Through the generosity of the Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation will award up to two $2,500 scholarships in 2021 to pharmacy students who have demonstrated commitment to a career in compounding pharmacy in the United States.
Details of the EduCon schedule will be available soon, but the deadline to apply for the scholarship is January 8, 2021. Email firstname.lastname@example.org with questions.
To grow our influence and effectiveness on state-level legislative and regulatory issues, the APC Board has approved the formation of a State Legislative & Regulatory Committee for 2021.
Incoming President Michael Blaire is looking to appoint to that committee APC members who are passionate and informed about state-level public policy affecting compounding. The committee is expected to meet quarterly in 2021 via teleconference.
*If you have interest in serving, shoot an email to email@example.com before Wednesday, December 23, 2020.
As part of our effort to save cBHT, APC is helping to gather evidence from physicians that supports its safety and efficacy of cBHT.
We have developed a brief survey on Google Forms, which will take no more than five minutes for your physicians to fill out: Compounded Hormones for Female Patients is a survey assessment of prescribing habits and methods used to evaluate the safety and efficacy of female compounded hormones. This survey includes an invitation to contribute with potential case studies for scientific publication.
Please ask the physicians you work with to participate (by February 15, 2021). The kind of real data it will help us catalog will be vital in establishing the safety and efficacy of cBHT.
Out of the loupe? SCOTUS has said, essentially, that yes, states can regulate PBMs. The PBMs had argued (so far successfully) that the federal ERISA law preempted state regulations. Any state regs, they said, were automatically tied to ERISA and thus pre-empted by it.
‘Nuh-uh,’ said the Supremes: “The Court holds that the Act [the Arkansas law] has neither an impermissible connection with nor reference to ERISA and is therefore not pre-empted.”
Did you miss our webinar on the truth about peptides compounding? Or maybe e-prescribing? No worries: APC’s got you covered with our on-demand CE archive of those courses and more, just for compounders.
If you’re looking for a particular class — or just to top off your CE requirements — don’t settle for same-old, same-old content. Visit A4PC.org/cearchive and check out our lineup of great self-paced classes covering hot topics like peptides, shortage compounding, cBHT, smart accreditation, and much more.
If you compound hormones for patients, you need to be worried — and so do they. The FDA has said it will consider restricting or even eliminating cBHT based on a faulty research study.
This is an existential threat for the compounding industry, and potentially a nightmare for the millions of Americans who rely on cBHT therapy. It will require an ambitious, long-term, and nationwide effort to stop it.
The Alliance for Pharmacy Compounding, with your help, is stepping up to protect your business and your patients.
We’re planning a three-year, multi-pronged campaign to focus not on statistics, but on the human face of compounded hormone therapy: the patients it helps.
What do we mean by “a human face”? We’ll show you. Check out this proof-of-concept video for a feel of the campaign’s tone:
APC is planning a nationwide electronic, print, and video effort targeted at the people who can make a difference. (Here’s a three-page brief on the campaign.)
We’ve already laid the groundwork with an independent analysis of the flawed NASEM study at the heart of FDA’s excuses (generously funded by the Pharmacy Compounding Foundation and available early next year). We’re also collecting testimonials about the human value of cBHT on our portal (A4PC.org/cbhtandme) — we have more than 2,400 so far, but we need at least twice that.
Both of these will provide helpful information — ammunition, if you will — for the fight ahead. But they aren’t nearly enough.
This must be a tremendous effort — we need to raise $250,000 by the end of December for development and testing of the print, electronic, and video ads for a launch in February 2021. The full rollout will need $3 million over three years. In fact, we have already raised more than $120,000.
If 100 compounding pharmacies pledged $2,500 each — a small investment considering the scope of the threat — we would hit our initial goal immediately.
If they each chipped in just one percent of their cBHT revenues each of the next three years, it would cover the entire campaign — and allow us to protect the other 99 percent of that revenue. A small price to pay.
But the question isn’t how much it will cost. The question is: What will happen to your business and your patients if you cannot compound hormone therapy?
Please, take a moment and join your colleagues as a part of the solution — protect your patients and protect your business before restrictions take effect.
This is more than a contribution. It’s an investment in the future of your compounding practice and the ability to provide patients with the compounded hormones they need.
Thank you. If you have any other questions, we’d be happy to answer. Drop a note to APC staff at firstname.lastname@example.org or call us at (281) 933-8400. And for more information on the threat to cBHT and what APC is doing, visit A4PC.org/cbht.
The USP Compounding Expert Committee is — thanks to APC’s earlier work — in the process of reconsidering BUDs. It met Wednesday to discuss revisions to USP <795> and <797>.
The gist: The <795> subcommittee has been reviewing appeal letters and stakeholder engagement reports to get a handle on the issues stakeholders had with the proposed chapter. It’s looking at ways to provide explanations for the scientific rationale used in establishing the default BUDs for nonsterile compounds.
The <797> subcommittee has also been going through stakeholder feedback. It’s looking at the overall framework for assigning BUDs to sterile items. Current thinking: Keep the current category 1 and category 2 CSP structure for assigning BUDs, but create a framework for allowing the extension of BUDs beyond the current defaults. (Subcommittee chair Connie Sullivan made it clear that the subcommittee has heard and understands the gap that exists between small 503A pharmacies and 503B outsourcing facilities.)
Both reports were somewhat encouraging in the sense that the subcommittees seem to have taken a deep dive into the comments and rationale provided by us — comments that point out the practical problems with the BUDs in both chapters.