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General Health & Fitness
Health & Wellness
Defend Your Access to Compounding Products: Send the FDA your comments
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<blockquote data-quote="Steve Williams" data-source="post: 45313" data-attributes="member: 12955"><p>Should we post comments on all of the open categories? Is it ok to post the same comment on each category?</p><p></p><p>This is, essentially, what I posted in each area open for comments:</p><p></p><p>"Thank you for your efforts to keep us safe but please take care to not regulate compounding pharmacies so heavily that our options as patients are limited.</p><p></p><p></p><p>The FDA has developed a negative reputation among patients (whether justified or not) because many patients think that this taxpayer funded government agency is being manipulated by the largest corporations in the pharmaceutical industry. Compounding pharmacies are a life saver to many of us patients who cannot get our medications through our insurance plans and punitive restrictions on compounding will only enhance the negative branding that the FDA is already feeling.</p><p></p><p></p><p>New laws, rules, and regulations always have unintended consequences. I believe that the FDA must seek 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. As a representative of taxpaying citizens, the FDA's efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it. </p><p></p><p></p><p>This House committee report (<a href="http://appropriations.house.gov/uploadedfiles/hrpt-114-hr-fy2017-agriculture.pdf" target="_blank">http://appropriations.house.gov/uploadedfiles/hrpt-114-hr-fy2017-agriculture.pdf</a>) should remind you 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.</p><p></p><p></p><p>Having run a small business, it seems to me that we do not need more regulations or tighter hoops to jump through, rather, we need better enforcement of the current rules. 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.</p></blockquote><p></p>
[QUOTE="Steve Williams, post: 45313, member: 12955"] Should we post comments on all of the open categories? Is it ok to post the same comment on each category? This is, essentially, what I posted in each area open for comments: "Thank you for your efforts to keep us safe but please take care to not regulate compounding pharmacies so heavily that our options as patients are limited. The FDA has developed a negative reputation among patients (whether justified or not) because many patients think that this taxpayer funded government agency is being manipulated by the largest corporations in the pharmaceutical industry. Compounding pharmacies are a life saver to many of us patients who cannot get our medications through our insurance plans and punitive restrictions on compounding will only enhance the negative branding that the FDA is already feeling. New laws, rules, and regulations always have unintended consequences. I believe that the FDA must seek 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. As a representative of taxpaying citizens, the FDA's efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it. This House committee report ([url]http://appropriations.house.gov/uploadedfiles/hrpt-114-hr-fy2017-agriculture.pdf[/url]) should remind you 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. Having run a small business, it seems to me that we do not need more regulations or tighter hoops to jump through, rather, we need better enforcement of the current rules. 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. [/QUOTE]
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General Health & Fitness
Health & Wellness
Defend Your Access to Compounding Products: Send the FDA your comments
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