Alliance for Pharmacy Compounding

How good is your liability insurance? Do you know exactly what it covers (and how to check) so you aren’t in for a nasty surprise? We saw that flicker of doubt on your face. You should come to a free briefing from Pharmacists Mutual on Oct. 22. It’s entirely virtual, just an hour long, and it might save you a lot of headaches. Sign up for “Coverage, Claims, and Compounding: What You Need to Know About Your Liability Insurance” with Pharmacist Mutual’s Kristen Jones — get briefed on what you need to know about compounding coverage and claims related to your insurance policy. And wipe that flicker off your face. https://lnkd.in/ejAfqn5t

We can help with that. To find out, you can look it up on your state board of pharmacy website. We've compiled a quick and easy guide on our website: https://lnkd.in/eqENMabY. If you can’t find it on that site, it may not be a legitimate pharmacy licensed to serve patients in your state.

Hey Seattle area! It's time for your CompoundED UpDATE. Join us on October 3 for an evening of learning, networking, and eating at the Washington State Pharmacy Association headquarters in Renton. What you get: - Two hours of live CE on the benefits of low-dose naltrexone (learn the latest on dosing, safety, science and physiology) and restoring thyroid balance (including the latest on compounding with thyroid APls). - A briefing on current compounding issues, including GLP-1s - A great catered dinner - The chance to network with compounders in your area It’s all just $25 thanks to a generous grant from PCCA. If you’re in the area, you don’t want to miss it. For details and to sign up visit: https://ow.ly/8Wf650Tqqak

Here's how to have confidence that the compounding pharmacy you're using is legit.

A leaked document from the DEA indicated that it’s planning to reinstate limits on telehealth prescriptions for controlleds. Those limits had been lifted during the pandemic, and that helped millions of people get easier access to the medications they needed. Hearing that DEA might want those limits to return triggered an outpouring of messages against the idea, and asking Congress to intervene if necessary to protect access. Read it here: https://ow.ly/EViX50Txv3v

Have you registered for next month's briefing, Coverage, Claims, and Compounding: What You Need to Know About Your Liability Insurance? Well, it's time to do so! Get answers to questions like, is ketamine compounding covered in your insurance policy? Or sterile GLP1s? In fact, what exactly does your liability insurance cover, and how does it work? In this webinar, Pharmacist Mutual’s Kristen Jones will brief you on what you need to know about compounding coverage and claims related to your insurance policy. It’s a session to help you understand and manage risk – and hopefully avoid claims. A one-hour briefing. Register: https://ow.ly/Jkiy50TwJEe

The latest step toward weaning the US off our dependence on Chinese APIs is a $14 million investment from HHS’s Administration for Strategic Preparedness and Response in a non-profit consortium called the API Innovation Center (APIIC) for it to “lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used to treat asthma, diabetes and anxiety disorders” specifically albuterol, desmopressin acetate, and lorazepam.) Read it here: https://ow.ly/781O50TvKbG

Hey Seattle area! It's time for your CompoundED UpDATE. Join us on October 3 for an evening of learning, networking, and eating at the Washington State Pharmacy Association headquarters in Renton. What you get: - Two hours of live CE on the benefits of low-dose naltrexone (learn the latest on dosing, safety, science and physiology) and restoring thyroid balance (including the latest on compounding with thyroid APls). - A briefing on current compounding issues, including GLP-1s - A great catered dinner - The chance to network with compounders in your area It’s all just $25 thanks to a generous grant from PCCA. If you’re in the area, you don’t want to miss it. For details and to sign up visit: https://ow.ly/8Wf650Tqqak

A settlement has been reached in a lawsuit brought by Evexias et al against FDA over the agency's 2023 addition of a number of substances to Category 2 of the 503A bulks list. Almost a year ago, the FDA announced that it had updated the list of bulk drug substances nominated for use under section 503A. Notably, several peptides were added to Category 2 “because FDA has identified significant safety risks with [those] substances,” the agency said. That raised alarms from some prescribers and pharmacy compounders, who were concerned that patient access to what they say are legitimate therapies that are clinically effective was taken away and that FDA did not substantiate the “safety risks” it says it identified related to those substances. APC agreed that in not showing its work on the evidence of safety risk, FDA once again failed to document its action. “Trust us” is not a sufficient explanation for agency actions. APC wrote a letter last year to Gail Bormel, director of FDA’s Office of Compounding Quality and Compliance, calling for transparency regarding the addition of substances to category 2. Evexias Medical Group and Farmakeio Outsourcing sued FDA for that lack of transparency in placing more than a dozen peptides in category 2 of the 503A interim bulks list. One result of this week’s settlement is the publishing of a Federal Register notice for two upcoming meetings of the Pharmacy Compounding Advisory Committee, in which it will review four of those peptides and their nomination for inclusion on the FDA Bulks list. The two PCAC meetings are scheduled for October 29 and December 4. This settlement is a win in that it reiterates that FDA must go through proper notice and rulemaking process — including PCAC review — before taking action to categorize any API. It also gives stakeholders the chance to present evidence surrounding the patient use and benefits of the peptides in question. “The best way to have the Pharmacy Compounding Advisory Committee consider and recommend substances for inclusion in category 1 of the bulks list — which means they can be compounded — is to make a compelling case for clinical efficacy and submit it to FDA,” said APC’s Chief Advocacy Officer Tenille Davis, PharmD. “Such a case would need to rely on rigorous science, credible research, and potent patient outcome data. If you have that evidence, this is your chance to offer it.”

This year’s CCH featured the induction of seven new APC fellows — members who have demonstrated that they are “exemplary in their commitment to the practice of pharmacy compounding.” The APC Fellows Program was established in 1997, and in 2022 it began recognizing pharmacy technician leaders. Regardless of the position, candidates must meet strict requirements that demonstrate their commitment to patient care through quality pharmacy compounding, continued professional growth, and — maybe most importantly — adherence to the highest ethical and professional standards. The 2024 inductees include: Gina Besteman, Tyler Chamberlain, Stacy Hightower, Dawn Ipsen, Peter Koshland, Anna Rashidi, and Doug Yoch For information on becoming an APC Fellow, including requirements and an application form, visit: https://lnkd.in/eg_Qen-j