APC: News

APC News

FOR TECHNICIANS ONLY: Here’s a career-changing opportunity for you

Published November 11, 2022

The difference between holding a job and a having a career has as much to do with you as it does with where you work. Sure, you can make a living being “just a technician,” but there’s a great career to be found in growing your skillset and becoming indispensable in the compounding pharmacy where you work.

You can join the ranks of the elite technicians…and we can show you how.

Join us on December 6 at 2pm ET for Practically Indispensable: How You Can Become an Elite Pharmacy Technician. Presenter Cicely Simpson will share tips and techniques you can employ to grow your influence, enhance your value to your pharmacy team, and turn that “just a technician” job into a rewarding career.

If you work for a pharmacy or facility that is a Pharmacy/Facility Member of APC, the fee for the hour-long webinar is only $10. For all others it’s $50.

Can’t attend the live webinar? No worries, password access to the recorded program will be available to those who register for it in advance.

Get registered here. It just may be a career-launching opportunity.

Bormel says “DTE remains available.” But how?

Published November 11, 2022

One takeaway from compounding industry leaders’ meeting this past Wednesday with FDA officials about the reclassification of desiccated thyroid extract as a biologic: The agency is inconsistent about which substances it has reclassified and which products the reclassification affects.

“DTE remains available,” FDA OCQC Director Gail Bormel said in the meeting, noting that commercially available Thyroid USP remains on the market. APC leaders pointed out that while the manufactured DTE products continue to be available, the letter sent to NABP and ultimately to boards of pharmacy had caused some suppliers of DTE to stop selling the API to pharmacies, and some pharmacies are being told by their board inspectors that they can no longer compound DTE to meet the needs of their patients.

When asked what policy goal the agency was trying to address in reclassifying DTE as a biologic, Bormel indicated that the reclassification was always going to happen because of the BCPI Act (passed by Congress in 2010, with enforcement that began March 2020). APC leaders replied that Thyroid USP was never listed in any official notices regarding BCPI reclassification—unlike other substances like HCG—and also that thyroglobulin is not an active ingredient in Thyroid USP, and is not listed in its monograph, package insert or labeling.

“The agency seems to be focused on thyroglobulin based on research related to some old products that had listed it as an active ingredient, but which were taken off the market years ago,” said APC President Dave Miller after the meeting. “So they’re jumping to DTE, which contains thyroglobulin as a by-product, and they’re making no distinction that it’s not the active ingredient.”

The agency seemed quite interested in rough data APC provided citing at least 60,000 patients who are affected by the agency action restricting compounded DTE, and asked APC to submit those numbers – and its other arguments as well—via the docket the agency has established on this issue.

“We have heard a lot on this issue,” said Bormel. “The concerns are definitely on our radar.”

The virtual meeting had been requested by APC and was also attended by more than 30 representatives of FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, as well as APC-invited representatives from the National Association of Board of Pharmacy, American Pharmacists Association, National Community Pharmacists Association, and the Outsourcing Facilities Association. APC President Dave Miller, Board member Michelle Moser, member Matt Martin of PCCA, and CEO Scott Brunner enunciated APC’s concerns.

What can you do?

Submit written comments to the FDA docket and focus those comments in particular on the patient impacts of the reclass – including why compounded DTE is the best alternative for many patients. Your comments should be well reasoned and science-based, documented to the extent possible with citations supporting the research to which you may refer.

APC is considering issuing a call-to-action to DTE patients, and we’ll likely have more to share about that soon.

Registration opens for “Best Practices” Conference

Published November 11, 2022

Amid ever-changing regs and standards, EduCon 2023: Best Practices in Compounding is where you go to stay current and to update your expertise. Because true professionals never stop learning.

Registration is now open and early bird pricing is in place until January 4, 2023. (Pharmacy/Facility Members receive reduced pricing on both early bird and regular registration.)

NOTE: Live CE credit is only available February 9 and 10, 2023. On-demand will be home study CE credit.

Hey PFMs: Stick it!

Published November 11, 2022

We’re stuck on our Pharmacy/Facility members—literally, via this handy magnet we’re sending ’em that lists the PFM-only resources they can access. 

If you’re a PFM, please display it where your entire team can see it. And if you’re not a PFM, fix that here.

Chapter <797> includes BUD, batch size restrictions

Published November 11, 2022

The revised USP Chapter <797> related to sterile compounding, released on Tuesday, includes restrictions on beyond-use dates and batch size for CSPs that APC and others had argued were not supported by scientific evidence. USP also released a revised Chapter <795>, related to non-sterile compounding.

“We’re disappointed but not surprised at the restrictions in <797>,” said APC President Dave Miller. “It was clear throughout the process that USP’s Compounding Expert Committee was pursuing arbitrary restrictions on BUDs and batches. What no one has been able to demonstrate, though, is how patients are made safer by these restrictions.”

In written comments and public presentations earlier this year, APC had urged CEC “to withstand pressures to implement arbitrary restrictions on batch size and Category 3 BUDs until it can clearly demonstrate the scientific basis for those restrictions and enunciate how patients are objectively better served by them. Not only will patients be harmed if [USP] proceeds in finalizing Chapter <797> with those restrictions, but so too will USP’s high reputation.”

That stance was echoed in comment letters to USP from APhA and NCPA.

“What they’ve done in effect is apply BUDs for the most unstable CSPs to all CSPs,” said pharmacist and APC Vice President Tenille Davis, who led APC’s Beyond-Use Date Task Force, which crafted APC’s comments on the proposed <797> revisions. “Reason would dictate that BUDs should be rooted in the properties of a particular CSP, rather than applying the most extreme case to all CSPs. If a stability study can support a BUD for a product, the pharmacy should be able to use that data instead of a one-size-fits-all BUD.”

Davis also notes that the arbitrary batch size limitation of 250 units in the new chapter will require more frequent entry into the clean room, increasing the potential for contamination. “If USP felt that a stronger system was needed for sterility assurance for larger batches and longer BUDs, then why didn’t they build it?” she asked.

“Ultimately, it’s our patients who are going to be disadvantaged by these restrictions,” said Miller. “They’re going to see decreased access, increased costs, and the need for more frequent refills on their medications. It’s beyond frustrating, because there were more effective approaches USP could have taken to address these issues.”

APC’s BUD Task Force will meet soon to review the new chapters in detail and develop guidance to assist our members in complying.

The chapters are available on USP’s website only to those who subscribe to the USP Compendium.

A confusing proposed rule in Delaware

Published November 11, 2022

A proposed rule by the Delaware Board of Pharmacy has the potential to limit office stock compounding for veterinarians by 503A pharmacies. APC is submitting a comment letter and will be attending the board meeting on November 16.

Current Delaware regulation is confusing. It allows 503A pharmacies to compound office stock for veterinarians but is limited to 10 percent of the pharmacy’s total non-patient prescriptions. But it also requires compliance with federal law, meaning that Delaware-licensed 503A pharmacies are prohibited from compounding for vet office stock. Why? Because federal law (FDCA) allows only patient-specific compounding by 503A pharmacies.

The proposed rule authorizes 503B outsourcing facilities to compound for vet office stock and exempts them from the 10 percent cap, subject to federal law. The problem is that Section 503B of the law, like Section 503A, applies only to human drugs, not animal drugs (although some outsourcing facilities are now compounding animal drugs).

“GFI #256 reads as if written to apply to 503A state licensed pharmacies, and CVM has not announced any intention to exempt out outsourcing facilities from that process and the positive list of substances for office stock that it will establish,” said APC Director of Public Policy Savannah Cunningham.

“We are concerned that boards of pharmacy are being misinformed that FDA prefers outsourcing facilities over pharmacies for veterinary office stock or that GFI #256 does not apply to outsourcing facilities, and that some are changing their rules in ways that will limit or prohibit 503A pharmacies from compounding for vet office stock in those states. That’s why what happens in Delaware bears watching.”

Tempted to compound semaglutide sodium? Don’t.

Published November 11, 2022

Okay, let’s review.

We know that to be compounded, an active ingredient must meet one of the following conditions:

  • Be a component of an FDA-approved drug.
  • Have an applicable USP or National Formulary monograph.
  • Appear on a 503A bulks list published by the FDA.

And we also know that semaglutide meets one of those criteria: It’s a component of an FDA-approved drug product. FDA-approved drug products containing semaglutide use this medication in its base form. But when it comes to compounding it…well, it’s complicated.*

But what’s not complicated is the issue of semaglutide sodium, which meets none of the criteria above and should not be used in human drug compounding. And while it may be more readily available from suppliers, it’s not a substitute for semaglutide base.

Consider yourself reminded.

*This is an APC member-only document. To become an APC member, click here.

Share this: The PCF scholarship application is now open

Published November 11, 2022

Through the generosity of the Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation (PCF) will award up to two $2,500 scholarships in 2023 to pharmacy students who have demonstrated commitment to a career in compounding pharmacy in the United States.

If you know a P3 or P4 pharmacy student, please pass on this information— they may be eligible to apply for one of two $2,500 scholarships being awarded in 2023.

Please feel free to share this link: A4PC.org/scholarships for more information. Or simply…

It takes a lot of money to make nothing happen.

Published October 10, 2022

It has been two years since we started talking about FDA’s implicit threat to restrict compounded hormones. So far, the agency has done nothing.

We’d argue that the fact FDA has so far done nothing publicly to make good on that threat—which started with the release of the now discredited NASEM report in mid-2020—is in part due to the pressure APC has exerted on the agency via our Campaign to Save Compounded Hormones.

Our digital ads have reached 25 million Americans. We’ve collected more than 6,000 patient testimonials, and patient and APC member messages have reached majority of Congressmembers. Dozens of members of Congress have written or reached out to FDA, putting the agency on notice that it must not impede patient access to compounded hormone therapy based on a flawed report. It’s clearly been enough to make the agency pause.

But now APC’s Campaign to Save Compounded Hormones is low on funds, and we don’t know what 2023 holds. Yes, we’re happy to take credit for FDA’s delay thus far in moving to restrict hormone compounding, but we’re not naïve. The agency could announce its intention to add hormones to the “difficult to compound” list at any time. Our job must be to forestall that effort as long as we can and to make the agency think twice before it meddles with therapies that benefit millions of Americans.

We can only do that with your help. Whether you are a regular giver to our campaign or someone who has not yet given, your patients and your profession need you.

We are currently about $200,000 short of our 2022 cBHT Campaign goal. That doesn’t bode well for continuing this campaign, does it?

Nothing has happened. Not yet, anyway. Without your help, the chances of FDA moving to restrict compounded hormones only increases. PLEASE invest NOW in APC’s ability to sustain this campaign.

Burch, Brunner recently featured on menopause-focused podcast

Published October 10, 2022

Image by StockSnap from Pixabay.com.

APC member Jennifer Burch (owner of Central Compounding Center in Durham, NC) and APC CEO Scott Brunner recently did their part to clear the confusion regarding compounded hormone therapy and enhance awareness of its many benefits.

The two were featured guests on an episode of the Hotflash Inc. podcast, during which they discussed the benefits of pharmacy compounding, the role it plays in treating menopause, examples of when compounded medications help where pharmaceuticals cannot, and the looming threat that could potentially take this valuable treatment away from millions of women.

Click here to listen to the full podcast.

Image by StockSnap from Pixabay.

« Newer EntriesOlder Entries »