The voice for pharmacy compounding │ 25 August 2023             

This issue is sponsored by PCCA

Are you registered yet for PCCA’s International Seminar 2023, October 26-28 in Houston? Make sure you’re there – in Houston or online – so you can stay in the know, all while catching up with your compounding colleagues! Act fast to save $200 on your in-person registration – Early Bird deadline is Friday, September 8. REGISTER TODAY: 

www.pccainternationalseminar.com

From our Board Chair

Want better regulation? Start here.

Are you as frustrated as I am by misguided and inconsistent regulation – regulation for which there’s no consistent interpretation or demonstrable benefit to patient safety? Yeah? Well then, help us do something about it.


A better regulatory environment starts with helping educate elected officials who are willing to listen to our concerns, willing to hold regulators accountable, willing to co-sponsor our key legislation.  

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You have three opportunities to do that coming up. APC and CompPAC will be hosting three “friends of compounding” at Compounders on Capitol Hill, and we’re urging compounders like you to make a contribution to their campaigns. That’s something you don’t have to attend CCH to do. In fact, just click the links below to send a little dough to the respective campaigns. It will be noted and will help us make a difference for your pharmacy compounding practice and job.


  1. CompPAC is hosting a fundraising reception with special guest Senator Ben Ray Luján (D-NM) – member of the Senate HELP Committee – on September 19. Give to CompPAC here. And support Senator Luján here
  2. CompPAC is hosting a 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 support that dinner here. Again, you don’t have to attend. The support is what counts.
  3. We’ll host House Energy & Commerce Committee member Diana DeGette (D-CO) at breakfast on September 20. (This is not a political event, it’s a policy briefing.)


If you want better regulation, help us turn friends into champions. That’s what support for these events – and CompPAC – can help accomplish.


Make a contribution today, even if you’re unable to attend CCH.


– 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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ICYMI

This week's news

RED ALERT:

Special CCH hotel rate ends Tuesday!

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.

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Arizona BOP changes course, will not adopt new USP chapters just yet

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.

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The million $ question: What’s it worth to ya?

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.

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Ending Sept 1: Webinar savings

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.

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Short takes

Potter's House Apothecary hosts AZ rep. Long-time friend of compounding Congresswoman Debbie Lesko (center) stopped by this week for a tour and visit with owner Kevin Borg and his team at his pharmacy in Peoria, AZ.  


503B bulk list update. Earlier this week, FDA announced it had not included two substances in the list of bulk drug substances that may be used in compounding by outsourcing facilities (503B bulks list). The agency made the determination not to include ephedrine sulfate and hydroxychloroquine sulfate because it found no clinical need for 503Bs to compound drugs using these substances.

The semaglutide beat:  

  • A recent NYT article (sorry, paywalled) explains that, while we’re happy with the effects of weight loss drugs, the reasons those drugs work is still murky.
  • Patients may love the quick convenience of getting semaglutide scripts via telehealth appointments, but there are two players who aren’t happy about it: payers and employers.
  • A common fiber supplement (behind paywall) is showing a resurgence in popularity as consumers look for weight loss options outside of semaglutide.


Congress and FDA attend to drug shortages. Three recent actions align with APC’s focus on drug shortages:

  • FDA Commissioner Robert Califf called for Congress to give the agency more power to tackle drug shortages.
  • House Energy and Commerce Chair (and APC member) Cathy McMorris Rodgers (WA) released a discussion draft on tackling drug shortages.  
  • The Senate HELP Committee passed legislation (behind paywall) that would mandate drug manufacturers notify the FDA about potential drug shortages.


Calories consumed during CCH don't count. Here's another sweet incentive to attend next month's Compounders on Capitol Hill: DC is home to Georgetown Cupcakes, the bakery featured on TLC's reality show, DC Cupcakes. (A cupcake run is no excuse for missing your Capitol Hill appointments, by the way.)

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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:


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 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, Best Practices in Safety & Quality for USP 797 – it’s not just SOPs


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

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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