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APC News

The vaccine mandate and your employees

Published January 1, 2022

You probably heard that the Supreme Court upheld the Biden administration’s Covid vaccination requirement for healthcare workers — aka, the CMS portion of the requirement. (It struck down the OSHA portion. Yes, confusing.)

That means, as NCPA explains, that if your pharmacy participates in Medicare or Medicaid programs or you provide services to a facility that does, you are likely covered by the mandate.

Depending on what state you’re in, that would mean your employees have until January 27 or February 14 to get their first (or only) Covid-19 vaccine dose.

Note: CMS says a facility with more than 80 percent of staff vaccinated and a plan to achieve 100 percent staff vaccination rate within 60 days of February 14 will not be subject to enforcement actions.

USP extends BUD comment deadline

Published January 1, 2022

Today we learned that USP has extended the comment period for its proposed changes to chapters <795> and <797>.

APC, APhA, and NCPA sent a joint letter to USP in December asking for the comment period to be extended through the end of April. USP has agreed to extend it through March 17.

We welcome this extension, and we thank USP for granting it. We’ll use this additional time to continue to educate compounders and prescribers about the potential impact these proposed BUDs would have on their patients.

Speaking of which, please remember that APC is holding a 30-minute briefing for prescribers this coming Thursday, January 20, to educate them about the complications such BUDs could bring to patient care. Please let the prescribers you work with know about this briefing — we need to get the word out quickly. Thank you!

Urge prescribers to attend this briefing on proposed BUDs changes

Published January 1, 2022

Maybe you know that USP is considering restricting BUDs for many compounded medications. But there’s a good chance the prescribers you work with are not aware — and these changes are going to affect their patients’ access to medication.

That’s why NCPA and APC are co-hosting a 30-minute virtual briefing for prescribers on January 20. We need to explain the USP proposal, and engage them so they join us in expressing concern to USP by the January 31 comment deadline.

But we don’t know your prescribers. You do. We’re counting on YOU to make them aware of this briefing and urge them to participate.

Please reach out and ask them to join us for just 30 minutes on January 20 to learn why this is such an important issue — then register to attend (it’s free) at A4PC.org/budbriefing. Thank you!

Associations ask USP to extend comment deadline

Published January 1, 2022

In December, APC, APhA, and NCPA sent a joint letter to Brenda Jensen, chair of USP’s Compounding Expert Committee, asking that the CEC extend the comment period on its proposed USP Chapters <757> and <797> by three months, until April 30, 2022.

Many pharmacists and prescribers do not realize that their activities are considered compounding, and therefore, more education of those stakeholders is required before we can gather meaningful feedback on how these changes would impact patient care.

You can read the letter here (2-page PDF).

NCPA and APC to brief prescribers on BUD issues Jan. 20

Published January 1, 2022

Maybe you’re already aware of a proposal from the U.S. Pharmacopeia that would restrict beyond-use dates for many compounded medications you dispense. But there’s a good chance the prescribers you work with are NOT aware of the proposed changes — and what they don’t know can hurt them and their ability to care for their patients.

That’s why NCPA and APC are co-hosting a 30-minute virtual briefing on January 20 especially for providers you work with — the physicians, physician assistants, and nurse practitioners who prescribe compounded medications for their patients.

But here’s the thing: We don’t know the prescribers you work with. We don’t have their email addresses. So we’re counting on YOU to make them aware of the briefing and urge that they participate.

USP has set a January 31 deadline for comments on its proposals. The aim of this briefing is to inform prescribers so they can join us in expressing concern to USP by the comment deadline.

Thanks in advance for helping us engage your prescribers on this important patient access issue. But hurry, please: January 20 is not far away!

APC members defend cBHT on TV

Published January 1, 2022

APC past president Shawn Hodges and board member Tara Thompson (both of Innovation Compounding in Kennesaw, GA) were on Atlanta’s WSB-TV, correcting FDA’s misinformation about compounded hormones.

The story featured Hodges, Thompson, and a local cBHT patient, plus a handful of quotes from an FDA press release.

(This is why we’ve been pushing so hard for you to support the cBHT media campaign — it’s critical we keep doing what Shawn and Tara did and get the word out about the threat to compounded hormones!)

Check out cover guy Gopesh Patel!

Published January 1, 2022

Recognize the guy on the cover of NCPA’s America’s Pharmacist December magazine? Of course not — he’s wearing a mask. But underneath is APC member, pharmacy owner, and great compounding pharmacist Gopesh Patel of Brooklyn. Congrats!

Wishing you all a wonderful New Year’s

Published December 12, 2021

Even APC staff gets a break for the holidays. Our offices will be closed Friday, December 24 through January 2 so our team can enjoy family, friends … and maybe a nap or two. (Whoever said “not a creature was stirring” meant it — at least for the next several days.)

We hope you, too, are able to take a breath and enjoy the holiday. We’ll see you next year!

Congressmembers to FDA: On cBHT, remember the patient

Published December 12, 2021

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).

Is your board of pharmacy aware of USP’s BUD proposals?

Published December 12, 2021

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.

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