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A Government Affairs Call

Continuing to inform both 503A and 503B compounders on the ever-changing political landscape.

MEDISCA has actively solidified its role as a leader in the industry, not only for innovation and quality, but for playing an instrumental role in the advancement of compounding related issues before the FDA.

The goal of the Pharmacy Legislative Advocacy Group (PhLAG) is simple, to ensure that every Pharmacy/Outsourcing Facility has a platform to learn, participate, and be heard.

The current regulatory environment is shrouded in a cloud of uncertainty. State Boards of Pharmacy struggle with implementations of revised chapters of the USP and <800>. Furthermore, Outsourcing Facilities, created by Congress, have seen tighter restrictions from the FDA.

PhLAG and MEDISCA want to help traditional compounding pharmacies, as well as outsourcing facilities, navigate these imperative issues.

Join the monthly calls every second Wednesday of each month, at 1:00PM (EST)!

PhLAG 2020

Topics

Patient Access to Personalized Medicine
Dietary Supplement Monographs
Providing an Answer to the Drug Shortage Epidemic
Push Back on Agency Overreach
2018 Farm Bill – and CDB Allowance


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The Latest On the Citizen's Petition Filing

Medisca has worked with the American Association of Naturopathic Physicians (AANP) to file a "Citizen's Petition" outlining our thoughts on the protection for access to bulk drug substances. The petition outlines many arguments preserving the right to push back on the FDA if they do not create a fairer process to use those substances in compounded medication needed for both 503A and B facilities.

Please see the video below for a brief explanation of the petition:

The AANP has filed the petition with the FDA and we expect to hear back from the FDA within the next 5 months. Please see the AANP's submission:

READ SUBMISSION


Here is the AANP's page on what they have done and a message they have sent out to their membership.

AANP MESSAGE



Aaron Lopez, JD

Aaron Lopez is the founder of Political Capital LLC. and for over 20 years, he has worked with leading clients in multiple industries to provide insight and a voice in legislative and political processes at the international, federal, and state levels. For the past 2 years alongside MEDISCA, Aaron has been fighting for the rights of compounding and has become a leading expert on legislation that affects the industry.


Stephen Snow, JD

Stephen is a consultant for retail, compounding, and health system pharmacies in cases of alleged liability and disciplinary matters before the State Board of Pharmacy and the U.S. Department of Justice. He counsels clients on best practices and regulatory compliance at the state and federal levels, frequently involving issues of 503(A) compounding pharmacy regulations, 503(B) outsourcing facility registration, Medicare billing and reimbursement, Board of Pharmacy matters, and FDA inspection and oversight.

Be Informed. Be Part of the Conversation.

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