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Editorial: Just Thinking about 503b�

Granted the number of pharmacies "voluntarily" registering with the FDA as Outsourcing Facilities (OF) to provide drugs in short supply is low, a few thoughts have crossed my mind lately, as follows:

1. What "Expiration Date" is going to be used for the manufactured products? Since these are not compounded preparations and are under GMPs and not USP chapters, the USP chapter BUDs should not apply. The USP BUDs are very short and are not appropriate for manufacturing. Manufacturers use Expiration Dates that are determined by extensive laboratory testing in specific container-closure systems. If the OF uses the same container-closure system, can they use the same 2 to 3 year expiration date the manufacturers use if the products are identical?
2. What happens if an OF prepares a large batch (e.g., 10,000 vials) of a product, has it tested, etc. and it is ready for shipment, then, the commercial product comes back on the market and the OF still has 8,000 vials on hand that are not shipped out, can the OF continue to ship them out until they are all used up? Or, must they stop distribution and take a financial loss? (Note: This assumes the OF charges the same as the original manufacturer.)
3. If the commercial product in short supply is not identical with the USP monograph, what formulation should the OF use?
4. Will manufacturers share information with 503b facilities during the time of shortage?

Hopefully, it will all work out with the OF provided with some assurances and protection, but these are just a small sampling of questions that have been asked.


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

Drugs Denied to Dying Patients
The FDA program that allows patients to use experimental drugs for "compassionate use" has many wondering if there might be a way to make it a little more compassionate. Richard Klein, Director of the FDA's patient liaison program, told CNN he's pleased with the compassionate-use program. However, many would beg to differ. A physician said he was "heartbroken" to receive desperate e-mails seeking his advice on how to navigate the program. Many drug company executives agree that the system is deeply flawed and a main complaint is when patients take to social media and make very public campaigns to get the drugs they want.
http://edition.cnn.com/2014/04/05/health/cohen-compassionate-use/

Glaxo Bribery Accusations in Iraq
A person familiar with Glaxo's Mideast operations emailed the company saying, "I believe GSK practices in Iraq violate the FCPA and the U.K. Bribery Act." The U.S. Foreign Corrupt Practices Act addresses bribery of foreign officials by U.S. businesses or foreign corporations trading securities in the U.S. The person said Glaxo hired 16 government-employed physicians and pharmacists in Iraq as paid sales representatives for the company while they continued to work for the government. Also, a government-employed Iraqi emergency-room physician has prescribed Glaxo products, even when they weren't in the hospital's pharmacy and a competitor's brand was in stock, an email said.
http://online.wsj.com/news/articles/SB10001424052702303532704579476862300832806?mg=reno64-wsj

Sebelius Resigns as HHS Secretary
Kathleen Sebelius, HHS Secretary, is resigning, ending a stormy five-year tenure marred by the disastrous rollout of President Obama's signature legislative achievement, the Affordable Care Act. Her resignation comes as the administration tries to move beyond its early stumbles in carrying out the law.
http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0

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�that this Sunday is "Palm Sunday," a Christian celebration that falls on the Sunday before Easter? Palm Sunday is the Christian commemoration of Jesus' triumphal entry into Jerusalem, an event mentioned in all four Gospels. In many Christian churches, it includes a procession of worshipers carrying palms, representing the palm branches the crowd scattered in front of Jesus as he rode into Jerusalem.

Celebrate Palm Sunday with your family this week as we prepare for Easter Sunday.

The whale put Jonah
Down the hatch,
But coughed him up
Because he scratched!
     Burma Shave

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

Village Compounding Pharmacy, Houston, Texas; Brad Pylant, bradleypylant@yahoo.com. Re-accreditation for Sterile & Nonsterile Compounding

The Compounding Pharmacy, Hickory, North Carolina; William Mixon, wmixon@thecompoundingrx.com. Re-accreditation for Sterile & Nonsterile Compounding

Vital Care of Meridian, Meridian, Mississippi; Harry Wheat, RPh, licensing@vcmeridian.com. Re-accreditation for Sterile & Nonsterile Compounding

Magnolia Pharmacy, Magnolia, Texas; Steve Hoffart, PharmD, steveh@magnoliapharmacy.com. Re-accreditation for Sterile & Nonsterile Compounding

McGuff Compounding Pharmacy, Santa Ana, California; William Blair, PharmD, williamblair@mcguff.com. Re-accreditation for Sterile & Nonsterile Compounding

MD Custom Rx, Brookfield, Wisconsin; Monica Zatarski, PharmD, monicarph@mdcustomrx.com. Re-accreditation for Nonsterile Compounding