The voice for pharmacy compounding │ 4 August 2023             

This issue sponsored by Medisca

From our Board Chair

We’re the fix for temporary drug shortages

You’re likely aware of the drug supply issues caused by the unexpected damage to Pfizer’s North Carolina manufacturing facility. And the current shortage of drugs used in cancer treatments like cisplatin and carboplatin. 


While supply chain interruptions and lack of availability of FDA-approved manufactured drugs are nothing new to us, shortages have rightly been getting more attention on the Hill and from FDA.

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Rest assured APC has been asserting itself in these drug shortage conversations to make clear that compounders – both 503B outsourcing facilities and 503A pharmacies – are part of the solution.


The concept is pretty simple. When drug manufacturers are unable to meet patient demand, 503B outsourcing facilities should be the first-line back-up supplier. But if outsourcing facilities aren’t already making the medication that is unexpectedly in shortage, 503A pharmacies should have the ability to provide those medications to hospitals and clinics until outsourcing facilities can bring those medications on-line.


Essentially, all three types of drug producers – manufacturers, outsourcing facilities, and pharmacies – have a proper role in helping assure patients have continued access to medication.

 

The recent events at Pfizer’s North Carolina facility give us a prime opportunity to educate lawmakers and the FDA on this concept and to drive home the solutions like these:


  • Supporting legislation that incentivizes 503B outsourcing facilities to invest in producing shortage drugs by allowing 503Bs to continue selling those drugs for a period of time after they become available again from the drug manufacturer.
  • Supporting HR 167, legislation that would allow 503A pharmacies to provide urgent-use medications for hospitals and clinics when those medications are not available from drug manufacturers or outsourcing facilities.
  • Until the above legislation is enacted, urging FDA to introduce temporary guidance to remove roadblocks shorten the ramp-up time for outsourcing facilities to more quickly respond to manufacturer supply chain issues – and to allow 503A pharmacies to fill the gap in providing urgent use medications not available from a 503B to hospitals and clinics.

 

This is why attending CCH this year is important – it’s an opportune time for members of Congress to hear solutions to drug supply chain issues – and you are exactly the right person to educate your representatives about how compounding can help. Join us.

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– 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

ICYMI

This week's news

15-hour online compounding program goes LIVE

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As pharmacy compounders, what you don’t know can hurt you一and the patients you serve.


Your competence and credibility rests on your ability to prepare compounded medications with the utmost care and in complete compliance with all the laws and regs and standards that guide pharmacy compounding practice. Just one mistake can lead to serious patient harm and a hit to your credibility and your pharmacy’s, too. 


It’s essential that you know a set of constantly changing regulations and standards that guide every aspect of how you prepare a compounded medication—not just the what but the why


That’s why APC has partnered with the Pharmacy Compounding Foundation and the Virginia Commonwealth University School of Pharmacy to launch a new 15-hour online continuing education program called “The Ethical Legal & Regulatory Foundations of Pharmacy Compounding.” 


As the name implies, it’s meant to be foundational learning for compounding pharmacists and technicians. It’s high-quality, affordable training you can access without travel or additional expense. (If you are an employee of an APC Pharmacy/Facility Member, the registration fee drops from $495 to $395!)*


You can learn about the program here.


*Not a PFM? Not a problem! Learn more here or contact jason@a4pc.org

Laura Bray is an angel for change

At CCH, you’ll hear how the organization she founded is addressing drug shortages – and equipping 503Bs 


Laura Bray’s daughter Abby was undergoing chemotherapy and had developed a life-threatening allergy to one of her critical treatments. Unfortunately, the only alternative had been in drug shortage for years. The doctors told Laura there was nothing they could do.


Well, Laura tracked down the much-needed treatment in 10 days, plus two more drugs that were in shortage during Abby’s treatment.


She realized that if her family was experiencing these issues, others were, too. So, she founded Angels for Change to make sure no one else was refused access to life-saving medications due to drug shortages. 


Laura is one of our speakers at this year’s CCH, joining an esteemed list that includes FDA’s OCQC Director Gail Bormel, and House Energy & Commerce Committee member Diana DeGette (D-CO).


Compounders on Capitol Hill, September 19-20, is 18 hours packed with learning and Capitol Hill advocacy, all focused on assuring your patients can access the medications they need. Join us.


Click here to register now.

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Drug shortage proposal has "long tail" provision for 503Bs

An extensive drug shortage legislative package is being contemplated by House Energy & Commerce Committee leadership. Included in the outline of that package are provisions for a 180 day lag period for 503B outsourcing facilities to distribute drugs that were compounded due to a shortage. 


“This ‘long tail’ is much needed and would create more of an economic incentive and greater efficiencies for 503Bs to fill gaps created by drug shortages,” said APC’s public policy director Savannah Cunningham.

Your mission: Help emphasize the threat to cBHT

Last week we shared the TV spot that recently aired on Fox Business News. This commercial is just one element in a comprehensive media campaign, which was made possible by your generous investments in our “Save cBHT” campaign. 


In addition to the commercial and long-form video being televised over the next year, we have developed a series of emails that will be sent to PBS’ 1 million (!) subscribers.


But that’s not all! As the saying goes, “It takes a village…” Your support for this campaign doesn’t stop at watching the TV spot: We’ve developed a special marketing toolkit that you can use to:


  • Air the video in a loop in your waiting area of your pharmacy.
  • Share the video with the prescribers you work with (and ask them to invest in the “Compounding the Joy” campaign).
  • Show the video in your exhibit booth at any prescriber- or patient-focused trade shows you participate in.


Here’s that toolkit. Thank you in advance for your support.

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Commenting on FDA’s 503B wholesaling draft GFI

Hey 503As, we’ve already asked our 503Bs; now we need your help in determining the substance of APC's comments on FDA’s draft guidance on 503B wholesaling. We’ll be submitting our comment letter later this month.


Please take this short survey by August 14.

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Short takes

Pound wise and penny wise. A recent study determined that, if Medicare covered the cost of obesity drugs, the savings would save the program (and taxpayers) billions一yes, billions一of dollars over a 10-year period. The savings would be realized in the form of reduced demand for services associated with obesity-related health conditions, such as heart disease.


Clear as mud, right? The media is slowly realizing something we've known for a very long time: The prescription drug supply chain is killing local pharmacies.


Picky, picky… Habitual nose-picking is associated with an increased risk of contracting the coronavirus, researchers in the Netherlands have found. Soooo...now you know.

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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 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, Best Practices in Safety & Quality for USP 797 – it’s not just SOPs. More details coming soon.


September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC


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


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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