By Norman J Clement RPh.DDS, Norman L.Clement Pharm Tech, Jelani Z.Clement Pharm Tech
written August 10, 2017
“Exactly 2 years later in August 29, 2019 DEA, investigator Richard Albert, issued an Order To Show Cause stating Pronto Pharmacy was an Imminent Danger to Public Health for illegally manufacturing on the very same issue which were resolved by the State of Florida.. This case will proceed before a Federal District Court in Tampa Florida, Dale Sisco Esq is the attorney 813-224-0555“
IN THIS AGE OF FAKE NEWS AND ALTERNATIVE FACTS (BOTH WHICH HAVE ABSOLUTELY NO MERITS IN THE PROFESSION OF PHARMACY)
NOTES
THERE IS ONE THING I’VE LEARNED IN LIFE from a man I didn’t like nor voter for, but have come to GREATLY respect:
PRESIDENT RONALD REAGAN;
“WE MUST TRUST AND VERIFY”
PRONTO PHARMACY LEGAL TALKING POINTS
The complaint filed by the Florida Department of Health (Case Number PH201705581) is without LEGAL MERIT, lacks ANY LEGAL FOUNDATION, and lacks probable cause.
The United States Congress’s intent was to allow compounders to compound a batch of drugs in anticipation of receiving patient-specific prescription.[i]
- Federal Law and Florida State Law clearly allows and has always allowed that a licensed pharmacist can compound “in limited quantities before the receipt of a valid prescription order for such individual patient.”
- More importantly President Donald J Trump address this issue and signed into law H.R 244 which clarifies several compounding regulations implemented in the Drug Quality and Security Act(DOSA 2013).
- The law clarifies that Congress did not intend to redefine “distribution” to include “dispensing,” specifying Congress only intended FDA to regulate distribution– not “dispensing” to a patient over state lines.
- The law mandates that FDA recognize that federal oversight of 503A was not the intent of Congress and that compounding pharmacies are not drug manufacturers—rather they are “state-licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within the state.”[ii]
- FDA LAW 503A (a)(2) states the following examples:[iii]
a). “A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounded drug X. The highest number of units of drug X for which the compounder has received valid patient-specific prescriptions in a 30-day period in the last year is 500 units. Compounding up to 500 units of drug X in advance of receiving prescriptions for the drug, and holding no more than that amount to fill new valid patient-specific prescriptions as the compounders receive them, would be consistent with this policy. [iv]
b). “ A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounder drug” {FURTHER REVIEW PG 6,7,8,9 FDA GUIDELINES}
The complaint further alleges upon a routine inspection on 03/03/2017 the pharmacy was opened without a pharmacist. On March 3, 2017 the pharmacy was open with a pharmacist. March 3rd was Norman J Clement 66th birthday.
IN THIS ERA OF ALTERNATIVE NEWS AND FACTS, WE LEARN THAT CONCEPT HAS ABSOLUTELY NO BASES IN PHARMACY. OUR ATTITUDE IS BASE AROUND PRESIDENT RONALD REGAN “TRUST AND VERIFY”
- The Pharmacy was not opened for dispensing, on 3/30/2017. The pharmacy was locked and secured no medications were being dispensed and the pharmacy being monitored through our security system by a Florida Licensed Pharmacist. The Pharmacy waiting room was open for guests to sit and watch television until the pharmacist arrived on-premises, more importantly, the woman observed in the window is the pharmacist’s wife and an owner the window is not in the filling area. The licensed technician is the pharmacist’s son and was not dispensing, filing medications until his father arrived.
- “THE MISSION OF THE DEPARTMENT OF HEALTH IS TO PROTECT, PROMOTE & IMPROVE THE HEALTH OF ALL PEOPLE IN FLORIDA THROUGH INTREGRATED STATE, COUNTY AND COMMUNITY EFFORTS” therefore Pronto Pharmacy LLC can fill and dispense prescription from anywhere in the State of Florida.
The complaint the Pharmacist Clement advised that he gives the customers a choice on if they want capsule or tablets…and that capsules are cheaper than the tablets.
- Florida laws differs to and empower the patients IN THE STATE OF FLORIDA, All Pharmacy are required to post by law visible to the public “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW
- Cocktail: Drug Optimization, CML: Gleeves, Cytarbine, Doxirubecine, Vincristine, Chlorambucil, Use in “cocktails”. Cocktail is prosecutorial slang, just like pill mills, in order to secure convictions by juries and fail to inform juries of drug optimization, mechanism of action, and pathophysiology.
A) if such combination weren’t being use larger amount of the Opiate would be required.
B) Such so called prosecutorial expert testimonies are serious flawed and go unchallenged. Ref: Edward Imwinkelreid, when science takes the Stand.
10. RED FLAG IN LIFE ARE NOT LIKES STOP SIGNS IN TRAFFIC…document, evaluate, access every case individually, (don’t lie to us), distant documented same reason I go to the Henry Ford Hospital Center in Detroit (HFH) for colon cancer treatment, local pharmacy areas does not fill my prescriptions,” rejected 25 times particularly minorities,” statement of a patient coming to pronto.. may set us up for discrimination and/or profiling. We simply treat people with dignity and respect.
11. DX Codes: Question: What Purpose: we are here to render a second opinion, eg: dental ridge augmentation, sinus lift, dentist complaint patient unable to get medication filled.
A)Concern: Flip flopping if we consult with the provider charged with conspiracy, conclusion so we avoid or limit our contact.
B)Moving the Goal Post backward and forwards.
12. Insurance: Critical discussion most insurances aren’t avail to small pharmacy establishment rules for eligibility change all the time.
13. CHINESE DISIDENT: ARTIST AL WEIWEI, I cannot live in fear we must live by the law, where is the law DEA: put it in writing miles, diagnostic codes( Costco’s, Sam’s, CVS, Walgreens, anticipatory compounding, cocktails, pill mills, insurance, cash payment
Living in the Spirt of Sankofa
For Now You’re Within The Norms
[i] http://www.pharmacist.com/article/federal-funding-law-includes-compounding-language-apha-win
[ii] https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm496286.pdf
[iii] In this example, it would be consistent with FDA’s policy if, after distributing 200 units of drug X pursuant to valid patient-specific prescriptions, the compounder produces up to 200 additional units of drug X so that the total number of units that the compounder is holding for distribution returns to 500 units.
- [iv] The limited quantities policy, which relates to the amount of inventory held by the compounder, does not alter the product’s BUD. For example, if the BUD for the product is 9 days, the compounder should not produce more units than can be distributed pursuant to valid prescriptions and used within 9 days.
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