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The voice for pharmacy compounding │ 24 June 2022

From APC's President

Coffee for a cause 


My wife Cathy loves Starbucks and I suspect that many of you do, too. 


There is something about that little cup of hot, aromatic brew that triggers dopamine centers in the brain. Cathy believes it is an investment worth making to ensure her day starts off on a good, thoroughly caffeinated foot. 


I'd like to suggest another wise investment you should be making regularly: APC’s CompPAC.


CompPAC is how we develop relationships with members of Congress, and support their campaigns, thereby giving us opportunities to advocate for our patients—who also happen to be their constituents.


Last year, CompPAC raised $105,000, thanks to you. So far this year – an election year – we are only on pace for about $50,000. In order to be taken seriously, CompPAC must raise $150,000 per year to be considered “influential" and to get our champions elected.


Let’s go back to Starbucks. If every one of you invested a year's worth of the cost of two cups of Starbucks per month—$10 per month, $120 annually—we would raise $276,000. (Of course, $10/month is just a suggestion. You could also make it a grande cinnamon dolce with 8 pumps of flavor, almond milk, extra hot, if you wish.)


The point is, instead of the 50 or so donors that we currently have donating to CompPAC, we are asking all 2,300 of you to donate to help us meet our goals.


Won’t you join me in the Starbucks challenge? To make a one-time or an ongoing monthly contribution to CompPAC, click here.


• • •


David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at [email protected].

ICYMI

Five recent stories that you shouldn't miss:

  

This week

APC, sister groups present to FDA 


APC, APhA, NCPA, and PCCA were singing from the same sheet of music last week in FDA’s annual Pharmacy Compounding Listening Session.


In prepared remarks, each organization’s representatives were largely unified in the concerns they raised, from the final GFI on animal compounding to ambiguity in FDA’s insanitary conditions guidance to the implicit threat that FDA will restrict compounded hormone therapy.


Other issues raised with FDA were:

• The agency’s slowness to close 483 files after mitigation is completed.

• Next steps on the MOU regarding interstate shipping of compounded drugs.

• The desire to work with FDA in creating a coherent, state-based adverse events reporting framework for compounded medications.

• Problems with the PCAC process.

• The need for a pathway for 503As to compound shortage drugs for hospitals and clinics.


“We think there is common ground to be found in dealing with a range of pharmacy compounding issues,” APC’s Scott Brunner said in APC’s comments. “That common ground can help FDA achieve its policy objective of keeping patients safe, while also preserving patient access to essential compounded medications. And it’s a much better alternative than ongoing head-butting, overreach, and litigation.”


Most of the presenters—including those for APhA, NCPA, and PCCA—were APC members, including Natalie Young, Steve Hoffart, Cheri Garvin, Amy Shank, and AJ Day.

MOU Op Ed:

FDA is in a hole. It should stop digging.


An opinion piece by APC’s Scott Brunner, published this week in Pharmacy Times, argues that the FDA ought to abandon the MOU on interstate shipments of compounded medications “because the specific problem the MOU was conceived in 1997 to address no longer exists.” Instead, Brunner writes,


“…The FDA should join with the compounding profession to change the law. Eliminate that out-of-date MOU requirement—an MOU that several states have already said they can’t sign (because of state law) or won’t sign (because of the administrative burden). In its place create a statutory regime for reporting shipping info to state boards of pharmacy, to be shared with FDA.”


Read the full op ed here.

Meet two APC members running for state legislature 


We can never have too many APC members in elected office. Here are two who are seeking their first terms in their states' elections:


  • Phillip Rigsby is running for election to the Alabama House of Representatives, representing District 25. He won his primary election and is on the ballot in the general election on November 8, 2022. Learn more about Phillip here—and how you can help provide him the support he needs to win.


  • David Rochefort recently announced his candidacy for New Hampshire State Representative for District 1, a newly created 3-seat district. We’ll share a link to his campaign page when it’s up and running.
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Share Williamsburg Drug’s "Save cBHT" card with your patients


Our friends (and PFM members of APC) at T.W. Taylor’s Williamsburg Drug Co. in Williamsburg, Va., have produced a nifty patient-facing card about the threat to compounded hormones—and they’re allowing us to share it with you.


You can download the card here. Print it on card stock, place it on your counter and use as a bag stuffer to help educate your patients on how they can help assure their continued access to cBHT.

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Save these dates

June 29: The Itch Cannot Scratch: Veterinary Dermatology Webinar, presented by ARL Bio Pharma


June 30: APC's Tech Connect, a virtual Town Hall with Pharmacy Technicians


June 30: APC Fellows Program application deadline


July 21: APC Briefing: Credit Card Fee Savings


September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC


October 2629: PCCA's International Seminar, Houston, TX (in-person + virtual)

Short takes

Congrats! Two APC members were recognized at the Arizona Pharmacy Association's annual convention last week: Tenille Davis received the 2022 AzPA Pharmacist of the Year, and Melinda Browning received the 2022 Pharmacy Appreciation Award. Both women work for Civic Center Pharmacy in Scottsdale.


Mark Cuban shows Medicare how it's done. The billionaire businessman launched a direct-to-consumer generic prescription drug company earlier this year. The prices of 89 generic drugs sold by Cuban's pharmacy compared to the prices Medicare paid in 2020 showed that the latter overpaid by $3.6 billion in one year. Read the full story here.

Quick links



APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill 2022


Continuing education

• Live webinars

• On-demand webinars


Current issues:

GFI #256 on animal compounding

Urgent-use compounding

Prohibition on peptide compounding

La Vita Case amicus filing

Insanitary Conditions amicus filing

   


Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund


Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members


Affinity service providers

Accounting & Tax Services: Rx Advisors

Office Equipment: TUI Solutions

Online Payments Platform: HealNow

Patient-Reported Outcomes: OutcomeMD

   

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APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to [email protected].