{"id":3926,"date":"2022-01-21T10:48:20","date_gmt":"2022-01-21T15:48:20","guid":{"rendered":"https:\/\/a4pc.org\/?p=3926"},"modified":"2022-04-29T10:49:16","modified_gmt":"2022-04-29T14:49:16","slug":"cc-january-21-2022","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-01\/cc-january-21-2022\/","title":{"rendered":"CC: January 21, 2022"},"content":{"rendered":"

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

The voice for pharmacy compounding | January 21, 2022\n<\/p>\n


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THIS EDITION SPONSORED BY HEALNOW<\/h1>\n
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From APC\u2019s President<\/h1>\n

The power of one<\/h2>\n


David J. Miller, RPh
APC President<\/p>\n

I\u2019m asking you for one. Only one. Let me explain.<\/p>\n

One contact.<\/strong> We have many opportunities and face many threats in 2022. The best way we can take advantage of opportunities and fight the threats is by increasing our numbers. <\/p>\n

Would you make one call or send one e-mail this week?<\/em> Or one telephone call or e-mail? Would you call a colleague who is not an APC member and ask them to join, or enroll one of your technicians? Yes, only one. If every member gets another to join APC, we can double in size this week!<\/p>\n

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One percent.<\/strong> The threat we face with cBHT is tremendous. It is expected that the FDA will take action on the NASEM report sometime this year. For the past 20 years, I have taken the 1 percent rule: I donate 1 percent of revenue to defend my profession. I have taken this to heart with the cBHT campaign. I donate 1 percent of my cBHT revenue to APC to protect this important part of our profession. <\/p>\n

For many of us, half our revenue could come from cBHT \u2014 without this important segment of our business, many of us would go out of business. Isn\u2019t 1 percent worth it to help protect the other 99 percent? Please consider donating to the Campaign to Defend cBHT.<\/p>\n

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More one percent<\/strong>. Political action committees or (PACs) are the chief way that organizations can develop relationships with law makers who can influence legislation with is favorable to compounding. I donate 1 percent of my personal income to APC\u2018s CompPAC to ensure that these relationships are developed and strengthened. <\/p>\n

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Do you believe in the \u201cpower of one\u201d? Will you join me making one contact this week, contributing 1 percent of your cBHT sales to the Campaign to Save cBHT, and 1 percent of your personal income to the CompPAC? It is vitally important to our profession. We need only one!<\/p>\n

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\nDavid 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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USP BUD changes: \u2018Where\u2019s the patient benefit?\u2019 ask presenters in prescriber briefing<\/h2>\n

APC and NCPA hosted a briefing Thursday to explain USP\u2019s proposal to restrict beyond-use dates in Chapters <795> and <797> \u2014 and the ramifications for patients. Nearly 800 registered for the briefing. The aim is that, seeing the risk to those patients, providers will join with pharmacy compounders to comment on the proposals \u2014 and to ask in particular that the proposed restrictions on BUDs for sterile compounds be reconsidered.<\/p>\n

In the briefing, presenters Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., and Anthony Grzib of Wedgewood Pharmacy in Swedesboro, N.J., asserted that USP has provided insufficient rationale or scientific evidence for how these proposed changes will benefit patients.<\/p>\n

USP\u2019s proposed changes to sterile<\/em> compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add \u201clikely cost-prohibitive\u201d to that list: Stability studies have a price tag of around $30,000, Davis said.<\/p>\n

The proposals would also limit batch sizes across the board to 250 units \u2013 a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times.<\/p>\n

USP\u2019s proposals would also impose arbitrary upper BUD limits as low as 60 days \u2014 even if existing, rigorous stability data justify a longer BUD.<\/p>\n

\u201cAt the end of the day, these proposals won\u2019t do anything for patients except require them to refill more frequently and increase the costs of those refills,\u201d said Grzib.<\/p>\n

For more detail, on the USP proposals, you can read the slides presented at the town hall here<\/a> (PDF) or watch (and share it with your prescribers!) this video of the briefing:<\/strong><\/p>\n

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At the request of APC, APhA, and NCPA, USP has extended the deadline for comments on its proposals to March 17. We urge you to submit comments:<\/em> <\/p>\n