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The voice for compounding pharmacy | July 26, 2019
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From IACP's President...
This week I'm giving over my column to IACP EVP Scott Brunner, CAE, to brief you on a new development in our ongoing conversation with FDA over its proposed MOU with states. Like I said last week, I'm proud of IACP's leadership in proposing a solution to FDA that may just allow us to finally get an MOU that works for compounders, prescribers, regulators and patients - and I want you to be well informed about it. PLEASE READ ON.
Jennifer Burch, PharmD, RPh, CDE
President
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Threading the needle
Looking to end the impasse, IACP and its partners have proposed a "middle way" for FDA's MOU with states. Is FDA willing to listen?
By Scott Brunner, CAE
In hopes of ending the stalemate with FDA over the proposed memorandum of understanding with states, IACP and its partners NCPA and APhA last week submitted to FDA a letter outlining a "middle way" forward. We've proposed a framework for an MOU that we believe accommodates FDA's
need for data on the interstate shipment of compounded medications
while preserving state board of pharmacy oversight of patient-specific dispensing and assuring patient access to essential compounded medications.
If that sounds like a remarkable act of needle-threading, well...it is. That's why we think FDA may pay attention to it: because it helps them get out of the corner they've painted themselves into with their earlier and (we believe) onerous iterations of a proposed MOU that many state boards of pharmacy have indicated they may not sign.
Drafted earlier this year by IACP's legislative consultant David Pore at my request, our "middle way" concept was shopped to and improved upon by IACP member leaders and industry partners through spring and early summer. It was presented by a coalition of IACP members, along with representatives of NCPA, APhA, and NHIA, to FDA in June at an invitation-only listening session. We followed up last week with the joint letter to FDA, which is signed by IACP, NCPA, and APhA.
Here, in broad strokes, are the main points we've proposed (PLEASE READ our letter to FDA, linked below, which presents more detail and nuance than this bulleted summary):
- By defining the term "distribution" to include patient specific dispensing for purposes of both the MOU and the statutory default 5% cap for pharmacies in states that do not sign the MOU - as FDA's second iteration of the proposed MOU does - FDA has asserted regulatory authority over the very essence of the practice of pharmacy in a way that is inconsistent with the Federal Food, Drug, and Cosmetic Act and that will lead to serious patient access problems throughout the country.
- We believe the FDA should incorporate the suggested redline changes to the MOU (related to requirements on the states but without the footnote on "distribution") submitted by NABP into a new, revised draft MOU.
- We believe a workable solution can strike a better balance between FDA's need for data on the interstate shipments of compounded medications and the ability of patients to get their compounded medications from the state-licensed and compliant pharmacy of their choosing.
- Our proposed solution to allow for robust patient access is for FDA to rescind the current draft MOU and issue a new revised draft MOU for public comment that accomplishes the following:
- For purposes of the MOU and the 5% cap, define the term "distribution" to mean a transfer of a compounded drug product to a prescribing physician:
- where authorized under applicable state pharmacy laws,
- pursuant to a prescription drug order from the physician,
- that indicates a medical need for administration to the patient in an office or clinical setting.
- "Distributions" could only be done by 503A pharmacies in limited quantities prior to receipt of a valid prescription order.
- Establish within the MOU that the administering physician must provide the pharmacy with an electronic or written prescription within 30 days of administration of the drug to the patient.
- Establish within the revised draft MOU on the prescription requirement that a 503A pharmacy is permitted to "distribute", pursuant to a drug order, a limited quantity.
- Establish within the revised draft MOU a requirement that a drug order for limited quantity office-use compounding must indicate that the compounded medication is not currently available from outsourcing facilities in the limited quantity needed by the prescriber.
- For purposes of the 50% inordinate quantities threshold that triggers tracking, investigating and reporting requirements on the state BOPs, include both "distribution" and "dispensing" (all interstate shipments).
- Establish a good faith/reasonable effort safe harbor clause for pharmacies on the prescription requirement in the MOU.
- Define what will happen when compounders exceed the 50% distribution threshold, which will include a statement that FDA will be using the information it collects on interstate shipments only to inform its risk-based inspection schedule.
- Our proposal for a revised MOU on the prescription requirement would settle the legal questions surrounding FDA's redefining of key statutory terms, would draw broad stakeholder support, and would have the effect of greatly incentivizing states to sign the MOU. It would give the FDA key data on interstate distributions (and dispensing) of compounded drug products to better inform the agency's risk-based inspection schedule, while not applying an arbitrary cap on patient specific dispensing that is not consistent with the statute and that would severely limit access to medications.
I encourage you to read the letter thoroughly and understand what we're proposing and why we believe it's a smart move strategically. It's our best attempt at helping FDA avoid the litigation that is sure to follow if the agency finalizes the MOU in its current proposed form. Not only that, but resolving this issue also will allow IACP and its partners to focus on other pressing policy issues impacting your compounding practice.
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Sterile compounders: Contact USP NOW about <797> BUD extension concerns
We alerted you last month that recent changes to USP <797> will limit Beyond Use Dates (BUDs) and does not provide a way for pharmacies to use valid scientific data to support longer BUDs.
IACP's board of directors met with USP representatives two weeks ago via conference call to express our grave concerns. It is likely that the Board will also support a formal appeal of the provisions this coming week.
But you need to contact USP, too.
Reach out to USP via email and social media. Explain to them your concerns with the restriction on BUD extensions and ask them about the scientific basis for that restriction
. Your outreach will help alert USP to the extent of the concern about the new chapter. USP's Twitter handle is @USPharmacopeia. You can email them at [email protected].
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Hey, 503Bs: We need your feedback
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Mark your calendar for CCH 2020: New format, new time of year
IACP's Compounders on Capitol Hill 2020 will be held in Washington, DC., September 9-10. Our new only-one-night-away-from-home format will make it easier and more affordable to come to our nation's capital to advocate for your compounding pharmacy. Add those dates to your calendar: September 9-10, 2020 now.
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Save the date for EduCon 2020
We're working on a plan for EduCon 2020. Tentative dates are Tues-Thurs, April 7-9, 2020. More information coming soon.
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Get your free photos from CCH 2019 here
We've got some great photos from CCH, the IACP Foundation's RxMixer and IACP Comp-PAC events held this past May in Washington, DC this year.
Click here to view the photos.
For a limited time, you can download photos for free.
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USP's Evolution and Advances
in Compounding
is August 6-7
On August 6 & 7, 2019, USP will host its 2nd workshop on improving the quality of compounding to enhance patient safety through the development of standards for compounded medicines.
'Evolution and Advances in Compounding'
will convene a wide range of stakeholders to explore current and emerging stakeholder needs in the compounding realm. Registration ends next Friday, August 2. Registration details and the agenda are available here.
Sign up for live courses on revised USP Chapters <795>, <797>, and <800>
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Money-saving, risk-mitigating services for IACP members only
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.)
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If that makes us needy, so be it...
We need your help to amplify IACP's voice. How? By liking and sharing our tweets. Facebook posts, too. In doing so, you amplify our voice and energize our social media presence.
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Other stuff worth reading
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IACP Compounder Calendar
IACP's
Compounder Calendar
is your one-stop resource for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs.
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LIVE Summer Webinars:
1:00 - 2:00 p.m. CST
Mark Compo
Director of Process Cleaning and Healthcare Divisions - Veltek Associates, Inc.
Too often we focus on decontamination of HD's in the workplace. Our focus should be to deactivate whenever possible. We should also formulate a sound program which incorporates verification of the program's overall objectives. This session will address the core concepts of both.
1:00 - 2:00 p.m. CST
Scotty Sykes, CPA
This course will identify concerns we see all too often in pharmacy, poor accounting fundamentals. Fundamentals are key for tax planning. Also, we will discuss areas of tax law applicable for pharmacies that are often overloaded by those unfamiliar with the industry.
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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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!
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