PCF names new directors
|
|
|
|
|
|
APC has posted an updated version of our compilation of state by state adoption of USP <795>, <797>, and <800>. It’s an APC members-only resource, and provides information about the method by which each state adopts USP chapters, the current status of USP chapter adoption and effective dates by state, and links to state websites where USP-related law and/or regulations may be found.
Though we cannot guarantee accuracy, it’s based on recent data-gathering and is a helpful resource for compliance. You’ll need your APC member login and password to access it.
We’ll let you read it for yourself. Interesting how the reporter seems to take Novo’s word for it, no?
(This is a late-breaking story. APC and its attorneys are reviewing and may issue a statement.)
A U.S. District Court judge approved APC filing an amicus brief this week in Novo Nordisk’s lawsuit against Tennessee compounder (and APC PFM) DCA Pharmacy. “This is great news,” said APC’s Scott Brunner. “It means the brief, which explains the essential role compounding pharmacies play in preparing copies of FDA-approved drugs when those drugs appear on the FDA drug shortage list, was accepted and will be considered by the court. The brief also clarifies for the court that pharmacy compounding is authorized in state and federal law and is not, as Novo asserts, ‘unauthorized drug manufacturing.’” APC awaits responses from courts to its requests to submit the amicus brief in the three other Novo lawsuits against compounding pharmacies. APC is represented by Boesen & Snow Law, Scottsdale, Arizona. The legal action is supported by APC’s Legal Action Fund, which is funded by contributions from APC members. |
![]() |
|
|
|
|
The photo inset below on the left was taken last Friday morning at Preston’s Pharmacy (a PFM, I might add) in Arlington, Virginia. It’s not a pharmacist or technician in the photo. It’s a healthcare reporter for a national media organization whose beat includes pharmacy compounding. She and I connected initially during Compounders on Capitol Hill back in September when she reached out with questions about shortage drug compounding and HR 167. When I asked her if she’d never even been in a compounding pharmacy, she admitted she had not, but would like to see one. |
Because she is DC-based, I reached out to Scott Welch, the PIC at Preston’s, about his interest in conducting a tour of his pharmacy for a reporter — a tour that would include allowing the reporter to garb-up and scrub-up just like compounders do. Scott said yes, of course, and that’s how that reporter and I found ourselves at Preston’s last Friday. Because the conversation was “on background” and informational — nothing we said could be quoted or attributed — it was wide-ranging. We talked about the difference between traditional dispensing and compounding, about sourcing FDA-approved drugs versus API for compounding, about vendor validation and testing and USP standards. We covered non-sterile versus sterile compounding, and hazardous drug compounding and the NIOSH list. We discussed how FDA talks about compounding and the need for reporters to dig a little more, rather than taking those statements at face value. And of course she had questions about semaglutide and ketamine and other therapies that are making headlines lately. |
She seemed to come away impressed with the sophistication and high compliance rigor of pharmacy compounding. That’s largely a credit to her tour guide, Scott Welch (pictured with me in the lower photo), who was well-informed, easy-going, and non-defensive in his explanations. He did a tremendous job guiding the tour and fielding questions. I suspect the 60 minutes that reporter spent in his pharmacy will shape the way she reports on compounding from here on — which is the point, of course. This model — bringing healthcare reporters into compounding pharmacies (particularly sterile compounding pharmacies) to allow them to see what compounders actually do — has legs. We’ve now scheduled pharmacy tours in coming weeks with healthcare reporters from four major national news organizations. Three will be touring Preston’s in Arlington; one will tour Joe Navarra’s Total Town Compounding on Long Island. I’m happy I’ll get to tag along and provide color commentary for those. It’s yet another way APC is helping take back your story. One reporter at a time, we’re sharing what you do in your labs and how it benefits patients. —Scott |
|
|
In response to inquiries from state boards of pharmacy regarding the enforceability of revised USP Chapters <795>, <797>, and <800>, a recent memo aims to clarify references in the Food, Drug & Cosmetic Act. APC issued the memo this week as a resource for state boards of pharmacy.
The focus is on Section 503A of the FD&C Act, which pertains to compounded drugs. Contrary to concerns, the memo emphasizes that the reference to USP standards in Section 503A applies specifically to bulk drug substances only — the API must be USP-compliant — and not to all compounding. It underscores that compliance with USP compounding chapters’ references to bulk drug substances is mandated, but it does not require states to adopt entire USP chapters for all compounding practices.
APC’s clarifying memo aims to guide state boards in navigating the complex landscape of the new USP chapters.
Last week, we sent a letter to the California Board of Pharmacy requesting clarification of its position on compounding semaglutide.
The letter is the result of several reports of conflicting statements from California BOP staff that seemed to deviate from current FDA guidance on shortage drug compounding.
APC is recruiting committee members for 2024. We rely on the work of our committees to help our Board of Directors determine our policy positions and tactics. We couldn’t do what we do without their expertise. Best of all, most committees only require an hour or so of your time each month.
Committees available for appointment are:
If you’re interested in serving (and sharing!), send an email to info@a4pc.org and tell us which committee you’re interested in, and include a brief explanation of your expertise or interest in that committee’s functional area. We’ll announce appointments in December.