United States Court of Appeals 

FOR THE DISTRICT OF COLUMBIA CIRCUIT 

Norman Clement, 

Case: No. 21-1262 

Petitioner 

v. 

Drug Enforcement Administration, 

Respondent

___________________________________________________

PETITIONER’S THIRD ADDENDUM TO DISPOSITIVE MOTION TO VACATE ADMINISTRATIVE JUDGES FINDINGS AND DEA ADMINISTER’S ORDERS, RESTORE CSA REGISTRATION of PRONTO PHARMACY LLC AN AWARD DAMAGES,

OUT OF A MOUNTAIN OF DESPAIR COMES A STONE OF HOPE

Now, Comes forth a Michigan Man, the Petitioner, Norman J Clement, pro-se (a Rattler) armed with a Laser-Guided Meteor of Wisdom and Knowledge,  Pursuant to the Court’s Order of  January 09, 2022, and D.C. Circuit Rule 28(a)(1), Case No. 21-1262 submits this 3rd addendum, to his Dispositive Motion respectfully seeking and demanding justice and hereby further states,

STATEMENT OF FACTS

The government has a legitimate interest in deterring diversion and misuse of controlled substances, especially amid the illicit drug overdose crisis. But a standard for criminal liability that overly deters and may cause medical professionals to act against their best medical judgment due to fear of oversight, have a chilling effect on their willingness to care for patients in pain, and even encourage them to engage in self-protective practices that risk the safety and endanger the lives of a patient receiving pain care 

As damaging as ‘pill mills’ may have been the DEA has massively committed more damage than they ever did by imprisoning innocent doctors, pharmacists, dentists, and nurse practitioners literally crippling and killing hundreds of thousands, perhaps even millions of pain patients who were guilty of nothing but severe pain. That is indeed what any reasonable person would think to be true, however, the DEA does not believe that there is a pain in existence that should require more than 90 MME (MORPHINE MILLIGRAM EQUIVALENT) of Narcotic Analgesic medications per day. 

The DEA must be stopped and the CDC must rescind these deadly opioid prescribing guidelines which were “created by making up false data, statistics to “create” misguided charts released to treat public healthcare.

DEA ARCOS SYSTEM 

The DEA ARCOS is an automated, comprehensive drug reporting system, which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level – hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions. 

ARCOS accumulates these transactions which are then summarized into reports, which give investigators in Federal and state government agencies information that can be used to identify diversion of controlled substances into illicit channels of distribution. “Information on drug distribution is used throughout the United States (U.S.). by U.S. Attorneys and DEA investigators to strengthen criminal cases in the courts.”  Through their own word usage and practice ” DEA uses statistical analyzation to review to determine and identify the diversion of controlled substances into illicit channels of distribution.”  

ARGUMENT

Leo Beletsky of Northeastern calls the government crackdown on prescribers getting low-hanging fruit. “The DEA measures success based on the number of arrests and prosecutions. Doctors are minor players. 263 physicians were convicted by the DEA on charges between 2003-2017, and over 3000 were forced to surrender their licenses. Data mining billing records and prescription databases have become the hunting ground. The DOJ has partnered with insurance companies to share data.” 

They create their targets. Who is the biggest prescriber in a region, state, and nationwide? They are investigated. Who does the most procedures? They use ‘flags’ like distance traveled forgetting that by disincentivizing and terrorizing prescribers there is no one left to prescribe, and patients must travel farther for the same services.  The flags created during the pill mill era are now self-perpetuating. If you mine data enough you might find something and law enforcement can access data without individualized suspicion, probable cause, or any judicial review. 

Two doctors recently indicted who have run a pain clinic for decades were under investigation for four years. One was indicted over two prescriptions for a moderate number of opioids. “Numbers alone can’t determine whether a crime has been committed: The ‘normal’ amount of opioid prescribing for a physician treating pain or addiction will inevitably be much higher than the average for all doctors or the typical amount in most other specialties.” 

PROBABILITY MATHEMATICS

What the DEA is doing is applying probability mathematics. Probability is a mathematical tool used to study randomness. It deals with the chance of an event occurring. Through this agency application of probability statistical mathematics, the DEA uses its ARCOS as an instigation tool to identify the diversion of controlled substances into illicit channels of distribution. 

What this federal agency is doing is monitoring, “the point of sales from the point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level – hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions.”   In essence, this agency is doing is monitoring and prosecuting medical professionals for performing their licensed medical fiduciary responsibilities on patients.

The trouble with probability mathematics is if a doctor is good and performs exemplary service that medical professional would be targeted despite his or her professional services. 

For example, with the DEA ARCOS system, when a doctor or pharmacist orders a class 2 medication, the DEA knows the exact number of the medication ordered. With the DEA ARCOS system, the agency knows when the doctor’s prescription and who by name receives the prescription. The agency knows when the pharmacist filled the prescription and by name as to who received the amount and type of class2 medications.

It has been clearly seen that his agency applies geographic enforcement tactics, to identify diversion of controlled substances and illicit channels of distribution using probability and statistics. 

When we examine the charges placed against medical professionals, we can clearly see the application of the ARCOS system when the agency write within their affidavit “C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”  

To analyze and establish probability mathematics that a licensed professional and state “mis-practicing pharmacist “knowingly fill[s]” a “purported’” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”  This statement clearly establishes that the agents apply circumstantial analytical evidence to substantiate a violation.

By using the ARCOS system each DEA understood well in advance how their system tracks and identifies each prescription and who received the medication and how much medication was provided to the patient.

In essence, the DEA is applying inferential statistics, the null hypothesis that two possibilities are the same. If a pharmacist orders 6000 class oxycodone pills, the DEA approves the reception of the medication. In fact, the DEA approves the shipment and authorizes the reception of the medication at the pharmacy.   However, with their knowledge of their approval for the pharmacist to receive the medication, the DEA often calls a pharmacy ‘pill mills.’. 

“Distributors report sales of Schedule, I, II and some III opioid-based medications to the Drug Enforcement Administration (DEA) for its database, known as the Automation of Reports and Consolidated Orders System (ARCOS).  From the point of manufacturing through commercial distribution to delivery to DEA- and state-registered pharmacies, hospitals and other healthcare providers.”

It should be made clear in the DEA, they apply its ARCOS system data analytical reports, such as reports that must be provided within or attached to the investigative reports.  No citizen should ever be subjected to inferential statistical investigatory tools and be subjected to governmental enforcement. 

ARCOS BIAS

By speculation, the DEA reviews computerized data that they have previously approved and applies that information to subjugate African-American medical professionals. With the use of computerized data, they base their reasoning of criminal activity on the belief that criminal activity was occurring through the perceptions of their economic growth and not reality.

15 licensed medical professionals were identified. Each of these facilities was raided by the DEA drug trafficking and diversion or DOs for healthcare fraud. The main focus of the DEA actions was a review of their ARCOS system. Each of these medical facilities was operating according to medical, state, and federal standards. Based on their academic achievements and business knowledge. 

The results of their business growth triggered a criminal investigation of their accumulated “transactions which are then summarized into reports, which give investigators in Federal and state government agencies information which can be used to identify diversion of controlled substances into illicit channels of distribution.”

SELECTIVELY TARGETING BASED ON RACIAL BIAS

WITH LINDA CHEEKS MD

HERE:

To use the ARCOS system as a tool to identify target successfully growing license African American medical facilities who practices and conduct successful medical practice that provides good, and mannered customer service, as a source of diversion of controlled substances into illicit channels of distribution. 

When the DEA uses their computer system and develops a suspicious element that criminal activity is taking place, they then apply a multitude of charges to support their assertion that the medical facility is the source of diversion of controlled substances into illicit channels of distribution. All this is done despite the professionalism and legal standards each facility conducts.

These acts by the DEA occur throughout the country upon Asian-Americans, India-Americans, African-Americans licensed medical facilities.

Neil Anand MD Anesthesiologist Philadelphia, Pennsylvania

Eugene Fletcher RPH Columbus, Oh

Walter F. Wrenn MD Internal Medicine Philadelphia, Pennsylvania

Ashok Jain MD Psychiatrist, Dickerson, Tx

Vilashni Ganesh MD San Francisco, California 

Dravales Edward  DO   Texas 

Michelle Clark RPH Wheatland Pharmacy, Dallas, TX

Lesly Pompy MD Anesthesiologist, Monroe Michigan

Aaron Howard RPH, Ft Myers Fl   At Cost RX

Ricardo Fertil RPH Cape Coral Fl

Cathleen London MD NY NY 

Jay K. Joshi MD  Chicago Ill  

Masoud Bamdad MD  Missouri

Louis Ladson RPh, Lincourt Pharmacy Clearwater Fl

Superior Pharmacy, Tampa FL

We Care Pharmacy, Tampa FL

When these medical facilities are identified by the DEA’s ARCOS system, they then create and manufacture criminal charges, the agents create false charges. To use such tactics as a source of probable cause violates the very essence of the fourth amendment. In Brinegar v. United States, the U.S. Supreme Court defines probable cause as “where the facts and circumstances within the officers’ knowledge, and of which they have reasonably trustworthy information, are sufficient in themselves to warrant a belief by a man of reasonable caution that a crime is being committed.”

USES OF GOOGLE MAPS TO ESTABLISH DIVERSION

The development of probable cause was based on a rationale that a crime or sets of crimes were committed. Based on a GOOGLE MAP search.  Yet, there are no reasonable rational thoughts of criminal justice criminal acts to support the DEA accusations of diversion.

Through the negligence of the DEA not to consider or investigated the patient and to determine why they responded to a Florida pharmacy.  Had the DEA not used Google Maps and conducted an actual investigation they would have discovered that at least one patient lived with his mother in Florida. There is no distance or travel laws that prevent any individual or animal from obtaining any prescription in Florida, Florida Department Health Mission Statement clearly states, “Our mission is to protect, promotes and improve the health of all people in Florid through integrated state, county and community efforts” 

COCKTAIL MEDICATIONS

The DEA listed and name a licensed medical and pharmaceutical practice as Cocktail Medications. Without medical and scientific reasoning, the DEA claimed that both ARRIC Pharmacy and Gulf Med Pharmacy created a mixture of drugs so that their combined effect would be more potent than that of any of the drugs used individually.  

However, The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process. One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a). 

Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States 

DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716. 

While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. 

The DEA agents failed to display testimony from medical experts that examined and or interviewed the prescriptions and or patient.  The DEA can neither express knowledge that any patient suffered harm in any matter after an examination and after receiving their prescription from a pharmacist. 

The DEA agents stated, “Cocktail medications are combinations of a controlled substance that are widely known to be abused or diverted, and when taken together create or enhance abusive or euphoric effects, but also significantly increase a patient’s risk of death or overdose”.  The DEA Agents and its experts failed to document on paper and in court the death rates and or drug overdose rates created by ARRIC, Gulf Med,  Pronto’s Pharmacy or any other licensed pharmaceutical facility.  Within a pharmacy, there is no such thing as cocktail medications.

On February 14, 2018, the Special Agent, or Task Force Officer of the Drug Enforcement Administration of the Department of Justice conducted a raid based on a signed search warrant that failed to describe or define the elements of a crime.  This search warrant was decrepitude in that it failed to illustrate and support the rudimentary descriptions defining Probable Cause.  

The investigator wrote, “Application having been made, and probable cause as defined by 21 U.S.C. § 880(d)(1) having been shown by the affidavit of Diversion Investigator Norita N. Persaud, United States Drug Enforcement Administration, for an inspection of the controlled premises of Aarric, Inc., dba At Cost Rx, 16970 San Carlos Boulevard, Suite 110, Fort Myers, FL 33908, with DEA number FA2125640, it appears that said inspection is appropriate under 21 U.S.C. § 880”. 

The investigator agent clearly expressed his knowledge of probable cause as defined by 21 U.S.C. § 880(d)(1).  Yet, he did not, within the search warrant, describe the place to be searched and the descriptive elements to support and clearly identify any elements of a crime that would provide a reasonable officer to conclude that probable cause exists.  

FAILURE TO ESTABLISH PROBABLE CAUSE

The signed warrant authorized the investigating Agent “to seize from the above-described controlled premises such of the following records, information, reports, documents, files and inventories, as are appropriate and necessary to the effective accomplishment of the inspection, and for the purpose of copying or verifying their correctness, or that is used or intended to be used in violation of the Controlled Substances Act whether in electronic or printed media format as noted above”.  

The Supreme Court has defined “probable cause” as an officer’s reasonable belief, based on circumstances known to that officer, that a crime has occurred or is about to occur. Carroll v. United States, 267 U.S. 132, 149 (1925).

By the fact, this inspection warrant lacked sufficient levels of evidence to support probable cause. The act to inspect the premises was not based on a reasonable officer.   

As a nation, we must fear the acts of this search that a law enforcement officer can obtain a baseless warrant and search a premise at will.  The act of the DEA to inspect without cause violates the “Fourth Amendment to the United States Constitution. Which protects the people’s right “to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures.”   

After the inspection, the investigating officer was further authorized to seize legally sanctioned ‘Class two, three, and four controlled substances from the premises; The agent wrote “Such of the following records, information, reports, documents, files and inventories, as are appropriate and necessary to the effective accomplishment of the inspection, and for the purpose of copying or verifying their correctness, or that are used or intended to be used in violation of the Controlled Substances Act whether in electronic or printed media format”.  This inspection warrant is a document to look at and examine.  However, nothing in the inspection warrant authorized the seizure of property.

The racial indifference has prevented African American Pharmacy owners from operating a business in Florida. Had these practices been equally applied to White Own Pharmacies, there would be no operating pharmacies in Florida.  This attack upon African American own Pharmacies in Florida is raced based. 

SELECTIVE Discriminatory EnforcementS 

According to DEA Certificate of Registration Number FP230207621, U.S.C. § 824(d), “because Pronto Pharmacy’s continued registration constitutes an imminent danger to the public health or safety.”  

During the period of DEA operation upon Ponto’s Pharmacy, there were nine pharmaceutical facilities, within a six-mile radius of Pronto pharmacy, operating and selling opioids.        

During the same period of time, the DEA’s raided Ponto’s Pharmacy.  These pharmacies fill opioid prescriptions and are continue to operate to this day.  Of the nine pharmaceuticals facilities currently operating each pharmacy is filling more prescriptions for Opioids than Pronto Pharmacy.

The acts and actions of the DEA, have made it clear that federal agents have targeted Pronto Pharmacy. Moreover, the agency that employs the DEA agents have identified and targeted Pronto Pharmacy with false claims.  The DEA has ignored their own data and caused to blame the owner-operator of Pronto Pharmacy to cause the public imminent danger under U.S.C. § 824(d). 

Examining two of the nine pharmacies located in Hillsborough County along with Pronto Pharmacy.  The DEA ARCOS system identified three pharmacies within a six-mile radius of Pronto Pharmacy African American own and operated facility.   

• PMSI Pharmacy, Tampa Florida (White Owned) 

• OMNICARE PHARMACY OF Florida, Tampa Florida (White Owned)

• Pronto Pharmacy, Tampa Florida (Black Owned) 

PMSI Pharmacy:  Between 2006 and 2012, 26,253,800 class 2 pills were shipped to this pharmacy

OMNICARE PHARMACY: Between 2006 and 2012, 13,816,900 Class 2 pills were shipped to this pharmacy.

Pronto Pharmacy: Between 2006 and 2012, 348,000 Class 2 pills were shipped to this pharmacy.  

Pronto Pharmacy received substantially fewer Scheduled II pills than Omnicare and PMSI.  The DEA agents has applied their cultural indifferences and deliberately attack and destroy African American-owned pharmacies, around the country.   

PMSI received and processed 25,305,800 more pills than Pronto pharmacy and Omnicare pharmacy received and processes 13,468,900 more pills than Pronto Pharmacy.  

If African American pharmacists single handily contributed to the growth of opiates and single-handedly placed the community in imamate danger, how then is PMSI Pharmacy allowed to operate when they are filing for more opioids within the same time frame and geographical location as Pronto Pharmacy. 

At some point in time, the DEA will expand into other areas to promote their reign of terror. This agency has become so corrupt that it has become impossible to determine who is the good or bad guy.

The lines of justice are becoming blurry. If an agency can act with immunity based on color then that agency is not objective and has placed a dark cloud on the people of America.  

The real question that must be asked is, what will this agency become to America, and who is this agency serving?  Americans, or themselves. 

The DEA HAS GONE ROGUE

Their main goals are to create rules and regulations that support and satisfy their internal ambitions. Like any gang, the main ambition is to create rules and regulations to support the organizational goals. The primary narrative driving policy is that the opioid epidemic is driven by overprescribing by clinicians, leading patients to become addicted. This has led to draconian laws that have harmed chronic pain patients and the use of invasive prescription monitoring programs throughout the country.

The black box algorithms mine data and have never been subjected to independent verification. Patients and prescribers alike are flagged as problematic.  Although prescribing has dropped dramatically since the introduction of prescription monitoring, overdose deaths have risen dramatically to record highs, driven by the illicit fentanyl market. Despite this, law enforcement continues to focus on the diversion of prescription medication. 

The drug prohibition policy set out by the Department of Justice (DOJ) is a misguided attempt to address skyrocketing opioid overdoses. It is their way of trying to fix the issue which was the unchecked distribution of opioids. The blame for that falls on the DEA (Drug Enforcement Agency), Congress and lobbyists. 

This focus on limiting the prescribing of legal opioids has led to an increasingly lethal illicit opiate supply. The DOJ continues to erroneously cite diversion of licit legitimate prescriptions of opioids as the problem. As a result, doctors have been imprisoned for terms ranging from twenty years to life without parole, all for practicing medicine. Others have had their careers and reputations irreparably harmed.

RICHARD JAMES ALBERT DEA EXPERT FROM COURT RECORD DOCKET NO. 19-42 FINDING OF FACT AND CONCLUSION OF LAW

9. DI Richard Albert

11. Richard James Albert, Jr. (“DI Albert”) is a DEA diversion investigator stationed in the Tampa, Florida field office.  Tr. 24:17-23.  He has been a diversion investigator for over seven (7) years.  Tr. 24:24-25:2.  His training as a diversion investigator included basic diversion school – a 12-week course held in Quantico, Virginia.  Tr. 25:8-11.  DI Albert testified that, during the aforementioned 12-week diversion investigator course, he was taught to be thorough in his investigations and to gather as much information as he could to support any allegation he investigated.  Tr. 121:16-24.  
12. During the 12-week diversion investigator course, DI Albert was instructed on federal law.  However, DI Albert has had no education regarding Florida law as it pertains to pharmacy operations.  Tr. 152:25-153:2.  DI Albert looked solely to federal law when investigating and analyzing Respondent’s case.  Tr. 153:3-5.  DI Albert admitted that he crafted the subpoenas that were served on the Respondent, and that he included references to Florida Administrative Code (“FAC”) provisions in the subpoenas because those provisions were significant to him.  Tr. 153:10-15.  However, DI Albert subsequently conceded that he did not know what significance the FAC provisions held for him, that the FAC provisions were already included in his subpoena template, and that he did not know what those provisions mean.  Tr. 153:16-154:2.
13. The duties of a DEA diversion investigator include the performance of cyclic investigations (every two (2) or three (3) years) of distributors, manufacturers, pharmacies, doctors, importers, exporters, and reverse distributors regarding matters of diversion.  Tr. 25:12-20.  
14. In his seven (7) years of service as a DEA diversion investigator, DI Albert has been involved in numerous diversion investigations.  Tr. 25:21-24.
15. DI Albert became involved in a diversion investigation of the Respondent pharmacy in approximately May of 2017.  Tr. 26:3-7.
16. In or around May of 2017, DI Albert conducted a 10-15 minute inspection of Respondent’s pharmacy.  Tr. 26:17-27:7.
17. In September of 2017, DI Albert served a subpoena on the Respondent seeking original Schedule II controlled substance prescriptions, receiving records, and batch records.  Tr. 27:12-20.
18. In response to the subpoena, DI Albert received the following records from the Respondent:
    1. A 52-page receiving record from “Auburn Pharmaceutical” to Respondent.  Tr. 28:1-24; GE 2.
    2. A 5-page receiving record from “B&B Pharmaceuticals” to Respondent.  Tr. 29:9-30:9; GE 3.
    3. A 5-page receiving record from “Fagron, Incorporated: to Respondent.  Tr. 31:18-32:1; GE 4.
    4. 36 pages of batch records for “hydromorphone 8 mg.”  Tr. 32:21-33:1; GE 5.
    5. 15 pages of batch records for “hydromorphone 30 mg.” Tr. 38:22-39:11; GE 6.
19. DI Albert did not know whose signatures and initials appeared on Respondent’s batch records.  Tr. 150:1-151:10.
20. As part of his investigation, DI Albert queried the E-FORSCE database, which he also referred to as the “Prescription Drug Monitoring Program” or “PDMP” database, for information pertaining to the Respondent.  Tr. 43:21-44:16.  
21. DI Albert generated three (3) reports pertaining to the Respondent from the E-FORSCE/PDMP database.  Tr. 44:25-51:19; GE 8, 9, 10.
22. In or around September of 2018, DI Albert served an administrative inspection warrant (“AIW”) and subpoena upon the Respondent.  Tr. 52:14-53:10; GE 67.
23. DI Albert, accompanied by a “computer tech” person from “SFL9” and at least five (5) other DEA employees, conducted an inspection of Respondent’s pharmacy pursuant to the AIW.  Tr. 55:25-56:4; 164:23-165:4.  
24. During the inspection and execution of the AIW, DI Albert and the other DEA personnel took possession of and inventoried all Schedule II controlled substances in Respondent’s possession. Tr. 56:2-8; 59:17-60:1; GE 7.  
25. Neither DI Albert nor any of the other DEA agents conducted interviews of patients or Respondent’s staff during the inspection and execution of the AIW.  Tr. 168:2-16.  
26. DI Albert acknowledged that Respondent’s only obligation in connection with the DEA’s inspection and execution of the AIW was to direct DEA agents to the location of records that were responsive to the administrative warrant and/or subpoena.  Tr. 168:17-23.
27. With assistance from Norman Clement, Jr., DI Albert located and took possession of all hard copy records in Respondent’s possession that were responsive to the administrative subpoena.  Tr. 61:7-24.  Additionally, DI Albert was able to obtain all electronic records requested in the administrative subpoena with the assistance of the SFL9 computer tech person who, DI Albert testified, “mirrored” Respondent’s hard drive and copied the records thereon onto a CD.  Tr. 62:17-24.  The records contained within the digital data retrieved by SFL9 included records pertaining not only to the specific patients identified in the AIW and administrative subpoena, but also to patients who were not the subject of DI Albert’s investigation of the Respondent.  Tr. 92:23-94:9.
28. DI Albert stood next to the computer tech person from SFL9 when the latter accessed Respondent’s computer to image Respondent’s hard drive.  Tr. 135:11-18.  From this vantage point, DI Albert was able to ascertain that the Respondent used “Rx30” – a computer program commonly used by pharmacies to keep track of dispensing information – as its pharmacy software.  Tr. 135:19-136:1.  
29. DI Albert possesses no training in the use of the Rx30 software.  Tr. 136:2-8.
30. DI Albert did not know what process the SFL9 technician used to convert Rx30 data obtained from Respondent’s computer system into Microsoft Excel format, or whether that conversion correctly performed by the SFL9 technician.  Tr. 136:13-23.
31. In response to the administrative subpoena that was served in connection with the September 2018 AIW, DI Albert received the following records from the Respondent:
    1. A 3-month dispensing report covering the period from November of 2015 to January of 2016, consisting of ten (10) pages.  Tr. 68:10-69:10; GE 12.
    2. A spreadsheet document of an unspecified nature.  Tr. 70:4-23; GE 13.
    3. A PDMP record for patient A.G.  Tr. 71:14-72:16; GE 14.
    4. A spreadsheet document showing patient information and patient notes for patient A.G.  Tr. 73:18-74:1; GE 15.
    5. A dispensing record for patient A.G.  Tr. 76:13-78:4; GE 16.
    6. Another dispensing record for patient A.G.  Tr. 80:14-81:3; GE 17.
    7. A PDMP record for patient A.H.  Tr. 81:22-82:16; GE 19.
    8. A compilation of other records, which DI Albert testified were either obtained from the Respondent in connection with the AIW and accompanying administrative subpoena or queried from the PDMP database.  Tr. 85:10-86:3; GE 20-43; GE 46-52.
32. Following the execution of the AIW, DI Albert engaged Mr. Sullivan as the DEA’s expert and began to prepare the OSC.  Tr. 88:3-17.
33. In May of 2019, DI Albert served an additional subpoena on the Respondent seeking patient profiles for several individuals identified on a list attached to the subpoena.  Tr. 88:21-90:6; GE 68.
34. As part of Respondent’s response to the May 2019 subpoena, DI Albert received a 9-page compilation of documents pertaining to patient A.G., including a patient questionnaire, a patient prescription summary, an E-FORSCE data printout, and front-and-back copies of prescriptions.  94:18-96:17; GE 18.
35. As part of Respondent’s response to the May 2019 subpoena, DI Albert also received a 9-page compilation of documents pertaining to patient R.B.  DI Albert testified that this compilation contained the same types of records included in the compilation of records for patient A.G.  97:11-98:12; GE 44.
36. DI Albert conducted several searches, using “Google Maps,” of approximate distances and travel times between the address of Respondent’s pharmacy and the cities in which various patients purportedly reside.  Tr. 99:16-105:11; GE 54.  DI Albert also conducted Google Maps searches to determine approximate the one-way distances and travel times between the Respondent’s pharmacy and the address at which each of several patients purportedly resides.  Tr. 108:18-112:17; GE 56-60; GE 62-65.  In one instance, DI Albert used Google Maps to determine the approximate round-trip distance and travel time from a patient’s purported home address, to the purported address of the patient’s doctor, to Respondent’s pharmacy, and back to the patient’s purported home address.  112:23-118:7; GE 61.  However, DI Albert did not know whether the Patients in fact travelled the routes estimated in his Google Maps searches to obtain prescriptions from the Respondent.  Tr. 133:5-20.
37. DI Albert conceded that it would have been important for him to speak to the eleven (11) patients that were the subject of his investigation (hereinafter, the “Patients”) in order to determine whether those patients had information that might be relevant to certain red flags – for example, the reason why certain patients travelled to Respondent’s pharmacy.  Tr. 123:22-124:1.  However, DI Albert admitted that he never contacted, spoke with, or attempted to contact or speak with any of the Patients.  Tr. 123:6-124:9.  
38. DI Albert testified that, in reviewing Respondent’s prescription data, he became suspicious because certain prescriptions were written for tablets but filled in capsules.   Tr. 125:8-20.  However, DI Albert admitted that he is not familiar with FDA guidelines regarding compounding and, further, that he did not analyze the records he obtained from the Respondent to compare the patients who received capsules that were compounded at Respondent’s pharmacy to the anticipated patient need.  Tr. 152:2-18.  Likewise, DI Albert did not compare the number of doses of capsules documented as having been compounded by the batch reports to the amount of drugs dispensed by the Respondent.  Tr. 154:3-8.
39. DI Albert admitted that speaking with the prescribing physicians identified in the E-FORSCE data would have been a simple and straightforward method to ascertain whether any of those prescribers had, in fact, authorized the substitution of capsules for tablets for a particular prescription, and he testified further that there was nothing to prevent him from contacting all but one (1) of the physicians who wrote the prescriptions for the Patients at issue.  Tr. 126:17-127:25.  However, DI Albert never contacted, spoke with, or attempted to contact or speak with any of the prescribing physicians.  Tr. 126:17-20; 128:5-7; 177:24-180:3.
40. DI Albert did not know of any federal or state law or regulation that limits the geographic area in which a pharmacy can dispense drugs.  Tr. 154:9-19.
41. Apart from asking Respondent’s pharmacist questions during an inspection, DI Albert made no efforts to ascertain whether there was a reasonable basis or explanation as to why certain Patients allegedly travelled long distances to fill prescriptions at Respondent’s pharmacy.  Tr. 154:20-155:13.
42. DI Albert did not know of any contracts between Respondent and any insurance company or pharmacy benefit manager (“PBM”) in 2017, 2018, or 2019.  Tr. 156:11-14.  
43. DI Albert was not aware of any federal or state regulation requiring a pharmacy to accept insurance.  Tr. 158:12-19.
44. DI Albert has learned from pharmacist with whom he has been on inspections that PBMs have been pushing down reimbursement rates to independent pharmacies.  Tr. 156:15-157:3.
45. DI Albert is aware that some distributors limit the amounts of Schedule 2 controlled substances that they will supply to independent pharmacies.  Tr. 157:9-14.
46. DI Albert testified that the DEA is putting pressure on distributors through the “Know Your Customer” initiative to ensure that distributors sell a much higher percentage of non-controlled substances than controlled substances to pharmacies, and that part of that analysis involves calculating the ratio of dispensing of controlled substances versus non-controlled substances, though he was not aware of the DEA’s precise desired ratio.  Tr. 157:15-158:10.

JEFFREY SHEARER FORMER TAMPA POLICE OFFICER FROM COURT RECORD DOCKET NO. 19-42 FINDING OF FACT AND CONCLUSION OF LAW

2. Jeffrey Shearer

47. Jeffrey Shearer (“Mr. Shearer”) is a self-employed owner of a private investigation business, which he has operated for five (5) years.  Tr. 182:2-6.  He formerly served as an officer of the Tampa Police Department for sixteen (16) years, the last five and a half years of which he spent as a task force officer in the tactical diversion squad of the Tampa District Office.  Tr. 182:8-12.   
48. Mr. Shearer participated in a prior investigation that indirectly involved the Respondent and the execution of a search warrant at Respondent’s premises in May of 2012.  Tr. 183:3-9.  However, Mr. Shearer admitted on cross examination that the proximate cause of the investigation was not the Respondent, but rather a pharmacist named Christopher Switlyk.  Tr. 188:15-20.  Mr. Shearer conceded that the investigation of Mr. Switlyk had nothing to do with Dr. Clement.  Tr. 194:4-6.
49. During the execution of the May 2012 search warrant, Mr. Shearer seized Respondent’s inventory.  Tr. 190:13-21.  Mr. Shearer was certain that the seized inventory had significant value.  Tr. 194:9-14.  However, Mr. Shearer testified that the inventory was never returned to the Respondent, even though neither Respondent nor Dr. Clement was ever charged with any crime or offense, or joined as a defendant in a False Claims Act or similar civil action.  Tr. 190:13-25.
50. During the search warrant execution, Mr. Shearer also interviewed Dr. Clement regarding Respondent’s compounding practices.  Tr. 183:10-21.  Dr. Clement was not in custody and agreed to be interviewed.  Id.  Mr. Shearer 
51. According to Mr. Shearer, Dr. Clement told him that the Respondent compounded oxycodone and hydromorphone capsules, with a similar bioavailability to commercially available tablets, for the sake of cost effectiveness.  Tr. 183:22-185:2.  Mr. Shearer testified further that Dr. Clement used a “formulary,” or mix of controlled substances, to produce the particular dosage that would be required.  Tr. 184-2-10.  
52. Mr. Shearer did not recall discussing with Dr. Clement how Dr. Clement determined which patients would receive capsules versus tablets, though he recalled Dr. Clement stating there were some patients who did not want capsules.  Tr. 185:18-23.
53. Mr. Shearer did not recall anything else of note from the interview related to compounding.  Tr. 186:5-7.
54. During or after the execution of the May 2012 search warrant, Mr. Shearer prepared a DEA-6 form.  Tr. 186:23-187:3.  Mr. Shearer reviewed the DEA-6 form in preparation for his testimony at the final hearing in this case.  Tr. 187:6-8.  The DEA-6 form was not produced to Respondent or its counsel.  Tr. 187:9-188:12.

Ruan v. United States Consolidated Oral Argument

The Supreme Court heard oral argument in Ruan v. United States, a consolidated case on whether physicians can be convicted for illegal distribution of controlled substances, like opioids, if they believed the drugs they prescribed were done so under professional norms and treatment purposes. Under the Controlled Substances Act (CSA), it is illegal for anyone to “manufacture, distribute or dispense” controlled substances. There is an exception for physicians who prescribe opioids for legitimate medical purposes in medical settings. The issue, in this case, is whether the prescribing physician did so in good faith and whether this standard should be applied when considering criminal cases and convictions. This case stems from the conviction of two physicians the federal government claimed ran “pill mills,” terminology often used to describe instances in which mass amounts of opioids are prescribed for inappropriate uses. 

https://www.c-span.org/video/?517837-1/ruan-v-united-states-consolidated-oral-argument

Truth and Justice 

The Drug Enforcement Administration has no steady-state of enforcement.  It appears they are led to apply arbitrary rules to justify selective enforcement tactics.  

According to DEA Certificate of Registration Number FP230207621, U.S.C. § 824(d), “because Pronto Pharmacy’s continued registration constitutes an imminent danger to the public health or safety.”  

During the period of DEA operation upon Ponto’s Pharmacy, there were nine pharmaceutical facilities, within a six-mile radius of Pronto pharmacy, operating and sell opioids.        

During the same period of time the DEA’s raided Ponto’s Pharmacy.  These pharmacies fill opioid prescriptions and are continue to operate to this day.  Of the nine pharmaceuticals facilities currently operating each of pharmacy is filling more prescriptions for Opioids than Pronto Pharmacy.      

The acts and actions of the DEA, have made it clear that federal agents have targeted Pronto Pharmacy. Moreover, the agency that employs the DEA agents have identified and targeted Pronto Pharmacy with false claims.  The DEA have ignored their own data and caused to blame the owner-operator of Pronto Pharmacy to cause the public imminent danger under U.S.C. § 824(d). 

• It becomes clear that individually each of these two pharmaceuticals received and produce more opioids to the streets than Proto Pharmacy.  Whereas with Pronto Pharmacy, 348,000 pills were shipped to this pharmacy between 2006 and 2012. About enough for less than one pill per year for each of the 104,932 people who live within five miles of this pharmacy.

After examining the DEA data, it becomes obvious their data points are inaccurate.  Each of these pharmacies are within 6 miles of each other.   These data points would therefore overlap multiple pharmacies within the data areas.  If they included the entire area, it would be plain to see that Pronto pharmacy would produce less than one pill per year for each of the 104,932 people who live within five miles of this pharmacy. The true number would most likely be .5 pills per year of each (…).  

The DEA has used fraudulent calculations to acquire a sense of achievement. 21 USC § 841 the trafficking law of selling drugs for personal gain, is the law that has been wrongfully applied to doctors who are practicing medicine and caring for some of the 8 million US citizens whose pain is treated with opioids. The DEA uses this law to falsely portray physicians as practicing medicine contrary to non-existent federal practice standards. The practice of medicine is regulated by the states.

They therefore used an arbitrary calculation to single out Norman Clement, an African American male, owner operator of Ponto’s Pharmacy, to raid and destroy his business.  This is clear that no other pharmacy within the area are being forced to stop business operations.   

If it could be reason that an African American Male single handily contributed the growth the opiate crises.  How then is PMSI Pharmacy is allowed to operate when they are filing 25,905,800 more opioids within the same time frame and geographical location of Pronto Pharmacy and they are still operating.  Yet, an African American male is prevented from conducting business in Tampa Florida, Hillsborough County.  

          DONALD SULLIVAN DEA EXPERT FROM COURT RECORD DOCKET NO. 19-42 FINDING OF FACT AND CONCLUSION OF LAW

3. Donald L. “Donnie” Sullivan, Ph.D.

55. Donald L. “Donnie” Sullivan, Ph.D. (“Dr. Sullivan”), has been employed for the past five (5) years as a professor of clinical pharmacy at Ohio State University College of Pharmacy, where he teaches and conducts research.  Tr. 196:21-197:16.  Dr. Sullivan’s courses pertain to state and federal laws, in roughly equal proportions, related to the practice of pharmacy.  Tr. 198:1-4.  Prior to Ohio State, he was employed for seventeen (17) years at Ohio Northern University.  Tr. 197:3-4.  Dr. Sullivan is a registered pharmacist in Ohio and Florida, and holds a bachelor’s degree, a master’s degree in pharmacy administration, and a doctorate in pharmacy administration.  Tr. 198:7-16.  
56. Dr. Sullivan has worked as a community pharmacist in Ohio, but not in Florida.  Tr. 198:17-20.  
57. Dr. Sullivan has never worked as a retail pharmacist in Florida.  Tr. 442:22-24.
58. Dr. Sullivan is not a physician.  Tr. 407:24-408:1.  
59. In preparation for his testimony in this proceeding, and as the basis for his analyses and opinions in this case, Dr. Sullivan reviewed the Respondent’s Pre-Hearing Statement, a portion of the Government’s Pre-Hearing Statement, the PDMP data, and three (3) months of dispensing data from Respondent’s computer system.  Tr. 341:1-342:6; 342:25-343:22; 360:25-362:10.  
60. Dr. Sullivan was not provided and did not review any prescriptions for any patient of the Respondent pharmacy.  Tr. 347:25-348:7.  
61. Dr. Sullivan testified that a physician’s annotations on the face of a prescription are significant to the question of whether “red flags” were resolved “in certain instances,” but could not say whether any physician’s notes were relevant in this case because he did not review any of the prescriptions involved in this case.  Tr. 348:3-349:13.
62. Dr. Sullivan reviewed the information provided to him by DI Albert but did not request any additional information.  Tr. 358:17-21.
63. Dr. Sullivan did not review the batch records in this case.  Tr. 433:23-434:1.
64. In preparing for this case, Dr. Sullivan did not review the statutes in Florida that are applicable to the giving of expert testimony against a healthcare provider, including, inter alia, § 766.102(5), Florida Statutes.
65. Dr. Sullivan has never been to Respondent’s pharmacy.  Tr. 407:14-16.
66. Dr. Sullivan has never spoken or attempted to speak to any of the patients whose E-FORSCE data he reviewed.  Tr. 407:17-23.
67. Dr. Sullivan does not know the location or current medical condition of any of the patients involved in this case, nor does he know whether any of those patients is still receiving the same or a similar medication regime as they received when they were obtaining prescriptions from the Respondent’s pharmacy.  Tr. 461:21-462:6.
68. Dr. Sullivan conceded, with no small amount of reluctance, that he formed his opinions in this case without evaluating the prescriptions or observing or speaking with any of Respondent’s patients.  Tr. 414:23-416:16.
69. Dr. Sullivan did not know whether the Respondent or any of its pharmacists performed any diagnostic testing on any patients, including the patients whose PDMP data he reviewed in connection with this case.  Tr. 412:7-12.
70. Dr. Sullivan testified that the Respondent dispensed four (4) to (5) prescriptions per day on average, which he considers to be a “very low volume” of prescriptions.  Tr. 419:2-20.
71. Though he testified at length with respect to data that was extracted into the Government’s demonstrative exhibit, he did not compare the Government’s data in the Government’s demonstrative exhibit to the data contained in the PDMP or E-FORSCE records, and so did not know whether the information in the demonstrative exhibit was complete.  Tr. 357:3-11.  
72. In fact, when confronted with apparent inconsistencies between the Government’s demonstrative exhibit and prescription data presented by the Respondent, Dr. Sullivan appeared to concede that the information missing from the Government’s demonstrative exhibit would have changed his opinion if he had been aware of said information earlier.  Tr. 471:3-473:9.
73. According to Dr. Sullivan, Florida law and federal law both impose a duty on pharmacists to ensure that each prescription is a valid prescription for a legitimate medical purpose.  Tr. 206:3-207:1.  
74. Dr. Sullivan testified that, pursuant to Florida Administrative Code Rules 64B16-27.810, .800, and .831, pharmacists must take certain steps to verify that a prescription was written for a legitimate medical purpose.  Tr. 207:9-208:1.
75. Dr. Sullivan acknowledged that, under Florida law, a pharmacist must make attempts to resolve red flags before refusing to fill a prescription.  Tr. 487:7-16.
76. Dr. Sullivan agreed that no person may interfere with a pharmacist’s exercise of his or her independent professional judgment when validating a prescription, as set forth in FAC Rule 64B16-27.831.  Tr. 446:11-447:3.
77. Dr. Sullivan testified that the first step a pharmacist must take to verify the legitimacy of a prescription is to verify that all information legally required to be contained on the face of the prescription is properly included.  Tr. 208:4-11.  Then, the pharmacist must use his or her clinical expertise to evaluate several other factors, including over-utilization, under-utilization, the possibility of clinical misuse or abuse, whether a legitimate medical purpose exists for the prescription, and the potential for undue risk of side effects, adverse effects, and/or overdose situations.  Tr. 208:12-19.
78. Dr. Sullivan testified that pursuant to Florida Administrative Code Rule 64B16-27.800, Florida pharmacies must maintain certain information in a patient record system or patient profile system, including the full name of a patient, the patient’s age or date of birth, the patient’s gender, a list of all new and refilled prescriptions obtained by the patient at the pharmacy, and the pharmacist’s comments relevant to the patient’s drug therapy.  Tr. 209:10-210:4.
79. Dr. Sullivan testified that, under Florida law, the standard of pharmacy practice requires pharmacists to document the resolution of issues encountered during a prospective drug utilization review.  Tr. 210:5-17.  However, Dr. Sullivan later testified that neither Florida law nor Federal law mandates how, if at all, the resolution of such issues, or “red flags,” must be documented.  Tr. 435:18-437:9.  He also conceded that the Florida regulations that governs the steps Florida pharmacists must take before refusing to fill a prescription do not require (or even suggest) that pharmacists must document their efforts to resolve “red flags” or otherwise validate prescriptions.  Tr. 449:10-450:1.  In fact, Dr. Sullivan acknowledged that the applicable Florida regulations “nowhere” mandate that a pharmacist must document resolution of “red flags” on either the prescription or in the pharmacy software.  Tr. 452:20-25.
80. Dr. Sullivan was unfamiliar with the Florida definition of the prevailing professional standard of care for healthcare providers as set forth in § 766.102, Florida Statutes, but agreed that the definition therein is the appropriate definition of the standard of care in Florida.  Tr. 438:3-439:2.
81. Dr. Sullivan testified that the “gold standard” of pharmacy practice, on which he instructs his students, is the equivalent of the standard of reasonable care in Florida.  Tr. 478:5-479:11.
82. Dr. Sullivan testified that, under Federal law, pharmacists and prescribing physicians have an equal “corresponding responsibility” to determine whether a prescription has been written for a legitimate medical purpose.  Tr. 201:18-211:7.
83. Dr. Sullivan testified that, many times, a pharmacist may simply rely on the information contained on a prescription, though in some instances the pharmacist should call the prescribing physician or speak with the patient in connection with a prospective drug utilization review.  Tr. 211:8-18.
84. Dr. Sullivan testified that the term “red flag” refers to a warning sign or warning symbol indicating that there’s something wrong with a prescription, or that the patient may be either abusing or diverting it.  Tr. 211:19-212:1.
85. Dr. Sullivan averred that examples of “red flags” include the following:
    1. Patients traveling long distances to see the physician.  Tr. 214:16-215:1.
    2. Patients traveling long distances to the pharmacy.  Id.
    3. Prescribing of “drug cocktails.”  Id.
    4. Prescribing of “large quantities.”  Id.
    5. Patients paying for prescriptions in cash.  Id.
    6. Over-prescribing of immediate release pain killers.  Id.
    7. Patients coming in groups.  Id.
    8. Early prescription fills.  Tr. 226:16-21.
86. According to Dr. Sullivan, national statistics show that the “average patient lives two miles from a pharmacy.”  Tr. 216:24-217:6.  Based on this purported statistic, Dr. Sullivan opined further that it is “well known in the pharmacy community that patients traveling long distances to get prescriptions filled are most likely because [sic] other pharmacies would not fill them and it’s hard for them to find a place to fill those prescription [sic].”  Tr. 220:1-8.  
87. However, on the whole Dr. Sullivan’s testimony regarding distance as a “red flag” was quite ambivalent, as he later conceded that distance, by itself, is merely a “potential red flag” and admitted that “it’s not always a red flag by itself. . . .”  Tr. 474:7-23.  He subsequently admitted, with great reluctance, that distance as a “red flag” could be resolved.  Tr. 483:1-5.
88. Dr. Sullivan testified that one of the more well-known drug cocktails is the opioid-benzodiazepine combination.  Tr. 220:12-17.  However, Dr. Sullivan acknowledged that benzodiazepines may be prescribed for “a number of different things,” including the treatment of anxiety and sleeplessness, as well as other permissible off-label uses.  Tr. 458:14-459:3.  Though he testified in several instances on direct examination that the “drug cocktail red flag” was unresolvable, he eventually conceded that this “red flag” is, in fact, resolvable, if only in rare instances.  Tr. 483:12-15.
89. Dr. Sullivan testified that under state and federal law, pharmacists are required to perform a drug utilization review, which means to check the patient profile to ensure that the patient has not been prescribed a “drug cocktail” from different doctors on different dates at different times.  Tr. 223:1-14.
90. According to Dr. Sullivan, a pharmacist would be very reluctant to dispense a prescription for a combination of drugs that is subject to an FDA “black box” warning.  Tr. 223:15-224:1.
91. Dr. Sullivan testified that cash payment for a prescription is a “red flag” because, in theory, the patient is using cash because he or she has obtained cash from selling the drugs.  Tr. 224:22:225:4.  Dr. Sullivan added that, other than making cash payments for prescriptions because they are uninsured, patients may also pay for prescription in cash because they do not want their insurance company or employer to know that they are taking certain medications.  Tr. 225:5-11.  Dr. Sullivan also testified categorically that an insured patient will most likely use his or her insurance to pay for a prescription rather than paying in cash because the (unspecified) prescription is cheaper.  Tr. 225:11-15. 
92. Dr. Sullivan acknowledged that there is no Florida or Federal law that prohibits a pharmacy from accepting cash as payment for a prescription, and that if a pharmacy does not have contracts with insurance companies or PBMs, then the pharmacy would have to be paid in cash.  Tr. 444:12-25.  Nevertheless, even while he admitted that the Respondent would have no choice but to accept cash in the absence of insurance or PBM contracts, Dr. Sullivan refused to admit that this explanation would resolve the “red flag” of cash payments.  Tr. 475:6-22.
93. Dr. Sullivan testified that an early fill of a prescription for a Schedule II controlled substance is a “red flag” because it signifies that the patient is not taking the medication as directed by the physician or is taking the medication faster than directed.  Tr. 226:16-24.  However, Dr. Sullivan was unable to determine whether any of the instances of purported early fills in this case were authorized by the prescribing physician or otherwise subject to a reasonable explanation because Dr. Sullivan did not review any prescriptions, speak with any of the prescribing physicians or patients, or attempt to ascertain any such information from the DI Albert.  Tr. 348:3-16.  
94. Despite testifying in several instances on direct examination that an early fill “red flag” is unresolvable, Dr. Sullivan eventually conceded that a “red flag” raised by a patient request for an early fill can, in fact, be resolved.  Tr. 483:6-11.
95. According to Dr. Sullivan, when a Florida pharmacist receives a prescription that presents “red flags,” “there are several things a pharmacist could do.”  Tr. 226:25-227:4.  These include:
    1. First, having a conversation with the patient to “find out what are some of the potential issues with some of these red flags.”  Tr. 227:7-10.
    2. Second, having a conversation with the physician or physician’s agent.  Tr. 227:10-12.
    3. After the pharmacist has spoken to the patient and the physician, looking at:
       1. the patient record, 
       2. the prescribed drug, and
       3. the quantity and strength of other medications the patient is taking.  Tr. 227:13-18.
96. Dr. Sullivan testified that even after a pharmacist speaks with a patient and prescribing physician as part of a prospective drug utilization review, the pharmacist still has a corresponding responsibility to “make an independent judgment themselves as to whether they think it’s for a legitimate medical purpose or not.”  Tr. 227:19-24.
97. Dr. Sullivan testified that a pharmacist’s failure to document the result of communications made during a prospective drug utilization review as part of efforts to resolve red flags would be outside the standard of care.  Tr. 227:25-228:8.  
98. Though he testified that the prevailing standard of care requires a pharmacist to document resolution of “red flags” either in the notes on the pharmacy’s computer system or on the face of the prescription itself, Dr. Sullivan did not bother to request or review the prescriptions, or copies thereof, for any of the patients involved in this case.  Tr. 441:7-412:3.
99. Dr. Sullivan admitted that individual “red flags” can sometimes be resolved, but there can also be combinations of “red flags” that are unresolvable.  Tr. 228:9-14.  As an example of a purportedly unresolvable combination of red flags, Dr. Sullivan testified that if a patient presents a prescription for two immediate release narcotic pain killers in very high doses, a pharmacist would not fill the prescription even after speaking with the prescribing physician.  Tr. 228:20-229:8.  However, Dr. Sullivan later made precisely the opposite assertion when he testified that there would be instances in which two (2) immediate release opioids could be used together.  Tr. 481:12-25.
100. Dr. Sullivan averred that if a pharmacist cannot satisfy himself that a prescription was issued for a legitimate medical purpose, then the pharmacist is obligated to decline to fill the prescription.  Tr. 228:15-19.
101. Dr. Sullivan testified that a pharmacist can never make a decision to fill a prescription based solely upon what the prescribing physician tells the pharmacist about the prescription.  Tr. 229:15-22.
102. Dr. Sullivan described “compounding” as the means by which a pharmacist makes a drug “from scratch” to meet the unique therapeutic needs of a patient.  Tr. 230:4-9.
103. Dr. Sullivan testified that a pharmacist may compound a drug for a patient who is allergic to a particular ingredient in the commercially available formula of the drug, or if the patient needed a dosage or strength of the drug that was not commercially available.  Tr. 230:11-231:16.
104. Dr. Sullivan testified that a pharmacist may properly fill a prescription using fewer units of a drug at a higher strength as long as the pharmacist notifies the prescribing physician and documents the substitution.  Tr. 231:17-232:8.
105. As to each patient with respect to whom Dr. Sullivan reviewed PDMP and/or E-FORSCE data excerpted in the Government’s demonstrative exhibit, he testified that several “red flags” were presented, none of those “red flags” were resolvable, and no documentation he reviewed demonstrated that the “red flags” in question were, in fact, resolved.  Tr. 254-339.  However, Dr. Sullivan later conceded that it would be possible for a pharmacist to resolve all of the red flags that he earlier testified were “unresolvable,” and thus conceded that all of those red flags are potentially resolvable.  Tr. 501:4-14.
106. Dr. Sullivan testified that oxycodone 30mg and hydromorphone 8mg are commercially available drugs.  Tr. 232:19-24.
107. Dr. Sullivan averred that there is no legal or regulatory prohibition against a pharmacy adjusting its business model to primarily or solely dispense controlled substances.  Tr. 246:1-7; 247:3-13.
108. Dr. Sullivan admitted that the rates at which insurers and pharmacy benefit managers (“PBM”) reimburse pharmacies for certain products is less than the cost to the pharmacies to acquire those products.  Tr. 430:24-431:3.  He acknowledged that this phenomenon is “a problem,” and that it creates an economic hardship for small independent pharmacies such as the Respondent.  Tr. 430:6-431:6.
109. As a result of the decline in reimbursement rates from PBMs and insurers over the past two (2) to three (3) years, Dr. Sullivan agreed that small pharmacies have had to look for niche markets in order to stay in business.  Tr. 431:7-12.
110. Dr. Sullivan does not know and did not attempt to ascertain whether the Respondent had any contracts with insurers or PBMs.  Tr. 443:4-9.
111. Dr. Sullivan testified that unless a prescribing physician (i) indicates in his own handwriting on the face of a prescription that the prescription must be dispensed as written, or (ii) orally informs the pharmacist of this fact, the pharmacist otherwise has an obligation to substitute a less expensive drug product.  Tr. 431:24-432:6.  
112. Dr. Sullivan acknowledged that Respondent’s average unit dose price for oxycodone 30mg capsules, at $3.60 per dose, was roughly $3.00 less expensive per dose than the commercially available oxycodone 30mg tablets, which had an average unit dose price of $6.67 per dose.  Tr. 476:16-477:16.
113. Dr. Sullivan agreed that pharmacists, with the consent of the patient and the approval of the prescribing physician, may make changes to the delivery form of medication as long as the dosage forms are bioequivalent.  Tr. 432:10-15.

DONALD SULLIVAN’S LONG HISTORY OF PROFESSIONAL, ACADEMIC FRAUD, AND JUDICIAL PERJURY CONTINUES

The year is 2020, the case docket 09-42, Tampa, Florida the United States Drug Enforcement Agency vs Pronto Pharmacy LLC., Norman J Clement RPh, DDS from the record it reads,

 DEA Judge Mark D. Dowd writes:

“I question the sufficiency of the factual foundation for Dr. Sullivan’s expert opinion that the above prescriptions were an apparent attempt to mask scores of improper opioid prescriptions. The relevant medical records were not reviewed, the prescriber’s justification for the prescriptions were not considered by Dr. Sullivan, nor was the patient’s input as to the subject prescriptions considered. I find Dr. Sullivan’s subject opinion, on the basis of this record, to be improperly speculative and unjustified as an expert opinion.”  

“This finding does not affect the probity of Dr. Sullivan’s opinions as to the therapeutic effect of the subject medications, their contraindication with other prescribed medications, or the justification of their prescription.”

THE ARROGANCE OF HUBRIS

DEA Judge Mark D. Dowd writes:

“Dr. Sullivan demonstrated a commanding grasp of pharmacy practice and of the distinctions between pharmacy compounding and manufacturing. 

However, there were several matters for which he had diminished credibility. For one, he was unaware that Florida had codified the standard of care for medical personnel. 

Although I later determined the statute in question did not apply to pharmacists, it was somewhat surprising he was unaware of it, as he teaches Florida pharmacy law, More problematically, he quickly agreed that it was consistent with his understanding of the standard of care for pharmacists in Florida, which was somewhat surprising, as the standard of care for medical personnel is a highly generalized standard, a prudent healthcare provider standard. “

While the standard of care for pharmacists in Florida, as set out in the relevant Florida regulations, is highly specific in listing particular responsibilities and duties. 

He arguably conceded an alternate generalized standard of care for pharmacists in Florida, which is not consistent with Florida law or regulation.

DEA Judge Mark D. Dowd writes:

“Secondly, he gave inconsistent testimony regarding unresolvable red flags. He described several red flags as unresolvable, that no explanation could warrant the filing of the subject prescription. Later, he conceded that those same red flags could be resolved. At one point he suggested no single red flag was unresolvable, rather it was the combination of red flags which made them unresolvable. Accordingly, because of these inconsistencies, in the absence of a reliable principle or method employed by Dr. Sullivan, I reject his conclusions regarding his claim that certain red flags were unresolvable. For each of the red flags, he testified were “unresolvable,” I accept his alternate opinion that each of those red flags went unresolved in this matter, a finding clearly supported by the evidence.”

DEA Judge Mark D. Dowd writes:

“An expert, however, must base his knowledge on more than “subjective belief or unsupported speculation.” Daubert, 509 U.S. at 590 (discussing Federal Rule of Evidence 702). Without additional supporting evidence I am unable to rely on Dr. Sullivan’s opinion regarding this red flag.  The same will be true with respect to the other patients as to whom he raised a similar red flag to this one. I will, however, accept his opinion that prescriptions for opioids and low-dose non-controlled drugs raise a red flag to the extent that a low-dose non-controlled medication “doesn’t make sense” alongside a high-dose opioid. In other words, I accept his testimony that low doses of non-controlled drugs are suspicious because they do not make medical sense when prescribed with high doses of opioids, but I do not accept his testimony that any doctor prescribed those non-controlled drugs with the intent to cover illegitimate treatment”

DONALD SULLIVAN: ORDER TO SHOW CAUSE AUGUST 29, 2019, PRONTO PHARMACY MILAGE AND DISTANCE

“Patients Traveling Long Distances” to Fill Prescriptions at Pronto Pharmacy: The DEA’s expert Donald Sullivan opined that it can be a red flag of abuse and diversion if a patient travels a significant distance to a specific pharmacy, especially if the patient also travels a significant distance to a particular prescriber. Numerous Pronto Pharmacy customers traveled significant distances to obtain and fill their prescriptions.

DEA’s expert Donald Sullivan opined that both patients traveling long distances from their residences and patients traveling long distances from the medical practices of the prescribers to have their prescriptions filled are significant red flags that the prescriptions being filled by Pronto Pharmacy were being abused and/or diverted and that a pharmacist who was properly exercising his corresponding responsibility would have recognized this and refused to fill most of these prescriptions. 

DEA Judge Mark D. Dowd writes in his recommended order May 05, 2020:

 “I am not accepting Dr. Sullivan’s testimony that the roundtrip distance from M.M.’s home to the doctor’s office, and then to the Respondent, and then back home, is a red flag. There was no evidence M.M. ever made that round trip. The 38 miles from M.M.’s home to the Respondent is not overly suspicious on its face. I believe the Government withdrew its allegation as to that distance. I will, however, accept Dr. Sullivan’s testimony that the 134 miles from M.M.’s home to the doctor’s office.” 

It appears U.S. Administrative Law Judge Mark D. Dowd was so busy trying to be a bigot, so busy trying to be a racist, so busy reading youarewithinthenorms.com  and the toughest man on the federal bench he forgot how to be fair. “ Sullivan prevails solely on privilege and not on science or fact,

DONALD SULLIVAN, MARK D. DOWD VS AMERICAN MEDICAL ASSOCIATION

However, The American Medical Association (AMA) June 16, 2020, wrote to Deborah Dowell, MD, MPH Chief Medical Officer National Center for Injury Prevention and Control U.S. Centers for Disease Control and Prevention 4770 Buford Highway, NE Atlanta, GA 30341 undermines The DEA’s Prescription Red Flag Crusade “Opioid War” against license Physicians, Dentist, Pharmacist, the testimony and conclusion drawn by both DEA Pharmacist Expert Donald Sullivan, DEA Judge Mark D. Dowd:

The AMA writes:

“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial, and much more dangerous overdose and the drug epidemic is driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens. This is why the AMA continues its aggressive advocacy efforts in support of patients with pain and those with a substance use disorder as well as broad support for harm reduction policies and practices that address the wide range of factors affecting patients. “

The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis. CDC has a great opportunity to demonstrate its commitment to patients with pain through a detailed re-examination of the CDC Guideline, and the AMA urges CDC to work with physicians and patients to ensure that the revisions support patients with pain and the physicians who care for them.”

The AMA further writes:

“We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist. 

The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication. 

The AMA urges CDC to provide strong guidance and support for physicians and pharmacists to work together rather than jumping to conclusions about a patient’s PDMP report.” ” Clinicians are encouraged to have open and honest discussions with their patients so as to avoid stigmatizing the decision to start, continue, or discontinue opioids or non-opioid therapy. This discussion also must account for the treatment options accessible to the patient based on their health condition, social determinants of health (e.g. transportation, employment, childcare responsibilities, race, gender, age) and insurance coverage.” 

DEA vs. HAROLD EUGENE FLETCHER

The year is 2010, the case docket 09-48, Columbus, Ohio The United States Drug Enforcement Agency vs East Main Street Pharmacy (‘‘Respondent’’), of Columbus, Ohio Harold Eugene Fletcher PharmD an African America Pharmacist, from the record it reads, The Government called Donald Sullivan, R.Ph. and Ph.D., as its expert witness. Dr. Sullivan, who holds active pharmacist licenses in both Ohio and Florida. Sullivan obtained a B.S. in Pharmacy from The Ohio State University, as well as both an M.S. and Ph.D. in Pharmaceutical Administration, also from The Ohio State University. 

Before this Court Professor Dr. Sullivan testified that under both Ohio and Federal law, there ‘‘is corresponding responsibility between the physician and the pharmacist.’’ He further explained that ‘‘a lot of pharmacists think that just because the physician wrote it, I have to fill it.’’ However, Dr. Sullivan stated that there is nothing in Ohio law that says you have to fill any prescription.’’ He then explained that ‘‘one of the first things we try to get the students and pharmacist to understand is that under Ohio law, and federal law 50 percent of the responsibility falls on the pharmacy, the pharmacist, 50 percent falls on the physician. Don’t just fill it because the doctor wrote it.’’ Similarly, in his report, Dr. Sullivan, after discussing the CSA’s prescription requirement (21 CFR 1306.04(a)), explained that: 

“The State of Ohio has similar language in its laws and regulations. Ohio Law states that: The pharmacist who fills any prescription has a corresponding responsibility with the physician to make sure that the prescription has been issued for a Legitimate Medical Purpose. The responsibility to ensure that a prescription is for a legitimate medical purpose in the usual course of a prescriber’s professional practice is equal for both the physician and pharmacist. (Fifty percent of this responsibility is on the pharmacist and 50% is on the physician). The argument that ‘‘Just because a physician wrote the prescription, 

However the DEA Judge wrote in her observations of Dr. Donald Sullivan in 2010:While the Ohio courts may have interpreted State law as described above, as explained below, Dr. Sullivan’s testimony that Federal law allocates fifty percent of the responsibility to the physician and fifty percent to the pharmacist is not a correct statement of the law, which has been amply explained in numerous decisions of the Federal courts and this Agency. To make clear, Federal law does not apportion the responsibility for dispensing unlawful prescriptions between a prescribing practitioner and a pharmacist. Rather, Federal law imposes separate and independent duties on the prescriber and the pharmacist. 

More specifically, the prescriber must act within the usual course of professional practice and have

a legitimate medical purpose to lawfully issue a controlled-substance prescription. 21 CFR 1306.04(a). As the Supreme Court and numerous federal courts have made plain, to lawfully prescribe a controlled substance the physician must act ‘‘in accordance with a standard of medical practice generally recognized and accepted in the United States.’’

The DEA Judge further notes:

” By contrast, a ‘‘pharmacist is not required to practice medicine.’’ United States v. Hayes, 595 F.2d 258, 261 (5th. Cir 1979). ‘‘What is required of [a pharmacist] is the responsibility not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows [or has reason to know] that the issuing practitioner issued it outside the scope of medical practice.’’ 

However, Dr. Sullivan’s statements that: (1) A pharmacist is not required to fill any prescription, and (2) it is not an excuse that because a doctor wrote the prescription, it can be legally filled, are consistent with Federal law. According to Dr. Sullivan, as part of the prospective drug utilization review, a pharmacist is required to check a patient’s profile for the following: ‘‘(a) over-utilization or under- utilization[;] (b) therapeutic duplication[;] (c) drug-disease state contraindications[;] (d) drug-drug interactions[;] (e) incorrect drug dose or duration of treatment[;] (f) drug-allergy interaction[;] (g) abuse/ misuse[;] (h) inappropriate duration of treatment[; and] (i) documented good/nutritional supplements- drug interactions.’’ 

Creating Element of Crimes That Doesn’t Exist

They have based their reasoning of criminal activity on the numerical sale of schedule II medications, and the agency further miscarriage pharmaceutical procedures identify systems legally licensed pharmacy procedures as manufacturing when in actuality the pharmacist is caring out the licensing procedure of compounding.

This agency has morphed into becoming is a principal element of criminal activity by identifying licensed medical facilities as acting in criminal conduct.

The DEA then misuses its authority to seize all classes of scheduled control medications (II, II, IV, V) which are never to be seen again by the pharmacists/physicians now defendants nor the prosecutorial staff. The location of the evidence remains unknown to all both judiciary and defense.

When examining an organization like the DEA we have seen over the years members of the DEA working directly with the drug cartels. This can only be possible with knowledge management and supervision. With the vast amounts of money within the drug world, what part of this organization is not compromised?  

In an article published January 14, 2014, in the American Thinker “DEA working with drug cartel for more than a decade” By Rick Moran

“The Drug Enforcement Agency had a secret arrangement with the notorious Sinaloa cartel “that allowed the organization to smuggle billions of dollars of drugs while Sinaloa provided information on rival cartels.” Sinaloa, led by Joaquin “El Chapo” Guzman, supplies 80% of the drugs entering the Chicago area and has a presence in cities across the U.S. There have long been allegations that Guzman, considered to be “the world’s most powerful drug trafficker,” coordinated with American authorities.”

It can plainly be seen that the DEA is operating as a corporate corrupted organization.  Whenever an organization operates without defined checks and balances, it operates  under the guidance of deception. When the governmental agency develops probable cause based on a on a GOOGLE search, and such contrived rational that a crime or sets of crimes were committed were not challenge by upper management and or the courts, are both unconstitutional and dangerous. Yet, there are no reasonable rational thoughts of criminal justice criminal acts to support the DEA accusations.

BACKGROUND

The Petitioner, Norman Clement pro-se, was born in Detroit is the second son of 6 boys of a mother and father who immigrated from Panama in January 1951, two months prior to his birth in March. All of the Clement Brothers completed College training, the Petitioner’s Brother Walter R. Clement was a Law Enforcement officer with the Detroit Police department for some 33 years has two master’s degrees pertaining to law enforcement. His expertise has been critical in exposing the defects of DEA search warrants and enforcement. 

The Petitioner has been married 48 years have 3 children, of which their two sons attended on football scholarships and graduated Hampton University ( The Real HU) and both worked part-time at Pronto Pharmacy as License Florida Pharmacy-Technicians. Our family is scrappy, unbowed, determined,d and stands up like men and women against these abuses by DEA.

EDUCATION

The Petitioner was the first to finish college in his family both a licensed Pharmacist, Dentist and not a drug street dealer engaged in drug trafficking  The Petitioner, as well as his older brother and his daughter are graduates of Florida A&M University College of Pharmacy and both worked part-time at Pronto Pharmacy LLC. 

THE BLOG AND VIDEOS BARES WITNESS AND ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE

YOUAREWITHINTHENORMS.COM 

Richard James Albert (An African-American) DEA Diversion Investigator was supposed to be the lead man on this project (to hide the race factor) to bring about a criminal indictment of Norman J Clement and his entire family, as drug king-pins, that’s how he came upon the newly created blog, “youarewithinthenorms.com” and presented it as evidence in the Administrative Tribunal proceeding. Mr. Albert’s goal was to institute a case for DEA-DOJ asset forfeiture and criminal indictment.

THE PAINFUL DISCUSSION OF BEING UNDERESTIMATED, UNDERVALUED, AND MARGINALIZED

Let it be clear the poor training and limited comprehension, lack of understanding of pharmaceutical science, pharmacy law, and pharmacy protocols of DI Richard James Albert are deliberate yet essential and purposefully crafted by his handlers to perform his mission an  Albert at their command. (11) 

DI Albert’s handlers know they can prevail with him in spite of their dismissiveness toward medical science and protocols.  DI Albert could never be used successfully against a large Chain Drug Store or a Jewish, or  White-owned pharmacy because the quality of his knowledge and training would quickly be exposed in a legal proceeding. 

REGULATORY RACISM AND PROFILING

However, DI Richard James Albert can prevail against a Black own Pharmacy despite any facts we present or laws because the built-in institution of racial injustice particularly within the Judicial System or in the field of medical science, sports, politics the military,  will default to all knowledgeable, educated Black persons as arrogant and uppity, as we see this in our history particularly in the United States especially when one is right and dares challenges the morae within the system. (12)

Arrogance is rate-limiting as defining all by a preconceived standard of what we are expected to know and further based on a preconceived level of knowledge expectation and skill of what one should have obtained. This is likely an eighth-grade education anything beyond that becomes suspicious, surprise, unearned, and requires further examination of one’s credentials and instead of being well verst, you are detested. 

Arrogance stops one in their tracks to be undervalued, underestimated, and marginalized. This is a reality that all Black professionals face especially those who are licensed in any profession and we only quietly discuss this amongst ourselves. 

YET, THE PEOPLE AREN’T AS STUPID AS THE DEA THINKS WE ARE!

These authors of this article have learned one thing;  in America, you either stand for something or nothing at all. (13) So if standing against DEA’s abuses by redefining medical science procedures, their lies, and deceptions perpetrated by this Federal Institution (DEA), then we are one more set of uppity arrogant  Black N-Word S.O.B’s the DEA, DOJ or anyone else just don’t have to like. (14) We are simply tired and fed-up of being targeted and pushed around because of our success.

Because we stand and rise against to oppose this system of injustice, which treats license pharmacists as a common drug dealer and through Ether through this Court reversal or Congressional Oversight using our wisdom and knowledge  we will put an end to the United States Drug Enforcement as an agency of Government and to the word of defining people of color as Arrogant.    We have learned from our ancestors, “just to to sit still would be a sin:”

 “There is no human activity you can ever perform that will ever lift the shroud of this racial constructs in this system the restraint is the color of your skin” 

_______________________________________________

11.A SUMMARY OF THE TESTIMONY OF RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH

A SUMMARY OF THE TESTIMONY OF RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH

12.OF ROLE MODELS AND INVISIBLE MEN: EXPOSING THE RISE AND MISSION OF THE FILTERED negroe(S)

OF ROLE MODELS AND INVISIBLE MEN: EXPOSING THE RISE AND MISSION OF THE FILTERED negroe(S)

13.THE FORM: RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH

THE FORM: RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH

14. THE FRAUDULENT WORK OF DONALD SULLIVAN PHD, THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY CLINICAL PROFESSOR: “FALSUS IN UNO, FALSUS IN OMNIBUS”

THE FRAUDULENT WORK OF DONALD SULLIVAN PHD, THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY CLINICAL PROFESSOR: “FALSUS IN UNO, FALSUS IN OMNIBUS”

The Petitioner created this blog  youarewithinthenorms.com, which the Respondent’s Counsel introduced as evidence in court and Judge Mark Dowd used as part of his proposed decision. This Blog consisting of 350 articles has served as a National Platform for many health practitioners finding themselves Targets of DOJ-DEA

The DEA has engaged in deceptive enforcement where enforcement can be arbitrary applied to any person without investigation, without law and dangerously without oversight. The Petitioner has exposed these gross patterns of  enforcement in his blog, youarewithinthenorms.com. The Blog and videos bares witness and allows all the system to be held accountable.

CONCLUSION SUMMARY

The Petitioner’s owned Pronto Pharmacy LLC, and was raided May 3, 2012 and  August 29, 2019 by the United States Drug Enforcement Administration (DEA) based on a sign warrant which stated No elements of a crime being committed. All schedule control medications were seized the Petitioner was never charged and equipment and property never returned. 

The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process.  One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a). 

Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States

DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716. 

While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.

DEA’s Pharmacy expert, Don Sullivan, interviewed no physicians/ dentist, no patient receiving prescriptions, nor reviewed any prescriptions of any patients from Pronto PHARMACY. Further DEA, expert Don Sullivan reviewed no radiographs, performed no physical examinations on the patients of Pronto Pharmacy to impeach the primary physician’s initial diagnosis. 

DEA Diversion Investigator Richard James Alpert had no training and stated he did no investigation. 

Notably, DEA’s evidence always realizes upon execration on numbers of “pills” and street language such as “pill mills,” “Holy Grails,” and “Cocktails,” not on medical disease states or clinical conditions. Prosecutors have found these forms of distortion, redefinition of medical procedures effectively sells juries. Further Judges often instruct the juries to ignore any clinical presentation or will not allow such testimony on the record. 

The damage to Healthcare Providers and the chronic pain patient populations is devastating and the DEA never takes into account the clinical needs of the patients. It’s as if they have criminalized pain management without the benefit of clinical knowledge. 

WHEREFORE, WE REQUEST UPON THIS COURT:

1. Grant this motion and reverse these findings and decision of the Administrative Court, return and restore all privileges of  the DEA Control Registration Certificates of Pronto Pharmacy LLC.
2. Further, Dismiss the Decision of the Administrative Judge Mark Dowd in agency case No: 19-42, Federal Registry filed 1927282  on December 20, 2021with extreme prejudice.
3. Return all Files, Equipment, Medication to Pronto Pharmacy Llc and its owner Norman J Clement of Tampa, Florida.
4. Reward damages and penalties of amounts greater than $187 million U.S. dollars, I’ve lost my life savings

RESPECTFULLY SUBMITTED

February 22, 2022

Norman J Clement

Norman J Clement, pro se

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on February 03, 2022 a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:

I, Norman J Clement, hereby certify that I’ve electronically filed and agree to utilize jointly the foregoing Respondent’s Notice of Filing the Certified List of the Record with the Clerk of the Court for the United States Court of Appeals for the District of Columbia Circuit, by using the appellate CM/ECF system, on February 22, 2022. I certify further that Petitioner is pro se, and that service will is accomplished  by electronic mail to

Anita Gay, Esq United States Department of Justice 

Criminal Division/ Narcotic and Dangerous Drugs Section

145 N Street, NE, Room 2E-404 Washington, D.C. 20002 

(202) 353-7629  anita.gay2@usdoj.gov 

Norman J Clement

Norman J Clement pro. se

prontopharmacy@aol.com

Reference:

American Thinker, DEA working with drug cartel for more than a decade. https://www.americanthinker.com/blog/2014/01/dea_working_with_drug_cartel_for_more_than_a_decade.html

THE SYSTEMATIC DESTRUCTION OF BLACKS PRACTICING MEDICINE IN AMERICA (A VIDEO OUTLINE WITH, CARL “CP” POPULUS, 21st CENTURY FOCUS GROUP)

FOR NOW, YOU ARE WITHIN

THE NORMS

APPENDIX

1. 21 U.S.C. 802(21) provides:

Definitions

As used in this subchapter:

(21) The term “practitioner” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dis- pense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled sub- stance in the course of professional practice or research.

2. 21 U.S.C. 821 provides:

Rules and regulations

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees re- lating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

3. 21 U.S.C. 822 provides in pertinent part:

Persons required to register 

(a) Period of registration

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(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the

(1a)

2a

Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.

(b) Authorized activities

Persons registered by the Attorney General under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals are authorized to possess, manufacture, distribute, or dispense such substances or chemicals (including any such activity in the conduct of research) to the extent authorized by their registration and in conformity with the other pro- visions of this subchapter.

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(f ) Inspection

The Attorney General is authorized to inspect the es- tablishment of a registrant or applicant for registration in accordance with the rules and regulations promul- gated by him.

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4. 21 U.S.C. 823(f ) provides:

Registration requirements

(f ) Research by practitioners; pharmacies; research ap- plications; construction of Article 7 of the Conven- tion on Psychotropic Substances

The Attorney General shall register practitioners (in- cluding pharmacies, as distinguished from pharmacists)

3a

to dispense, or conduct research with, controlled sub- stances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices. The Attorney General may deny an application for such reg- istration or such modification of registration if the At- torney General determines that the issuance of such registration or modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

(1) The recommendation of the appropriate State licensing board or professional disciplinary au- thority.

(2) The applicant’s experience in dispensing, or conducting research with respect to controlled sub- stances.

(3) The applicant’s conviction record under Fed- eral or State laws relating to the manufacture, distri- bution, or dispensing of controlled substances.

(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

(5) Such other conduct which may threaten the public health and safety.

Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be re-

4a

quired. Registration applications by practitioners wish- ing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the mer- its of the research protocol. The Secretary, in deter- mining the merits of each research protocol, shall con- sult with the Attorney General as to effective proce- dures to adequately safeguard against diversion of such controlled substances from legitimate medical or scien- tific use. Registration for the purpose of bona fide re- search with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground speci- fied in section 824(a) of this title. Article 7 of the Con- vention on Psychotropic Substances shall not be con- strued to prohibit, or impose additional restrictions upon, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter.

5. 21 U.S.C. 829 provides in pertinent part:

Prescriptions

(a) Schedule II substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no con- trolled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner, except

5a

that in emergency situations, as prescribed by the Sec- retary by regulation after consultation with the Attor- ney General, such drug may be dispensed upon oral pre- scription in accordance with section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled.

(b) Schedule III and IV substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no con- trolled substance in schedule III or IV, which is a pre- scription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without a written or oral prescription in con- formity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be re- filled more than five times after the date of the prescrip- tion unless renewed by the practitioner.

*****

(e) Controlled substances dispensed by means of the Internet

(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet with- out a valid prescription.

(2) As used in this subsection:

6a

(A) The term “valid prescription” means a pre- scription that is issued for a legitimate medical pur- pose in the usual course of professional practice by—

(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or

(ii) a covering practitioner.

(B)(i) The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demon- strates that a prescription has been issued for a legit- imate medical purpose within the usual course of pro- fessional practice.

(C) The term “covering practitioner” means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—

(3)

(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(ii) is temporarily unavailable to conduct the evaluation of the patient.

Nothing in this subsection shall apply to—

(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or

7a

(B) the dispensing or selling of a controlled sub- stance pursuant to practices as determined by the At- torney General by regulation, which shall be con- sistent with effective controls against diversion.

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6. 21 U.S.C. 841(a) provides:

Prohibited acts A 

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally—

(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dis- pense, a controlled substance; or

(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

7. 21 U.S.C. 885 provides in pertinent part:

Burden of proof; liabilities

(a) Exemptions and exceptions; the presumption in simple possession offenses

(1) It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceed- ing under this subchapter and the burden of going for-

8a

ward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.

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(b) Registration and order forms

In the absence of proof that a person is the duly authorized holder of an appropriate registration or order form issued under this subchapter, he shall be presumed not to be the holder of such registration or form, and the burden of going forward with the evidence with respect to such registration or form shall be upon him.

*****

8. 21 C.F.R. 1306.04 provides:

Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical pur- pose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of profes- sional treatment or in legitimate and authorized re- search is not a prescription within the meaning and in- tent of section 309 of the Act (21 U.S.C. 829) and the per- son knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the pen- alties provided for violations of the provisions of law re- lating to controlled substances.

9a

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for “detoxifica- tion treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifi- cally for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in § 1301.28 of this chapter.

(d) A prescription may be issued by a qualifying practitioner, as defined in section 303(g)(2)(G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii), in accordance with § 1306.05 for a Schedule III, IV, or V controlled sub-stance for the purpose of maintenance or detoxification treatment for the purposes of administration in accordance with section 309A of the Act (21 U.S.C. 829a) and § 1306.07(f ). Such prescription issued by a qualifying practitioner shall not be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients.

9. 36 Fed. Reg. 7799 (Apr. 24, 1971) provides in pertinent part:

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306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility

10a

for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law re- relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs, in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.

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