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NEW IN 2019!

NEW IN 2019!

NEW IN 2019!

Over the last 2 years, MEDISCA has actively solidified its role as a leader in the industry, not only for innovation and quality of products, but by being at the forefront of policy at the regional, state, and federal level. MEDISCA has been instrumental in advancing compounding issues before the FDA at special 503A and 503B meetings.

A Government Affairs Call

In 2019, MEDISCA has proudly launched
Pharmacy Legislative Advocacy Group (PhLAG) initiative.

PhLAG is a result of MEDISCA’s commitment to being an industry leader in the advancement of compounding, with the goal to ensure that every Pharmacy/Outsourcing Facility has a platform to learn, participate, and be heard.

The regulatory environment can be challenging to understand. State Boards of Pharmacy are currently struggling with how to implement revised chapters of the USP as well as the new <800> chapter. The revised chapter <795> brings a new requirement of stability testing without clarifying if the use of external studies will affect compliance. Furthermore, tensions arise between the states and the FDA’s newly introduced Memorandum of Understanding (MOU). Many states are concerned with the FDA’s definition of “distribution” and what the funding requirement is for inspection in the MOU.

Outsourcing Facilities, created by Congress, should be seeing greater cooperation from the FDA. Instead, tighter restrictions have been applied. During the past year, the release of guidance documents has limited the access to bulk drug substances; creating uncertainty within the industry.

PhLAG and MEDISCA want to help traditional compounding pharmacies, as well as outsourcing facilities, navigate these imperative issues. As an industry, we need to come together and inform ourselves of what is going on at state and federal levels. PhLAG will provide a platform accessible to all.

Join the monthly calls and stay up to date with the compounding industry.

Join Aaron Lopez, JD and co-host Stephen Snow, JD
Live PhLAG calls every second Wednesday of each month at 1:00p.m. (EST)

503A

Topics

The revised memorandum of understanding
Guidance document on insanitary conditions
Pharmacy Compounding Advisory Committee


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503B

Topics

Access to build drug substances
The promise of a cGMP Lite guidance document
The inconsistent requirements from State Boards for licensing


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Missed a call?


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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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2018: YEAR IN REVIEW

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