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The voice for pharmacy compounding | March 11, 2022<\/p>\n
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<\/p>\n Last week, I addressed APC\u2019s greatest weakness: membership. (Did you make your one call?)<\/p>\n The \u201cO\u201d in SWOT stands for opportunity.<\/em><\/p>\n APC has many, many, many opportunities. I could write a series on this one alone. Our future is bright. Let\u2019s talk about the positive direction of our alliance.<\/p>\n I could go on and on and on. The opportunities for us are tremendous in the next few years. Please join me in helping APC realize those opportunities.<\/p>\n <\/p>\n David Miller<\/strong> is APC\u2019s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com<\/a>.<\/p>\n<\/div>\n <\/p>\n <\/p>\n Earlier this year, seven members of Congress wrote to FDA, asking that the agency release the next version of its Guidance for Industry #256 on animal compounding as a draft rather than a final GFI.<\/p>\n On Wednesday, FDA responded to that letter with one of its own<\/a>. Notably, the agency says the guidance will<\/em> be final when it\u2019s issued \u2014 not a draft as requested. (And it\u2019s expected soon.) But that final version, FDA says, has been substantively amended based on stakeholder input.<\/p>\n We look forward to learning exactly what that<\/em> means.<\/p>\n<\/div>\n <\/p>\n <\/p>\n Last week, hundreds of cBHT prescribers received an email that purported to brief them on the threat to compounded hormones. It even urged them to go to compounding.com<\/a> and send a message to their members of Congress (and maybe leave a testimonial on the way out). Many, many of the recipients did exactly that.<\/p>\n Problem: The email \u2014 which did not<\/em> come from APC \u2014 had some misleading information, and it may have come across as crying wolf. The wolf is out there, make no mistake, but this message jumped the gun. It said FDA has announced plans to restrict compounded hormones. In fact, while FDA has dropped strong hints<\/em> to that effect \u2014 stating it will base its next steps on that discredited NASEM report \u2014 no plans have been announced. (You would have heard from us if they had!)<\/p>\n The nuance matters: FDA has made no announcements and has taken no action thus far to restrict cBHT. To suggest they have \u2014 particularly to suggest it to members of Congress \u2014 undermines APC\u2019s credibility. So please, take care how you portray this threat: We firmly believe restrictions are coming. But they haven\u2019t yet been proposed.<\/p>\n However:<\/strong> That inadvertently inaccurate email last week was apparently a wake-up call to the prescribers who received it. Many rushed to compounding.com<\/a> to send messages to Congress and alerted their patients to do the same.<\/p>\n That\u2019s exactly what we need them doing BEFORE FDA ACTS: We need prescribers to engage and help us confront this threat.<\/p>\n We’ve got three resources to help you engage YOUR prescribers (and patients!) in confronting this very real threat to compounded hormones.<\/strong><\/p>\n 1. A PRESCRIBER BRIEFING: The Threat to Compounded Hormone Therapy<\/a><\/strong><\/p>\n Share this short .pdf with all the cBHT prescribers you work with. It\u2019s accurate and to-the-point about FDA\u2019s implicit threat and how prescribers can help confront it. It ought to light a fire under \u2018em.<\/p>\n 2. BRIEFING PAPER: The Campaign to Save Compounded Hormone Therapy<\/a><\/strong><\/p>\n Here\u2019s a quick look at the campaign, including what we accomplished last year (as in raising $1.5 million and reaching 25 million Americans), how the money we raised last year was spent, and our plans for the $850,000 we need to raise by the end of April 2022 to continue the effort.<\/p>\n 3. APC\u2019s cBHT Campaign Resources Page<\/a><\/strong><\/p>\n Here\u2019s where you\u2019ll find tools and resources to help reach patients and prescribers \u2014 window clings, bag-stuffers, posters, and more. They\u2019re all free, by the way. Use them to spread the word to patients and prescribers about the threat!<\/p>\n And don\u2019t forget what may be the most important thing of all: Invest NOW in the campaign.<\/strong><\/p>\n <\/p>\n Please welcome \u2014 and visit \u2014 our two newest Corporate Patrons:<\/p>\n![\"Our](\"https:\/\/whizkid.com\/a4pc\/files\/2022-Sponsor-Block.png\")
<\/a><\/p>\n<\/div>\n\n\u27a4 From APC\u2019s President<\/h1>\n
SWOT, Part 4<\/h2>\n
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\n\u27a4 This Week<\/h1>\n
\nFDA plans final version of GFI #256<\/h2>\n
\nDon\u2019t miss out newest CE webinar<\/h2>\n
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<\/a><\/p>\n<\/div>\n\nJust the cBHT facts, please<\/h2>\n
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<\/a><\/p>\n<\/div>\n\nTwo new Corporate Patrons join APC<\/h2>\n
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<\/a><\/p>\n<\/div>\n![\"\"](\"https:\/\/whizkid.com\/a4pc\/files\/EduCon2022_60-Days.png\")
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