"FDA is proposing that DMPS (2, 3-dimercapto-1-propanesulfonic acid) NOT be placed on the 503A bulk list…”

McGuff Compounding Pharmacy has been invited by the FDA to make a presentation to PCAC supporting the nomination of DMPS

If the FDA gets their way, DMPS will not be added to the Bulk Drug Substance List and DMPS will no longer be available through compounding pharmacies… at all.

Later this month the FDA’s Pharmacy Compounding Advisory Committee (PCAC) will meet to determine if the committee will approve - or not approve - DMPS being placed on the Bulk Drug Substances List for 503A compounding pharmacies.

If a Bulk Drug Substance is approved by the FDA and is placed on the Bulk Drug Substance List, then all compounding pharmacies may compound with the Bulk Drug Substance. If a drug is not on the Bulk Drug Substance, all compounding pharmacies are prohibited from compounding it. It is as simple and straight forward as that.

This is an enormous issue for those that prescribe and use DMPS

On June 23, 2016 the PCAC will meet in Washington DC to decide if they will or will not recommend DMPS to be on the Bulk Drug Substance List. The PCAC recommendation may be overruled by the FDA but it would be important for the PCAC to decide in favor of placing DMPS on the Bulk Drug Substance List.

The only avenue left for physicians and patients who believe in DMPS and its unique chelating properties is to appear and present their case before the FDA’s Pharmacy Compounding Advisory Committee. Unfortunately, the FDA does not invite public comment and has only invited a few organizations to present.

McGuff Compounding Pharmacy is the only pharmacy invited by the FDA to make a presentation to the FDA’s PCAC. The invitation is for us to present information to support the nomination of DMPS to the Bulk Drug Substance List. Total time allotted for all DMPS presentations to the committee is … 10 minutes.

This is a very short time.

McGuff, and four other organizations, worked tirelessly last year to nominate and present evidence to FDA on DMPS’s chemical properties, compounding, controls, safety and indications. No one else bothered.

Only the four organizations and McGuff who submitted the DMPS nomination and evidence to FDA, will be allowed to present to the PCAC.

We, the tireless few working on your behalf, are invited to present at the FDA’s PCAC meeting.

International Academy of Compounding Pharmacists
John Voliva, R.Ph., Executive Vice President
John@iacprx.org

McGuff Compounding Pharmacy Services, Inc.
Ronald M. McGuff, President/CEO
answers@mcguff.com

American Association of Naturopathic Physicians
Michael Jawer
Director of Government and Public Affairs
mike.jawer@naturopathic.org

Alliance for Natural Health USA
Gretchen DuBeau, Esq Executive and Legal Director

Integrative Medical Consortium
Michael J. Cronin, N.D., Chair, Integrative Medical Consortium
mjcroninnd@gmail.com

If you would like to read the FDA’s position:

The briefing document that FDA has prepared for its Advisory Committee is posted HERE. Unsurprisingly, FDA is recommending that all substances we nominated be disapproved. The last 17 pages of the document (Tab 6b, pp. 209-224) lay out the agency’s position on DMPS.

If you believe in DMPS, drop an email of thanks or better yet join one of these organizations if you have not already done so. These organizations and McGuff are working very hard to maintain your freedom to write prescriptions for the drugs your patients need.

Sincerely,

Ronald M. McGuff
President

McGuff… More than sales and service… we are involved.

FDA Invitation:

“Good morning,

The U.S. Food and Drug Administration (FDA) will publish a Federal Register notice regarding the June 23, 2016 Pharmacy Compounding Advisory Committee (PCAC) Meeting on June 3, 2016. The notice is on advance display today at: https://www.federalregister.gov/public-inspection.

In the Agenda portion of the notice, the agency announced that the nominators of the following substances and products will be invited to make a short presentation supporting the nomination: Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS).

Attached please find a letter of invitation from the agency regarding your potential participation at the upcoming meeting, including the contact person for response, if necessary…”

1. FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting June 23, 2016, Section III,B .3. (Page 7)

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