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The voice for pharmacy compounding │26 August 2022

BREAKING NEWS


APC was able to negotiate a brief extension of our special conference hotel room rate of $299. However, it expires at 12 midnight ET tonight, August 26. Note that inventory is limited and not guaranteed. 


ACT NOW  and click here to reserve your CCH hotel room.

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From APC's President

It's time to talk


Is the FDA friend or foe? While it may never be the former, APC is working hard to ensure it is not the latter.


I admit I have long viewed the FDA as an adversarial agency trying to keep us from helping our patients and possibly trying to shut down my compounding pharmacy. This became much more pronounced after the NECC tragedy.  


Whatever sentiment we each feel for the FDA, we need to face facts: It is a huge government agency that holds a lot of power over pharmacy compounding. We can stand on our soap boxes and shake our fists proclaiming that section 503A of the Food, Drug and Cosmetic Act leaves the practice of compounding pharmacy to the states and not the federal government (any of us who have experienced an FDA inspection know that line is blurry, at best). 


It looks like we are on opposite sides of the fence, but we are actually walking down the same path: We—FDA and compounding pharmacies—all want our compounds to promote patient safety and to be efficacious. We work hard to ensure this, and the FDA does, too.


This shared focus is a mutual space for us to work together in the interest of our patients. 


In recent years, APC has been working to establish a respectful relationship with the FDA. We have extensively engaged the agency’s Center for Veterinary Medicine, and our input is being heard. We are working with them to delay and revise the flawed GFI 256 for animal compounding. We are also engaged with the FDA CDER’s Office of Compounding Quality on several issues, including MOU implementation, clearer definitions of “insanitary conditions,” and urging the agency to slow down on restricting compounded hormones.


Because of the relationship we’ve built thus far, FDA's Office of Compounding Quality and Compliance Director Gail Bormel has agreed to join us for an interview with our CEO Scott Brunner at Compounders on Capitol Hill on September 14. This is a don’t-miss session and the perfect opportunity for us to communicate our positions with passion and credibility. 


We can continue to argue, sue and counter-sue ad infinitum, but these aren’t always productive, and they require extraordinary resources that we don’t always have. I implore you to please put personal grievances aside and join us in a dialogue with the FDA with our patients’ health in mind. We may just make some progress.


I look forward to seeing all of you at CCH in Washington September 14-15. If you have not yet registered, here’s where to do that—for your business and your patients.


• • •


David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

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ICYMI

Catch up on these recent stories that you might've missed:

This week

1,957 prescribers tell FDA:

Preserve access to compounded hormones

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Earlier this week, APC submitted a letter signed by nearly 2,000 prescribers of compounded hormones to FDA Commissioner Robert Califf, urging FDA to assure continued patient access to compounded hormone therapy. 


“This letter is an extraordinary demonstration of support for APC’s efforts to protect access to compounded hormones, and it’s all thanks to the APC members and partners who reached out to prescribers they worked with and urged them to sign the letter,” said APC CEO Scott Brunner. “Thank you, thank you, thank you to those members who answered our call for help on this project.”


The letter addressed the flawed 2020 report FDA commissioned from the National Academies of Sciences, Engineering, and Medicine (NASEM), and what the repercussions would be should FDA use that report as the basis for restricting access to compounded hormones


The prescribers also noted that access to compounded medications provides the ability for them to uniquely tailor and personalize medications to meet the needs of individual patients for whom, in the prescriber’s judgment, commercially available drugs are not suited. Therefore, by implementing across-the-board restrictions on compounded hormones, the letter stated that that these would interfere with the practice of medicine and prevent them from treating their patients.


The signers closed the letter expressing support for expanded education on the use of bioidentical hormones for all healthcare practitioners involved in caring for patients, as well as creation of a reasonable, consistent framework for adverse event reporting for compounded medications.

FDA’s Gail Bormel to appear at CCH

FDA’s director of the Office of Compounding Quality and Compliance, Gail Bormel, has accepted APC’s invitation to attend Compounders on Capitol Hill. She’ll participate in a special interview-style session with APC CEO Scott Brunner on Wednesday afternoon, September 14, prior to Capitol Hill visits the next day.


In addition to FDA’s Bormel, the conference includes presentations by Ranking Member of the House Energy & Commerce Committee Cathy McMorris Rodgers (WA) and Senate HELP Committee member Senator Jacky Rosen (NV).


“I can’t think of a more urgent need for compounders to come to DC,” said Brunner. “The threat to compounded hormones, the ambiguity in CVM veterinary compounding GFI, and a potential opportunity for compounders to mitigate drug supply chain issues are all on the table. But none of those things will come about if our members don’t attend and brief their members of Congress.”


To learn more about CCH and to register, please click here.

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Ready/not ready for GFI #256? Tell us!

We’re conducting a survey of compounding pharmacies to help APC understand your readiness for compliance with the GFI #256 so we can provide tools and training to support you in this transition and so that we can advise FDA about whether an enforcement delay is warranted.


Please click here to take this quick survey.

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Save $100 towards A4M MMI's BHRT symposium registration

APC members can get $100 off their registration (use code APC100) to this year's Endocrine Balance and Bio-Identical Hormone Restoration Symposium. Presented by A4M MMI, the in-person event is being held in Boston, September 16-18.


Click here to learn more and to register.

Save these dates

August 30: FDLI Drug Compounding Webinar, Updates and Developments in Drug Compounding


September 2: A free APC informational webinar, How GFI 256 will change your compounding operation


September 68: FDA's virtual Compounding Quality Center of Excellence Annual Conference


September 14: APC's Annual Meeting during Compounders on Capitol Hill, 2:00-2:30pm ET, Hilton National Mall, Washington, DC


September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC


September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS


October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS (registration link coming soon)


October 2629: PCCA's International Seminar, Houston, TX (in-person + virtual)

Short takes

The heroes we want and need. In an effort to save their patients money, some pharmacists are opting to take generic prescription drug pricing into their own hands, leaving insurance companies and PBMs out in the cold. Read the full story here.


In DC, there's a real-life version of the National Treasure movie franchise. In 1792, the cornerstone of the White House was laid in a star-studded Masonic ceremony. No one has seen it since. Here’s the story of the missing cornerstone.

After attending Compounders on Capitol Hill in DC next month, stay in town another day (or two!) to learn more about our nation's capital and the secrets she keeps.

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Quick links



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Current issues:

GFI #256 on animal compounding

Urgent-use compounding

Prohibition on peptide compounding

La Vita Case amicus filing

Insanitary Conditions amicus filing

   


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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.