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July 24, 2015  |  Volume 12  |  Issue 30
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
USP Compounding Expert Committee (CMP EC) Roster 2015-2020

The following is from the USP website and is the Compounding Expert Committee roster for the next five years. The list also includes the government liaisons and USP staff involved with the Committee.

Committee Members

  • Gigi S. Davidson, RPh, DICVP, Chair
  • Lisa Ashworth, BS Pharm, RPh
  • Gus Bassani, PharmD
  • Ruth Ebiasah, PharmD
  • Edmund J. Elder, Jr., PhD
  • Ryan Forrey, PharmD, MS
  • Deborah Houston, PharmD
  • Brenda Jensen, MA
  • Patricia C. Kienle, MPA
  • William A. Mixon, MS
  • John Musil, PharmD
  • David Newton, PhD
  • Alan Parr, PharmD, PhD
  • Abby Roth
  • Robert Shrewsbury, PhD
  • Connie Rae Sullivan, BS Pharm
  • James Wagner
  • Brenda Yuzdepski, BS Pharm

Government Liaisons

  • Jane Axelrad, JD
  • Jonathan Bray, BS
  • Ian DeVeau, PhD
  • Edisa Gozun, PharmD
  • Susie Homire, DVM
  • John Metcalfe, PhD
  • Erika Pfeiler, PhD
  • Sara Rothman, PhD

USP Documentary Standards Staff

  • Shawn Becker, MS, BSN
  • Rick Schnatz, PharmD
  • Jeanne Sun, PharmD

Primary Points of Contact

  • Rick Schnatz, PharmD (rxs@usp.org)
  • Jeanne Sun, PharmD (jhs@usp.org

Congratulations to the CMP EC members that were selected!


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

 

News

ASHP Says State Compounding Agreement from the FDA May Cause Hardship
A proposed FDA agreement with states outlining requirements and regulations for sterile compounding could negatively impact some home infusion pharmacy services, ASHP warned in comments to the FDA this week.

Unless the state has a memorandum of understanding (MOU) in place with the FDA, the DQSA limits to 5 percent of the total drugs dispensed or distributed the amount of compounded medications that can be distributed across state lines. Pharmacies in states that sign the MOU may distribute up to 30 percent compounded products relative to the total number of drugs dispensed or distributed.
http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=1583

Justification for Excessive Drug Prices!
Pharmaceutical companies are coming under pressure to disclose their development costs and profits for their medicines and the rationale for charging what they do; as complaints grow about exorbitant drug prices! Pharmaceutical cost transparency bills have been introduced in at least six state legislatures in the last year. "If a prescription drug demands an outrageous price tag, the public, insurers and federal, state and local governments should have access to the information that supposedly justifies the cost," says the preamble of a bill introduced in the New York State Senate in May.
http://www.nytimes.com/2015/07/23/business/drug-companies-pushed-from-far-and-wide-to-explain-high-prices.html?ref=health&_r=0

Cancer Doctors Call for Curbs on Rising Drug Prices
Top cancer experts called for steps to curb the rapidly escalating price of oncology drugs. An article in the journal Mayo Clinic Proceedings, signed by 118 physicians from cancer centers across the country, cited startling, if now familiar, evidence of the dramatic rise in cancer-drug prices. The physicians noted that in 2014, every new drug approved by the FDA was priced at more than $120,000 per year; the cost for each additional year lived by a patient has skyrocketed from $54,000 in 1995 to $207,000 in 2013.
http://www.washingtonpost.com/national/health-science/cancer-experts-call-for-curbs-on-rapidly-rising-drug-prices/2015/07/22/9dafc7b0-3082-11e5-8f36-18d1d501920d_story.html

Baxter Recalls Two Lots of IV Solutions Due to Insects
Baxter International Inc. announced it is voluntarily recalling two lots of intravenous solutions to the hospital/user level due to the potential presence of insects that were identified as a result of a customer complaint. Fortunately, the situation was identified prior to patient administration, and there have been no adverse events associated with this issue reported. This recall affects the following lots:

Product CodeProduct DescriptionLot NumberExpiration DateNDC
2B13010.9 % Sodium Chloride Injection, USP, 50 mL VIAFLEX Plastic ContainerP31992112/31/20150338-0049-11
2B00430.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG Plus ContainerP32763512/30/20150338-0553-18

http://www.fda.gov/Safety/Recalls/ucm455370.htm

 

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Did You Know ...

�that we are in the "Dog Days of Summer"?

 

Tip of the Week

The Old Farmer's Almanac lists the traditional period of the Dog Days of Summer as the 40 days beginning July 3 and ending August 11. This coincides with the ancient heliacal (at sunrise) rising of the Dog Star, Sirius, and are the days of the year with the least rainfall in the Northern Hemisphere.

The "Dog Days" is the most sultry period of summer and was named in early times by observers in countries bordering the Mediterranean; this period was reckoned as extending from 20 days before to 20 days after the conjunction of Sirius (the dog star) and the sun.

 

Looking Back

Free, Free,
A trip to Mars,
For 900,
Empty jars!
     Burma Shave

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