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David Pore
Looking to end stalemate, IACP and partners propose ‘middle way’ for FDA’s compounding MOU

ALEXANDRIA, VA (6 August 2019) – In hopes of ending a stalemate with the Food & Drug Administration over the proposed memorandum of understanding with states, the International Academy of Compounding Pharmacists and its partners, the National Community Pharmacists Association and American Pharmacists Association, 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,” said IACP Executive Vice President Scott Brunner, CAE.
 
The Drug Quality and Security Act of 2013 reiterates that the FDA must establish an MOU with state boards of pharmacy regarding interstate shipments of compounded medications. Though FDA has proposed successive versions of an MOU, concerns raised by pharmacists, prescribers, patients and state boards of pharmacy have slowed down FDA’s efforts to finalize the MOU. Earlier this year, just prior to his departure as FDA commissioner, Dr. Scott Gottlieb announced that the FDA planned to finalize the MOU before the end of 2019.

“We think our proposal helps get FDA 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,” Brunner said. “If states refuse to sign the MOU, out-of-state shipments of compounded medications will be capped at no more than five percent of a pharmacy’s compounded medications, including patient-specific medications prescribed by a physician. Because many patients whose health depends on compounded medications get those medications from out-of-state pharmacies, the effects of such a cap on shipments will be catastrophic for patient access and will likely put a number of small-business compounding pharmacies out of business.”
 
The IACP proposal was presented verbally to FDA officials at a June at listening session by a coalition of IACP members, along with representatives of NCPA and APhA. The groups followed up last week with the joint letter to FDA, which is signed by IACP, NCPA, and APhA.
 
Following is a summary of IACP’s concerns and the “middle way” it is proposing, excerpted from its letter to the FDA:

  • 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. 
  • 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:
  1. where authorized under applicable state pharmacy laws;
  2. pursuant to a prescription drug order from the physician;
  3.  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" (in other words, 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 percent 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.

“We believe this 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,” said Brunner. “In fact, if the FDA were to commit to something akin to the course we’ve proposed, IACP and its partners would lead the way in encouraging state boards of pharmacy to sign the MOU.”

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The International Academy of Compounding Pharmacists (IACP) is the voice for compounding pharmacy, representing thousands of pharmacists, technicians, students, and suppliers. Compounding pharmacists work directly with prescribers to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications. Thousands of patients and prescribers also belong to our organization via the grassroots advocacy group, Partnership for Personalized Prescriptions, known as P3. Learn more at www.iacprx.org.
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