{"id":3896,"date":"2022-04-15T10:27:41","date_gmt":"2022-04-15T14:27:41","guid":{"rendered":"https:\/\/a4pc.org\/?p=3896"},"modified":"2022-04-29T10:31:31","modified_gmt":"2022-04-29T14:31:31","slug":"cc-april-15-2022","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-04\/cc-april-15-2022\/","title":{"rendered":"CC: April 15, 2022"},"content":{"rendered":"

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\"Masthead\" <\/p>\n

The voice for pharmacy compounding | April 15, 2022<\/p>\n<\/div>\n

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\"Our<\/a><\/p>\n<\/div>\n

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From APC\u2019s President<\/h1>\n

$233 Million per year \u2014 some of it to oppose you.<\/h2>\n


\nDavid J. Miller, RPh
\nAPC President<\/span><\/p>\n

That\u2019s the amount of money the big pharmaceutical companies are using to build relationships with members of Congress. And I\u2019m sure it\u2019s not lost on you that pharma is using some of those relationships to spread a message that isn\u2019t very compounding-friendly.<\/p>\n

Perspective<\/h4>\n

Last year, the Alliance for Pharmacy Compounding\u2019s Political Action Committee raised a record $100,000 \u2014 our best year ever, and we felt pretty good about it.<\/p>\n

That was only 0.053% of what the commercial pharmaceutical industry spent on lobbying. For every dollar we spent on relationship development, Pharma spent $1,864.<\/strong><\/p>\n

APC has one registered lobbyist. Big Pharma has 1,274<\/strong>.<\/p>\n

You get the idea. And it\u2019s particularly important during an election year \u2014 relationships built during tough races are not forgotten.<\/p>\n

Think ahead<\/h4>\n

So far this year, CompPAC has raised about $47,000 and the truth is that only 34 of our 2,000 members have invested. Thirty-four<\/em>. And yes, invested<\/em>. The money you spend on CompPAC is an investment in the long-term viability of your business.<\/p>\n

Our goal for 2022 is $150,000<\/strong>. Help us meet this goal.<\/em><\/p>\n

If 100 of you donated a tiny fraction of your salary to CompPAC, we\u2019d meet that goal in a day. We have 1,200 new technicians among our ranks since January. If each of them spent $125 on the future of the profession, that would do it too.<\/p>\n

Whatever you can afford to give, please do so \u2014 $10, $100, $1,000. It\u2019s an election year, and your profession is depending on you.<\/p>\n

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Remember, all PAC contributions need to be from personal, not company, funds; maximum contribution is $5,000.<\/em><\/p>\n

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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

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This Week<\/h1>\n

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FDA releases final animal compounding\u00a0GFI<\/h2>\n

On Wednesday FDA released the long-awaited final version of its Guidance for Industry #256<\/a> on animal drug compounding.<\/p>\n

We\u2019ve begun reviewing the 22-page document<\/a> in detail but our preliminary take is that the Center for Veterinary Medicine accepted at least some<\/em> of the changes we and others recommended, although it also appears that some of our most substantive concerns with the earlier draft GFI were not fully addressed.<\/p>\n

For example, and most notably, this final GFI retains the positive list for office-stock compounding. That\u2019s troubling because we believe it is not supported by federal law and will unnecessarily preempt state pharmacy and veterinary laws. The effect could be be to limit access to drugs needed by vets to treat animals.<\/p>\n

You can read our first-look summary of this final GFI, as well as the changes compared to the 2019 draft version \u2014 here<\/a><\/strong>.<\/p>\n

\u201cWe appreciate that the CVM took the time to hear our concerns and to address some of them in the final GFI,\u201d said APC President Dave Miller. \u201cWe understand the need to balance animal health and safety with the availability of essential compounded meds to veterinarians.\u201d<\/p>\n

Miller said he looks forward to discussing our continuing concerns with the CVM team. The agency has already invited APC leaders to sit down with them for that discussion, in fact.<\/p>\n

Of note to veterinary compounders, we\u2019ve been told that there will be some enforcement \u201cbreathing room\u201d of at least a few months before FDA begins enforcement, during which time the agency will be engaging stakeholders to detail how it expects the policy to work and to receive feedback.<\/p>\n

APC will provide more information on GFI #256 after we\u2019ve had more time to analyze it. Keep an eye on your inbox and for future editions of Compounding Connections<\/em>.<\/p>\n

APC holds briefing on La Vita situation<\/h2>\n

More than 150 people registered for APC\u2019s town hall briefing this week on the California Board of Pharmacy\u2019s complaint against La Vita Compounding Pharmacy. California regulators have filed a complaint against La Vita for compounding sterile preparations with glutathione and methylcobalamin. It\u2019s a matter that has nationwide implications \u2014 as APC Board Chair Michael Blaire said in the briefing: \u201cIf California gets away with this, other states will try it, too.\u201d<\/p>\n

Money quote:<\/p>\n

It\u2019s hard to believe in 2022 we\u2019re fighting for vitamin B12, but here we are.<\/em> \u2014Chris Givant, co-founder of La Vita Compounding Pharmacy<\/p>\n

With support from our Legal Action Fund, APC submitted an amicus<\/em> brief in support of the pharmacy, and is keeping a close eye on the court proceedings.<\/p>\n