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.
OR SEND
$100, $250, $500
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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
THE NORMS
