The voice for pharmacy compounding │ 18 August 2023             

From our CEO

We’re little, but we’re loud

“We will be heard.”


That’s more than just a theme for Compounders on Capitol Hill 2023. It’s something we really mean.


When it comes to the role of outsourcing facilities and traditional compounding pharmacies in providing solutions to temporary drug shortages, we will be heard.

When it comes to repealing an obsolete MOU directive and replacing it with robust reporting by pharmacies to state boards of pharmacy – including adverse events reporting by 503As – we will be heard.


And when it comes to protecting patient access to life-enhancing compounded hormone therapy, we will be heard. 


Sounds good, right? But here’s the dirty little secret: We need you to help amplify our voice.


To be effective, we must be so loud we can’t be ignored. And we’re only as loud as the number of congressional offices we visit during CCH. And we can only arrange visits with those offices who have a constituent – that’s you – requesting a Capitol Hill meeting.


We’ll do the legwork, scheduling your meeting for you, making sure you’re well briefed. All you have to do is come, and add your voice to those of your compounding colleagues from across the country. 


We’re little, but we’re loud. If you join us – get registered and attend CCH – we’ll be a little bigger and a little louder. 

 

With your help, we will be heard.


Read on for more news.


– Scott


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

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ICYMI

This week's news

Help us cultivate champions

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, 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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As Nov 1 looms, is your team prepped for 795/797 compliance?

New 15-hour curriculum includes modules on new USP chapters

When we launched our new 15-hour compounding curriculum two weeks ago, we told you it was foundational learning for your entire team. What we didn’t say is that the course includes modules on the new USP Chapters 795, 797, and 800 that can help your team comply in advance of USP’s November 1 effective date. 


The program is The Ethical, Legal and Regulatory Foundations of Pharmacy Compounding – yeah, it’s a mouthful – and it includes a whole lot more than those USP modules. Check it out – to assure you and your teammates have the skills you need to compound with excellence.

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APC responds to Oregon BOP fiscal impact request

Last week, APC submitted a comment letter to the Oregon Board of Pharmacy in response to the Board’s fiscal impact request regarding compounding-related proposed regulation changes. 


In the letter, APC offered support for the proposed rule that would allow regular compounding of an approved drug if a wholesale distributor drug outlet is unable to obtain an adequate supply to meet patient needs.

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Updated NIOSH companion docs released

We continue to wait on a revised NIOSH hazardous drug list. But according to a recent article in Specialty Pharmacy Continuum, NIOSH recently released updated versions of two companion documents to the hazardous drug list, which itself is still in draft form. 


These documents include a "Procedures for developing the NIOSH list of hazardous drugs in healthcare settings,” which explains how NIOSH will evaluate drugs to place them into one of the tables.


The second one, “Managing hazardous drug exposures: information for healthcare settings,” suggests steps to consider incorporating into work operating procedures.

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New AIHA doc complements USP 800

The American Industrial Hygiene Association has released its Hazardous Drug Surface Contamination Guidance Document, which was developed to answer questions for compounding pharmacies when handling hazardous substances.

Short takes

Quirks of the US Capitol (to check out for yourself at CCH 2023):

  • Take me to the Senate bathtub! It’s possible to ask this of a Capitol Hill staffer and not get in trouble because there actually IS a bathtub in the basement of the building! Four marble tubs were installed in 1859 when most senators lived in boarding houses on Capitol Hill that had no running water, so they washed at work. One of these baths can still be seen today.


  • The teeny tiny doors. Throughout the building you may notice small arched doors in the walls. An 1851 fire in the building led to the creation of a plumbing system that was accessed via the mini closets. Since then, there have been considerable upgrades to the building’s fire prevention and safety, so while the closets no longer serve their original purpose, the doors remain intact.
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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, 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


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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