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Forum Category: Ask the Doctors, and Other Medical Related Topics
  
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 Originator Date Posted 
   Senate Bill S.959 Pharmaceutical Compounding Quality and Accountability Act  

SCOTTSDALE, AZ
6/4/2013 19:22
Posted By:  - SCOTTSDALE, AZ  
 
Date Posted: 6/4/2013 19:22
  

For those of you using compounded hormones, this is very important.  It involves all compounded medications.  It may have the most impact on those of us using Subcutaneous Pellets.

If you have not heard about this bill, please Google it and read it.  They plan on voting on this in the next few weeks.  If you want your voice heard, please contact your Senator and tell them to vote this bill down!  While I agree that there should be some type of quality control in place within compounding pharmacies so that the deaths that happened within New England Compounding Center, in MA be avoided.  I totally disagree that the FDA should be the sole governing agency.  Look at how many deaths that have occurred from the horrible side effects of the many government approved medications, including one I use called Enbrel.  In my heart, I feel that once you let the FDA control this, then it will certainly impact our BHRT. 
 



I know a compounding pharmacist pretty well.  Here is his take on the bill.  

So far it means that the compounds, including pellets and any bio-identical formula, if prescribed for a specific patient, then shipped to the patient directly (to be used as a prescription at home, creams, gels and sublinguals) and then taken into the doctor’s office for insertion would still be allowed and no interference with the current system.  
 


If a doctor insists on buying at the office level, in other words a quantity of pellets shipped directly to the doctor’s office for use in any patient as needed, then the pharmacy would have to file for the special compounding license and would be governed by the FDA, not just the Board of Pharmacy in each state.  Most pharmacies won't want to have this extra license and be inspected by the FDA as well as the Board of Pharmacy.  Doctors won't like that, because then they lose income and can't charge the patient for the pellets as well as the insertion fee.  This is how I interpret it so far, and I am also under the opinion that it will pass after the deaths of 51 patients since last Fall by NECC. 
 


Pellets are sterilized before shipping to patients and doctors, so they fall into the sterile category. 
 


Hope this helps all of you understand the language so far as proposed,  I think it is almost a done deal.  Pellets will continue to be available, though some pharmacies will drop them, prices may go up, and some doctors will balk at it all and may even stop inserting pellets?  For Testosterone, the DEA may even get more involved?  
 


Also, a new category of pharmacy will be established,  a Compounding Manufacturer, and the license fee to become one will be in excess of $15,000.00/year;  instead several hundred dollars a year.  So the number of pharmacies participating will dwindle greatly, in my estimation.

 Here are some links: 
http://www.help.senate.gov/hearings/hearing/?id=96c56d5d-5056-a032-52c5-e7208991a71a


 http://www.govtrack.us/congress/bills/113/s959


 Click this link and there is another link to contact your senator.  “MyMedsMatter”
http://www.mymedsmatter.com/content/bioidentical-hormone-replacement-patients-take-action  


This is very important and we need to do our part to protect our hormones.  Please don't hesitate to email me if you have questions.

Nancy




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