From APC's CEO

Three things you should know (and do)

1. Coming March 22: An hour-long compliance training webinar on GFI 256. In advance of the April 1 enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance – and to make sure the vets you work with understand the changes required by GFI 256. A registration link will be available very soon. Watch your email.

2. On that same topic: Please make sure your state board of pharmacy members get a copy of FDA’s answers to our questions about compliance with GFI 256. Why? Because for consistency (and yes, to fend off possible overreach), it’s important that states understand how FDA views compliance with the GFI and create enforcement protocols that mirror FDA’s. We shared the FDA answers with BOP executive directors. We’re looking to you to share them with board members.

3. On a different topic: You’ll read below that the Owner Summit hotel has extended the special room rate through this Tuesday. Doesn’t mean you can’t get a room later, only that after that date you’ll pay more. This is the year’s biggest business-focused event for compounding pharmacy owners. In addition to great how-to sessions, we’ll also share news on our credit card processing GPO and patient-reported outcomes initiatives. Don’t miss it.

Read on for more news and opportunities.

Scott Brunner, CAE is APC’s chief executive officer. Reach him at scott@a4pc.org.

ICYMI

Catch up on these recent stories that you might've missed:

• Owners: Don’t miss this one
• Share CVM’s GFI 256 reply with your BOP
• APC Fellow nominations are OPEN
• HHS projects October 2023 MOU release
• EduCon continues…

This week

Special Owner Summit room rate extended to March 7

For compounding pharmacy and facility owners, Owner Summit is the top learning, planning and idea-sharing event of the year—and it’s less than one month away!

And here’s some good news: We’ve managed to buy you a few extra days to take advantage of our reduced hotel room rate for the conference. The new cutoff for special rates at Marriott’s Grand Hotel is NOW Tuesday, March 7.

Please note the APC room block has very limited availability remaining for March 26 - 28. However, the APC room block for Friday, March 24 and Saturday, March 25 is currently sold out.

This year’s fast-paced Owner Summit program is guaranteed to wake you up from the doldrums with sessions on growing your pharmacy team, incorporating new ideas, and increasing operational efficiency. We guarantee you’ll take home new ideas you can implement immediately.

Free access to Townsend e-letter

Over the past two years, The Townsend Letter has partnered with APC to alert prescribers and others about the threat to restrict compounded hormone therapy. Now, the folks at The Townsend Letter want to make sure you know you can get a free subscription to their weekly e-newsletter.

Founded by Jonathan Collin, MD, The Townsend Letter serves as a forum for integrative and naturopathic practitioners. It’s a free subscription available by request from subscription@townsendletter.com.

Dr. Collin invites compounding pharmacies to subscribe, and also to submit articles, invitations for webinars and meetings, etc. Recent issues are always posted at www.townsendletter.com.

Proposed telehealth prescription rules affect testosterone

Proposed DEA rules would provide safeguards for telemedicine consultations by a medical practitioner who has never conducted an in-person evaluation of a patient that result in the prescribing of a controlled medication for that patient. This would affect prescriptions for compounded testosterone, for instance.

However, the proposed telemedicine rules would allow medical practitioners to prescribe 30-day supplies of both Schedule III-V non-narcotic controlled medications and buprenorphine for the treatment of opioid use disorder.

Access the full proposals here and here. The public has 30 days from February 24 to review and comment on the proposals, which DEA will then consider before drafting final regulations.

Save these dates

March 14: A PCCA webinar, Quality & Compliance

March 21: A FREE ARL Bio Pharma webinar, USP 51 Antimicrobial Effectiveness Testing & USP 71 Sterility Testing

March 22: An APC/PCCA webinar, GFI 256: Coming Into Compliance. Details coming soon.

March 23: An APC webinar, Compounding Health - As an "Adjunct to Diet and Exercise"

March 26–28: APC's Owner Summit 2023, The Grand Hotel Golf Resort + Spa;

Point Clear, Alabama.

April 6: An APC webinar, Making the Case for Advanced Pharmacy Technicians. More details coming soon.

April 20: An APC webinar, Compounding for Women’s Health Conditions. More details coming soon.

May 25: An APC webinar, IV Nutrition. More details coming soon.

June 6: An APC webinar, Compounding for Cosmetic Needs. More details coming soon.

June 29: An APC webinar, Trends in Veterinary Compounding. More details coming soon.

May 16–17: PCCA's ACT Legislative Conference, Washington, DC

September 19–20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

Short takes

FDA alert restricts xylazine imports. This week, FDA announced an Import Alert to restrict the unlawful entry of drugs containing xylazine into the country. The agency says this action aims to prevent the drug from entering the US market for illicit purposes, while maintaining availability for its legitimate uses in animals.

Owner Summit bonus: Bask in the history of the hosting venue. The Grand Hotel Golf Resort & Spa dates back to 1847 and has been a member of the Historic Hotels of America since 2011. Only 300 hotels are recognized under the Historic Hotels of America designation. Register for APC’s Owner Summit (March 26-28) so you, too, can see it up close.

Quick links



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Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

EduCon 2023

Owner Summit 2023

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• Shipment Trackers, a shipping costs auditor  

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.