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From APC's President

The good, the bad, and the ugly ...

Admit it: You read the headline and automatically thought of Ennio Morricone’s catchy, creepy movie theme. Fair enough. This column doesn’t have a song, but it does have a theme: some good, bad, and ugly goings-on with APC and compounding in general. And don’t worry: It’s much shorter than the movie.

The good

• In just seven months, APC’s membership has grown from 990 to 3,400 people, thanks to more than 70 pharmacies and facilities who’ve joined as PFM members. Curious as to why? Learn more.
• The number of pharmacies subscribing to OutcomeMD, our patient-reported outcomes portal, is growing. It’s the way we can prove compounding’s value to FDA, so yes, you need to check it out.
• We’re seeing plenty of downloads of the prescriber briefing documents APC and the Pharmacy Compounding Foundation developed to help you educate physicians and others about compounding – what you can and can’t do under the law.

The bad (?)

• Our Campaign to Save Compounded Hormones is stalled, out of cash – despite FDA’s recent action to restrict thyroid hormone. Without funding, APC can’t engage patients and prescribers in the effort to push back against FDA overreach. Got thoughts – or dollars? Share ‘em.
• As you’ll read below, USP has announced it will release the new <795> and <797> chapters November 1. Yes, APC provided USP with well-reasoned and substantive input countering their proposed BUD and batch-size limitations. But I don’t have a lot of confidence we were heeded.
• More about money: Investments in APC’s OneFund are off a good fifty percent so far this year – a worrying sign since that fund fuels our entire advocacy operation! Do your part here.

The ugly

• I’m a broken record on this one: FDA has declared desiccated thyroid extract (DTE) to be a biologic drug and therefore ineligible for compounding. Below you’ll find a link to yesterday’s Town Hall Briefing on the matter. Watch it, so you’ll know what we’re doing to confront this absurd imposition by FDA.

When it comes to compounding, I suspect there’ll always be some good, some bad, and maybe even some ugly. That’s why APC is always working for you. Thanks for your continued support.

–       Dave 

• • •

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

This week

Missed our Thyroid USP Town Hall? Watch it here.

More than 300 registered for APC’s town hall briefing yesterday on FDA’s back-door effort to reclassify of Thyroid USP as a biologic and thus prohibit compounding with it. Did you miss the Town Hall? Never fear: We taped it. Watch it, then stay tuned for a likely call to action from APC, coming soon.

USP to release new <795> and <797>

Did they or didn’t they? Did USP take seriously input from APC (as well as that of APhA, NCPA, and numerous other pharmacy stakeholder groups) urging the USP Compounding Expert Committee to avoid arbitrary limits on beyond-use dates and batch sizes in its new Chapters <795> and <797>? We’re soon to find out.

Earlier this week, in its Healthcare Quality & Safety e-newsletter, USP announced that it will release the revised chapters on November 1. The new chapters are set to become effective six months after release. Your APC team will be reviewing the new chapters carefully, and we’ll have a fuller report following their release.

Short Video: He’s using OutcomeMD … and thriving! 

How APC member Jack Korbutov has embraced patient-reported outcomes

When APC member Jack Korbutov heard about the OutcomeMD platform at APC’s Owner Summit back in March, he knew he wanted in. Now, six months later, he's implemented the patient reported outcome system in his pharmacy in Philly, and he says it's already paying dividends.

Korbutov shared his experience in an APC patient reported outcomes briefing last week. Here, we've captured his eight-minute presentation on video just for you. Watch it, and learn how your pharmacy can leverage OutcomeMD to demonstrate that the compounds you prepare do for patients what they're supposed to do. Then contact lkaiser@outcomemd.com to sign up!

Don’t be bored with our Board. Vote now!

You’re running out of time to cast your ballot in APC’s 2023 Board of Directors and officer election—and to approve changes to the APC Bylaws. Voting closes October 19 at 11:59p ET.

If you are an APC member, click here to vote. (If you’re not an APC member, may need to re-examine your life choices, eh?)

Oh, and here is the slate of candidates for review and the proposed bylaw changes.

Legal settlement spurs FDA to develop 503B bulks list

The Outsourcing Facilities Association announced this week that it reached a settlement agreement with the FDA that will spur the agency to promptly review long-pending nominations for active pharmaceutical ingredients for use by FDA-registered 503B outsourcing facilities to compound drugs needed by patients.

OFA says the settlement of an OFA-supported lawsuit will allow 503B facilities to improve health care provider and patient access to certain medications and to ease drug shortages in a timely manner.

Save these dates

October 14: Medisca Virtual Business Event, 10am – 5pm EDT.

October 19: APC 2023 Board of Directors election voting closes.

October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

November 10: An APC Webinar: Can You Compound That? A Quiz Show Webinar (details coming soon)

December 8: An APC Webinar: How to Use Medical Literature to Identify and Support Compounded Therapies (details coming soon)

2023

February 9–10: APC's EduCon 2023, virtual (more details coming soon)

March 25–27: APC's Owner Summit 2023; The Grand Hotel Golf Resort + Spa;

Point Clear, AL (more details coming soon)

Short takes

A drug for sleep apnea? The only reliable ways to treat sleep apnea are with a CPAP machine or hit-or-miss surgery. But Aussie researchers found a (possible) pharmaceutical treatment: reboxetine. The antidepressant stabilized breathing, reduced the number of sleep apnea events per hour, and improved oxygen levels — no mask required.

What, you worry? (Nope.) Halloween is coming, and with it the stories about What Parents Should Be Afraid Of. The latest comes from the DEA, which warns that drug dealers are targeting kids with “rainbow fentanyl” — pills that come in a variety of fun colors to attract kids. But drug experts say no, no they aren’t. Colors are just part of drug dealers' marketing (really), and no one is targeting kids.

Quick links



APC Career Center

• Job seekers

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APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill 2022

Continuing education

• Live webinars

• On-demand webinars

Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

Prescriber Briefing Resources  

Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund

Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members

Affinity service providers

• Accounting & Tax Services: Rx Advisors

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

• 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.