The voice for pharmacy compounding | March 6, 2020
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From APC's President...
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Lots going on, including some new stuff - and a reminder or two - from APC:
1.
A new Guidance for Industry #256 Fact Sheet focused on pet owners is now available on our website under the Advocacy tab. Click, download and share with your pet-owner customers so that they're aware of concerns with the FDA's draft animal compounding GFI.
2.
Speaking of GFI #256: Have you responded to our call to action? We've logged more than 600 comments to FDA about the draft GFI, but we're aiming for 1000. If you have not yet commented, PLEASE do so. We've made it quick and easy for you, with a template letter you can adapt as you wish or send as is.
Here's the link for commenting. Oh, and please share it with your fellow compounding team members so they can comment, too.
3.
We've launched a new section on our website, called 'I am APC.' It features members explaining why they value APC, and we think it can be a useful tool to help with member recruitment. In coming weeks we'll be adding technicians, educators, and others to those members featured.
Take a look and let us know what you think - and please share with nonmembers!
4.
The Foundation has a new name, new logo, and new fundraising push.
Watch your mailbox for a letter from Pharmacy Compounding Foundation leaders outlining the Foundation's new focus and asking you to contribute. It's how we ensure the future of compounding. I hope you'll give!
5. Lastly: We're a month out from the biggest pharmacy compounding event of the year, and the preferred hotel rate for EduCon2020 expires at midnight tonight. We've marketed and we've cajoled, now I'm pleading shamelessly: Your profession needs you to be there, where some of the greatest challenges in compounding will be addressed. Your business needs you to be there, too, to get ideas and solutions you can take home and implement to better serve your patients. Register here now, and we'll send you the link to make your hotel reservation before tonight's deadline. Can't wait to see you there!
There's lots more news below. Read on...
President
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UPCOMING:
March 31 - April 1:
PCCA's ACT Conference (Washington, DC Fly-In)
April 6 - 9:
APC's
EduCon2020
in Denver, CO
April 7: APC Annual General Membership Meeting, 2pm, Summit 6-7 Rooms, Gaylord Rockies Resort. This serves as formal notice of the annual general membership meeting, as required by the APC bylaws. Open to all APC members.
September 9 - 10: APC's Compounders on Capitol Hill (Washington, DC Fly-In)
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We'll send you a link to make your hotel reservation after you register for the conference. The special APC/NHIA conference hotel rate expires TODAY!
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FDA addresses implications of biologics reclass on compounding
On Wednesday, FDA released a final guidance for industry,
"The '
Deemed to be a License Provision of the BPCI Act: Questions and Answers
" that it says provides answers to common questions about FDA's implementation of the "transition" provision of the BPCI Act. One big question unanswered in that final GFI is how the reclassification will apply to compounding.
The BPCI Act requires that a marketing application for a "biological product" (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).
Thursday's communication from FDA states that items on the transition list - along with all other biologics - are not eligible for compounding exemptions under 503A or 503B, but that FDA's Mixing/Diluting/Repackaging of Biologics GFI provides some parameters under which FDA may exercise enforcement discretion. The communication explicitly addresses HCG and hyaluronidase and asserts that compounders can work with the approved biologic outside of the scope of the BLA as long as the conditions of the Mixing/Diluting/Repackaging of Biologics GFI are followed.
"FDA is asserting that compounding from bulk API is not allowed for any biologic," said APC's Legislative & Regulatory Counsel David Pore. "That means that if a 503A or 503B facility expects enforcement discretion related to a biologic, it must start with an FDA-approved finished biologic product and mix/dilute/repackage it according to the GFI, which explicitly prohibits the use of any bulk API."
Importantly, FDA's communication also clarifies what a biologics license application (BLA) is.
"Obviously, this communication from FDA is concerning and has huge implications for 503A and 503B pharmacies, physicians, and the patients they serve," said APC chief executive officer Scott Brunner, CAE. "We've joined forces with the Outsourcing Facilities Association to request a face-to-face meeting with FDA officials as quickly as possible to discuss the matter. Our aim is to avoid big disruptions in patient access and care."
ReedSmith submits GFI #256 comments on coalition's behalf
In a letter to the FDA on behalf of a coalition of compounding pharmacies, attorney Rachael Pontikes of ReedSmith LLP requests a withdrawal of FDA's draft GFI #256 related to animal compounding and urges that FDA "consider engaging in further dialogue" with industry stakeholders "on the best path forward to appropriately regulate veterinary compounding." The letter makes the case that FDA has no authority to regulate veterinary compounding; that FDA is practicing medicine by attempting to regulate veterinarians; and that the regulatory scheme envisioned by GFI #256 will have a severe negative impact on animal health.
APC supports NCPA-led coalition requesting DOJ scrutiny of mergers
Groups file amicus in Arkansas PBM case, plan Supreme Court rally
New NABP leader has roots in retail pharmacy
Honk if you love your technicians
...or better yet, forget honking, and sign them up as APC members instead. The annual membership dues rate for technicians is only $125 - and all APC events, CE and other activities are included at a discounted rate. You know you love 'em - so show 'em by making them a part of their profession's advocacy organization!
APC members get PCAB discount under renewed agreement
APC and the Accreditation Commission for Health Care have announced the renewal of their partnership. Through this collaboration, ACHC and APC aim to further elevate the practice of compounding pharmacies.
The partnership agreement allows APC members to receive special pricing on ACHC's Pharmacy Accreditation services, including services provided by the Pharmacy Compounding Accreditation Board, and discounts on ACHCU educational resources that can help prepare APC member compounding pharmacies for accreditation.
"We're delighted to continue our partnership with ACHC in support of PCAB accreditation," said Scott Brunner, APC CEO. "We believe accreditation is the single best way for compounding pharmacies to distinguish themselves to the patients they serve. It's the gold standard in compounding, and in this agreement with ACHC, we will to do what we can do to increase the number of accredited pharmacies."
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Say hello to our newest Bronze Level sponsors...
Introducing TWO new bronze level APC corporate patrons
- Sterile Lab Design works with compounders to tailer a space that will be fully compliant for FDA, USP, and/or cGMP with innovative and validated concepts.
- ZRT Labs is a CLIA-certified commercial and research laboratory that has pioneered innovative testing methods for hormones, neurotransmitters, heavy metals and more, offering health care providers convenient testing options in different body fluids.
Be sure and thank them for their support of your association. Better yet, do business with them!
4 great webinars coming next month...
APC is hosting four great education webinars in the upcoming months:
- April 14, 2020 | REQUIRED CMS Anti-Discrimination and Fraud, Waste & Abuse training | Denise Frank
- April 21, 2020 | The New North Star in Compounding Ethics: Do You Measure Up? | Denise Leard
- May 5, 2020 | Peptides 101| Anthony Campbell
- May 12, 2020 | Best Practices for Essential Copies | Reuben Nielsen
Mark your calendars now, and look for registration info coming soon!
Cleveland Clinic's Scott Knoer tells it like it is
Read it here.
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These APC partners will keep you out of trouble (and save you money!)
We offer members-only discounts on a range of products and services that can improve your practice and more than cover the cost of your annual APC dues. Here's the list and links:
- The APMS Patient Safety Organization (PSO), helps you put safety at the center of your pharmacy operations. Get a handle on the inherent risks in your pharmacy's workflow and discover opportunities for improvement in a legally protected environment. Find more information here.
- Get $500 off the cost of PCAB accreditation, the gold-standard certification for compounding pharmacies when you use code APC202.
- Save $200 on the registration for CBI's Compounding Compliance Conference. Details here.
- Get a no-cost, no obligation gap analysis of your business and liability insurance coverage via RiskAlert-Rx - a service specially designed to help APC member owners better understand risks of loss, plus you'll get step-by-step solutions to address any deficiencies.
- Get 10% off $500 or more of marketing services from Storey Marketing. (Valid one time per pharmacy owner.)
Don't miss these pre-recorded webinars, ready when you need them:
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