From APC's President

Black Friday

Last Friday, many of us honored the official start of the holiday shopping season by flocking to stores for the promise of finding great gifts at door-busting prices. 

What you may not know is that there's more than one "Black Friday." Originally the moniker referred to a Sept. 24, 1869, stock market catastrophe. On that day, after a period of rampant speculation, the price of gold plummeted, and the markets crashed. (It is definitely the less fun of the two same-named events.)

Knowing this, I worry about the potential for a third Black Friday, one where our compounding world crashes like the market did in 1869. 

I worry for the day when we lose our ability to compound desiccated thyroid extract for our patients. I also worry for when the FDA determines that cBHT is “demonstrably difficult” to compound, and our patients' health and well-being are threatened. Most of all, I worry for the day when compounding ceases to exist because our voices were dimmed by the louder ones that opposed us. 

The potential for a compounding-specific Black Friday lurks in the background and I don't want us to stand by idly with our hands in our pockets.  

Modern-day Black Friday encourages us to spend money on things for ourselves and our loved ones, which we enjoy doing. But we need to use our money to ensure future Black Fridays continue to be the good kind.

Here is my ask and challenge: Would you invest 10% of what you spent during this year's Black Friday or Cyber Monday to help ensure that we don’t endure the tragic and unfathomable world where your profession does not exist? Here are three opportunities for you to invest in compounding's future success. You are welcome to contribute to one...or all:

• Save cBHT, our campaign to protect patient access to compounded hormones
• CompPAC, APC's political action committee
• OneFund, which helps pay for APC’s critical advocacy apparatus

–   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.

ICYMI

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This week

EduCon programming offers a buffet of learning options

Hold on to your toboggans, kids: APC's EduCon is just over two months away.

APC's annual virtual conference focuses on compounding's best practices for keeping you and your team compliant and efficient.

Why do you need to attend EduCon 2023? Well, with up to 12 CE hours (approved for both pharmacists and technicians), EduCon is sure to be one of the best investments you can make in your professional development all year. Note: LIVE CE credit is only available on February 9 and 10. On-demand will be home study CE credit.

Here’s a taste of just three of the great sessions we’re offering:

The Compounders’ Code of Ethics and Your Commitment to Quality. Led by PCCA's AJ Day, attendees will be asked to consider their answers to sticky questions centered around the Compounders' Code of Ethics and the quality systems necessary to ensure your compounding pharmacy and team are in compliance.

Compounding for Thyroid the Right Way! Presented by Michelle Moser, Makers Compounding Pharmacy, this program will go deep into compounding specifics for your thyroid patients. Similar to following any recipe, compounding levothyroxine, liothyronine and thyroid USP requires attention to accuracy, dosage and potency.

Latest/Greatest Trends in Geriatrics and Hospice Compounding. Medisca's Mindy Cormier, will explore the growing need for compounding sterile and non-sterile preparations in geriatric and hospice applications, and how those treatments are used to help aging patients' particular needs.

Best of all, to sweeten the EduCon value package, APC is offering early bird rates for members and PFMs. (For PFM technicians, the rate is only $99 until January 4!) Registration is open now, don't miss out!

FDA updates DTE stance, APC interprets

In an email this week to members, APC's CEO Scott Brunner provided an update on FDA's recent response to requests for clarification on the agency's classification of desiccated thyroid extract and thyroid USP as biologic drugs, thereby making both ineligible for compounding.

Though some reading between the lines is required, Brunner said APC's interpretation is that FDA intends, at least for the foreseeable future, to take no action against compounders of DTE unless the agency receives a complaint about adverse events or product quality—in which case, the agency would commence an investigation of the pharmacy that prepared the DTE drug that is the source of the complaint. Brunner emphasized that this is an interpretation and is not definitive, and he urged members to seek legal counsel for advice on how FDA’s letters should guide DTE compounding activities in their respective states.

Brunner also discusses APC’s next steps in the update.

On amoxicillin compounding, APC urges – and FDA acts

At APC’s urging, FDA has released a final guidance document stipulating minimum steps pharmacies that compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

APC supported its plea to FDA with results of a survey showing the difficulty its members are facing in sourcing amoxicillin suspension.

Read more about the new guidance here.

Image by Victoria Model on Pixabay.com

Want to be influential at APC?

Sign up for a 2023 committee seat

2023 is coming, and with it, new opportunities for you to serve and advance your profession. One of those opportunities is for you to lend your expertise as a member of a 2023 APC volunteer committee.

Committees are the workhorses of the Alliance, developing programming, chasing possibilities, and recommending policy to the APC Board of Directors. They are also a talent pool for recruiting future APC Board positions.

We're seeking knowledgeable members for the following 2023 APC standing committees:

• Communications
• Education
• Federal Legislative
• Membership
• State Legislative
• Technician Services

If you would like to be considered for appointment, please send an email to info@a4pc.org, and include the following information:

• Your name
• Pharmacy/facility name
• Town and state
• APC committee(s) you’re interested in
• A brief description of your expertise in the subject area covered by that committee

But don't wait until the last minute! Committee requests are due to APC by COB December 20, 2022.

Maine BOP gives a little and takes some, too. APC Board Chair Michael Blaire testified this week on behalf of Wedgewood Pharmacy before the Maine Board of Pharmacy regarding a proposed rule that would allow compounding for veterinary office use for the first time in that state but requires a signed acknowledgment from a veterinarian with each order, an undue burden for both pharmacists and veterinarians. APC will be submitting comments on this rule to the board as well.

Save these dates

December 6: An APC webinar, Practically Indispensable: How You Can Become an Elite Pharmacy Tech

December 8: An APC webinar: How to Use Medical Literature to Identify and Support Compounded Therapies

December 13: An ARL live webinar: Understanding USP <797> Microbiology Testing Requirements

December 14: An FDA CDER webinar, What to Expect after an Inspection: 483s, Responses and Beyond

2023

January 4: Early bird rates end for EduCon 2023.

February 9–10: APC's EduCon 2023, virtual

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

Point Clear, Ala. (more details coming soon)

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

Short takes

Arginine hydrochloride and lysine proposed for 503B bulks list. FDA recently announced a proposal to include two bulk drug substances on the list of bulk drug substances that may be used in compounding by outsourcing facilities.

Pushback on Express Scripts appears to be working. Rumor has it that Express Scripts is extending another opportunity to independent pharmacies to participate in the Tricare network.

Job hunting in Oklahoma? The Oklahoma State Board of Pharmacy is hiring a full-time Pharmacist Compliance Officer for the Central Oklahoma area. Applications are being accepted until the role is filled.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

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

EduCon 2023

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.