.

For review prior to our brief coverage each week, the current General Notices can be accessed at: http://www.usp.org/pdf/EN/USPNF/USP34-NF29General%20Notices.pdf.


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

 
Other News

FDA Agrees With Drug Companies to Increased User Fees of 6% to Renew Law
PHARMA companies Pfizer and Eli Lilly agreed with regulators on a 6 percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017. This agreement would renew a federal law funding FDA evaluations of brand-name drugs for five years; it must be approved by Congress before the law expires on September 30, 2012.

The $40.4 million increase in user-fee revenue for fiscal 2012 brings the fiscal 2013 total to $712.8 million. The agency in turn will have to meet with companies in the midst of reviews to raise concerns and ensure that evaluations are carried out in a timely way.

The agreement "should allow more timely access to safe and effective new medicines," said David Wheadon, senior vice president for scientific and regulatory affairs at PHARMA. PHARMA companies fund about 60 percent of the cost of agency reviews, according to the FDA.

The device industry, however, rejected the agency's proposal to more than double fees to $770 million across five years from $295 million.
http://www.bloomberg.com/news/2011-09-01/fda-accord-with-drugmakers-raises-user-fees-6-in-law-renewal.html

FDA Wants To Make It Safer To Split Tablets
Splitting tablets is not new. Many people do so every day to save money or adjust dosages. But how does one know that each half—or portion—contains the needed amount of medication? Just because a tablet is scored is no guarantee that patients will get the exact dose they need.

The agency conducted internal research on tablet splitting and found, in some cases, possible safety issues, especially when tablets are not scored or evaluated for splitting. These include variations in tablet content, weight, disintegration, dissolution, and stability. The FDA has now issued a guidance for drug companies on data that is needed for applications to support scored tablets, including:

  1. The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therapeutic dose indicated on approved labeling.
  2. Modified release tablets in which the control of drug release can be compromised by splitting should not be scored.

Also, generic manufacturers must ensure that the tablets follow the same scoring as reference-listed drugs, or brand-name meds. For a copy of the new guidance, go to:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM269921.pdf

http://www.pharmalot.com/2011/08/fda-wants-to-make-it-safer-to-split-tablets/

Florida Shutting Down 'Pill Mill' Clinics
For a long time, Florida has been the nation's center for the illegal sale of prescription drugs: Doctors in the state purchased 89 percent of all the Oxycodone sold in the country last year. Now, the governor has signed a law that makes it harder for pain clinics and pharmacies to engage in the illegal distribution of prescription drugs. With the help of these tougher laws, officials have moved aggressively this year to shut down so-called pill mills and disrupt the pipeline that moves the drugs north. In the past year, more than 400 clinics were either shut down or closed their doors.

New laws also affect distribution because as of July, Florida doctors are barred, with a few exceptions, from dispensing narcotics and addictive medications in their offices or clinics. As a result, doctors' purchases of Oxycodone, which reached 32.2 million doses in the first six months of 2010, fell by 97 percent in the same period this year.

Pharmacies are also being scrutinized closer. The number of applications to open new pharmacies in Florida has nearly doubled in the past two years, possibly the result of doctors' facing tougher rules. Florida now makes up half of all the requests for new pharmacies in the entire country. Now, background checks are required for owners, employees, and violators. Whether they are pharmacists, doctors, or clinic owners, they face stiffer, swifter penalties.
http://www.nytimes.com/2011/09/01/us/01drugs.html?_r=1

FDA Chemist Reaping $3.77 Million in Profits Nearing Plea Over Insider Trading Charges
An FDA chemist and his son accused of making millions of dollars with inside information about drug approvals are close to reaching plea agreements. Cheng Yi Liang and his son Andrew were charged in March with conspiracy, securities fraud, and wire fraud for making $2.27 million in trades involving five pharmaceutical companies between November 2007 and March 2011. Securities regulators reported additional trades and that the father reaped more than $3.77 million in profits and avoided losses.

Even though insider trading cases are relatively common, the Liang case was unusual because it involved a federal government employee using sensitive information from the job to reap a windfall. Critical information about prescription drug approvals or denials can prompt big stock swings. Liang worked at the FDA beginning in 1996 in the Office of New Drug Quality Assessment and had access to the agency's internal tracking system for new drug applications. His salary was $122,744 a year, according to a court document.
http://www.reuters.com/article/2011/08/30/fda-insidertrading-idUSN1E77T0BT20110830

 
Did You Know...

�that pharmacist training and education begins at colleges/schools of pharmacy? We need to question whether or not the current programs are adequately training pharmacy students for practice in today's high-tech pharmacy!

 
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Doing It
If involved in compounding, "Do It Right, or Don't Do It!"

 
Upcoming Events
Program: Compounding Total Parenteral Nutrition Preparations: A 2011 Investigation of a Bacterial Outbreak
Sponsor: The Centers for Disease Control and Prevention (CDC) and USP
Purpose: The goal of this webinar is to inform healthcare practitioners of the lessons learned from this event. The CDC will provide a review of its investigation and the breaches identified, and USP will provide a review of the official standards for sterile compounding. Estimated duration: 60 minutes. No cost.
Date: Tuesday, September 20, 2011 at 1:00 p.m. Eastern Time.
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