|
The voice for compounding pharmacy | October 4, 2019
|
From IACP's President...
|
|
 |
I've been thinking about politics lately. Maybe it's because of the raft of threats our profession is facing and the ominous media coverage about compounding we've seen over the past couple of weeks (read about one of those below).
Or maybe it's because of the note pictured at left, received by IACP this week from a member who is the new owner of a compounding pharmacy. It accompanied a check made out to COMP PAC, IACP's political action committee.
I can surely relate to the fact that he has to watch out for his bottom line. And that's why I'm touched all the more by the fact that despite the pressures on his new business, he chose to invest. He chose to do something. He chose to do what he could to support his profession, and he wishes he
could do more.
I'm grateful for that investment and note. It reminds me why IACP and COMP PAC exist - to support and protect our members and the patients we serve.
It also reminds me that every little bit helps, even though we all wish we could do more.
Last month, IACP President-elect Shawn Hodges sent you a letter asking you to invest in COMP PAC. It included an investment card for you to fill out. We've received several new investments as a result of that letter, and we're grateful for those.
But we need more of you to invest, to do what you can. COMP PAC is how we support elected officials in Congress who think like you do about your compounding operation and patients. It's how we build relationships so that our voice is heard in discussions of issues that affect your business. We're certainly not the largest PAC out there by any means, but we've got a track record of effectiveness, and we're respected.
Without your investment, though, we can't continue to be successful.
At the end of this newsletter, I've asked staff to include the front and back of that COMP PAC investment card I mentioned above. Please print it out, fill it out, and do what you can to support pharmacy compounding.
We'll all be better for your support.
Cheers!
Jennifer Burch, PharmD, RPh, CDE
President
|
John Oliver blasts pharmacy compounding, IACP responds
And here's an added observation from IACP's executive vice president, Scott Brunner, CAE: "While Oliver's tirade lacked nuance, dredged up old examples, and offered no opportunity for the thousands of compounders who do things the right way to tell their story, he didn't get it all wrong. As ethical compounding professionals who take caring for your patients seriously, your reputation is damaged by the kinds of egregious behaviors Oliver highlighted, even though those bad actors are by far the exception to the rule. Consider that the video of Oliver's segment has now received more than 3.5 million hits on YouTube. There's no doubt it will influence consumer perceptions of compounding. That's why as an organization, IACP must do more to elevate the profession, to tell your story - the story of the millions of patients helped every day by pharmacy compounding. We must embrace a rational regulatory framework rooted not in emotion, but science. And our members must commit to a code of practice, process and conduct that distinguishes them as compounding professionals. In the months ahead, we hope to demonstrate progress on those essential steps."
|
Two thoughts on NABP's FDA grant to develop data-sharing technology
This week,
the U.S. Food and Drug Administration announced that it has awarded a grant to the National Association of Boards of Pharmacy to establish an information-sharing system for drug compounding activities that are primarily overseen by states. Said the FDA news release:
The roughly three-year pilot project undertaken through this grant will work to improve the information available to state regulators and the FDA about state-licensed entities, primarily pharmacies, that engage in drug compounding and distribute compounded drugs interstate. The overall goal is to help provide more targeted regulation and oversight of compounded drugs, while ultimately reducing risk to patients.
The agency's goal for the system developed through this grant is to help enable states to enter into memorandum of understanding (MOU) agreements, once finalized, with the FDA that will reduce the potential resource burden associated with collecting and sharing information on interstate distribution.
Our thoughts:
- This is a sign that FDA is really planning to move forward on an MOU soon, as they've said they would, but it does seem to get the cart before the horse. There are still serious issues with the MOU that will be impediments to states signing it - and FDA has given no sign that they're interested in working through those issues - so it seems premature to be talking about the data-sharing piece without addressing the other concerns, including but not limited to the unorthodox distribute/dispense definition FDA has included in the current MOU proposal.
- NABP is well-suited to create the sort of data-gathering system the grant envisions, and we look forward to working with them. Interestingly, some IACP members who are licensed in multiple states already have implemented sophisticated tech solutions for dealing with the state reporting on which the NABP grant is focused, and we'll be urging NABP to look at those.
|
Compounding peptides? Take care ...
We're hearing that some compounders are being asked by prescribers to compound peptides, especially those often prescribed by the anti-aging community of physicians. While there is a body of clinical evidence that supports the use of these peptides,
most do not meet the statutory requirements found in DQSA, which allow compounding of a substance:
- For which there's an applicable USP/NF monograph;
- That is an active drug component of an FDA-approved product;
- Or is on FDA's List of Bulk Drug Substances That Can Be Used Under Section 503A;
- Or on Category 1 of the list of substances nominated for the 503A list.
We urge IACP members to consider the risks/benefits of compounding preparations with peptides that are not compliant with DQSA, which could lead to FDA or state board of pharmacy enforcement action.
|
USP clarifies <800> status on NASPA call
The National Alliance of State Pharmacy Associations hosted a member call this week with USP staff to discuss the recent decision to postpone implementation of chapters <795>, <797> and <825>. On the call, USP staff reiterated that <800> will be informational and not compendial until chapters <795> and <797> are implemented. They also clarified that <800>, once implemented, will only be compendial for practice sites that are required to be compliant with <795> and <797>. However, state boards of pharmacy may require compliance at their discretion. USP indicated they would be distributing responses to frequently asked questions they received related to the postponement. We'll share USP responses and resources as we receive them.
|
Free policy briefing for pharmacy school student groups
The International Academy of Compounding Pharmacists - the voice for pharmacy compounding - is offering pharmacy schools a free hour-long Skype briefing called "Public Policy and Pharmacy Compounding"
if the schools are willing to promote student memberships in IACP. Student dues are only $5. The briefing covers the regulatory framework for pharmacy compounding and then dives into a handful of current policy issues that are impacting the practice, from USP <797> and <800> to FDA's regulation of interstate shipments of compounds to proposed new prohibitions on what substances can be compounded. Please share this blurb with your alma mater or local school of pharmacy, and tell them to contact IACP's Scott Brunner at
[email protected]
for details or to schedule a briefing.
|
|
The USP appeal: Everything you need to know
As you know - at least, we
hope
you know - USP in August rejected three appeals by compounding pharmacy groups, including one to which IACP was a party, regarding beyond-use date restrictions in the new <795> and <797>
chapters. As a result, IACP and
its partners have formally requested a hearing by a USP panel whose appointees are outlined in the USP Bylaws. USP has not yet set a hearing date, but announced recently that it has postponed the effective date of chapters <795>, <797> and <825> indefinitely as a result of BUD-date appeals.
For now, here are quick links to documents and other info about the appeal and USP's postponement:
- IACP's initial reporting on the BUD date restrictions in <795> and <797>
- IACP's Appeal (with Wedgewood and Innovations Compounding)
- USP Compounding Expert Committee's notification of rejection of the appeal
- IACP's (and partners') request for hearing on the appeal
- USP's announcement of indefinite postponement of the chapters
- IACP's briefing paper for members and state boards of pharmacy
- IACP's CALL TO ACTION to members to urge state BOPs to express concerns to USP
|
Where is office-use allowed by state law?
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 new
'State Compounding for Office Use and Veterinary Office Use' Resource,
created in collaboration with the National Alliance of State Pharmacy Associations and thanks to a grant from the IACP Foundation.
The resource is available at
www.iacprx.org/StateCompoundingLaw
. Because it is a members-only tool, IACP members are required to log-in to access it.
|
If you want to protect your practice, here's how ...
Invest NOW in IACP's OneFund. It's what fuels our advocacy efforts 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.iacprx.org/onefund and invest today. |
|
IACP Membership has its privileges. Here are a few...
Are you taking advantage of our
members-only discounts on a range of products and services
that more than cover the costs of your annual IACP dues
? Here's a short list:
- Get $500 off the cost of PCAB accreditation, the gold-standard certification for compounding pharmacies.
- Get a no-cost, no obligation gap analysis of your business and liability insurance coverage via RiskAlert-Rx - a service specially designed to help IACP member owners better understand risks of loss, plus you'll get step-by-step solutions to address any deficiencies.
- Save $200 on the registration for CBI's upcoming West Coast Compounding Compliance Conference. Details here.
- Get 10% off $500 or more of marketing services from Storey Marketing. (Valid one time per pharmacy owner.)
|
|
Do you follow?
Help amplify IACP's voice by liking and sharing our tweets. Facebook posts, too.
|
|
Other stuff worth reading
|
Upcoming LIVE Webinars:
Evidence Based Business - Metric Driven Decisions
Tuesday, October 22, 2019
1:00 - 2:00 p.m. CST
Scott S. Turner, PharmD, MBA
Innovation Compounding, Inc.
In light of regulatory and industry changes, it is critical for compounding pharmacists to not only have metrics in place, but also understand their use in making business decisions. Through better understanding of these metrics pharmacists can more efficiently manage operations, more accurately price products, and make better informed business decisions.
And don't miss these pre-recorded
webinars, ready when you need them, from IACP:
These are perfect for self-paced learning. Click title for details.
|
|
|
|
