The voice for pharmacy compounding | December 13, 2019
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From APC's President...
My term as your president is coming to a close, so I'm taking this second-to-last column to talk straight about this organization's greatest challenge - and what YOU can do about it. Call it preaching to the choir if you wish (in which case you won't mind forwar
ding this newsletter to at least three colleagues who aren't APC members). Nevertheless, I hope these few thoughts resonate.
- APC is a great organization. We have been re-energized this year, and I hope that has been evident to you. While we're not exactly flush with resources, our strategic and financial houses are in order, and I believe we're focused on the right things. We're getting stuff done.
- And yet. For all our leadership and assertiveness on important regulatory issues this year, our membership count has hardly budged. Yes, we reversed a three-year membership decline, but we're not seeing an influx of new (or former, for that matter) members, and that's a little puzzling to me. Maybe member growth is a trailing indicator. I sure hope so.
- Why does membership matter? It's our primary source of revenue. APC's influence grows or shrinks in relation to the members and resources we have. The dues revenue and the grassroots support additional members can provide will allow us to do more. Doing more helps elevate our credibility in Washington, DC.
- By our count, there may be 2000 or more pharmacists out there for whom retail compounding is the majority of their focus, but who are not our members. Add to that thousands of compounding technicians - including almost 1000 specially certified in compounding - most of whom are not our members. And think about another few thousand who compound in a hospital setting and who ought to be a part of APC. That's our recruitment pool.
- In January, we'll be doing two-phase reach-out to those first two audiences - first a mail piece, then an email follow-up. We think it may nudge some of them off the dime.
- I have found, though, that the best way to get folks to join an organization is for a colleague to ask them. I do it on the phone all they time: "Hey, by the way, are you an APC member? You should be." More often than not, they join. Maybe the fact is that pharmacists and technicians are not our members because, well ... you haven't asked them to join.
- SO ASK THEM.You know someone who isn't an APC member. Maybe several someones. I know you do. They may be on your pharmacy team. Or they may be your competitor across town. Or they may be someone you partner with in another town or state. Call them up or email them - send smoke signals if you think it will work - and urge them to join the only organization solely devoted to advocating for the compounding profession. Point them to a4pc.org/membership where it takes only about two minutes to sign up.
Thanks for reading and for doing your part to help your association help your profession. Our future looks bright. We're counting on you to help us ensure it.
Jennifer Burch, PharmD, RPh, CDE
President
P.S. Additional thought: An APC membership would be a great year-end bonus for your staff team!
One more thing: Discounted registration for EduCon 2020 ends December 31. It's looking to be our biggest and best EduCon ever, and you need to be there. Read below for details.
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USP appeals hearing dates and format confirmed
A January 21-22 hearing date has been confirmed on the appeal of beyond-use-date restrictions in the new <795> and <797> chapters by APC, Innovation Compounding and Wedgewood. After the initial appeal by IACP was denied by the USP Compounding Expert Committee in August, we requested an appeal hearing as provided for in the USP bylaws.
At the January 21-22, IACP and its partners will be allowed two hours to present to an appeals panel selected, USP says, to include relevant scientific and USP process expertise. The appellants may present both process and scientific arguments relevant to the BUD restrictions in the new chapters. In light of the appeals, USP in September indefinitely postponed enforcement of the new chapters.
Seeking input on FDA's reclassification of HCG as a biologic
At the request of several members, APC is considering whether to offer input to FDA on its announced reclassification of HCG and several other Section 505 drugs as biologics, announced back in August and set to take effect March 23, 2020.
Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA.
We're seeking your input about circumstances that you believe warrant compounding with HCG, and - more importantly - the scientific basis or documentation that validates that compounding need. Your input will help us in determining if there is a path forward for commenting on the reclassification.
Send to [email protected].
Following is documentation from FDA on the matter:
FDA issues info request on 503B challenges, opportunities
This morning
FDA released a request for information
titled "Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities." Verbatim, from the request:
"The Drug Quality and Security Act of 2013 created "outsourcing facilities" - a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Five years since its creation, this domestic industry is still relatively small and is experiencing growth and market challenges. In addition, FDA continues to find concerning quality and safety problems during inspections.
"To help this industry meet its intended function, FDA intends to engage in several initiatives to address challenges and support compliance and advancement. One initiative includes conducting in-depth research to better understand challenges and opportunities encountered by the outsourcing facility sector in a number of different areas. These include: Operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities related to compliance with federal policies and good quality drug production; and barriers and opportunities related to outsourcing facility interactions with FDA."
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APC seeks nominees for 2020 Alliance committees
2020 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 2020 APC volunteer committee. Committees are the workhorses of the Alliance, developing programming, chasing possibilities, and recommending policy to the APC Board of Directors.
We're seeking knowledgeable members for several 2020 APC standing committees.
In addition to those standing committees, APC also offers you to opportunity for you to share your expertise as a member of a limited duration special-purpose working groups. You'll see in the form below an opportunity for you to let us know about your special interests or expertise as we consider working groups for 2020.
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What are you waiting for?
Discounted EduCon 2020 registration ends December 31...
Go to
www.a4pc.org/educon2020
to register. And remember, you won't be able to reserve your hotel room at the preferred rate until you've registered for the conference.
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FDA draft GFI on animal compounding: By what authority?
In our previous edition, we reported that FDA has posted two important notices, one announcing a new guidance document on Compounding Animal Drugs from Bulk Substances and the other soliciting nominations for a positive bulks list for compounded veterinary office stock.
We believe FDA lacks specific statutory authority in this area, and we will be offering formal comments on that and other concerns at the proper time.
Please send your thoughts on this GFI or bulks list request to
[email protected]
.
Your input can help inform APC's comment letter.
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Absurdity o' the week (and our response to it):
CEO visits Wedgewood Compounding
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Check out these members-only compounding policy resources...
- Compilation of State-Adopted USP 795/797/800 Rules Need to know which states have adopted which parts of USP chapters <795>, <797> or <800>? You'll find answers in our new "Compilation of State-Adopted USP 795, 797, 800 Rules." Click here to access the resource.
- 'State Compounding for Office Use and Veterinary Office Use' Resource Need to know what a particular state's law or regulation has to say about office-use or veterinary compounding? You'll find answers in our 'State Compounding for Office Use and Veterinary Office Use' Resource, available here.
Because both resources are for APC members only, you are required to log-in to access them. If you need to renew your membership or are interested in joining APC,
here's where to do that.
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We can't succeed without your OneFund support...
Invest NOW in IACP's OneFund.
It's what fuels our advocacy work on your behalf, from our work on Capitol Hill to our work at FDA and USP. Your IACP dues alone are not enough to allow us to accomplish our mission. OneFund covers the costs of our lobbyist, attorneys and more.
PLEASE go
to
www.a4pc.org/onefund
and invest today.
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Try these pre-recorded webinars, ready when you need them:
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