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Senate Bill S 959 Pharmaceutical Compounding Quality and Accountability Act : Swingers Discussion 223107
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FORUMSGeneral DiscussionsMen TalkSenate Bill S 959 Pharmaceutical Compounding Quality and Accountability Act
TOPIC: Senate Bill S 959 Pharmaceutical Compounding Quality and Accountability Act
Created by: Greeneyes1029
Original Starting post for this thread:
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.

This is NOT good for our compounded meds. We all need to take action.

I can't post links here, so if you want to email me, I'll give them to you. Also search "MyMedsMatter". It's a great site that watches what goes on between the FDA and Compounding pharmacies.

Nancy

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No, I'm not saying that at all. It seems that the Big Pharma want to shut down the smaller compounding pharmacies so they can make more money. The deaths that occured from contamination in the MA pharmacy were horrible and should not have happened. However, there are more deaths from the drug Enbrel that I inject and they still sell it. I also understand that there is a difference between contanmination and lethal side effects.

I'm also saying that The Board of Pharmacy should also continue to be able to inspect and monitor Compounding pharmacies, not just the FDA.

Bottom line, it's all about money. Hormones are BIG money and Big Pharma like Weyth made lots and lots of money off Premarin which is synthetic. It comes from Pregnant Mares Urine. When the study in 2002 came out that Premarin/Prempro raised/caused cancer in women and millions went off of Premarin, so many went to Bioidentical hormones. They lost millions of dollars. They want that money back so they are going after the compounding pharmacies.

I was even banned from a Hysterectomy site for posting about Bioidentical hormone pellets. Weyth was a paid sponsor of that site. Go figure.

Bioidentical hormones and many other medications, which includes the vetinerary medical industry are "made to order". The pellets I get have to be sterile (as do others) since they are inserted under the skin of the rear and has to be done in a doctor's office. One can not just order online. It's not like buying a supplement.

Trimix injections that many men use for ED after prostate cancer surgery or other causes also come from compounding pharmacies.

If this bill passes, this is going to have huge consequences for millions of patients that depend on medications from compounding pharmacies.

Scottsdale AZ
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" 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, ..."

Greeneyes, are you saying FDA inspections make it *more* likely that contaminated drugs will reach the end user?

As long as people use drugs, there will be side effects of drugs, and people will die. The FDA has the job of minimizing these risks.

If the FDA doesn't inspect drug manufacturers (compounders), who does? You can probably still get your stuff cheaper from Singapore or wherever, if you want to take the risk.

Flat Rock NC
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(2984 posts)
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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.

This is NOT good for our compounded meds. We all need to take action.

I can't post links here, so if you want to email me, I'll give them to you. Also search "MyMedsMatter". It's a great site that watches what goes on between the FDA and Compounding pharmacies.

Nancy

Scottsdale AZ
Username hidden
(177 posts)
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TOPIC: Senate Bill S 959 Pharmaceutical Compounding Quality and Accountability Act