The voice for pharmacy compounding │ 8 September 2023             

 

This issue is sponsored by Pharma Source Direct

Pharma Source Direct is a proud sponsor and exhibitor at Compounders on Capitol Hill 2023. Don't miss this opportunity to engage with legislators and advocate for your patients and profession. While you're there, stop by Pharma Source Direct’s table, say hello, and learn about what we do as a wholesaler of fine chemicals for use in pharmaceutical compounding.  www.pharmasd.com

 

From our CEO

 

Mother Nature, Congress, and the case for compounding

Maybe the only thing more inscrutable than Mother Nature is Congress. 

 

But this week, the results of Mother Nature’s arbitrary, devastating handiwork – the destruction of a Pfizer plant in North Carolina back in July – contributed to a prospective invitation for APC to testify to a congressional committee about the role compounding pharmacies and outsourcing facilities must be empowered to play in mitigating the temporary drug shortages that are sure to result from that destroyed facility. 

(We’re using the word “prospective” only because, as of this writing, it hasn’t yet been formally posted to the committee calendar.)


Unlike the tornado, that potential invitation to testify isn’t arbitrary. It didn’t just happen. Rather, it is the result of APC using every arrow in our advocacy quiver over the past several weeks:


  • Lobbying by our capable team of David Pore and PCCA’s Amy Shank
  • Leveraging relationships we’ve cultivated via CompPAC, our political action committee
  • Calling on our congressional friends – especially Cong. Diana Harshbarger, who is a compounding pharmacist – to urge committee staff to include compounding in the hearing

 

Our proposal is simple: With some relatively minor tweaking to law or policy, pharmacy compounding can be a solution to temporary drug shortages in hospitals and clinics – 503As in the near-term and 503Bs in the longer term, when timing and economic model facilitate them ramping up production. We’re talking about a very intentional, cascading system in which the A fills the gap until the B can ramp up – very much like what FDA allowed with 13 COVID drugs under temporary guidance during the pandemic. And yes, we support a “long tail” of 180 days for 503Bs to continue to distribute shortage drugs after the drug comes off the shortage list.

 

That’s the case Revelation Pharma CEO and former APC Board Chair Shawn Hodges of Kennesaw, Georgia, will make (prospectively!) to the House Energy and Commerce Committee Health Subcommittee this coming Thursday, September 14. And it’s the case we’ll make to the rest of Congress via more than 150 Hill meetings during Compounders on Capitol Hill, September 19-20.

 

Mother Nature is arbitrary – and sometimes Congress can be, too – but when it comes to elevating your pharmacy compounding practice, APC is intentional. And persistent. And effective.

 

Stay tuned for more info coming next week about Shawn’s (prospective) testimony.


– Scott

 

Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.

ICYMI

 

This week's news

 

Welcome: A Bronze CP and 31 new PFMs

ReflexMD, a telehealth platform, is now a bronze-level APC Corporate Patron. APC's ability to protect your profession is in part due to the support from Corporate Patrons like ReflexMD.

We also welcome these 31 new Pharmacy/Facility Members into the fold, bringing our total number of PFMs to 130: 

Not a PFM and wondering if it’s right for your pharmacy? APC offers the PFM program for 503A pharmacies and 503B outsourcing facilities of all sizes as an alternative to individual memberships. With PFM, your entire team enjoys the benefits of APC membership. Learn more. 

It’s greatest hits week at APC

The APC team is busy getting ready for Compounders on Capitol Hill in 12 days, and we suspect you’re busy juggling work, back-to-school, and getting ready for CCH in 12 days, too.


So here’s a quick rundown of some recent, useful APC offerings, in case you missed them the first time around:

Foundational compounding education for you and your team. Called The Ethical, Legal and Regulatory Foundations of Pharmacy Compounding, it’s designed for new pharmacists and techs, but it’s also an excellent refresher for seasoned pros.


It’s especially relevant right now because the program includes modules on the new USP Chapters 795, 797, and 800, which can help your team comply in advance of USP’s November 1 effective date. Oh, and it’s completely online and priced at less than $500. 

Teach prescribers well. (Apologies to CSN)

Compounding fact sheets geared towards medical professionals

Medical professionals are not always as well-versed in how pharmacy compounding works and can benefit their patients' treatment plans, so it’s up to you to guide them. That’s why we offer a series of Prescriber Briefs that you can share with them. Topics include:


  • The Truth About Pharmacy Compounding
  • Compounding Peptides: It’s Complicated. 
  • Prescription Compliance: DEA’s “Wet Signature” Requirement. 
  • Documenting Medical Rationale. 
  • Compounding for Racehorses: An Overview for Veterinarians. 


Find them here, and share them with the physician offices you or your sales reps visit. (Note: It’s an APC member-only tool, so you’ll need your login and password to access it.)

cBHT: Tools of Engagement

In July and August, Fox Business Network aired an APC-produced ad on the threat to compounded hormones. That ad and this long-form version of it are part of a comprehensive media campaign made possible by your generous investments in our “Save cBHT” campaign. 

You’ll find those vids in our special marketing toolkit. Use these tools to help raise your patients’ and prescribers’ awareness of the threat to cBHT.

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Short takes

 

Buchta joins Buckeye BOP. APC member Anthony J. Buchta, Sr, with Central Ohio Compounding Pharmacy (an APC PFM) in Worthington, Ohio, has been appointed by Gov. Mike DeWine to the Ohio State Board of Pharmacy for a term beginning September 1, 2023, and ending June 30, 2027.  


In memoriam. We're saddened by the recent death of IACP past president David Nicoletti. He was the owner and operator of Prescription Lab Compounding Pharmacy in Tucson, AZ. David was always a great advocate for IACP/APC: He served on the IACP Board of Directors, including as president, and was an APC Fellow.


Mr. Vader goes to Washington. A sculpted head of Darth Vader is located on the northwest tower of the Washington National Cathedral amongst the gargoyles. You can check it out in person during Compounders on Capitol Hill, September 19 - 20.

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Save these dates

 

Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:


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


September 28: An ARL Bio Pharma live webinar, Beyond The Survey: Top Findings and How to Implement Change in Your Pharmacy


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


October 26-28: PCCA’s International Seminar 2023 in Houston, TX


2024

April 4-6: Owner Summit, La Jolla, CA


June 20-21: EduCon Virtual: The Ethical Compounding Conference

 

Quick links

 

APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill


Continuing education

• Live webinars

• On-demand webinars


Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding (HR 167)

• Adverse events reporting framework 

• Saving compounded hormones


EduCon


Owner Summit


Prescriber Briefing Resources


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

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

• Pharmacy Technician Certification Board

• Shipment Trackers, a shipping costs auditor 

• TUI Total Solutions

• TxtSquad


 
 

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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