It’s a congressperson-palooza! | |
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Just over a month away, it’s looking like Compounders on Capitol Hill 2023 will feature more influential members of Congress actually at our conference than we’ve had in years – and that’s not counting all the meetings compounders like you will be having up on Capitol Hill.
Here’s the rundown of who we’ll be hosting:
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Senator Ben Ray Lujan of New Mexico, member of the Senate Health, Education, Labor & Pensions Committee, will join us late afternoon September 19 for a CompPAC fundraiser. He’s interested in how compounding can help in alleviating drug shortages, and with the HELP Committee considering pandemic preparedness legislation, it’s a great opportunity to brief him.
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We’ll host a fundraising dinner for Rep. Richard Hudson of North Carolina, member of the House Energy & Commerce Committee and the E&C Health Subcommittee on the evening of September 19. The subcommittee is where two of our compounding priority bills are assigned. This dinner is our opportunity to talk not only about those two bills, but also the threat to compounded hormones. It’s $1,000 per person to attend. More info coming soon.
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Influential House Energy & Commerce Committee member, Congresswoman Diana DeGette of Colorado will speak at breakfast on September 20. She’s an advocate for compounded hormone therapy and she’s interested in both our drug shortage and adverse events reporting bills. There’ll be Q&A, so come with your patient stories!
Add to that the 150 or more Hill meetings with members of Congress, plus conversations with FDA’s Gail Bormel and Angels for Change’s Laura Bray, and you can see why we say attending CCH is the best investment you can make in your compounding practice all year.
Act now. Get registered so you’re assured of getting appointments with your members of Congress. Oh, and our special hotel room rate is only good for another couple of weeks.
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CCH will be a Congressperson-palooza, and you need to be there.
– Anthony
Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com
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What does HR 167 do?
New resource provides current vs. future comparison
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Sure, you know that 503A pharmacies may compound drugs on the FDA shortage list. What you may not know is that the authorization for that comes from an FDA guidance document, not federal law. Preserving that ability in law is one of several substantive provisions of HR 167 (Griffith/Cuellar), APC’s shortage drug legislation now pending in Congress.
To help illuminate all that HR 167 does, we’ve created this comparison brief.
For instance, the legislation would allow 503A compounding pharmacies to distribute small batches of compounded drugs to hospitals or clinics, including drugs on the FDA Drug Shortage List or the ASHP Drug Shortage List, within some regulatory guardrails. You’ll recall that FDA allowed this for 13 COVID drugs during the pandemic under temporary guidance that has now expired. HR 167 would make that pathway permanent and expand it to other drugs that hospitals are unable to source from a manufacturer or a 503B outsourcing facility.
“We urge our members to read up on this bill,” said APC’s Savannah Cunningham. “It will be a key priority for Hill visits during Compounders on Capitol Hill – and likely for the remainder of the year and beyond."
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Bears repeating: Our 15-hour compounding curriculum is LIVE | | |
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Our new 15-hour online compounding course, “The Ethical, Legal and Regulatory Foundations of Pharmacy Compounding," is live and accepting students.
Created in partnership with the Pharmacy Compounding Foundation and the Virginia Commonwealth University School of Pharmacy, the APC program fills what for many new compounding pharmacists and technicians may be a training gap: A thorough understanding of the myriad laws, regulations, and standards that govern the practice of pharmacy compounding.
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It’s a big deal – and priced at $495 for pharmacists and technicians, it’s affordable. For APC Pharmacy/Facility Members, the price is $395. Learn more at certificate.a4pc.org.
Gummi bears image courtesy of mayasherizl from Pixabay.com.
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Some decent reporting on compounded semaglutide | |
| Just how many adverse event reports were received? Not many. In fact, there were no more than 30 reports sent to the agency from August 2021 through May 2023, according to an FDA spoksperson. In the scheme of things, this is a tiny number of adverse event reports given the exploding popularity of these two drugs. | | |
The story also calls out King & Spaulding – the serially losing law firm in state-law-based lawsuits against compounders – and its representation of Novo Nordisk in suits filed last month against four compounding pharmacies for compounding semaglutide in shortage. | |
Call for comments: Alabama BOP proposal | |
The Alabama Board of Pharmacy has proposed new rules that may require all pharmacists (not just the pharmacist in charge) at non-resident pharmacies licensed in Alabama to obtain an Alabama pharmacist license in order to work remotely. Comments are due by September 4 ahead of the public hearing on September 20.
We encourage you to submit comments on how this change would affect your ability to provide care for patients in Alabama to Board Operations Manager Wendy Passmore at wpassmore@albop.com.
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We’re looking for a few good directors | |
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We’re seeking passionate, informed, influential compounding leaders to help guide our alliance as members of the APC or Pharmacy Compounding Foundation Boards of Directors.
If compounding has been good to you, consider lending us what you’ve learned. Consider putting your knowledge and leadership ability to work on behalf of your profession.
Learn more about APC's open Board roles and nominate yourself here. Learn more about the Foundation's open Board roles and nominate yourself here.
Deadline for nominations is August 22.
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APC Annual Membership Meeting is September 19 | |
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As required by our Bylaws, the 2023 Annual Membership Meeting of the Alliance for Pharmacy Compounding will be held on Tuesday, September 19, 2:15pm at the Hilton National Mall in Washington, DC, in conjunction with the Compounders on Capitol Hill (CCH) conference. Board Chair-Elect Tenille Davis of Scottsdale, Arizona, will preside.
No registration is required to attend the annual meeting; however, registration is required to attend any other CCH events.
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Telehealth clinics are driving GLP-1 prescriptions. This STAT News story is behind the paywall, but here’s the gist: “New analysis of claims data from Trilliant Health suggests that collectively, telehealth companies — in particular, cash-pay options that market directly to consumers — could account for many of the patients with insurance claims for GLP-1 prescriptions in 2022.”
Wegovy study shows cardiovascular benefits. A recent study found that in addition to its weight loss benefits, Wegovy lowered cardiovascular risks by 20 percent.
Weight loss drug demand still outnumbers supplies. According to a news release yesterday, Novo Nordisk doesn't see its Wegovy supply issues resolving any time soon.
A mini monumental fact. There's a miniature version of the Washington Monument hidden inside a manhole cover near the full-sized one. Be sure to check it out during Compounders on Capitol Hill next month. #CCH2023
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Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:
Now until September 1: Discounted webinars via Restore Health. Available topics include quality control, quality assurance, and regulatory compliance. Bonus: APC's OneFund receives 50 percent of proceeds.
August 17-18: Informa Connect's Compounding Pharmacy Compliance, The Westin Copley Place, Boston, MA. Use CODE: 23A4PC15 to get 15 percent discount on registration.
August 29: An APC webinar, Business Valuations - Myths, Methodologies, and Planning Ahead
September 7: OutcomeMD Express Lunch & Learn for existing users. Free but registration is required.
September 11-13: FDA's Compounding Quality Center of Excellence Annual Conference (free, virtual)
September 14: An APC webinar, USP <797> Best Practices - It's Not Just SOPs (Part 1): From Personnel to Facilities, Equipment, Cleaning and Processes
September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC
October 5: An APC webinar, USP 797 Best Practices - It's Not Just SOPs (Part 2): From Packaging to Handling, Stability, Documentation, and QA/QC
November 2: OutcomeMD Express Lunch & Learn for existing users. Free but registration is required.
2024
April 4-6: Owner Summit, La Jolla, CA
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Alliance for Pharmacy Compounding | A4PC.org | APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org. |
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