We’re conducting a survey of compounding pharmacies to help APC understand your readiness for compliance with GFI #256 so that we can advise FDA about whether an enforcement delay is warranted. read more →
In a joint, bipartisan letter this week, 22 members of Congress urged FDA to “craft patient-centered policies that preserve treatment options” related to compounded hormones. That communication is a result of efforts by APC and its members to educate members of Congress about FDA’s implicit threat to restrict compounded hormones.
The letter asserts that the recommendations of the flawed NASEM report on compounded hormones “would interfere with the practice of medicine and prevent practitioners from treating their patients with therapies that they determine are best for their patients.”
Key points in the letter were that continued access to compounded hormones is key and that the personalized therapies that compounding provides are essential given the limited number of FDA-approved manufactured hormone products on the market.
Signatories on the letter include nine Democrats and 11 Republicans. In addition to lead sponsors Jennifer Wexton (VA) and Jaime Herrera Beutler (WA), signers included: Brian Fitzpatrick (PA), Buddy Carter (GA), Gregory Murphy (NC), Kathy Castor (FL), John Moolenaar (MI), Mark Pocan (WI), Dutch Ruppersberger (MD), Chris Stewart (UT), Beth Van Duyne (TX), Gary Palmer (AL), Markwayne Mullin (OK), Diana Harshbarger (TN), Julia Brownley (CA), Morgan Griffith (VA), Chellie Pingree (ME), Neal Dunn (FL), Ron Kind (WI), Peter DeFazio (OR), Bonnie Watson Coleman (NJ), and Michael Burgess (TX).
Last week APC sent a letter to every state board of pharmacy to urge them to pay attention to USP’s proposed beyond-use date changes in Chapter <795> and <797>. “Without your input,” we wrote, “It’s possible your state will find itself saddled with certain regulations that limit patient access to compounded preparations while creating considerable waste and cost containment issues for the pharmacies that compound those preparations.” You can help by mentioning the letter to your pharmacy board members and executive director and offering to serve as a resource to the board in developing their comments to USP.
Funded by the Pharmacy Compounding Foundation, placement of ‘advertorial’ content on Everyday Health — a three-part series about compounded hormone therapy — debuted last week. Read it here, and share with your patients and providers you work with.
The news reports in the wake of the devastating tornado event in Kentucky have been heart-breaking. As relief efforts continue, you may be interested in helping from afar. Tragedy can bring people together in moments of crisis to provide assistance where it’s needed. The Kentucky Society of Association Executives has directed those who want to help to this list of local charity organizations. Do what you can, if you can, where you can.
While the science underlying the USP Compounding Expert Committee recommendations for using stability studies to establish extended BUDs may be sound, and the documentation provided by the Compounding Expert Committee supporting the processes involved in these studies may be valid, the imposition of arbitrary limits to BUDs (despite these studies, along with other arbitrary changes to batch sizes, microbial risk levels, etc.) only serves to generate noise. What is missing is any evidence to show that USP’s proposed changes represent any improvement in compounding quality and public safety over the chapters that have been in place for the past ten years.
PLEASE share with us your input, evidence, and real-world examples of the effect of the proposed changes by December 31. Send them to email@example.com.
Here’s a small thing you can do to help promote APC’s campaign to save compounded hormones: Simply paste the sentence below into your email signature – so that whoever you’re communicating with can be directed to compounding.com to learn more. It’s the little things, right?
Help us preserve patient access to compounded hormones. Learn more at compounding.com.
A 90-day cBHT fundraising campaign by our friends at Letco has resulted in 350 pharmacies donating to APC’s effort to save compounded hormones, many of those for the first time. On Letco’s website and via its sales team, customers we asked if they’d add and additional amount to their orders to support the cBHT campaign.
“It was a creative way to put the threat to compounded hormones on compounders’ radar and to raise money for our campaign,” said APC CEO Scott Brunner. “We appreciate Letco’s leadership in embracing the effort – especially their sales team members, who were wonderful ambassadors for the campaign.”
The effort generated $4,145 in new money for APC’s campaign. All contributor names have been added to the cBHT Honor Roll page on APC’s website.
One more thing: This week Letco included APC’s cBHT campaign as an option in its annual holiday charity drive. Check it out – and VOTE for us!
After we announced the fundraising effort for Phase 2 of our media campaign to save compounded hormones three weeks ago, we expected the dollars to start rolling in. After all, that’s what happened last year, when we raised an extraordinary $1.5 million to launch the campaign.
But the dollars are not yet rolling in for 2022. And it has us worried.
We must raise a total of $850,000 pronto to launch Phase 2. About $150,000 of that amount is already pledged, so we have $700,000 to go. Here’s our brochure outlining what the 2021 campaign has accomplished and what’s planned for 2022.
We know it’s the holiday season and you’re busy. But we also know you believe in this campaign. Take a moment and make your 2022 investment now – so we can get going with new media, messaging, and prescriber engagement.
In a comment letter submitted Monday, APC said FDA’s proposed grant of flexibility to hospital pharmacies related to the Food, Drug & Cosmetic Act’s prescription requirement is “strikingly inconsistent” with both the agency’s treatment of other state-licensed and -compliant 503A pharmacies and with the statute itself.
APC’s comment letter was submitted in response to FDA’s proposed Revised Draft Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.
From the letter:
APC strongly urges FDA to rescind both the revised hospital compounding GFI and the prescription requirement GFI (Docket No. FDA- 2016-D-0269) and issue a new GFI that implements 503A consistently between hospital and non-hospital pharmacies. The plain language of the statute makes no distinction for hospital pharmacies, and a new GFI should provide flexibility for providers and patients in both hospital and non-hospital clinical settings to access critical compounded drugs when needed in urgent medical situations but unavailable commercially or from an outsourcing facility.
Would you rather have good insurance or be a safer driver? What about the guy in the next lane? Doing things right in your compounding practice is your best form of protection. That’s what EduCon 2022 Virtual is all about. Find out more and register now!