Brought to you by the International Journal of Pharmaceutical Compounding
October 12, 2007 Volume 4, Issue 41
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: HEADLINE: Prescription Drugs Unavailable!

*80% of toys in the United States come from China (USA Today, Oct. 5, 2007)

*Over 60% of crude oil is imported into the United States (http://www.gravmag.com/oil.html)

*Most electronics are imported into the United States

*Imported automobiles reaching new records

*Most drug substances are imported into the United States for manufacturing and compounding

It seems like we are becoming a "consumer nation" instead of a "producer nation." What kind of a situation are we getting ourselves into? With most drug substances for pharmaceutical companies and for compounding pharmacies coming primarily from China and India, what might happen in the future? What are the possibilities of the following?

  1. Drug shortages may increase due to the difficulty in getting quality drugs imported through U.S. Customs for meeting the demand in the U.S.
  2. The U.S. is already dependent upon importing drug substances from other countries.
  3. If political relations deteriorate, the U.S. can be held "hostage" if the drug substances are held back until demands are met. Imagine the U.S. without antibiotics, hormones, cardiovascular drugs, and others.
  4. As with the oil industry, the cost of drug substances will increase, resulting in an increase in the cost of the final pharmaceutical product to pharmacies and to consumers.
  5. We have outsourced chemical synthesis of drug substances (partly due to rigid OSHA and EPA requirements), and pharmaceutical companies have taken the "economic" way out by outsourcing to countries where it can be done cheaper without all the environmental regulations.

The downside to participating in a global economy is being a consumer nation, rather than a producer nation, because we are no longer independent. In summary, it is quite possible that the desire for short-term profits by outsourcing to other countries is going to result in a catastrophic event in the supply of needed medications in the U.S.

Think about it!


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

 
New Standard Operating Procedures on CompoundingToday.com

CompoundingToday.com's list of available SOP's is expanding! The following SOP's will be added to the more that 330 existing ones starting tomorrow! All are available as easily modified MS Word documents to be customized for your pharmacy. See the complete collection at www.CompoundingToday.com/SOP

1.071Health Insurance Portability and Accountability Act (HIPAA) of 1996 Compliance
7.007.1 Media Fill for Low Risk Compounding
7.007.2 Media Fill for Medium Risk Compounding
7.007.3 Media Fill for High Risk Compounding
11.008 Establishing a Compounding Pharmacy Reference Library
11.009 Maintaining a Compounding Pharmacy Reference Library
 
Interesting Comment

U.S. Representative Jim Cooper, D-Tennessee, who is seeking a new commission to tackle the pending crisis in entitlement programs, stated that means testing is going to be a necessary part of all our entitlement programs. We simply cannot afford the promises we've made.

 
Winner of IJPC Mortar and Pestle

Bruce Winkleman of Scott Robison's Prescriptions in Tulsa, Oklahoma was the winner of the mortar and pestle drawing at the PCCA International Seminar in Sugar Land, Texas last weekend. Congratulations Bruce!

 
Compounding Tip of the Week

Just a reminder...

Testing requirements for potency testing are different than beyond-use dating (BUD) or stability testing.

Potency testing provides you with concentration information. This information can be used to check your compounding processes.

Stability or BUD testing should be conducted using a high-performance liquid chromatographic stability-indicating method. This is a method which has demonstrated chromatographic separation of drug ingredient from its degradant product.

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