The voice for pharmacy compounding │21 October 2022
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A new definition for biologics?
WARNING: IF YOU SERVE THIS DESSERT FOR THANKSGIVING DINNER, YOU MAY RUN AFOUL OF FDA.
Absurd, right? So is the agency’s position on desiccated thyroid extract (DTE) as a biologic because it contains thyroglobulin.
Let’s look at the definition of a biologic according to the industry:
“a 'biological product' is 'a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, . . . applicable to the prevention, treatment, or cure of a disease or condition in human beings.'”
Further, federal statute dictates that a protein which contains more than 40 amino acids is a “biologic product." So, what does gelatin have in common with the “biologic” thyroglobulin and “non-biologic” heparin?
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Product | # of amino acids | Condition treated | Appears in FDA's Purple Book? | Thyroglobulin | 2,770 | none | No | Gelatin | thousands | hunger | No | Heparin | approx. 15,291 | thrombosis | No | | |
As you can see, the agency’s arbitrary definition of DTE as a biologic is not consistent. If the agency declares the inactive byproduct of DTE production, thyroglobulin, as a biologic, where does it end? Can you imagine if the gelatin capsules used throughout the pharmaceutical and compounding industries were to be declared “biological products” because they encapsulate substances that are “applicable to the prevention, treatment, or cure of a disease of condition in human beings” and what havoc that will impart? Where will it end?
We must continue to push back. APC has a meeting scheduled with FDA CDER and CBER leaders on November 8, and we hope to know more after that meeting. For now, we must continue to educate our state Boards of Pharmacy, since the FDA has tasked them with enforcing the ban on compounded DTE.
We must continue to drive patient and prescriber advocacy efforts at compounding.com. When there is a call to action—and one is surely coming—we must have stakeholders mobilized and ready to act.
Last, we must support efforts to oppose these actions with time, talent and treasure. Many of you are already dedicating your time and talent. If you have treasure available, continue supporting this effort by clicking here.
In the meantime, enjoy the Jello. Its days may be numbered.
– Dave
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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.
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ICYMI
Catch up on these recent stories that you might've missed:
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FDA agrees to meeting on DTE |
FDA representatives have agreed to meet on November 9 with APC and other pharmacy organization leaders about FDA’s recent apparent reclassification of desiccated thyroid extract (DTE) as a biologic, thus prohibiting its use in compounding.
APC requested the meeting with representatives of FDA’s Center for Drug Development & Evaluation and Center for Center for Biologics Evaluation and Research in the wake of a September 16 FDA letter to NABP announcing the reclassification of DTE. APC has invited leaders of APhA, NCPA, and the Outsourcing Facilities Association to join the meeting as well.
“We’ve been clear with FDA that we’re concerned both about the substance of this reclassification and the back-door path they’ve taken in implementing it,” said APC President Dave Miller. “This can only be portrayed as an abandonment by FDA of the more than 60,000 patients who benefit from compounded thyroid therapy, so we look forward to hearing what FDA has to say.”
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Some of you may recall during this year's Compounders on Capitol Hill, Scott Brunner interviewed FDA's Gail Bormel. Among other things, the subject of how compounding pharmacies can avoid repeat 483 findings, and how FDA could educate compounders about them and how to avoid them.
She told Scott she liked this idea and clearly, she took it to task: On December 14, FDA is hosting a webinar, What to Expect after an Inspection: 483s, Responses and Beyond. We hope you can attend.
Learn more and register here.
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Patients respond to cBHT "Special Report" |
This week APC emailed a special report to thousands of patients and prescribers of compounded hormones to inform them about FDA’s prohibition of Thyroid USP for use in compounding, and to update them on the threat to compounded hormone therapy generally.
In addition to all APC members, state pharmacy associations, and other interested individuals, the email was sent to:
- More than 5,000 patients and prescribers who had visited compounding.com in the past year.
- More than 60,000 consumers who are part of APC’s Patients for Personalized Prescriptions (P3) group.
- Nearly 2,000 prescribers who recently signed a joint letter to FDA Commissioner Robert Califf about FDA’s threat to restrict cBHT.
Thus far, the email campaign has resulted in 19 additional contributions—totaling more than $16,000—to APC’s Save Compounded Hormones Campaign. It has also resulted in more than 70 new patient testimonials this week at compounding.com.
As you may know, our ability to continue to engage patients, prescribers, and policymakers on this issue is in jeopardy. Please help us continue to fight for your ability to treat patients with compounded hormone therapy. Give to the campaign via the button below.
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Congratulations to APC's newly elected officers and directors for 2023 | |
2023 Elected Board Members
Vice President – Joe Navarra, Town Total Compounding, Woodbury, NY
Treasurer – Alexander Pytlarz, Infuserve America, St Petersburg, FL
District II – Gopesh Patel, VLS Pharmacy, Brooklyn, NY
District III – Cheri Garvin, The Compounding Center, Leesburg, VA
District IV – Mark Filosi, Family Care Pharmacy, Plant City, FL
District VII – Erin Michael, PCCA, Cottonwood, CA
At-Large – Amy Frost, OSRX, Missoula, MT
Other Board Members include
Immediate Past Chair – David Miller, Keystone Pharmacy, Grand Rapids, MI
Chairman of the Board – Anthony Grzib, Wedgewood Pharmacy, Swedesboro, NJ
Chair-elect – Tenille Davis, Civic Center Pharmacy, Scottsdale, AZ
District II – Philip Smyth, Medisca, Lebanon, OH
District III – Chad Thompson, Tri-State Compounding Pharmacy, Cincinnati, OH
District IV – Tara Thompson, Revelation Pharma, Montgomery, TX
District V – AJ Day, PCCA, Houston, TX
District V – Stephanie Chacon, Empower Pharmacy, Houston, TX
District VI – Dave Hill, Belmar Pharmacy, Golden, CO
District VI – Gina Besteman, Women’s International, Madison, WI
At-large – Shaun Noorian, Empower Pharmacy, Houston, TX
At-large – Amy Frost, OSRX, Missoula, MT
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What compounding software are you using? | |
Earlier this year, APC announced a collaboration with OutcomeMD, a platform that allows compounding pharmacies to measure patient-reported outcomes (PROs) using the same validated measures that FDA requires in new drug approvals. We think that program is key to demonstrating to FDA that the compounded preparations you dispense are actually doing for patients what they are supposed to do.
During a recent APC briefing, Proving Your Value Via Patient-Reported Outcomes, we discussed how important it is to use platforms like OutcomeMD in order to consistently demonstrate the value of your patients' therapies.
One challenge is the integration of OutcomeMD with your compounding software and your pharmacy workflows. To work through some of those possible issues, we need to know which compounding softwares our members are using the most.
Will you please tell us which compounding software you’re using? This short survey will only take a few minutes.
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FDA extends period before enforcing out-of-state distribution limits |
Yesterday, FDA announced it is extending the period before it intends to begin enforcing the statutory five percent limit on distribution of compounded human drug products out of the state in which they are compounded for those states that have not already entered into a standard memorandum of understanding (MOU) with the agency addressing certain distributions of compounded human drug products.
The pre-enforcement period was originally scheduled to end on October 27, 2022.
FDA published a standard MOU in October 2020 but has suspended it pending rulemaking and publication of a new standard MOU.
| Welcome to our newest PFMs | |
For small and large 503A and 503B pharmacies and outsourcing facilities, APC offers a pharmacy/facility membership (PFM) as an alternative to purchasing several individual memberships.
Every registered employee of a pharmacy/facility member receives APC’s individual member benefits: continuing education opportunities, access to APC’s information services, professional development events, discounts on services, and more. In addition, PFMs get access to several exclusive benefits.
We’re pleased to welcome our newest PFM members to the fold, bringing the total to 80 pharmacies and facilities that have joined APC as PFMs since September:
- Boothwyn Pharmacy, Kennett Square, PA
- CRE8 Pharmacy Group, Coral Springs, FL
- Curexa Pharmacy, Egg Harbor Township, NJ
- Family Pharmacy - South Aiken, Aiken, SC
- FarmaKeio Custom Compounding, Richardson, TX
- FarmaKeio Outsourcing, Southlake, TX
- Harbor Compounding Pharmacy, Costa Mesa, CA
- NuRx Pharmacy, Harlingen, TX
- Wells Pharmacy Network, Ocala, FL
If you’re not already a PFM and would like to change that, please click here for details or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.
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Pleased to meet you, Mr. Senator. Last weekend, APC Board Chair Mike Blaire and his wife Dorothy (both at right) met Senator Jerry Moran of Kansas at an event in Arizona. And of course, Mike put in a good word with the senator about compounding.
Enough is enough. In a recent piece in APhA's Pharmacy Today, the association's CEO Ilisa Bernstein says the industry needs to evolve—and soon. Among other things, she notes that pharmacists are underpaid, understaffed, and burdened with unrealistic metrics. Read the full article here.
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