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Compounding Pharmacy Product Reviews
Interview with Compounding Product Expert Shaun Noorian from Empower Pharmacy- Part 1
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<blockquote data-quote="Nelson Vergel" data-source="post: 50131" data-attributes="member: 3"><p>Federal regulations put in place as part of the <a href="https://www.congress.gov/bill/113th-congress/house-bill/3204" target="_blank">Drug Quality and Security Act of 2013</a> aim to make drugs produced at compounding facilities safer than ever before.</p><p></p><p>These new regulations have generated <a href="https://www.statnews.com/pharmalot/2016/01/06/fda-compound-downing-labs/" target="_blank">significant pushback</a> from the compounding community. They have also placed many of these pharmacies at a crossroads: they must choose either to limit what they produce to lessen federal oversight or invest in a higher quality, larger-scale operation so they can offer a greater range of solutions for patients and providers.</p><p></p><p>The 2013 law essentially created two classes of compounding pharmacies: “503A” for so-called traditional compounding pharmacies that fill patient-specific prescriptions (one drug prepared at a time for one patient) and “503B” for sterile compounding outsourcing facilities that produce large quantities of medications, including those prepared for “office use” and those sold directly to hospitals and physicians.</p><p></p><p>"In response to the 2013 law, we chose the 503B outsourcing facility route. It was a difficult decision because of the tremendous amount of time and capital required, but it seemed to be the only path forward if we wanted to truly serve the needs of our growing patient base."</p><p></p><p><a href="https://www.statnews.com/2016/09/09/compounding-pharmacies-safeguard-public-health/" target="_blank">https://www.statnews.com/2016/09/09/compounding-pharmacies-safeguard-public-health/</a></p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 50131, member: 3"] Federal regulations put in place as part of the [URL="https://www.congress.gov/bill/113th-congress/house-bill/3204"]Drug Quality and Security Act of 2013[/URL] aim to make drugs produced at compounding facilities safer than ever before. These new regulations have generated [URL="https://www.statnews.com/pharmalot/2016/01/06/fda-compound-downing-labs/"]significant pushback[/URL] from the compounding community. They have also placed many of these pharmacies at a crossroads: they must choose either to limit what they produce to lessen federal oversight or invest in a higher quality, larger-scale operation so they can offer a greater range of solutions for patients and providers. The 2013 law essentially created two classes of compounding pharmacies: “503A” for so-called traditional compounding pharmacies that fill patient-specific prescriptions (one drug prepared at a time for one patient) and “503B” for sterile compounding outsourcing facilities that produce large quantities of medications, including those prepared for “office use” and those sold directly to hospitals and physicians. "In response to the 2013 law, we chose the 503B outsourcing facility route. It was a difficult decision because of the tremendous amount of time and capital required, but it seemed to be the only path forward if we wanted to truly serve the needs of our growing patient base." [URL]https://www.statnews.com/2016/09/09/compounding-pharmacies-safeguard-public-health/[/URL] [/QUOTE]
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Compounding Pharmacy Product Reviews
Interview with Compounding Product Expert Shaun Noorian from Empower Pharmacy- Part 1
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