Eight members of Congress wrote to FDA Center for Veterinary Medicine director Dr. Steven Solomon this week to express concern that CVM’s GFI 256 on animal compounding may result in delayed care for veterinary patients. read more →
Several changes to NABP’s new Model Act were recommended by APC, including a requirement that licensed compounding pharmacies provide to the state board of pharmacy basic information about their compounding operations. read more →
One hundred members of Congress signed a letter of concern sent last week to the Department of Defense in response to recent TRICARE changes that threaten beneficiaries’ access to community pharmacies, especially in rural areas. read more →
In a Sep 16 letter to NABP CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.” read more →
One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding read more →
The voice for pharmacy compounding | January 28, 2022
APC is grateful for our friends at Letco Medical for their support. Not only has Letco renewed its 2022 commitment as a Silver-Level Corporate Patron, but it’s also investing $35,000 in Phase 2 of our Campaign to Save Compounded Hormones.
The APC Board of Directors is in Atlanta today and tomorrow for a planning retreat. Check back in next weeks Compounding Connections to hear about what they accomplished.
Just six days till EduCon 2022
APC’s EduCon 2022 Virtual is live next week — February 3–4 — and there’s still time to register. But if you’re undecided, here are some great reasons to come:
It’s 100% virtual, so no travel, no lines, no maskless passengers — and no hotel fees.
You can grab 11 hours of CE credit in two days.
(If your state requires compounding CE credit, we’ve even got 6 hours of that.)
The content is focused on the best practices for keeping you and your team compliant and efficient — no ‘same old, same old’ here.
There’s an entire track dedicated to the hot issue of USP BUDs.
You can take these courses for up to 60 days! The live classes are February 3–4, but registration entitles you to take them on demand through April 8.
Be sure your team is efficient, compliant, and running at its best. TAKE A LOOK AT THE PROGRAM HERE, and don’t miss EduCon 2022 Virtual: Best Practices in Compounding
EduCon 2022 is presented by APC and the Ohio Pharmacists Association. It’s the smart way to ensure your team has the expertise it needs to practice with high competence and integrity.
FDA adds the first four bulk drug substances to the 503B bulks list
Cutting to the chase, the agency added…
diphenylcyclopropenone (DPCP) for topical use,
glycolic acid for topical use in concentrations up to 70 percent,
squaric acid dibutyl ester (SADBE) for topical use, and
cBHT campaign enters year two — and needs your support
With rumors swirling that FDA is set to act soon on proposed restrictions on compounded hormones, we urgently need you to renew your investment in the Campaign to Save Compounded Hormones. Without your funding, we simply can’t confront the threat. Simple as that, Oh, and time’s a-wastin’.
This year we‘ll continue to engage with patients, with practitioners, with media, and with Congress. And we must inspire everyone affected by this issue to take action.
Our goal for 2022 is to raise $850,000 to fund extensive advertising to everyone with an interest in ensuring access to compounded hormones — and especially to engage prescribers. We plan to pursue new and unique media opportunities, and to redevelop our compounding.com website as a hub for everyone affected by the issue.
Peds compounding — help with this important survey
Oral extemporaneous pediatric preparations and practices — they need to be standardized, and working toward that is the Pediatric Formulations Focus Group at the International Pharmaceutical Federation (FIP). FIP’s goal is to make age-appropriate medicines available and accessible to all children around the world.
The focus group needs your help with a short survey to “identify current oral extemporaneous pediatric compounding practices, challenges and needs in different geographic regions.” In other words, tell them how you handle that kind of pediatric compounding, so they can help establish a standard.
Help slow the overdose crisis: Our friends at APhA, concerned about the accelerating overdose crisis, want to expand access to medications for opioid use disorder such as buprenorphine. The Mainstreaming Addiction Treatment Act (H.R. 1384/S. 445) is bipartisan legislation that will help do just that. APhA is asking for our help getting the word out to contact your members of Congress to urge them to pass this important legislation. Email now: Click here to tell Congress to act now to prevent overdoses.
Your third-grade gym teacher was wrong: Using a combination of virtual reality, brain monitoring, and motion capture technology, University of Rochester neuroscientists proved that yes, if you have a healthy brain you can walk and chew gum at the same time.