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The voice for compounding pharmacy | October 18, 2019
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From IACP's President...
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The voice for pharmacy compounding (that's us) is changing its name - provided the membership (that's you) approves bylaws changes in voting that should begin next week (read more below about that).
Last week in Houston, the IACP Board of Directors voted unanimously to recommend Bylaws amendments that will change IACP's name to The Alliance for Pharmacy Compounding, a name that we believe more accurately reflects the 'big tent' of pharmacy compounding and our role as the primary advocacy organization for pharmacy compounding professionals and their patients. I hope you agree and will vote to approve the new name. When approved, we'll begin a slow rollout of it, starting with our new website launch in December, the URL for which will be a4pc.org. (Don't worry, though: if you type in our old URL, you'll go right to the new site.) Then in January, we'll debut our new name and logo broadly to partners, policymakers, news media and others. It's another positive development in the reinvention and reinvigoration of IACP. And there's more good stuff ahead!
Your IACP Board of Directors last week also finalized our Strategic ENDS - the outcomes we aim to achieve as an organization. These ENDS are our roadmap going forward - but they are still incomplete. The next step will be to determine how we'll measure our progress toward those ENDS and which tactics we'll pursue to achieve them. I look forward to sharing the final document with you before year-end.
Last thing for this week: Our Ethics Working Group will convene next week to begin its important work in strengthening the IACP Code of Ethics. In the wake of so much negative media spotlighting unscrupulous or careless behavior in compounding, we simply MUST enunciate and subscribe to a higher - highest - standard of professional behavior. Our patients are depending on it. We're delighted that Dr. Loyd Allen is chairing that working group, and we're looking forward to the recommendations they'll bring to the Board of Directors next April at EduCon2020. For now, here's the working group charge. Please share any thoughts with us and we'll pass them along to the working group.
Cheers!
Jennifer Burch, PharmD, RPh, CDE
President
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VOTING BEGINS: 2020 BOARD OF DIRECTORS, BYLAWS CHANGES
Voting on 2020 IACP Board of Directors and proposed bylaws amendments begins this coming week. IACP members will receive an email allowing them to access our voting portal, which will remain open for 30 days.
Please pay attention to the email you'll receive, and cast your votes promptly. It's a quick and easy process.
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Responding to letter, NASEM schedules cBHRT practitioner session
In response to a letter in which IACP, NCPA and APhA expressed concern about information-gathering for an FDA-commissioned study on cBHRT, the National Academies for Science, Engineering and Medicine has scheduled an additional public session hear from prescribers and pharmacists of cBHRT.
"NASEM has not had a public meeting to fully engage practicing physicians who prescribe or pharmacists who compound extensively cBHRT and hear their perspective and documented patient results they have achieved," wrote IACP and its partners in the October 7 letter to NASEM. "From our attendance, we observed that
in the information gathering sessions, a greater number of presenters opposing cBHRT were given time to present than were proponents of cBHRT. In addition, the presenters supporting cBHRT were not representative of the vast number of highly credible, mainstream physicians practicing cBHRT. Given that the NASEM committee members are not experts in cBHRT and thus would benefit from the expertise of practitioners, we urge you to schedule an additional hearing to provide a forum for physician and compounding pharmacist practitioners to testify on the importance of cBHRT to patients."
NASEM was prompt in responding to the request, announcing on October 10 the additional public session. IACP this week submitted to NASEM a number of recommendations of prescribers and pharmacists to present at the November 12 session.
NASEM is expected to conclude its information gathering and issue a report early next year.
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Indie pharmacies on the brink, says NCPA survey
A substantial majority of independent pharmacies say they may close their doors in the next two years, and the main culprits are multi-billion-dollar corporate middlemen who are shaking them down for fees on medicines long after the point of sale, according to a new survey release October 16 by NCPA.
"Neighborhood pharmacies are being mugged in broad daylight and no one in Washington is doing anything about it," said NCPA CEO B. Douglas Hoey. "If Congress or the administration don't act soon, we're going to see a wave of layoffs and store closures that will leave many patients stranded without access to a local pharmacist."
According to the survey, 58 percent of independent pharmacists say they are somewhat likely or very likely to close their doors in the next two years if things don't improve. Another 19 percent aren't sure they'll be around then. A nearly identical number (59 percent) rate the health of their business as somewhat poor or very poor.
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Executive order says federal agency guidance docs are non-binding
Last week the Trump Administration issued an executive order stating that federal agency guidance documents are not enforceable or legally binding.
"Agencies have sometimes used [guidance documents] inappropriately in attempts to regulate the public without following the rulemaking procedures of the APA," Stated the executive order. "Even when accompanied by a disclaimer that it is non-binding, a guidance document issued by an agency may carry the implicit threat of enforcement action if the regulated public does not comply."
It continues, "It is the policy of the executive branch ... to require that agencies treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract, take public input into account when appropriate in formulating guidance documents, and make guidance documents readily available to the public. Agencies may impose legally binding requirements on the public only through regulations and on parties on a case-by-case basis through adjudications, and only after appropriate process ..."
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NCPDP to no longer apply for NPI numbers for pharmacies
NCPDP will no longer apply for an NPI number on behalf of a pharmacy. This means that pharmacies needing an NCPDP ID in the future will need to apply for
their own NPI number
prior to filling out the NCPDP application. Additionally, NCPDP will no longer update pharmacies' NPI profiles on behalf of the pharmacy. Pharmacies that need to update their NPI profiles must do so by logging into the
NPPES website
. If you have any questions about your NPI profile or need login information to access your NPI profile, you can visit the NPPES website or contact the NPPES customer service line at 1-800-465-3203 and ask for an NPI Specialist.
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New: 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,"
an IACP members-only tool created in collaboration with the National Alliance of State Pharmacy Associations and funded by a generous grant from the IACP Foundation.
Click here to access the resource. Note: It's current as of the date marked on it and is updated as needed.
Because it is a members-only tool, IACP members are required to log-in to access it.
If you need assistance logging in, please contact us at (281) 933-8400 or email us at
[email protected]. If you need to renew your membership or are interested in joining IACP,
here's where to do that.
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Compounding peptides? Watch out ...
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.
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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.
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The USP appeal: Everything you need to know, in one place
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
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New photo book celebrates years of IACP advocacy
With support from our friends at PCCA, we've created a lovely photo book chronicling IACP's history of advocacy on behalf of compounders. Now you can have one for yourself - and support the IACP Foundation at the same time! Simply send a check for $135, payable to IACP Foundation, to us at 100 Daingerfield Road, Suite 401, Alexandria, Virginia 22314 with a mailing address where you'd like your book shipped. We'll credit you with a $100 donation to the Foundation. Your contribution to IACP Foundation, a 501(c)(3) non-profit, charitable organization, is tax-deductible to the extent permitted by law. Fair market value of this photo book is $30. Or if you'd rather pay by credit card, just phone us at 281-933-8400. If you've ever attended Compounders on Capitol Hill, there's a good chance you may find your picture in the book. Order your copy now!
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Corporate Member Spotlight
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Both products are USP800 compliant and meet requirements for testing for hazardous
drugs and for deactivating, decontaminating, and cleaning drugs.
For all p
roduct and ordering questions, please contact our sales team at 877-215-2705 Ext. 2 or visit our website at
www.chemoglo.com
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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.
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Other stuff worth reading
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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.
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