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Forum Category: General Lifestyle Discussion Topics
 Originator Date Posted 
   Testosterone, DEA and the FDA  

11/1/2013 14:00
Posted By:  - SCOTTSDALE, AZ  
Date Posted: 11/1/2013 14:00
Please forgive me for putting this here.  It's the most read category and this information needs to get out.

For those of you who get BHRT testosterone pellets, etc from compounding pharmacies, this will probably affect you.  Those of that use other delivery forms of testosterone won't be quite as affected, but still may be.

The Senate bill 959 passed which will place compounding pharmacies more under the control of the FDA.  This is not good news.

I spoke to two compounding pharmacies today.  But it affects all the compounding pharmacies.  Here is what is going on.

There is a rule in the DEA that controlled substances like testosterone pellets must be ordered via prescription and sent directly to the patient.  The DEA has not enforced this rule much and let doctors order in quantity to be shipped to their offices.

Well, the DEA decided to start enforcing the rule.  So one pharmacy is having patients sign a release authorizing them to send the pellets to the doctor's office.  The other pharmacy has their lawyers looking at it to determine the best path.  They will probably do the same. 

However, shipping sterile drugs to patients could lead to problems with lost shipments, contamination by others; either accidentally or deliberately, etc.

Senate Bill 959
This gives the FDA more control over the compounding pharmacies.  There will be a new classification of pharmacy called "manufacturing compounding pharmacy" or close to it for those that compound a sterile product.  The fees will be around $15,000 per year.  Many pharmacies may elect not to continue to manufacturer sterile products because of that.  Pharmacies may close and some doctors may elect not to do hormones or any other drug that falls under this classification.

So if you or your pets (includes veterinary medications too) use sterile compounded medications or sterile testosterone pellets, you should be aware that changes are happening.  Be proactive and talk to your doctor.



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