APC News
Published September 9, 2023
Earlier this week, APC submitted comments to the FDA docket regarding the draft guidance for industry, “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” The comments are in support of the draft GFI but request several specific clarifications be included in a final GFI.
Last Friday, APC submitted comments to the Energy & Commerce committee on drug shortages to encourage the inclusion of HR 167 in any legislation to address drug shortages that the committee may pursue.
Published September 9, 2023
Compounders on Capitol Hill 2023 is coming in hot, with less than three weeks to go. Thus far we’ve thrown plenty of good reasons at you for taking two days in September to fly to Washington DC and make a case for pharmacy compounding to your members of Congress.
But as our Board Chair’s column above makes clear, there’s one reason that trumps all the others: Advocating for your business on Capitol Hill is political insurance.
It’s how you protect your investment in your pharmacy or facility. It’s how you protect the jobs of those who you employ. It’s how you protect your ability to earn a living.
We need you with us on September 19-20. And so does your pharmacy.
Time is running out. Get registered:
Published September 9, 2023
Lots of you are new-ish to APC, so you may not know about the, um … shall we say superhuman? … work we do to advocate for you: your job, your practice, your patients.
To brief you, we’ve created a colorful new informational piece, coming your way soon in the mail. It tells the story of what we do, why the work we do matters, and what you can do to support us. Give it a look when it lands in your box. It’s super!
Published September 9, 2023
Keystone Pharmacy owner David Miller, his wife Cathy, and Wedgewood Pharmacy’s Michael Blaire are hosting a special fundraising event in honor of two compounding champions: Congresswoman Diana Harshbarger (TN-01) and Congressman John Moolenaar (MI-02). You don’t have to attend to support the event. If you can contribute to these champions, contact Dave directly.
Published August 8, 2023
If you’re coming, now’s the time to get registered
APC’s Compounders on Capitol Hill is just around the corner (Sept 19-20). It’s your once-a-year chance to meet with your members of Congress on their turf and help us advance compounding legislation that helps your practice and patients.
But there’s an upcoming deadline you need to be aware of: The special CCH hotel room rate of $319 ends this Tuesday, August 29. After that, the cost goes up significantly.
The 29th is also the deadline to let us know you want us to schedule meetings on your behalf with your Congresspeople. But you have to be registered for the conference for us to do that.
Don’t delay! Click HERE to secure your CCH meetings and accommodations.
Published August 8, 2023
Understanding the true value of your compounding pharmacy often gets pushed to the backburner while you focus on patient care and day-to-day operations. And many pharmacy owners hesitate to assess their business’s value due to perceived challenges in the valuation process.
Our August 29 live webinar, Business Valuations – Myths, Methodologies, and Planning Ahead, will help you define your biz’s worth. Financial expert Michael Tarrant will help you understand the importance of early business valuation, simplify the intricacies involved, and guide you in efficiently and accurately assessing your compounding pharmacy’s value to help ensure future informed financial decision-making.
Click here to register.
Published August 8, 2023
The Arizona Board of Pharmacy last week moved to delay enforcement of new USP 795, 797, and 800 chapters in the state.
At the request of the Arizona Pharmacists Association and other groups, the board vacated its June 2023 vote to adopt and enforce the new chapters starting November 1, and instead voted to convene a task force to review the new guidelines to determine whether they will be enforced at all, enforced in part, or enforced based on pharmacy service acuity/risk analysis.
The Scottsdale-based law firm Boesen & Snow represented the above-named clients in this matter and made persuasive arguments to the board.
This is a prudent step by the board, and we believe the June advisory memo we sent to state boards of pharmacy helped ensure the messaging was clear.
Published August 8, 2023
APC members who are looking to pick up extra CE credits but don’t want to break the bank have until September 1 to take advantage of discounted webinars via Restore Health.
Available topics include quality control, quality assurance, and regulatory compliance.
The best part of all? APC’s OneFund receives 50 percent of proceeds.
Check out the available programs here.
Published August 8, 2023
For two months now, APC has been marketing something called “CCH” – as if everybody and their brother knew exactly what we were referring to. But many of you may not be familiar with this event, and it occurs to us that some explanation might be helpful.
The following is to help you understand a bit about what happens during Compounders on Capitol Hill, Sept 19-20, and why it’s in your interest to attend.
What is it?
Compounders on Capitol Hill is also referred to as a fly-in. It’s where compounders across the nation “fly in” to Washington DC for meetings with their members of Congress.
Why can’t I just meet with them here at home?
You can. And we hope you will. But flying to DC to meet with your elected officials on their turf demonstrates a remarkable commitment to and passion for your compounding practice and the patients you serve. It tells members of Congress you’re willing to put your money where your mouth is and come to DC to get their attention. That makes them much more inclined to listen … and to act on your requests.
Sounds time-consuming.
It’s not. In fact, you’ll only need to be on the ground in DC for about 18 hours – about a day and a half. It’s only one overnight in a hotel for most attendees.
Okay, so what’s the program?
DAY ONE: Arrive by 11am or so on September 19, and participate in an afternoon of briefings on compounding’s priority advocacy issues – including two pieces of legislation we’ll be asking Congress to pass. You’ll also network, meet vendors, socialize, see your colleagues’ achievements recognized, and participate in events that are aimed at cultivating compounding champions in Congress.
DAY TWO: On September 20, you’ll head to Capitol Hill after breakfast to meet with your House member and two US senators and brief them on those priority issues you heard about the day before.
In about half or more of those meetings, it is the staffer of that elected official you’ll meet with, usually because the elected official has a conflict.
- You may be tempted to be disappointed if you have to meet with a staffer rather than the elected official himself or herself, but don’t be. It’s staffers who move policy forward, and meeting with them can often be just as productive as meeting with the elected official.
Uhhhh, I have no idea how up meetings with congresspeople.
Don’t sweat that part. APC schedules the meetings for you! After registering for CCH, you’ll receive a link to a short form for requesting your visits. Fill it out, then work to set your appointments. Your schedule will be sent out a few days before CCH begins, and you will use our conference app to keep track of where each appointment is and with whom you are meeting. (By the way, if your pharmacy has facilities in multiple jurisdictions, you can request meetings with the respective members of Congress where a facility is located, even if you are not a constituent.)
What happens during the meetings? What do I say?
Each meeting will be brief – usually 15-20 minutes. We’ll advise you on Tuesday how to maximize that limited time. It’s essential that you stay on point so that the elected official or staffer gets to hear the key points you are there to convey.
What are the issues?
The three main issues you’ll discuss are:
- The essential role of compounding pharmacies and outsourcing facilities in alleviating drug shortages, and how HR 167 will allow compounders to alleviate many temporary shortages.
- The ongoing threat to compounded hormone therapy.
- Legislation to eliminate the MOU and replace it with mandatory reporting requirements for compounding pharmacies that ship more than 50% of their production across state lines; and to implement a mandatory adverse event reporting framework for 503A compounding pharmacies.
Is there any follow-up I need to do after my meetings?
Yes. After each meeting you should send a follow-up email, thanking them for their time and reminding them briefly of the asks. You can share your notes from the meetings via the conference app (it’s quick and very easy!).
Ready to travel?
Great! Click here for the schedule and the registration link. We promise: Attending CCH 2023 will be the best thing you can do for your compounding practice this year.
We hope to see you in DC this September 19-20!
Published August 8, 2023
It’s good to have friends, but in Congress, it’s better to have champions.
Cultivating new compounding champions is the purpose of three upcoming events at Compounders on Capitol Hill, September 19-20, including:
- A CompPAC Fundraising Reception with special guest Senator Ben Ray Luján (D) of New Mexico on the afternoon September 19. Tip: You don’t have to be present to lend your support. Give to CompPAC here. And support Senator Luján here (be sure to indicate you’re a pharmacy compounder).
- Dinner for House Energy & Commerce Committee member Richard Hudson (R-NC) on the evening of September 19. Remember, E&C is where the majority of compounding legislation is assigned. You can attend that by registering here.
- Remarks by House Energy & Commerce Committee member Diana DeGette (D-CO) at breakfast on September 20. Support Congresswoman DeGette here.
Please help us cultivate new compounding champions by supporting these events – either attending in person or contributing from afar.
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