The voice for compounding pharmacy March 8, 2019
From IACP Executive Vice President Scott Brunner, CAE
Can we fix it?
When my twin sons were small, Bob the Builder was their hero. They loved wearing the bright yellow safety helmets and toolbelts full of colorful plastic tools, just like Bob's. When they weren't actually watching the popular
Bob the Builder
children's show, they'd spend afternoons traipsing about the house, searching for things in need of imaginary repair, and then putting those plastic tools to work.
"Can we fix it?" one of them would shout in gleeful imitation of Bob himself, to which the other would answer confidently, "Yes we can!" - and they'd go to work together on the "repair."
Here at the beginning of my tenure as the International Academy of Compounding Pharmacists' executive vice president, Bob the Builder's "Can we fix it?" mantra comes to mind. It seems apt for the tasks we'll be confronting together - for there's much to fix if your ability to practice and prosper as compounding pharmacists is to be preserved.
Storm the Hill with your colleagues May 18-21
We need you at CCH - NOW more than ever
There's no more powerful lobbyist for your business than you.
When you invest time and money to travel to DC and meet with your members of Congress on their turf, they take notice. They listen. And we can get things done for compounding.
May 18-21 in Washington, D.C. for IACP's 25th Annual Compounders on Capitol Hill.
for #CCH2019, and plan to stay through Tuesday, May 21st to walk the halls of Congress, meet with elected officials, and protect, promote, and advance the art of compounding. We need you and your voice now more than ever. Won't you join us?
(Oh, and don't forget to book your room at the Renaissance Washington at the discounted CCH room rate of $229. And hurry - Our room block will be full before you know it ...)
Let us put you on the map!
As of March 6th, compounders from the following states have registered for CCH and will join us for Hill visits on
Tuesday, May 21, 2019.
Join your fellow IACP Members. Let us add you to our map.
Look who's coming to Compounders on Capitol Hill
Thanks to these exhibitors who've already reserved their CCH booth - and are looking forward to seeing you there:
- Accreditation Partners
- Pestle® Pharmacy Compliance Software
- Accreditiation Commission for Health Care
- AirClean Systems
- American College of Apothecaries
- ARL Bio Pharma
- AX Pharmaceuticals Corp
- B&B Pharmaceuticals
- FlackTek SpeedMixer
- Hardy Diagnostics
- Humco Holding Group
- International Journal of Pharmaceutical Compounding
- Infinity Laboratories
- Lakeland Industries
- Letco Medical
- MDI Membrane Technologies
- National Community Pharmacists Association
- OptiFreight Logistics - Cardinal Health
- QI Medical
- Spectrum Pharmacy Products
- Storey Marketing
- Vitae Industries
- Willow Birch Pharma
- World Wide Medical Distributors, Inc.
We're also grateful to these CCH sponsors (please tell them thank you when you see them!):
- DoseLogix/Topi-CLICK - Pen/Notepad
- FlackTek SpeedMixer - Happy Hour
- MEDISCA - Congressional Handbooks
- PCCA - Hotel Room Keys, Education Session
- Spectrum Pharmacy Products - Education Session
Ditto to these individual sponsors - We can't thank them enough!
- Presidential: Jeffery Bray, CEO, MedQuest Pharmacy, North Salt Lake, Utah
- Congressional: Tommy Martincic, PharmD, Greenhill Specialty Pharmacy, Simpsonville, South Carolina
- Judicial: Bradley McCloskey, PharmD, University Compounding Pharmacy, Troy, Michigan
- Contributor: Jim Hrncir, RPh, Las Colinas Pharmacy, Irving, Texas
Opportunity knocks ...
If you're thinking about exhibiting or sponsoring, please contact IACP's Ashlyn Grant at
pronto. Only a few booths and sponsorships are still available. Or click here to access the Online Commitment Form.
Show Congress what compounders really do
Congress will be taking a break March 16-24 for what's called an "in-district work period." For compounders like you, that spells opportunity.
Invite your member of Congress to visit your compounding pharmacy during that time.
Call a couple of your fellow compounder colleagues to join you, and put on a pot of coffee. When the member of Congress arrives, give them a tour and let them see both the good you do for patients and the challenges you face. IACP can provide you with briefing info on our compounding legislation and FDA concerns, too. It's as easy as calling up your member of Congress's local office, extending the invitation, and working with them on scheduling. Let's show Congress what compounders really do. Extend that invitation today!
Can we continue this conversation?
As the voice for pharmacy compounding, IACP is active on social media. Join - and continue - the conversation by following us on Facebook, Twitter and LinkedIn today.
* On Twitter: Search @IACPrx and click "follow."
* On Facebook: Search for International Academy of Compounding Pharmacists and "like" our page.
* On LinkedIn: Search for International Academy of Compounding Pharmacists and join our group.
FY19 appropriations language for compounding in effect
Congress finalized appropriations report language for fiscal year 2019 regarding compounding pharmacy regulation under the Food, Drug, and Cosmetic Act (FDCA) and the Drug, Quality and Security Act (DQSA). The Committee states its expectations of FDA regarding the MOU, implementation framework and office use compounding, Pharmacy Compounding Advisory Committee (PCAC), and state-licensed compounding pharmacies. This does not change current law, but it does give congressional directives to FDA to clarify the regulatory guidance documents and processes that it has implemented. The Committee's specific concerns and expectations include the following:
- MOU: The Committee states concerns with FDA's Draft MOU due to FDA's intention to place requirements on states that will result in many states refusing to sign the MOU. The Committee also expects the FDA to clarify the distinction between dispense and distribute.
- Drug Compounding Implementation Framework and Office Use Compounding: The Committee expresses concerns that many provisions of the DQSA and the re-enactment of Section 50BA have been implemented through agency guidance documents instead of the formal notice and comment rulemaking process as required by federal law. The Committee directs FDA to explain how the agency will implement its use of guidance documents. The Committee expresses disapproval of the GFI "Prescription Requirement Under Section 503A of the FDCA" due to FDA's involvement with legitimate state licensed pharmacy practice. The Committee also encourages FDA to either prescribe a pathway for office-use, or hold a public meeting to explain the legal rationale for disallowing office-use.
- Drug Compounding Pharmacist on PCAC: The Committee reiterates the importance of FDA appointing voting members of the PCAC who have sufficient experience in preparing, prescribing, and using compounds to adequately represent the interests of providers and patients who use compounds.
- Drug Compounding Under State-Licensed Pharmacies: The Committee reminds the FDA that state-licensed compounding pharmacies are not drug manufacturers, but rather, are inspected by state boards of pharmacy pursuant to state laws and regulations. The Committee is also concerned that FDA is publishing inspection records of pharmacies on its website, but not publishing the same information for other manufacturing concerns. Therefore, the Committee directs FDA to use the same level of transparency for the findings of all inspection activities.
IACP comments on FDA's final bulk substance rule
IACP has reviewed the FDA's recently released final rule on bulk drug substances for which there is a clinical need under the FDCA ("the 503B bulks list"). We continue to have concerns about the restrictive criteria the agency is using to make a determination as to the "clinical need" for placing nominated substances on the 503B bulks list. By using restrictive criteria that so heavily favor compounding from FDA approved drugs as opposed to compounding from bulk ingredients, IACP is concerned that the agency is limiting the 503B bulk list in a way that will jeopardize patient access to compounded medications and stifle the outsourcing facility market from developing. Additionally, FDA's policies will make it less likely that 503A compounding pharmacies will choose to register as outsourcing facilities and less likely that the 503B outsourcing facilities will be able to meet the needs of patients and prescribers for compounded medications that must be administered to patient in office or clinical settings.
FDA seeks non-voting PCAC rep
The Food and Drug Administration is requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for vacancies which become available on November 1, 2019, for the 4-year term of November 1, 2019 to October 31, 2023.
Here's more info.
Here's where to submit your nomination.
Upcoming Live Webinars:
- March 12, 2019 - Compounding for Animals: The Essentials with Natalie Young, PharmD, FACVP, Director, Realo Veterinary Pharmacy
- March 19, 2019 - Compounding in 2019: Hot Button Issues with Jeffrey S. Baird, Esq., Chairman, Health Care Group, Brown & Fortunato, P.C.
- April 16, 2019 - IV Nutrition
Don't miss our JUST-IN-TIME
IACP offers multiple webinars throughout the year, perfect for self-paced learning. Click title for exact dates.
IACP Compounder Calendar
is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs.
It's an investment with a return... Please INVEST in IACP's One Fund and help preserve patient access to compounded medications via IACP's advocacy efforts!
Want to represent IACP at an industry meeting? Be an ambassador ...
IACP's Ambassador Program
members an opportunity to represent IACP as an ambassador at certain professional conferences and meeting. In return, IACP Ambassadors receive discounts on registration to IACP events and other benefits. If you're planning to attend any of the meetings below and would like to represent us, fill out the IACP Ambassador Online Application today and become an IACP ambassador.