The voice for pharmacy compounding | January 10, 2020
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Welcome to a new year ... and a new association ... and new opportunities!
re at the start of what I know will be a successful 2020 for our newly energized association, I want to thank the members who served last year on our committees. You helped spark the revitalization of our organization and helped ensure compounders can to continue to serve their patients.
Thanks also to my fellow APC Board members for your leadership. For those who don't know, our Board members give countless hours to help keep APC fulfill its mission. These Board members adjust their schedules to accommodate APC meetings - oh, and by the way, they pay their own travel expenses! I'm grateful to them for their insight, investments and leadership. It doesn't go unnoticed!
It's a real honor for me to serve as your APC president, and I'm grateful for your support. I'm looking forward to building on the great foundation laid by past IACP leaders, particularly by our 2019 president Jenn Burch. Her term will be remembered as pivotal in reinvigorating our organization. Thank you, Jenn, for your amazing service to the pharmacy compounding profession!
am also excited to be working with your CEO, Scott Brunner, who in only 10 months into his position has accomplished some amazing feats. He has identified ways to control costs, developed promising relationships with other organizations that have a stake in compounding, and is listening and responding to the needs of our members and corporate patrons. Thank you, Scott for your work!
Our name change to Alliance for Pharmacy Compounding is official. It reflects our new vision: to represent the entire scope of pharmacy compounding. That includes pharmacists, of course, but also
technicians, educators, researchers, students, supply chain professionals, policymakers, and even (especially) prescribers and patients.
Next weekend, the APC Board of Directors will meet in Irving, Texas, to determine performance measures related to how we do that. They will be fine-tuning
the strategic ends we aim to accomplish
. What does success look like? How will we measure it? Stay tuned for more about that after next weekend.
I suspect one of the things you look to APC for is to tell you what's important right now.
Let me spell it out for you: A-D-V-O-C-A-C-Y F-U-N-D-I-N-G. Having sufficient financial resources is the only way APC can protect your business and the patients you serve. It's the only way we can advance good legislation in Congress, fight bad regulation from FDA, challenge ill-considered standards from USP, and assist our state-level partners on state-specific issues. And now, after a year in which we aggressively pursued those aims, our coffers are low.
It's what's important right now. And it's why I'm asking you to do THREE IMPORTANT THINGS to assure APC's success:
- Help us grow our membership. If you're reading this, you're likely our member. Thank you. But are your pharmacy teammates members? If not, ASK THEM TO JOIN. If they enter the code NEWYEAR at www.a4pc.org/join before Feb. 15, they can save on their annual membership dues. If each member found just one more member, we would be in a very sound position to achieve all that is required of APC! Dues revenue is our bread and butter, so when it's time to renew your APC dues this year, do it timely.
- Invest in One Fund. It fuels our entire advocacy operation. Last year, we fell short of our OneFund investment goal by about $80,000. That shortfall will affect what we can accomplish in 2020 on a range of issues, from the proposed animal compounding GFI to the USP appeals to bulks lists to legislation on dietary supplement monographs. Please invest in OneFund NOW and help us make-up this shortfall.
- Help support members of Congress who think like you do about pharmacy compounding. Make an investment in COMP-PAC, our political action committee, to help make sure we're heard on issues that matter to your profession.
Don't have the ability to make a one-time payment to any of the above? We get it. Please feel free to select the monthly payment option to help keep your budget in line.
That's it ... for now, anyway. With your support, we can multiply our 2019 success in 2020, and make a difference for the patients we serve. Thank you in advance!
Shawn Hodges, PharmD
January 14 | NASEM cBHRT Study Committee Public Session, Washington, DC
January 17-18 | APC Board of Directors Meeting, Irving, Texas
January 19 | IACP Foundation Board Strategic Planning Session, Irving, Texas
| Hearings on USP Appeals of <795> and <797> BUD Restrictions, Rockville, MD
EduCon EXPO is already a sellout! Have you registered yet?
APC's EduCon2020 is 90 days away, but the Expo has already sold out. Member registration for the conference is not doing so bad either.
Conference seats are limited
to reserve your place.
Here are quick details:
- Co-located with NHIA's Annual Convention at the Gaylord Rockies Resort
- 1300+ attendees and a 125-booth Expo
- 11 hours of timely, top-notch compounding continuing education, including:
- Best Practices for Your cBHRT Practice
- Fast & Fabulous Ideas to Fire-Up Your Pharmacy Team
- Putting Safety at the Center of Your Compounding Operation
- More Than Counting, Pouring, Licking and Sticking: How to Leverage Your Technicians for Pharmacy Success
- Try a Little Strategery: How Strategic Planning Can Fuel Your Pharmacy's Future
- Minor Chapters, Major Impacts: What USP <51>, <61> and <1112> Mean for Your Practice
- Compliance with USP 800 - Sterile Requirements
- Compliance with USP 800 - Nonsterile Requirements
- What Else is in There?! Excipients, Inert Ingredients, and Fillers for Nonsterile Compounding
- CBD and Compounding: What Was, What Is, and What Might Be
- FDA Presentation on the Proposed Draft Animal Compounding GFI
- PLUS: Morning symposia on a variety of topics
- We'll send you the link to reserve your hotel room when you register for the conference
It's sure to be the biggest and best EduCon in years. You need to be there. REGISTER HERE.
Check out our briefs (so to speak)...
We've created one-page briefing papers on APC's advocacy priorities. You'll find them under the 'Federal Advocacy' tab on our website. They're perfect for briefing policymakers or as a refresher for you and your teammates. Included are new briefs on the draft GFI on animal compounding, dietary supplement monograph issues, 503A and 503B bulk lists, and HR1959. Share them as needed. Contact us with questions.
No clear path to challenge FDA's reclassification of HCG
Over the past 90 days, APC has talked extensively with members, industry partners and legal counsel in an effort to identify a path for successfully challenging the upcoming reclassification of HCG and several other Section 505 drugs as biologics. While a number of options exist, including litigation and legislation, the broad consensus is that the odds of turning back the reclassification are slim.
The change is set to take effect March 23, 2020. Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA.
"We know this isn't good news for those who compound HCG," said APC Chief Executive Officer Scott Brunner, CAE. "We continue to look at alternatives, including a direct plea to FDA to suggest that the proposed reclassification goes much farther than perhaps even FDA intended when it was approved several years ago, and may ultimately create patient care issues that FDA did not anticipate."
Stay tuned as we continue to investigate this issue with our industry partners.
Presenting (and loving) (and thanking)
our 2020 Corporate Patrons...
APC couldn't do what it does without them: our corporate supporters whose generosity helps fund our operations. For 2020, seven stellar companies are making substantive investments in APC as Corporate Patrons. We're grateful for their support. You should be, too. Please say thanks the next time you see one of their representatives.
Survey: Animal compounding GFI will have negative impact, vets say
new nationwide poll of veterinary practices confirms that new guidance proposed by the Food & Drug Administration (FDA) would have a significant negative impact on their practices and their patients' health if issued and enforced. The
began on December 18, shortly after FDA released its proposed "
Compounding Animal Drugs from Bulk Substances Guidance for Industry #256
. The results of the survey as of January 6, 2020, are available at
. The survey is still open as of this release.
A coalition of compounding pharmacies that specialize in veterinary medicine conducted the research to learn how practicing veterinarians would be affected if FDA's proposed guidelines were to be finalized. Although, even if issued, this draft FDA guidance is not binding on FDA, compounding pharmacies, or veterinarians, and will not be the law, FDA uses non-binding Guidance as the basis for its enforcement actions.
Marcy A. Bliss, president and CEO of
, said: "Once again, veterinarians have reiterated the importance of compounded medication for animal patients and don't see the need for change or the benefits of federalizing what are now the state-regulated practices of pharmacy and veterinary medicine. As one veterinarian put it, 'This is a solution looking for a problem.'"
USP updates FAQ on 795, 797 appeals
USP has updated its FAQ document on the appeals of BUDs in the new <795> and <797> chapters to include details about the upcoming January 21-22 appeal hearings. View it here.
Congress gives FDA direction on compounding in appropriation bill
Thanks to extensive advocacy by APC and its partners - and the help of our champions in Congress -
FDA's FY2020 spending bill includes directives from Congress:
- Encouraging the Food and Drug Administration to work with the States before finalizing the Memorandum of Understanding on compounding regulation.
- Noting awareness of concerns with the Food and Drug Administration's implementation of the Drug Quality Standards.
- Encouraging the Food and Drug Administration to appoint a qualified voting member with recent, actual, and diverse pharmacy experience to the Pharmacy Compounding Advisory Committee.
- Requiring FDA to provide a briefing to Congress on the agency's position on compounding with substances the subject of a USP dietary supplement monograph.
Actual USP <800> enforcement may vary...
In light of appeals of beyond-use date restrictions in the new USP <795> and <797> chapters, USP in September indefinitely postponed enforcement of those new chapters, and also of USP <800>.
However, state regulators may still choose to enforce <800
. For more information about whether your state will be enforcing <800> under state law or regulation, contact your state board of pharmacy.
You can also check out APC's
Compilation of State-Adopted USP 795/797/800 Rules
for answers to your questions. Click here to access the resource. Note that the compilation is an APC members-only resource, so you'll need your login and password to access.
Check out our pre-recorded webinars, ready when you need them: