Nelson Vergel
Founder, ExcelMale.com
Background information:
FDA compounding enforcement draws ire from Congress
The FDA is asking for comments now (Deadline July 18)
Please add your comments to defend the compounding industry before the FDA imposes more restrictions. They are requesting comments now.
https://www.regulations.gov/searchResults?rpp=25&po=0&s=compounding+pharmacies&fp=true&ns=true
I posted this comment on the 4 guidances (I focused on my HIV work since it is probably more effective to do so, but you guys should add your personal experiences in TRT, etc. You can cut and paste some of this content if you wish) :
"The FDA needs community representation when drafting guidances related to compounding pharmacies since patient's options will be decreased by the extra requirements on 503A and 503B facilities.
The exorbitant pharma prices are causing public backlash. So efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it.
I would like to thank the FDA for their efforts to keep us safe but feel compelled to stress that this effort cannot be so extreme that our options as patients are limited.
The FDA has a really bad reputation among patients who think that this taxpayer funded government agency is being manipulated by big pharma. This is probably unfair but increasing extreme requirements on compounding will only enhance that negative branding.
A recent report from a House committee reminded the FDA that "compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated healthcare providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states". Imposing regulations similar to ones imposed on big pharma represents an unnecessary extra burden on compounding pharmacies as small businesses.
Without access to low cost compounded products, I and many of my non-profit organization's constituents would have died of HIV wasting and other conditions. We find ourselves needing medications that insurance companies refuse to cover due to their shrinking formularies, so low cost compounded products have filled an important role in our quality of life and survival.
Please carefully review the need for extra burden imposed on these small businesses that have been affected by a few bad companies that did not follow sterility guidelines that are already in place."
Letter from members of Congress to the FDA: https://c.ymcdn.com/sites/iacp.site-ym.com/resource/resmgr/DQSA/Stewart_Cuellar_Office_Use_L.pdf
FDA compounding enforcement draws ire from Congress
The FDA is asking for comments now (Deadline July 18)
Please add your comments to defend the compounding industry before the FDA imposes more restrictions. They are requesting comments now.
https://www.regulations.gov/searchResults?rpp=25&po=0&s=compounding+pharmacies&fp=true&ns=true
I posted this comment on the 4 guidances (I focused on my HIV work since it is probably more effective to do so, but you guys should add your personal experiences in TRT, etc. You can cut and paste some of this content if you wish) :
"The FDA needs community representation when drafting guidances related to compounding pharmacies since patient's options will be decreased by the extra requirements on 503A and 503B facilities.
The exorbitant pharma prices are causing public backlash. So efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it.
I would like to thank the FDA for their efforts to keep us safe but feel compelled to stress that this effort cannot be so extreme that our options as patients are limited.
The FDA has a really bad reputation among patients who think that this taxpayer funded government agency is being manipulated by big pharma. This is probably unfair but increasing extreme requirements on compounding will only enhance that negative branding.
A recent report from a House committee reminded the FDA that "compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated healthcare providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states". Imposing regulations similar to ones imposed on big pharma represents an unnecessary extra burden on compounding pharmacies as small businesses.
Without access to low cost compounded products, I and many of my non-profit organization's constituents would have died of HIV wasting and other conditions. We find ourselves needing medications that insurance companies refuse to cover due to their shrinking formularies, so low cost compounded products have filled an important role in our quality of life and survival.
Please carefully review the need for extra burden imposed on these small businesses that have been affected by a few bad companies that did not follow sterility guidelines that are already in place."
Letter from members of Congress to the FDA: https://c.ymcdn.com/sites/iacp.site-ym.com/resource/resmgr/DQSA/Stewart_Cuellar_Office_Use_L.pdf
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