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Brought to you by the International Journal of Pharmaceutical Compounding
July 2, 2015  |  Volume 12  |  Issue 27
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
The Declaration of Independence: Then and Now!

IN CONGRESS, July 4, 1776.

The unanimous Declaration of the thirteen united States of America,

When in the Course of human events, it becomes necessary for one people to dissolve the political bands which have connected them with another, and to assume among the powers of the earth, the separate and equal station to which the Laws of Nature and of Nature's God entitle them, a decent respect to the opinions of mankind requires that they should declare the causes which impel them to the separation.

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.--That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed, --That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. �

The Declaration continues to present 27 Facts describing what led up to this action. To read these Facts, go to the following website:

http://www.archives.gov/exhibits/charters/declaration_transcript.html

It is quite interesting that some of these Facts seem to be re-occurring today; the change being the "American Citizens and States" are the Colonies and the "Government" acting like the King of England and usurping power from the states and freedom from the citizens.

Read and think about the loss of autonomy of the states and the citizens and the intrusion of the government in the lives of American citizens and into our professions. Our form of government has served us about 239 years making the USA the strongest nation in the world. However, the USA is rapidly losing its status and power because the thought processes, ideals, and foundational principles are not the same now as when the Declaration of Independence was signed.

Enjoy a very meaningful Independence Day�Happy Birthday America!



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

 

Coming in the Next Issue of IJPC

  • A composite list of drugs on the "Negative List" or "Do Not Compound List"
  • Selection of disinfectants for USP <797> sterile compounding
  • Much, much more
  • More formulas have been added to CompoundingToday.com
 

News

APhA Spearheads Joint Letter to USP Regarding Draft Chapter <800>
APhA and six other pharmacy organizations (AACP, ASCP, IACP, NACDS, NASPA, and NCPA), and the American Medical Association submitted a joint comment letter to USP regarding revised draft USP Chapter <800>. The letter notes support for the overall goals of <800>, but due to ongoing concerns with compliance difficulties and regulatory overlap, request that <800> be moved above <1000> while necessary cost and patient access analyses are completed. The letter also outlines areas of stakeholder concern with <800>, including duplicative requirements under state and federal law, unintended adverse effects on patient access, and new liability for physicians, pharmacists, clinics, and pharmacies. APhA remains committed to working with USP and other stakeholders to further refine and revise draft Chapter <800>.

Source: APhA Legislative and Regulatory Update, June 2015. For more information email:
infocenter@apahanet.org

Emend (Aprepitant) Antiemetic Shortage Announced
The FDA has announced that Emend (aprepitant; Merck) is currently in short supply due to an increased demand for the drug. An intermittent supply will be available to some, and it is anticipated that the backorder will be fully resolved in September. Emend for injection remains available. http://www.empr.com/safety-alerts-and-recalls/emend-drug-shortage-announced/article/423446/

FDA Acting Against Unapproved Rx Otics
The FDA has announced enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products labeled to relieve ear pain, infection, and inflammation. The action does not affect FDA-approved prescription otics or legally marketed otic products sold over-the-counter. In this action, the unapproved prescription otic products contain:

  1. Benzocaine
  2. Benzocaine and antipyrine
  3. Benzocaine, antipyrine, and zinc acetate
  4. Benzocaine, chloroxylenol, and hydrocortisone
  5. Chloroxylenol and pramoxine
  6. Chloroxylenol, pramoxine, and hydrocortisone

Manufacturers making and selling unapproved otic drug products covered by this action that are not currently listed with the FDA must stop manufacturing and shipping the products immediately.

 

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

 

Did You Know ...

�that media presentations (television, etc.) do not present stories in proportion to the number of individuals involved or affected? In other words, a story affecting a minority is afforded as much or more time as stories impacting a majority! Another issue is the number of times stories are "re-run" (think about the exaggerated coverage of adverse compounding situations while at the same time there are events and recalls almost daily from the pharmaceutical industry affecting more people but receive little or no coverage).

 

Tip of the Week

Evaluate the news carefully. A picture of a flooded area has sometimes been only a close-up of rushing water in a ditch or drain and some recent news stories have been discovered to be fabrications (lies).

 

Looking Back

Thirty days hath
September, April, June
And the
Speed Offender!
     Burma Shave

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