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FDA Must Have New Authorities to Regulate Pharmacy Compounding

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  Post Number #1  
Old 22nd March 2013, 05:57 PM
Ronen E

 
 
Total Posts: 3,736
Look! FDA Must Have New Authorities to Regulate Pharmacy Compounding

For those following the recent recalls due to contaminated pharmacy compounds, an interesting statement from Commissioner Hamburg:

http://blogs.fda.gov/fdavoice/index....ce=govdelivery
Thank You to Ronen E for your informative Post and/or Attachment!

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  Post Number #2  
Old 27th March 2013, 05:34 PM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

Do you know anyone who might have been affected this time around?

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery

Quote:
ACETYLCYSTEINE OPHTHALMIC SOLUTION
ALPROSTADIL IN NS INJECTION
ATROPINE INJECTION
BACTERIOSTATIC WATER FOR INJECTION BIMIX INJECTION
BUPRENORPHINE HCL, VETERINARY INJECTION
CIDOFOVIR OPH SOLUTION
CYCLOSPORINE OPHTHALMIC
DIAZEPAM INJECTIBLE
DEXAMETHASONE PF
DMSO AQUEOUS IRRIGATION 50%
GENTAMICIN SULFATE IRRIGATION
HCG CHORIONIC GONADOTROPIN
HYDROXYPROGESTERONE CAPR. (G.S.)
METHYLCOBALAMIN - PF
MIC WITH B6 & B12
NANDROLONE DECANOATE INJECTIBLE
QUADMIX INJECTION
TACROLIMUS OPHTHALMIC
TESTOSTERONE CYPIONATE/TESTOSTERONE ENANTHATE INJECTION
TESTOSTERONE CYPIONATE/PROPIONATE INJECTION
TESTOSTERONE CYPIONATE INJECTION
TRIMIX INJECTION
VANCOMYCIN OPTHALMIC P.F.
VERAPAMIL INJECTION

Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.

Users or recipients should discontinue use and return the recalled products...
  Post Number #3  
Old 12th April 2013, 04:27 AM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

Next chapter:

http://blogs.fda.gov/fdavoice/index....ce=govdelivery
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #4  
Old 17th April 2013, 09:05 AM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

...and (I'm guesstimating) some of the consequences of these proactive inspections:

http://www.fda.gov/Safety/MedWatch/S.../ucm348170.htm
http://www.fda.gov/Safety/MedWatch/S.../ucm348156.htm
http://www.fda.gov/Safety/MedWatch/S.../ucm347755.htm
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #5  
Old 23rd April 2013, 01:23 AM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

One more:

http://www.fda.gov/Safety/MedWatch/S...ce=govdelivery
  Post Number #6  
Old 24th April 2013, 03:16 AM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

The list goes on:

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery
  Post Number #7  
Old 8th May 2013, 06:35 PM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

Another one:

http://www.fda.gov/Safety/MedWatch/S...ce=govdelivery
  Post Number #8  
Old 13th May 2013, 05:14 AM
Ronen E

 
 
Total Posts: 3,736
Re: FDA Must Have New Authorities to Regulate Pharmacy Compounding

A more localized one (FL), nevertheless...

http://www.fda.gov/Safety/Recalls/uc...ce=govdelivery
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