LETTER TO FDA: IN SUPPORT OF CENTER FOR U.S. POLICY PETITION FOR IMMEDIATE TERMINATION OF DEA’s NARXCARE AND PDMP SYSTEMS AS MISBRANDED, DANGEROUS AND “CAUSING DEATHS”

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., TERENCE SASAKI, MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

NORMAN J CLEMENT RPH, DDS et. al
EDITOR, INDEPENDENT PHARMACY OWNER 

P.O. Box 280139
TAMPA, FLORIDA 33682
313-510-3378
youarewithinthennorms.com
Pronto Pharmacy, LLC
May 5, 2023
LETTER TO:
Division of Docket Management
Food and Drug Administration
Department of Health and Human Services
5630 Fisher Lane, Room 1061
Rockville, MD 20852
IN SUPPORT OF CITIZEN PETITION DEEMING NARXCARE SOFTWARE MISBRANDED, A DANGER TO HEALTH RESULTING IN DEATH

Our group and writers of youarewithinthenorms.com and Pronto Pharmacy LLC, Tampa Fl are in full support of the Citizen Petition Submitted by the Center for U.S. Policy to request the Commissioner of the U.S. Food and Drug Administration (“FDA”) to deem the Bamboo Health (“Bamboo”) NarxCare software a misbranded device and take administrative action to prevent serious, adverse health consequences and death. We further demand the immediate removing this dangerous software from all healthcare systems.

DR. NORMAN J. CLEMENT RPH, DDS
A group of Black Pharmacy Owners was under racist attack by the United States Drug Enforcement Administration (DEA). They organized together with a diverse group of Black Scholars into a Think Tank called the North Star Pharmacy Group and began identifying and exposing systemic racial drug policies and injustices in healthcare delivery policies within both DEA/DOJ. They’ve further exposed racial targeting of black-owned pharmacy businesses and physicians by DEA/DOJ; there is a demand for Congress to ACT to investigate this agency. READ https://youarewithinthenorms.com/2021/02/20/the-raid-on-pronto-pharmacy-review-of-the-deas-search-warrant-and-raid-august-29-2019/. This is happening all over America
Dear Senator Rapheal Warnock We need your help……

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Specifically, The Petitioner asks FDA to:

(1) deem Bamboo’s NarxCare software a misbranded device;

(2) issue a Warning Letter to Bamboo;

(3) commence mandatory recall procedures with respect to the NarxCare software; and

(4) take any other prompt action the agency deems appropriate to prevent serious, adverse health consequences or death.

NarxCare is a clinical decision support (“CDS”) software product that meets the definition of a “device” under the FD&C Act. Yet, based on a search of FDA’s publicly available databases, it appears that the device’s manufacturer, Bamboo, violates several provisions of the Act and its implementing regulations. Specifically, before introducing NarxCare into interstate commerce, Bamboo did not comply with the establishment registration, device listing, or premarket notification requirements set forth in Section 510 of the Act. 

FDA MUST REMOVE AND BAND NARXCARE

When there is a violation of the Federal Food, Drug, and Cosmetic Act, the FDA may allow individuals and firms to make voluntary and prompt corrections by taking advisory action. NARXCARE is a danger to healthcare delivery and must be removed

Norman J Clement RPh. DDS

Owner Pronto Pharmacy LLC.

Head Editor 

youarewithinthenorms.com

FOR NOW, YOU ARE WITHIN

DAILY REMEDY, EDITOR JAY K. JOSHI, MD (DEA TARGETTING VICTIM)

THE NORMS

STUDY BY CENTER FOR UNITED STATES POLICY SHOWS DEA’s PDMP “NARXCHECK” SYSTEMS USED BY NEARLY ALL HOSPITAL AND PHARMACIES TO BE MISBRANDED, DANGER TO HEALTHCARE, and USE MUST BE SUSPENDED IMMEDIATELY BY FDA

VENDOR DATA FRAUD: BAMBOOZLED BY “BAMBOO” STUDY SHOWS DEA HAS OPERATED AS A CRIMINAL ENTERPRISE RESULTING IN THOUSAND OF DEATHS AND FALSE IMPRISONMENT OF DOCTOR’S

OF LAW AND DISORDER: MOVE CONTROL-REGISTRATION LICENSING AND AUTHORITY TO THE OFFICE OF UNITED STATES SURGEON GENERAL FROM DEA. “IT IS NOW PAST TIME”

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