PRONTO PHARMACY LLC., FILES 1st ADDENDUM TO MOTION TO VACATE DEA ADMINISTER’S ORDER AND TO RESTORE CONTROL REGISTRATION

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

Pursuant to the Court’s Order of  January 09, 2022, and D.C. Circuit Rule 28(a)(1), Petitioner’s Norman Clement pro se, in Case No. 21-1262 submits this addendum, to his Dispositive Motion and hereby further states,

AT ISSUE

The Petitioner Norman J Clement, is a licensed Pharmacist, Dentist not a drug street dealer engaged in drug trafficking, as such has been and has been for more than 45 years. I file this petition because the DEA has engaged in deceptive enforcement where enforcement can be arbitrarily applied to any person without investigation, without law, and dangerously without oversight and and Pronto Pharmacy Llc has been unjustly treated.

The DEA’s actions have promoted regulatory racism, unconditionally violated every aspect of our Constitution, and has orchestrated a plan of the injustice of robbing another generation of medically educated Black business persons of their dignity and wealth.  Wherefore we command upon this Court for equal protection and Justice.

The issue in the case is whether the record as a whole establishes by a preponderance of the evidence that Pronto Pharmacy’s DEA Certificate of Registration Number FP2302076 should be revoked and whether any pending applications for renewal or modification of such registration and applications for any other pending DEA registrations should be denied pursuant to 21 U.S.C. 824(a) (4) and 21 U.S.C. 823(f).

ARGUMENT

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. 

Administrative Law Judge: Mark M. Dowd

U.S. Tax Court

Timberlake Federal Annex

501 East Polk Street

Courtroom 1201

Tampa Florida, 33602

DEA Chief Counsel: John E. Beerbower, Esq

Drug Enforcement Administration

Division and Regulatory Litigation Section

Office of Chief Counsel

8701 Morrisette Drive

Springfield, VA 22152

202-307-4736

john.e.beerbower@usdoj.gov 

Court Reporter: Neal R. Gross

Court Reporters and Transcribers

1323 Rhode Island Ave. N.W.

Washington, DC 20005-3701

Diversion Investigator: Richard Alpert (Expert Witness)

Private Investigator: Jeffrey Shearer – starting on page 181 of transcript (

PETITIONER: Norman Clement

FAILURE TO TRAIN AND INVESTIGATE  IN THE UNDERSTANDING OF PATHOPHYSIOLOGY OF PAIN DEA TARGETING OF PETITIONERS PHARMACY IS BASED ON NUMBER COUNTS OF “PILLS” NOT DISEASE STATE OF PATIENTS

Red Flags – Cocktails, Pattern Prescribing

Pain is a complex and subjective experience initiated by an unpleasant (or noxious) stimulus associated with actual or potential tissue damage. 

Pain Management is a very complex issue.  More often than not in chronic (non-acute) pain, comorbidities need to be addressed.  Therefore, when a practitioner finds a combination of medications that successfully treat chronic pain they are reluctant to stray from that protocol.  It’s akin to other protocols that are used in medicine that address chronic conditions such as cancer protocols, ALS protocols, hypertension step-care therapy, anti-coagulation protocols, and others.  

Typically, there is inflammation and therefore non-steroidal anti-inflammatories are used.  Patients often experience anxiety so anti-anxiety agents such as benzodiazepines or tricyclics are used.  In nociceptive pain, Gabapentin is often the first drug of choice.  In lower back pain, whose underlying causes can be quite different from each other the presentation of muscle spasm or hypersensitivity, muscle relaxers such as cyclobenzaprine, metaxalone, baclofen, carisoprodol, or others represent standard therapy.

It is unreasonable to expect a Diversion Investigator to have a complete understanding of these complex issues with their 12-week course when Physicians and Pharmacists require years of training to make adequate choices in this arena.  

At Issue

However, the DEA states it  “..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..” 

Page 24, 25 (Training of Diversion Investigator)

Testimony of Diversion Investigator Alpert: 

Q Where were you stationed before that?

A Nashville, Tennessee.

Q And what training did you undergo to become a diversion investigator?

A Basic Diversion School.  It’s about a 12-week course held in Quantico, Virginia

THE ISSUE HERE :

1. A.The issue here is the length of training.  Medical professionals take years to train in the art of medicine or pharmacy or dentistry or nursing.  Pain management is a very complicated subject and someone training in such little time will miss the vast amount of the education that is needed to form an opinion that is based upon the needs of the patient and the morbidities and comorbidities involved in pain management. 
2. B. 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. 
3. C.Therefore, anything that he says has to be suspect and lacks the fundamental basics to make a true assessment of the validity of the patient prescriber relationship or even the validity of a prescription at all.

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Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://nationalaffairs.com/publications/detail/the-truth-about-painkillers

DEA’s RAID ON PRONTO PHARMACY 

More importantly, nothing within the actions of the DEA was created by statutory rulings. Nothing,  the assertions made by the government agents you will see that this agency created and designed a plan to attack our society. The intent of this law implies that it shall be unlawful for any person knowingly or intentionally— to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance. Pronto Pharmacy is a licensed Community Pharmacy. 

In their search warrant, the government agents wrote, Pronto Pharmacy engaged in manufacturing-controlled substances. This erroneous assertion is far from true in that the Government agents crafted a law to achieve their objectives. Wherefore, in fact, the Government agents said that Pronto Pharmacy was compounding medications. This act within Pronto Pharmacy is perfectly legal and supported by laws created by the legislative processes. 

REFLECTING THE DISTINCT ROLES OF PRESCRIBERS AND PHARMACIST, § 1306.04 IMPOSES LIABILITY ONLY ON PHARMACIST WHO “knowingly” fill an illegitimate prescription.

Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care. (See Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. the United States of America)

Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs. The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.

The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a) and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842. 

The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). 

The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.

Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:

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 professional treatment or 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 relating to controlled substances.

21 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.” 

These critical limitations on a pharmacist’s possible liability under § 1306.04 are no accident. They were added to the regulation intentionally to avoid the un- warranted and counterproductive imposition of liability. 

When first proposed in 1971, the regulation lacked the word “knowingly,” which would have allowed penalties for any “person filling [an illegitimate] prescription.” Purpose of Issue of Prescription, 36 Fed. Reg. 4847, 4948 (Mar. 13, 1971). 

Pharmacists protested such an expansive rule, however, and during the comment period specifically “objected to the responsibility placed upon a pharmacist under § [1306.04] to determine the legitimacy of a prescription.” 

Comments and Objections to Part 306, 36 Fed. Reg. 7776, 7777 (Apr. 24, 1971). 

The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require knowledge.”

Therefore, how then can a government agency act in this manner and secure a warrant based on false pretenses and carry out their acts through the courts’ systems. Why? Because we as American people have an inherited trust of the DEA. 

Whenever has one heard the DEA acted improperly… likely sure never. This is to be a trusted agency yet they have violated our trust. 

1. They said and determined that Pronto Pharmacy engaged in manufacturing and compounding- controlled substances.
   
2. Individual patient drove many miles to fill prescription outside the standard of care in Florida. There is absolutely NO laws that supports the DEA’s assertions.
   

THE WHITE HORSE THEORY

In this case, the DEA image is to ride the White Horse pretending to be the do-good agency, however, they jump off the White Horse committing their misdeeds of constitutional violations, redefining medical/pharmaceutical procedures, profiling of healthcare practitioners, illegal seizing of property and equipment then return to the White Horse to jump back on.

THE LAWHERN LETTER

However, quite to the contrary we clearly demonstrate this flip flop on how the DEA reports it supposedly doesn’t enforce laws when DEA Deputy Assistant Administrator Diversion Control Division states in a letter to Richard A. Lawhern Ph.D., digitally signed 02/12/2021. (see exhibit Letter attached)

Richard A. Lawhern, Ph.D. 3691 Nestling Lane
Fort Mill, South Carolina 29708 lawhern@hotmail.com 

Dear Dr. Richard Lawhern:“ This letter is in response to your email dated July 15, 2019, to the Drug Enforcement Administration (DEA). In your correspondence, you raised concerns regarding chronic pain management, closure of pain treatment centers, and the “exodus of providers out of the pain management practice.” DEA appreciates the opportunity to address your concerns, and clarify information regarding this matter. 

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. Therefore, it is important for you to check with your state medical board, as the issues that you have raised, maybe the result of new laws or regulations enacted by your state. Where state law or regulations impose requirements beyond those in federal law and regulations, practitioners must 

Richard A. Lawhern, Ph.D. Page 2 

comply with the additional state requirements, provided such state requirements do not conflict with the Federal requirements. 

I trust this letter adequately addresses your inquiry. For additional information regarding the DEA Diversion Control Division, please visit http://www.DEAdiversion.usdoj.gov. If you have additional questions regarding this issue, please contact the Diversion Control Division at (571)-362-3260. “

Sincerely, 

Thomas W. Prevoznik
Deputy Assistant Administrator Diversion Control Division 

Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legitimate medical purpose

The Supreme Court has long recognized that the state’s protection of “the health of its citizens . . . is at the core of its police power,” Sporhase v. Neb. ex rel. Douglas, 458 U.S. 941, 956 (1982), and has expressly rejected the notion that the CSA grants either DOJ or DEA the broad authority to regulate the practice of medicine: 

[t]he [CSA] and our case law amply support the conclusion that Congress regulates medi- cal practice insofar as it bars doctors from us- ing their prescription-writing powers as a means to engage in illicit drug dealing and  trafficking as conventionally understood. Beyond this, however, the statute manifests no intent to regulate the practice of medicine generally. The silence is understandable given the structure and limitations of federalism, which allow the [s]tates “[ ]great latitude un- der their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.[ ]” 

Gonzales, 546 U.S. at 269-70 (emphases added). 

Not only does Congress know how to explicitly delegate the authority to regulate controlled substance prescribing to a federal agency, it has done so in one— and only one—narrow category: opioid use disorder (OUD) treatment. Id. at 271 (holding that 42 U.S.C. § 290bb-2a is the only arena in which Congress has set federal medical standards and “indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute”); see also Anderson et al. at 98 (“Despite the longstanding norm of federal noninterference in medicine, . . . the federal government can regulate medical practice if it makes its intention to do so clear and un- ambiguous.”). 

And even then, Congress expressly delegated the authority to set federal medical standards regarding OUD treatment to the Department of Health and Human Services (HHS) and not a federal law enforcement agency. 42 U.S.C. § 290bb-2a (“The Secretary of Health and Human Services, after consultation with the Attorney General . . . shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction. . . .”). 

Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legiti- mate medical purpose and are necessary to maintain the health and general welfare of the American people.” 

21 U.S.C. § 801(1). Congress, therefore, did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before in- initiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”). 

Furthermore, this Court has expressly held that DOJ cannot criminally prosecute OUD prescribers under CSA Section 841(a)(1) unless they sell “drugs, not for legitimate purposes but ‘primarily for the profits to be derived therefrom’ ” and are acting outside the usual course of professional practice such that their behavior is akin to that of a “large-scale [drug] pusher, not as a physician.” Moore at 345. 

Congress’s refusal to permit a federal agency to regulate the practice of medicine beyond illegal trafficking is further evidenced by the Narcotic Addict Treatment Act (1974) (NATA), which amended the CSA to permit HHS to regulate OUD treatment. NATA’s legislative history demonstrates that the Senate Judiciary Committee carefully weighed the states’ long-standing authority to regulate “the general practice of medicine” against “the specialized circumstances within the purview of the bill [e.g., OUD treatment], which entail inordinate risks of diversion and unethical profiteering.” S. Rep. No. 93-192, at 13 (1973). 

The Committee report further explains that the purpose of the NATA amendments was to “re- affirm the commitment Congress made to the nation when it passed the [CSA] by . . . facilitating the pros- ecution of those who engage in the criminal distribution of legitimate narcotic drugs for profit.” Id. at 15. 

In sum, the CSA permits the federal prosecution of prescribers who operate as drug traffickers as tradi- tionally understood and, thereby, knowingly or intentionally engage in prescribing conduct that exceeds the bounds of professional practice. Congress never intended to delegate to law enforcement the authority to regulate the practice of medicine by criminalizing good faith medical mistakes. See 21 U.S.C. § 903. 

The CSA also depends on state law to determine which medical professionals constitute “practitioners” acting “in the course of professional practice” and are, therefore, presumptively eligible for federal controlled substance registration. 21 U.S.C. § 823(f ) provides that “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled sub- stances under the laws of the State in which he practices”) (emphasis added); id. § 802(21) (defining “practitioner” to include “a physician . . . licensed by the United States or the jurisdiction in which he practices . . . to . . . dispense . . . a controlled substance in the course of professional practice”) (emphasis added). 

The CSA further mandates that DOJ defer stating medical licensing authorities before denying, suspending, or revoking a state-licensed prescriber’s registration. Id. § 823(f )(1) (explaining that the Attorney General may deny, suspend, or revoke a state-licensed prescriber’s registration if doing so is in “the public interest” and that the first of the five factors that the Attorney General must consider in making such a de- termination is “[t]he recommendation of the appropriate State licensing board or professional disciplinary authority”). 

A rising tide lifts all boats

The DEA and the drug war system in America have developed into rogue agencies that must be disbanded. These agencies have failed to recognize a people’s chronic disease conditions of intractable pain, while further failing to understand or comprehend human suffering, the science of clinical treatment, and the value of human life.  While the comparison may seem silly, in today’s anti-opioid climate a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s very bad medicine. The deeply flawed policies that are being enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication than is permitted per patient per day. 

While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons.   

The CDC MME chart, in fact, the entire concept of morphine milligram equivalents may be convenient for bureaucrats but because of differences in the absorption of different drugs into the bloodstream, half-life of different drugs, the impact of one or more other drugs on opioid levels, and large differences of the rate of metabolism caused by genetic factors, is not only devoid of scientific utility, but actually causes far more harm than help by creating “guidelines” that are based upon a false premise. When a policy is based on deeply flawed science, the policy itself will automatically be fatally flawed. It cannot be any other way. 

In today’s anti-opioid climate a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s very bad medicine. The deeply flawed policies that are being enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication than is permitted per patient per day. 

While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons. 

Flawed science yields meaningless results

Below is a chart published by the CDC, a “guide” (2) for physicians who prescribe pain drugs. Morphine is normalized to 1.0 and the conversion factor reflects the relative potency of other opioid drugs. So, if the daily MME – the maximum dose of drug allowed – is 90 mg (3) then a patient may receive no more than 90 mg of morphine, 90 mg of hydrocodone, 60 mg of oxycodone, or 30 mg of oxymorphone per day. 

Although the conversion table seems to be straightforward enough, it is based on an assumption that all opioids behave similarly in the body. But this assumption could not be less accurate. Once we see the profound differences in the properties of the drugs and the difference between individuals who take them it becomes clear that not only is the CDC chart flawed, but the MME is little more than a random number. 

Table 1. MME equivalents. Source: CDC

Not all opioids are created equal, especially in the body

Anyone with even a passing knowledge of pharmacology would immediately be skeptical of data in the chart. Let’s take, for example, the two drugs at the bottom. 

Although Table 1 tells us that Oxymorphone is twice as “strong” as oxycodone it does not take into account a number of critical properties that paint a more complete picture of the fate of the drug once swallowed. In other words, there is no information about pharmacokinetics –  the effect of the body on the drug. 

The overall opioid prescribing rate in the United States peaked and leveled off from 2010-2012 and has been declining since 2012, but the amount of opioids in morphine milligram equivalents (MME) prescribed per person is still around three times higher than it was in 1999.1 MME is a way to calculate the total amount of opioids, accounting for differences in opioid drug type and strength.

There was a more than 19% reduction in annual prescribing rate from 2006 to 2017. The declines in opioid prescribing rates since 2012 and high-dose prescribing rates (≥90 MME) since 2008 suggest that healthcare providers have become more cautious in their opioid prescribing practices.

Problems and more problems:

Some opioid drugs will be absorbed and pass to the bloodstream very well and some will do so very poorly.

• Even opioids that appear to be structurally and functionally similar will be metabolized at very different rates.
• Other drugs can drastically alter the physiological response of a pain patient to a given opioid; the second drug may increase a person’s response to the opioid or it may decrease it.
• Even under ideal conditions – two people taking the same opioid drug at the same dose, at the same interval, and taking no other drug – huge variations of innate metabolism from one individual to another will necessarily result in a wide range in clinical response to that drug.

It is the single most heinous governmental agency whose tactics have led to the increased cost of medications and healthcare across America,  by misinterpreting the purpose and roles of medications needed to treat acute, chronic, neuropathic, and psychological pain.  

They have waged a campaign of misinformation to persuade the public that these medications are dangerous drugs whose dosages are “RED FLAGS”  indicating abuse and trafficking, which contributes to the so-called Opioid crisis in America.

The DEA has  become a rogue agency  that has lost its mission, using threats and intimidation such as; 

1. Tactics of no-knock raids and  arrest,

2. Forfeiture,

3. Threat of prison time 

These agents lacking in both knowledge and understanding  of Opioid Pain receptors, come  armed with  “BADGES, GUNS AND PROFOUND STUPIDITY.” They impose their will onto the medical profession (nurses, pharmacists, physicians, dentists, and especially drug wholesalers) and their patients. 

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 Josh Bloom, Ph.D., “Comments to the FDA – Opioid Dosing Based on Milligram Morphine Equivalents is Unscientific”,  American Council on Science and Health, May 24, 2021, https://www.acsh.org/news/2021/05/24/comments-fda-opioid-dosing-based-milligram-morphine-equivalents-unscientific-15561

https://www.acsh.org/profile/josh-bloom

Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://nationalaffairs.com/publications/detail/the-truth-about-painkillers

Red Flags – Rotational Therapy (using 2 different short-acting opioids in the same patient)

The state of the art of pain management is constantly being studied and advances in therapies do occur.  It has been found that rotational therapy is highly effective in chronic pain therapy and often leads to the need of lower doses over time.  There are 4 different metabolism rates that are genetically determined and since it is rare to do expensive genetic testing the titration of opiate therapy can be quite challenging but empirical therapy is evolving to include rotational therapy on an ever increasing rate due to its efficacy and safety.  

3. Pain is a primitive response that motivates us to withdraw from the source that is causing the pain and protect the body from further damage.  The unpleasant feeling associated with pain is also stored in our memory so that we can avoid similar situations in the future. While the pain complex may seemingly be intimidating, its basic understanding is not all that difficult. 

4. “The nervous system is divided into two main parts: the Central Nervous System (CNS) and the Peripheral Nervous System (PNS). The CNS consists of the brain and spinal cord, while the PNS consists of all the nerves that branch out of the spinal cord into the body.” 

5. “The PNS is divided into the somatic, autonomic, and enteric nervous system. The somatic nervous system is responsible for transmitting information from the motor and sensory neurons to the CNS. 

6. “The autonomic nervous system is largely responsible for regulating autonomic functions, such as digestion, respiratory and heart rate, pupillary response, and certain reflexes (e.g., coughing, sneezing, swallowing, and vomiting)  activities that occur in response to a perceived harmful event, attack, or threat to survival i.e. fight-or-flight response.

7. Therefore, It is unreasonable to expect a Diversion Investigator to have a complete understanding of these complex issues. Notwithstanding the basic foundation of pathophysiology is not in their 12-week course as compared to Physicians and Pharmacists requiring years of training to make adequate choices in this arena. 

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 OF ROLE MODELS AND INVISIBLE MEN: EXPOSING THE RISE AND MISSION OF THE FILTERED negroe(S) https://youarewithinthenorms.com/2020/06/18/of-role-models-and-invisible-men-exposing-the-rise-and-mission-of-the-filtered-negroes/)

RED FLAGS COMPOUNDING/MANUFACTURING; THE TESTIMONY OF DEA DIVERSION INVESTIGATOR, RICHARD JAMES ALPERT

DEA Diversion Investigator, Richard Albert prepared a warrant based on red flags that Pronto Pharmacy engaged in manufacturing-controlled substances. This was an assumption that a crime was committed within the Pronto Pharmacy.  Pronto Pharmacy is a licensed pharmaceutical company by law that can compound medications. 

Yet, through the process of creative deceptive prosecutions, the United States Department of Justice (DOJ) has sidestepped Constitutional issues based on a lack of legal standing.

As further written December 29, 2020, the Wall Street Journal Editorial Board in a stark rebuke of the United States Department of Justice (DOJ) lawsuit filed in federal court in Delaware claims that: The Walmart DOJ complaint also includes:

” more than 190 mentions of “red flags” about suspicious opioid prescriptions. It claims Walmart often didn’t adequately resolve them and sometimes knowingly filled illegitimate prescriptions despite the warnings. 

But Walmart notes in its lawsuit that the Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”

“The feds try to side-step this problem by claiming that, under the Controlled Substances Act and regulations, “the pharmacist’s conduct must adhere to the usual course of his or her professional practice as a pharmacist.” The complaint argues that catching and resolving “red flags” for opioid prescriptions is “a well-recognized responsibility of a pharmacist in the professional practice of pharmacy,” so “failing to fulfill this responsibility” is a violation of the federal law.” 

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see THE DEPARTMENT OF INJUSTICE UNDERMINES YOUR HEALTHCARE:” A Case Against Walmart Mocks Justice – WSJ” https://youarewithinthenorms.com/2020/12/29/a-case-against-walmart-mocks-justice-wsj/)

However, the Wall Street Journal Editorial Board further points out:

” All of this raises constitutional issues based on a lack of legal standing. A negligence claim like the one alleged here is supposed to have a specific party claiming a specific injury caused by someone specific. Those are typically claims by one private party against another. The government can sue for violations of law, not because someone was negligent. The government’s claims of Controlled Substances Act violations are so general that they seem contrived to add some violation of the law.(1)

COMPOUNDING VS. MANUFACTURING

Pharmaceutical Compounding licensed by the State of Florida 

64B16-27.700 Definition of Compounding

“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. 

The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.

(1) Compounding includes:

(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.

(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.

(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis, and the patient has been made aware that the compounded product will be prepared by the pharmacist. 

The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible without notice to the practitioner.

2) The preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or entities for purposes of dispensing or distribution is not compounding and is not within the practice of the profession of pharmacy, except that the supply of patient specific compounded prescriptions to another pharmacy under the provisions of Section 465.0265, F.S., and Rule 64B16-28.450, F.A.C., is authorized.

(3) Office use compounding, “Office use” means the provision and administration of a compounded drug to a patient by a practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner for office use by the practitioner in accordance with this section provided:

(a) The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner’s office before the expiration date of the drug;

(b) The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the practitioner’s practice;

(c) The quantity of compounded drug for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.

(d) The pharmacy and the practitioner enter into a written agreement. The agreement shall specifically provide:

1. That the compounded drug may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity,

2. That the practitioner shall include on the patient’s chart, medication order, or medication administration record the lot number and the beyond-use-date of any compounded drug administered to the patient that was provided by the pharmacy,

3. That the practitioner will provide notification to the patient for the reporting of any adverse reaction or complaint in order to facilitate any recall of batches of compounded drugs.

(e) The pharmacy shall maintain readily retrievable records of all compounded drugs ordered by practitioners for office use. The records must be maintained for a minimum of four (4) years and shall include:

1. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order,

2. The name, strength, and quantity of the compounded drug provided, including the number of containers and quantity in each,

3. The date the drug was compounded,

4. The date the compounded drug was provided to the practitioner,

5. The lot number and beyond use date.

(f) The pharmacy shall affix a label to any compounded drug that is provided for office use. The label shall include:

1. The name, address, and phone number of the compounding pharmacy,

2. The name and strength of the preparation of a list of active ingredients and strengths,

3. The pharmacy’s lot number and beyond-use-date,

4. The quantity or amount in the container,

5. The appropriate ancillary instructions such as storage instructions, cautionary statements, or hazardous drug warning labels were appropriate; and,

6. The statement “For Institutional or Office Use Only – Not for Resale,” or if the drug is provided to a veterinarian the statement “Compounded Drug.”

(g) In the case of compounded sterile products intended for human use, the pharmacy must be in full compliance with 21 U.S.C. §353b, including being registered as an Outsourcing Facility. 21 U.S.C. §353b (eff. Nov. 27, 2013) is hereby adopted and incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-04180.

Rulemaking Authority 465.005 FS. Law Implemented 465.003, 465.0155, 465.0265 F

If the officers were asked the difference between compounding and manufacturing, they must know what they are being asked. A reasonable officer could not support or testify to the facts of any item or file that was within the seized computer or secondary storage systems.  In the warrant, the DEA deliberately misinterpreted compounding as manufacturing control substance.

PHARMACEUTICAL COMPOUNDING IS DEFINED BY FDA

The FDA has designated 503A compounding as those that compound according to prescriptions specific to particular patients and are required by state boards of pharmacy to comply with USP and other guidelines.

These facilities are limited to dispensing only for home use and are not allowed to compound large batches, an ability that can lead to the lower product cost. Must comply with USP <795> and <797> along with state board of pharmacy regulations. Environmental Monitoring must be performed every six months. Beyond Use Dating (BUD) may be assigned based on internal or external scientific literature showing stability. Pronto pharmacy was designated as a 503A.

The DEA investigation was an act of brazen misconduct against a licensed retail pharmacy that is licensed by law to compound medications. 

These cases are not only about bad science but bad law and poor training. Diversion Investigator Richard Albert prepared a warrant that was “opinion based on a red flag,” that Pronto Pharmacy engaged in manufacturing-controlled substances. 

_________________________________________________

(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)

This is an assumption that a crime was committed within the Pronto Pharmacy, wherein a licensed pharmaceutical company by law, that can compound medication. Diversion Investigator wrote,

ILLEGAL MANUFACTURING?? 

Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA,  without a separate DEA registration authorizing it to manufacture controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28. 

“In addition, the Government previewed that its evidence will show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer’s registration.”

To support this allegation, the Government intended to show that in May 2012 the Respondent’s owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors. 

THE MANUFACTURING OF OXYCODONE

Pronto Pharmacy does not manufacture Oxycodone or Hydromorphone, which is a far more complex process. Pronto would have to:

1. Acquire large tons of harvested opium paste from Tasmania, India, or Afghanistan, transporting these volumes to Tampa, Fl., for processing.
2. Process the opium paste, large volumes of agents, reagents, equipment, and space would be needed, notwithstanding the fact that to bring the product Oxycodone and Hydromorphone to a pharmaceutical-grade that meets FDA purity standards.
3. The water bill and electrical bill at Pronto Pharmacy would be enormous.

The manufacturing of Oxycodone into a bulk product is an extremely complex procedure and would involve: (see google scholar manufacture Oxycodone footnote 4)

https://patents.google.com/patent/US6864370B1/en

Oxycodone is manufactured in high yields and with high purity using codeine or salt of codeine as the starting material. The manufacturing process involves the following steps:

• (a) codeine or a codeine salt (e.g., codeine phosphate) is converted into the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine,
• (b) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine resulting from step (a) is oxidized to yield the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone;
• (c) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone resulting from step (b) is enolized with a base and the resultant enolate is thereafter methylated to yield the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine;
• (d) the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine resulting from step (c) is reduce to yield thebaine;
• (e) the thebaine resulting from step (d) is oxidized to yield the intermediate 14-hydroxycodeinone; and
• (f) the intermediate 14-hydroxycodeinone resulting from step (e) is hydrogenated to yield oxycodone.

THERE WAS NOT ONE SINGLE CAPSULE EVER MANUFACTURED AT PRONTO PHARMACY

1. There is not one piece of equipment that the DEA seized from Pronto that was used in manufacturing. All equipment taken was for compounding.

2. All medications compounded was purchased from two wholesalers (Fagron and B&B)

3. There is not a single controlled substance compounded for encapsulation at Pronto Pharmacy which was manufactured at the pharmacy or by a Pronto pharmacist and/or their technicians.

4. The containers of powders were obtained from B&B Pharmaceutical and were recorded into the CSOS system which reported back to the DEA and wholesalers. Therefore, Richard James Albert should have known this but chose to falsify his warrant to put Pronto out of business and its owners in prison.  

DEA MOVING THE GOAL POST BACKWARD AND FORWARD AND SETTING QUOTAS

We see this early in the case of Pronto Pharmacy when Diversion Investigator Richard James Albert (DI Albert) came upon compounding, and when he could not repeatedly find anything wrong with the pharmacy’s records His Supervisors Amy Hickerson and Susan Langston instructed him to redefine this long-standing pharmaceutical methodology as manufacturing.

It is more than clear from his testimony that the DEA Diversion Investigators were operating in absent the law based on mis-facts, lies, distortions. DEA has learned well. When there is no evidence of wrongdoing, DI Richard James Albert’s supervisors cleverly instructed him to redefine the meaning of pharmaceutical procedures to accomplish their goals. The Diversion Investigator’s charges and findings were easily scientifically debunked.

It became clear from his court testimony he did not understand compounding or its procedures. But likely learned from his handlers like Amy Hickerson, who was guiding him on how to divert both meanings to convince a Federal Administrative Judge to secure a warrant to shut Pronto Pharmacy LLC down. 

Additionally, he testified that he did not “know or understand the law(s) or how any law applies to the practice of Pharmacy.  Florida Statue 499.1.2 states the wholesaler must assess the purchases of control medication by an individual pharmacy

Testimony of Diversion Investigator Alpert

Page 26 (compounding vs manufacturing)

Q And how did you become involved?

A We got a call from Department of Health about a pharmacy was compounding hydromorphone and oxycodone. And myself and my supervisor at the time, met the Department of Health Investigator out at Pronto Pharmacy.

Q And so you went to Pronto Pharmacy?

A Yes, sir.

THE ISSUES HERE

1. A.The issue here is that in the initiation phase the Diversion Investigator testified that the pharmacy was compounding and not manufacturing according to the Department of Health Investigator.  
2. B.Therefore, an investigator with superior knowledge of the law in this matter has informed the Diversion Investigator of the fact of compounding and somewhere along the line the DEA erroneously conflates manufacturing with compounding contrary to the actual legal definitions of both terms.
3. C. 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. 

1. 1.Norman Clement was acting in the capacity of a license’s pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drug.  
2. 2.This definition and is a statue within the Florida Administrative Code & Florida Administrative Register.  The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) possession with the intent to distribute and distribution of oxycodone and hydromorphone. 

Testimony of Diversion Investigator Alpert

Page 26 (29-31)

Q If you could go to Government’s Exhibit Number Do you recognize this document?

A Yes, I do.

Q What is this?

A It’s receivable records from B&B Pharmaceuticals to Pronto Pharmacy.

Q And can you tell, receiving records for what, exactly?

A It’s hydromorphone, which is a Schedule II controlled substance. 

THE ISSUE HERE:

1. The issue here is the possession of the schedule II, controlled substances and is therefore a non-issue by virtue of the DEA license possessed by the Petitioner.

1. Norman Clement was acting in the capacity of a license’s pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drug.  This definition and is a statue within the Florida Administrative Code & Florida Administrative Register.  

2. The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. 

Testimony of Diversion Investigator Alpert

Page 26 (35 – 36)

Q And if you look in the middle of the page there’s a column, manufactured by?

A Yes.

Q What are those initials?

A Those will be the actual — looks like they would be the distributor

1. The issue here is the lack of understanding of basic Pharmacy practice.  Often times there are forms generated or copied from other sources and can contain erroneous headings but in practice are used and not adherence to any particular law but just for convenience of the user.  
2. In this case even though the form indicates manufacture it is a generic form in that the legal definition of manufacturing does not apply due to the nature of manufacturing and the nature of the practice. It is no more valid than a typographical error.
3. 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. 

Pages (152 – 154)

Testimony of Diversion Investigator Alpert: 

Q Are you familiar with the FDA guidelines with regard to compounding?

A No, sir.

Q As part of your training, the 12 weeks diversion investigator training, did you receive training with regard to the compounding of medication and the laws that apply to it?

A Not compounding, manufacturing.

Q Okay. But not compounding?

A Not specifically compounding.

Q All right. And one of the things that you’re trained on in that 12-week course is the law; right?

A Yes.

Q And Federal law, I presume?

A Yes.

Q And have you educated yourself on Florida law that applies to pharmacy operations?

A My answer will be no on that.

Q So in your analysis of this case, you looked solely to federal law?

A Correct.

Q Even though, for instance, your subpoena references specific Florida Administrative Code provisions?

A Correct.

Q You drafted the subpoena, didn’t you?

A Yes.

Q Okay. So when you put those code provisions in there, they had some significance to you; didn’t they?

A Yes.

Q Okay. What was the significance that they had?

A I don’t know, sir.

Q Okay. So you don’t know what — you put them in there but you don’t know what they mean?

A They’re already in there, actually.

Q Oh. So it’s just a template?

A Part of it, yes, sir.

Q Okay. So you just plug it in. But you really don’t know what it means?

A No, sir,

THE ISSUE HERE:

1. The issues here are several.  The Diversion Investigator has testified in open court that he has no understanding between the difference between compounding and manufacturing.  However, in light of this discrepancy he continued with the warrant without educating himself about what he was doing.  
2. Furthermore, there is no indication that anyone on his team took the time to educate him on this crucial factor.  This is somewhat problematic in that how can you prove by the preponderance of evidence that this Pharmacy is non-compliant in the law without the investigator knowing what is in the law?
3. Since this investigator drafted the subpoena, he needed to have probable cause to present to an administrative law judge to sign.  Without adequate probable cause there is no warrant.  
4. Without a warrant there is no case due to violation of the constitutional protection of illegal search and seizure. Without the subpoena there is no case.  

E. 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. 

F. Therefore, this fails by the virtue of the “fruit of the poisonous tree doctrine.”

________________________________________________

see A SUMMARY OF THE TESTIMONY OF RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH, https://youarewithinthenorms.com/2021/01/01/the-full-testimony-of-richard-james-albert-dea-investigator-and-the-diversion-of-the-truth/

DEA DISPLAYS A LACK OF KNOWLEDGE AND OF IN THE PHARMACEUTICAL MEDICAL PRACTICE 

The warrant issued identified Items that are evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.   

The intent of this law implies that it shall be unlawful for any person knowingly or intentionally— to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

The DEA uses the law with intent to imply a license for Pharmacists and medical professionals as a person that illegally distributes, or dispense controlled substances.  

The DEA has deliberately reinterpreted the law to support their effort to attack Pharmacist, in essence, the DEA willfully and knowingly misguided the courts that the petitioner a licensed pharmacist was in violation of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.   The officers should be charged under Giglio.

As a licensed pharmacist, the Petitioner carried out his fiduciary responsibility of Petitioner, Norman J Clement was acting in the capacity of a license’s pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drugs.  

This definition is a statute within the Florida Administrative Code & Florida Administrative Register.  The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. 

Pharmaceutical Compounding licensed by the State of Florida

“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. 

The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.

(1) Compounding includes:

(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.

(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.

(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis, and the patient has been made aware that the compounded product will be prepared by the pharmacist. 

The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible without notice to the practitioner.

If the officers were asked the difference between compounding and manufacturing, they must know what they are being asked. A reasonable officer could not support or testify to the facts of any item or file that was within the seized computer or secondary storage systems.  In the warrant the DEA deliberately misinterpreted compounding as manufacturing control substance.

The DEA investigation was an act of brazen misconduct against a licensed retail pharmacy that is licensed by law to compound medications. These cases are not only about bad science but bad law and poor training. Diversion Investigator Richard Albert prepared a warrant that was “opinion based on a red flag,” that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy, wherein a licensed pharmaceutical company by law, that can compound medication. 

Diversion Investigator wrote, ILLEGAL MANUFACTURING:

Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA,  without a separate DEA registration authorizing it to manufacture controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28. 

“In addition, the Government previewed that its evidence will show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer’s registration.”

To support this allegation, the Government intended to show that in May 2012 the Respondent’s owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors. 

THE MANUFACTURING OF OXYCODONE

Pronto Pharmacy does not manufacture Oxycodone nor Hydromorphone, which is a far more complex process. Pronto would have to:

1. Acquire large tons of harvested opium paste from Tasmania, India, or Afghanistan, transporting these volumes to Tampa, Fl., for processing.
2. Process the opium paste, large volumes of agents, reagents, equipment, and space would be needed, notwithstanding the fact that to bring the product Oxycodone and Hydromorphone to a pharmaceutical-grade that meets FDA purity standards.
3. The water bill and electrical bill at Pronto Pharmacy would be enormous.

The manufacturing of Oxycodone into a bulk product is an extremely complex procedure and would involve: (see google scholar manufacture Oxycodone footnote 4)

https://patents.google.com/patent/US6864370B1/en

Oxycodone is manufactured in high yields and with high purity using codeine or salt of codeine as the starting material. The manufacturing process involves the following steps:

• (a) codeine or a codeine salt (e.g., codeine phosphate) is converted into the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine,
• (b) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine resulting from step (a) is oxidized to yield the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone;
• (c) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone resulting from step (b) is enolized with a base and the resultant enolate is thereafter methylated to yield the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine;
• (d) the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine resulting from step (c) is reduce to yield thebaine;
• (e) the thebaine resulting from step (d) is oxidized to yield the intermediate 14-hydroxycodeinone; and
• (f) the intermediate 14-hydroxycodeinone resulting from step (e) is hydrogenated to yield oxycodone.

THERE WAS NOT ONE SINGLE CAPSULE EVER MANUFACTURED AT PRONTO PHARMACY

1. There is not one piece of equipment that the DEA seized from Pronto that was used in manufacturing. All equipment taken was for compounding

2. All medications compounded was purchase from two wholesalers (Fagron and B&B)

3. There is not a single controlled substance compounded for encapsulation at Pronto Pharmacy which was manufactured at the pharmacy or by a Pronto pharmacist and/or their technicians.

Here are the containers. ( see below)

4. The containers of powders were obtained from B&B Pharmaceutical and were recorded into the CSOS system which reported back to the DEA and wholesalers. Therefore, Richard James Albert should have known this but chose to falsify his warrant in order to put Pronto out of business and its owners in prison.  

DEA MOVING THE GOAL POST BACKWARD AND FORWARD AND SETTING QUOTAS

We see this early in the case of Pronto Pharmacy when Diversion Investigator Richard James Albert (DI Albert) came upon compounding, and when he could not repeatedly find anything wrong with the pharmacy’s records supervisors to redefine this long-standing pharmaceutical methodology as manufacturing.

It is more than clear that the DEA Diversion Investigators were operating in absent the law based on mis-facts, lies, distortions. DEA has learned well.  When there is no evidence of wrongdoing, DI Richard James Albert’s handlers cleverly instructed him to redefine the meaning of pharmaceutical procedures to accomplish their goals. The Diversion Investigator’s charges and findings were easily scientifically debunked.

It became clear from his court testimony he did not understand compounding or its procedures. 

Most notable his supervisors guided him on how to divert both meanings to convince a Federal Administrative Judge to secure a warrant to shut Pronto Pharmacy LLC down. Additionally, he testified that he did not “know or understand the law(s) or how any law applies to the practice of Pharmacy.  Florida Statue 499.1.2 states the wholesaler must assess the purchases of control medication by an individual pharmacy.

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

YOUAREWITHINTHENORMS.COM 

It was apparent that the Administrative Law Judge (Mr. Dowd), the Diversion Expert (Mr. Alpert), the Prosecutor (Mr. Beerbower), as well as the Expert Witness (Mr. Sullivan) are not likely to understand the level of care and clinical issues. 

The Petitioner created a blog youarewithinthenorms.com, which the Respondent’s Counsel introduced as evidence in court and Judge Dowd made in part his decision from this blog.

This Blog consisting of 350 article has served as a National Platform for many health practitioner finding themselves Targets of DOJ_DEA

THE CONDUCT OF DEA’S PECULIAR COURT SYSTEM NEEDS SERIOUS JUDICIAL REVIEW

The Court System of the Drug Enforcement Agency (DEA), has slipped through both Judicial review and Congressional oversight, and operates outside the Federal Rules of Civil and Criminal Procedures not bounded by Giglio and in contempt and violation of those protections of the Constitution of The United States of America.

The DEA has acted as an unregulated medical agency policing medical facilities and medical practices without legal standards and grounds and the DEA Administration Court System body, which operates within the Department of Justice (DOJ), as a runaway unconstitutionally entity, and immune to all laws of governance to all courts within the Justice System. 

The DEA has set up a system of de-facto discrimination through Cognitive Dissonance which encourages Pharmacists to profile patients by the Processes of “RED FLAGGING.”  The term Red Flag has no statutory meaning in the areas of pharmacy and or within the medical profession.  

Those pharmacists who merely question these DEA policies risk loss of employment and/or administrative sanctions. The DEA can impose these errant actions because they possess unchecked authority and weapons the ability to intimidate by seizings property and assets.  That these DEA policies are applied so arbitrarily makes them discriminatory.

This Administrative Court acts in the capacity as both Criminal and Civil Court. The Judges of this peculiar court system make their own decision and rules which permits DEA Agents, and Diversion Investigators to act as rogues to which no Federal or Constitutional protection are they bound to respect or abide by.  

The DEA Court is known to those Attorneys who choose to defend their clients in these “Orders To Show Cause” proceedings as the Court of the  Kangaroos. The DEA Court System, is so unique its conduct is separate from any of DOJ formal guidelines; which permits the DEA Agents to operate like un-regulated gangsters.

While in my attorney’s office on February 24, 2020, I over heard a call, placed, to one attorney co-counsel who had his first case representing Oak Hill Pharmacy, Wv., vs. Uttam Dhillion et al. acting administrator of Drug Enforcement Agency.  

The Attorney pointed out, he had clerked in both the Federal District Court and Federal 4th Circuit Appeals Court Systems, and never in his legal career had he ever seen such Court rules and procedures as he described as arcane, stealthy, bizarre as found in DEA Administrative Court System. 

Currently, there is not one law in America the DEA or its Court System is bound to respect:

1. Federal RULES OF CIVIL PROCEDURES ARE NOT PERMITTED.
2. Jenks rulings or procedures are not allowed.
3. Gigilio rulings or protections are not allowed.
4. Federal rules of evidence are not allowed.
5. The Judge of a DEA Court works for the DEA Administrator (DRUG CZAR), and he/she has final say so in all hearing decisions.
6. If the DEA administrator does not agree with the Administrative Judges recommendations, the Judge is terminated.
7. Attorneys who practice before this Court, describe rules as arcane, stealthy, very bizarre.
8. Most of All cases are heard in Virginia, putting the Respondents from around the Country and their Attorneys in a logistical disadvantage and nightmare.
9. Until recently, the DEA Administrator has final decision on all recommendations, he/she has can sit on a recommended order as long as 3 years.

Associate Supreme Court Justice Gorsuch wrote April 20, 2020, Ramos v Louisiana 

“Imagine a constitution that allowed a “jury trial” to mean nothing but a single person rubber stamping convictions without hearing any evidence but simultaneously insisting that the lone juror come from a specific judicial district “previously ascertained by law….And if that’s not enough, imagine a constitution that included the same hollow guarantee twice—not only in the Sixth Amendment but also in Article III.8 No: The text and structure of the Constitution clearly suggest that the term “trial by an impartial jury” carried with it some meaning about the content and requirements of a jury trial”

The officers of this peculiar Court system, mission is not to seek out the truth and but to promote injustice by eliminating the truth supporting junk science and unscientific bias.  

The DEA continues and explicitly express actions that prohibit officers from targeting people based on their religion, national origin, or other characteristics.  The DEA agents have substituted the legal standing of reasonable suspicion and probable cause and applied a lesser standard of cause to single out pharmaceutical facilities to obtain their organizational objectives. 

The constitution protects for unwarranted government intrusions.  Whereby the government DEA agents express that filled prescriptions without corresponding responsibility is the fundamental actions of a pharmacist.  This assumption by the DEA is fundamentally incorrect.  

DANGEROUS MIS-INTERPRETATIONS OF THE LAW

DEA agents across the country have applied what they reason as the law or searching and seizing medical facilities.  This act in which the DEA agents apply is too vague to be valid.   

The DEA executed a show cause search warrant in August 2019 at Pronto Pharmacy LLC 1461 W Busch Blvd, Tampa, FL 33612.

While the purpose of the search was to obtain evidence of illegal Opioid distribution. The agents took files in the act of searching to discover items to suggest a criminal act took place or is taking place. 

The act of taking files, remove all electronic devices, remove scales, capsule making machines, ungunator an ointment maker. Diversion Investigator Richard James Alpert, along with his crew, the Miami DEA Head Director, Supervisors, legal counsel, agents of the DEA who were on site participants of the August 29. 2019 raid, set out to damaged Pronto Pharmacy computer hard drives and returned the monitor with smash screens 60 days later

The goal and purpose of this raid was to inflict such physical destruction to put Pronto Pharmacy out of business. DEA wanted to send their calling card message to Pronto Pharmacy or to any other Pharmacy they feel that gets out of line.

Thus this DEA Court System has allowed this Federal Agency to gain the powers over the entire field of medicine (healthcare science) and permitted the Agency to redefine medical procedures medical science.

DEA ADMINISTRATIVE JUDGE MARK DOWD AND DEA EXPERT DONALD SULLIVAN

Judge Mark Dowd’s decision of May 5, 2020, has been labeled ridiculous by Pronto Pharmacy Attorney Dale Sisco and more than demonstrates his incompetents and fails as a Juris. Most importantly, had Judge Dowd simply took a look at the DEA website under 21 USC 1301.13 which he deliberately goes out of his way to misinterpreted this law:

” A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.“

DEA’s argument, has been Pronto Pharmacy’s compounding of control medications was concluded as manufacturing and Pronto Pharmacy needed a separate manufacturing registration. This was because their retail registration license does not cover for manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his supervisors against Pronto Pharmacy. 

The DEA Diversion Investigator Richard James Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy engaged in manufacturing-controlled substances. Albert’s actions and those of his handlers (The crew) were both deliberate fabrications of the laws and distortion of truths in order to shut Pronto Pharmacy down. Specifically, these are the assumptions purposely perpetrated by The Crew that crimes were being committed within the Pronto Pharmacy to justify the removal of their Control Substance Registration Certificate. 

Pronto Pharmacy LLC is a licensed retail community pharmacy by law and permitted under this license to compound control medications. The below chart demonstrates Richard James Albert nor his handlers comprehended existing laws and/or rules guiding the practicing of Pharmacy; DEA Judge Mark Dowd was just as complicit in their ignorants.

More specifically control medications and this chart under (iv) practitioners, hospitals retail pharmacies are permitted under their DEA Federal Registry certificate to process Schedule medications II-V. This chart specifically outlines:

“A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture.“

DEA WEBSITE UNDER 21USC 1301.13

(iv) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)

Schedules II–V

New–224 Renewal–224a

731

3

May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.

Yet, more, troublesome these guidelines are from the DEA’s own website under 21 USC 1301.13 under certificate new license and renewal (224&224a) and the cost for this license is $731.00 and it is good for 3 years. The importance is DI Albert didn’t appear to know any of laws, nor does it appear searched for any laws and his handlers, Aimee Hickerson, Susan Langston, John Beerbower kept him ignorant of the laws.

JUDGE MARK DOWD’S 48 PAGE RULING

Analysis of Unlawful Manufacturing Allegation

“Finally, the Government alleges that the Petitioner engaged in “manufacturing” controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing the manufacture of controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28. Specifically, the Government alleges that the Petitioner compounded oxycodone and hydromorphone capsules in such large quantities that this activity constituted manufacturing rather than permissible compounding for individual patients. Id.

DEA regulations require registrants to obtain a separate registration for each regulated business activity in which they engage. 21 C.F.R. § 1301.13(e). Section 1301.13(e) provides ten separate business activities, to include manufacturing and dispensing.44 Id. at (e)(1)(i), (iv). Each business activity is “deemed to be independent of each other.” 21 U.S.C. § 1301.13(e). In other words, a registration for one activity does not authorize the registrant to engage in another activity. Id. To engage in both dispensing and manufacturing, a registrant would need to apply for and obtain separate registrations for each activity. No person or entity may engage in a regulated business activity “until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person [or entity].” 21 C.F.R. § 1301.13(a).”

The opinion of Judge Mark Dowd is seriously flawed and contrary to the DEA own  and requires this Court just based upon the DEA’s own website. 

Furthermore, while we have been extremely critical of  Mark D. Dowd, U.S. Administrative Law Judge, his opinion of May 5, 2020, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE, he states;(2) (page 40-41)

” I find Dr.Sullivan’s subject conclusion more in the nature of speculation. I don’t believe the record provides sufficient factual foundation to support this expert opinion. I also find it inconsistent with the facts of the case. Accordingly, on the basis of the instant record, I find Dr. Sullivan’s subject conclusion unjustified.

Dr. Sullivan made a similar conclusion regarding the prescribing of non- controlled substances and of controlled substances not subject to abuse or diversion. Again, he deemed such prescriptions as an apparent subterfuge on the part of the prescriber, designed to mask the improper prescribing of controlled substances highly subject to abuse and diversion, and creating a red flag, which went unaddressed by the Respondent. 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.”  

Yet, Judge Mark D. Dowd appears to freely admit he accepted Dr. Sullivan’s testimony solely on his “White Privilege” stating,

” 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 PROBITY: DEA JUDGE MARK D. DOWD AND THE ARROGANCE OF HUBRIS https://youarewithinthenorms.com/2020/08/18/the-probity-judge-mark-d-dowd-and-the-arrogance-of-hubris/

THE DEA’S CADRE OF JUNK SCIENCE-TIERS AND SUPER DEFRAUDERS OF THE AMERICAN TAXPAYER’S MONEY

They’ve (DEA) exploited the use of a network of medical practitioner hustlers such as Donald Sullivan RPh., Phd., Timothy Munzing, MD., in Court Rooms who have been paid millions by the United States Federal Government see GovTribe. (1),(2),(3) Their testimony which often relies on tacit bias without examining radiographs (X-rays) the patients or interviewing prescribing practitioners in many cases are equivalent to the discredited bite mark evidence once used in courtrooms.

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”

In contrast The American Medical Association wrote on June 16, 2020:

“While the AMA understands that the apparent goal of the Centers for Disease Control (CDC) Guideline was to reduce opioid prescribing, we believe the proper role of the CDC is to improve pain care. It follows that a dedicated effort must be made to undo the damage from the misapplication of the CDC Guideline.

“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.” 

RED FLAG DISTANCE TRAVELED; TESTIMONY OF RICHARD ALPERT DISTANCE TRAVEL AND LACKS FOUNDATION

In an arbitrary reasoning, the DEA agents claim their actions are based factors applied that “Traveling Long Distances to Fill Prescriptions can be a red flag of abuse and diversion if a patient travels significant distance to a particular pharmacy. However there is no law, rule or policy anywhere in both federal or State of Florida that establishes a boundary or restrict any person from having any prescription filled including all Scheduled medication. Distant traveled to fill a prescription is found no-where in the CSA Act or is a statue within the Florida Administrative Code & Florida Administrative Register. There is no such law rule or policy.

THE ISSUE HERE:

1. Much of this testimony deals with the distances travelled by the patients. All of this testimony is irrelevant because the most that it could suggest is a suspicion of wrongdoing and could not possibly rise to the level of true diversion without actual indications that were gleaned from people who were actually diverting these substances.  
2. There is a federal law that gives patients the right to travel.  There is a Supreme Court Decision that gives people the right to travel.  And, there is a Federal law that gives patients the right to chose whatever Pharmacy that they want. 

C. 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. 

Testimony of Diversion Investigator Alpert

Pages (154 – 155)

Q To your knowledge, based upon your training, education and experience, is there a Florida statute that limits the geographic area in which a Florida pharmacy can dispense prescriptions?

A Not to my knowledge.

Q So when you are conducting an investigation that relates to allegations that a pharmacist is not resolving red flags, it would be important for you to examine all available information to determine whether or not there was a reason or a rationale for a patient traveling from Cape Coral to Tampa, is that right?

A Well, when I asked the pharmacist during the inspection, he would not answer that question.

Q Other than asking the pharmacist, did you do anything else?

A As far as what, sir?

Q Well, you already told us you didn’t talk to any of the patients.

A No, I did not.

Q Did you do anything else?

A I was going to attempt to talk to one of the doctors but wasn’t able to.

THE ISSUE HERE:

1. A.In this case the Diversion Inspector who should be very versed upon the Federal law as well as Florida law is unaware of any law that limits travel distance for a prescription to be filled and the DEA does explicitly state a travel distance that rises to even the lowest level of suspicion a so called “red flag’” there is absolutely no way that a reasonable and prudent pharmacist should document the resolution of this suspension.   (see THE FORM: RICHARD JAMES ALBERT DEA DIVERSION INVESTIGATOR AND THE DIVERSION OF THE TRUTH: https://youarewithinthenorms.com/2021/01/04/the-form-richard-james-albert-dea-investigator-and-the-diversion-of-the-truth/)
2. B.Indeed, in all cases before the DEA in the past no one standard has been shown to be a rule that a medical professional can use in daily operations. 
3. C. 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. 
4. D.Therefore, it puts an undue burden upon a health professional to comply with a rule that has at it’s core a level of mutability that would allow for the DEA to target individual pharmacies at will in violation of the constitutional doctrine of “equal protection under the law.” Even if such a ruling were to occur after the fact it would be an “ex post facto” requirement that is also unconstitutional.  In any case fails to rise to the level of the preponderance of evidence that is required in this case.

[ —– INSERT CITATIONS ——]

In this and other cases, DEA Diversion Investigators falsely established diversion based solely on the use of googles maps and performed absolutely no follow up investigation as found in Wheatland Pharmacy, 78 FR 69441, 69445 (2013) to establish diversion or evidence that any patients had diverted any prescription medication filled by pharmacists from At Cost Pharmacy. 

Similar misconduct by DEA Diversion Investigations are on the record in investigations of Pronto Pharmacy LLC., Tampa Fl, Lincourt Pharmacy LLC, Clearwater Florida, Superior Pharmacy, Tampa, Fl., Gulf-Med Pharmacy, Cape Coral,  Florida. 

2. The DEA has no laws, rules, policy both Federal or State and Congressional has pass no law statistical guidelines to support or establish boundary levels, which are indicative of a criminal act.  The DEA guidelines are tactic acts that specifically target American Pharmacist.   

3. The DEA has criminal elements of free commerce by criminalizing distance travel as elements of criminal conduct.  

4. Where as in the case of AARRIC pharmacy the DEA reasoned that an individual regularly filled controlled substance prescriptions for individuals who traveled an unusual distance.  The DEA further stated that “Obtain or fill a controlled substance is indicative of diversion and/or abuse, and that such behavior is a red flag that must be addressed prior to dispensing.”  The DEA reasoned that traveling 78 miles round trip and over 53 miles round trip is a red flag that must be addressed prior to dispensing. The DEA also claimed that traveling 45 miles round trip and or 44 miles round trip is a red flag that must be addressed prior to dispensing.

5. The DEA applied fictitiously  a distance law USING GOOGLE MAPS on Pronto Pharmacy to falsely established probable in their search warrant.  

“Approximately 140 miles from that a prescription was filled to a patient who was “located approximately 130 miles from Respondent’s registered address and another lived “approximately 145 miles yet another USING GOOGLE MAPS lived approximately 160 miles from Respondent’s registered address.

It must be noted the DEA agents applied a higher mileage factor in different warrants to obtain a sense of urgency to support their cause.  In AARRIC Pharmacy Rx, of Fort Myers Florida, the DEA said that traveling 78 miles round trip, and over 53 miles round trip is a red flag that must be addressed prior to dispensing. In 

5. In Pronto Pharmacy case, the DEA USING GOOGLE MAPS stated, a patient was “located approximately 130 miles from Respondent’s registered address and another lived “approximately 145 miles yet another lived approximately 160 miles.  

6. If distance of traveling to obtain a prescription is a factor, these rules should and apply to mail order pharmacies, to citizens driving to Canada and to pharmacy that fills prescriptions to individuals.  Moreover, these Class 2 medications are delivered from manufactures via UPS and other delivery services.  

7. By the DEA standards, the manufacturers are operating a criminal drug enterprise and the delivery service operated as drug carriers. Therefore, the entire pharmaceutical industry is at risk when the DEA applies their unabashed rules.  Such actions of a government agency are to be feared. And such actions violated the 1^st, 4^th, 8^th and 14^th amendments.        

8. The DEA’ S expert Donald Sullivan opined that traveling long distances ALONG WITH THE USE OF GOOGLE MAPS can be a red flag of abuse and diversion if a patient travels significant distance to a specific pharmacy, especially if the patient also travels significant distance to a particular prescriber. Distant traveled to fill a prescription is found no-where in the CSA Act or is a statue within the Florida Administrative Code & Florida Administrative Register. There is no such law rule or policy.

9. The facts to support probable cause cannot be justified by mere suspicion, (SEE OAK HILL final order 12/23/2019) “DEA’s expert opined that it can be a red flag of abuse” this cannot support an express intent that a crime was afoot. Thus, it cannot establish probable cause.  In fact, by the DEA statements that long distances “can be” a red flag of abuse and diversion, is a clear application that narrowly supports Responsible Suspicion.  

10. Norman Clement was acting in the capacity of a license’s pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drug.  This definition and is a statue within the Florida Administrative Code & Florida Administrative Register.  The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. ( see  200 years https://youarewithinthenorms.com/2020/06/07/mark-d-dowd-drug-enforcement-agencies-dea-administrative-court-law-judge-overturns-nearly-200-years-of-medical-and-pharmacy-law-and-protocols/)

Testimony of Diversion Investigator Alpert

Pages (151 – 152)

Q. Based upon the investigation that you conducted. did you attempt to determine what the volume was of prescriptions that were being dispensed at Pronto Pharmacy?

A No, sir.

Q But you could tell from the dispensing records, for instance, how man prescriptions were being dispensed each day, each week, each month or each year; right?

A I would be able to tell that, yes.

Q But you never made an attempt to do that?

A No, sir.

Q And did you analyze the records, the prescribing records that you obtained via the administrative inspection warrant to compare the patients who received capsules that were compounded at Pronto Pharmacy to the anticipated patient need?

A No, sir.

THE ISSUE HERE

1. The Issue here is that the even though the Immediate Suspension Order indicates excessive dispensing of CII controlled substances the Diversion Investigator never made any attempt to quantify the actual number of controlled substance prescriptions involved and as such any allegations of wrongdoing cannot be met. 
2. 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. 
3. AMERICAN MEDICAL ASSOCIATION CALLS CDC GUIDELINES OFTEN USED IN PROSECUTING PHARMACISTS AND PHYSICIANS, “WRONG”: CONGRESSIONAL INVESTIGATIONS NEEDED TO HALT PROSECUTORIAL CORRUPTION!/; https://youarewithinthenorms.com/2021/03/25/american-medical-association-calls-cdc-guidelines-often-used-in-prosecuting-pharmacists-and-physicians-wrong-congressional-investigations-needed-to-halt-prosecutorial-corruption/)

THE ISSUE HERE:

1. This shows Alpert and investigation or basic research therefore this invalidates  his order to show cause

2. “A decade into the crisis, more and more prescription drug users turned to the black market. Even though the D.E.A. had tried to “eradicate” illicit drugs for nearly 50 years, users could easily buy stolen and counterfeit pills, along with a cheaper option, heroin.”

3. According to Professor Leo Beletsky and Jeremiah Goulka, (ii.) Director of Northeastern University’s Health in Justice Action Lab, where Jeremiah Goulka is a senior fellow in their September 17, 2018 New York Times article; 

The DEA was supposed to curb problematic drug use, but failed to do so because its tactics were never informed by public health or addiction science.(iii.) Despite the investment of hundreds of billions of taxpayer dollars and the earnest efforts of thousands of employees, the D.E.A.’s track record is abysmal.

3. According to Professor Leo Beletsky and Jeremiah Goulka, (ii.) Director of Northeastern University’s Health in Justice Action Lab, where Jeremiah Goulka is a senior fellow in their September 17, 2018 New York Times art.

Pages (156 – 158)

Q And you’re aware, are you not, based upon your work in the field, that PBMs are pushing down the reimbursement rates available to independent pharmacies; right?

A I have heard that.

JUDGE DOWD: Explain what that is. Your understanding of what —

THE WITNESS: 

Right. My understanding from pharmacists that I’ve been on inspections with, is that they’re not getting reimbursed the amount of money that they think they should be reimbursed with using insurance companies. And that’s just what I’ve heard in talks from pharmacists.

JUDGE DOWD: Based on some kind of ratio?

THE WITNESS: I have no idea, sir.

THE ISSUE HERE:

1. A.Based upon this testimony that the DEA is aware of the shrinking reimbursements in retail pharmacy and their “red flag” that indicates that cash payments are suspicious even though they know that in this country we do not have universal healthcare a reasonable and prudent individual would conclude that the DEA and its actions against healthcare providers especially pharmacists could be construed as an attempt to enslave this class of people.  
2. B. 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. 
3. C.This along with their history of targeting non-white citizens and resident aliens in this country is grotesque to any person who is aware of the checkered past of this great nation.  18 USC 1589 (a)(3)

18 U.S. Code § 1589.Forced labor

(a)Whoever knowingly provides or obtains the labor or services of a person by any one of, or by any combination of, the following means—

(1)by means of force, threats of force, physical restraint, or threats of physical restraint to that person or another person;

(2)by means of serious harm or threats of serious harm to that person or another person;

(3)by means of the abuse or threatened abuse of law or legal process; 

JUDGE DOWD: Okay. Mr. Sisco.

BY MR. SISCO:

Q Well, you understand, based upon your work as a diversion investigator, that distributors are limiting the amounts of controlled substances that they will dispense to independent pharmacies; isn’t that right?

A Some distributors, yes, sir.

Q Well, isn’t it true that the DEA is putting pressure on distributors through the Know Your Customer initiative, to make sure that they’re selling a much higher percentage of non-controls to pharmacies than controlled substances?

A What I do know is that the DEA is putting pressure on distributors about Know Your Customer and doing the due diligence.

Q And part of that analysis is doing a comparison of the ratio of controlled and non-controlled dispensing; correct?

A I believe they do that.

JUDGE DOWD: Do you know what that ratio is?

THE WITNESS: No, sir.

JUDGE DOWD: Do you know if there is an exact ratio of controlled and non-controlled?

THE WITNESS: I haven’t seen anything as exact ratio, no, sir.

JUDGE DOWD: Okay.

BY MR. SISCO:

Q You’re not aware of any federal regulation that requires a pharmacy to accept insurance; isn’t that true?

A No, I’m not aware, no.

Q And we’ve already asked you about Florida. You don’t know about Florida law, right?

A Well, not to that extent. No, sir.

THE ISSUE HERE:

A. Even though the DEA is aware of the decreasing supply of adequate pain medications in various areas of Florida, as well as nation wide and the increasing difficulty that patients face in their own neighborhoods, they compound their negative impact on the public by using these totally ineffective tactics to combat the “opioid crisis” by putting undue burden on patients, caregivers, prescribers and pharmacists in violation of their own mandate to decrease drug diversion and addiction according to the Office of the Inspector General. 

B.) See: https://oig.justice.gov/reports/2019/e1905.pdf We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000. We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively.

C.) 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. 

Since Mr. Alpert , admitted under oath he didn’t know Florida State law in the practice of pharmacy and testified under oath he did not investigate any patients, interviewed no medical practitioner of Pronto Pharmacy.

 HIS ENTIRE TESTIMONY should be dismissed and the ISO order voided.

I’ve been a Pharmacist 45 years and have been practicing Pharmacy the same way  for those years (see Since When law enforcement) http://youarewithinthenorms.com/2019/12/10/since-when-has-it-become-the-job-or-the-role-of-law-enforcement-dea-to-dictate-and-define-medical-procedures-and-protocols-a-reflection/

Testimony of Diversion Investigator Alpert and Pharmacist Expert Sullivan should be voided 

The entire testimony of Both Don Sullivan and Mr. Alpert as Government witnesses should be dismissed. Alpert admitted under oath he didn’t know Florida State law or for that matter Federal Law which appeared on the Order to Show Cause. He simply uses a default form of the DEA. Both Sullivan and Alpert testified under oath they did not investigate any patients, interviewed no medical practitioner of Pronto Pharmacy. Sullivan never verified any prescriptions because DEA never sent them to him.

For example, Government witnesses stated Pronto manufactured 33,333.00 capsules of 8 mg hydromorphone over an 18 month period. If the average prescription of Hydromorphone 8 mg was 120 capsules the amount would calculate to 277.77 prescriptions in total. 

Then divided by 18 months would amount to 15 prescriptions per month, then divide that total by 22 the day open per month translates to .666 prescriptions for hydromorphone 8 mg 120 capsules, per day.  

This is hardly manufacturing. Not only does Both Alpert and Sullivan not understand compounding they can’t even do the math correctly.

Manufacturing would entail producing a product and dispensing it to an outside entity and most importantly it would require a form 222 transfer plus invoices. 

All compounding at Pronto Pharmacy was for our patients and we made anticipatory dosages as allowed by pharmacy law.

However, Alpert never took the time to know the laws of pharmacy or the procedures of  Control Substance Transfer.  Alpert doesn’t have any knowledge of pharmacy procedures, especially in compounding. 

Nor does pharmacist expert Don Sullivan(see Walter Clement Pronto assessment) who interviewed no physicians/dentist, no patient receiving prescriptions from Pronto PHARMACY, and reviewed no radiographs or had performed a physical examination on each patient of Pronto Pharmacy to impeach the primary physician initial diagnosis. 

What Don Sullivan, does is offer an opinion based on a bias,  by cleverly eviscerating the physician-patient relationship by using GOOGLE MAPS and distance travel and concluding these prescriptions are not for legitimate medical purpose.

What further undermines the credibility of Don Sullivan and Alpert most is the 11 patients they identified as unresolvable ‘RED FLAGGS,” are still being treated today, by the same doctor for the exact same amounts at non- black own Pharmacies. Most importantly prescriptions being filled as these other pharmacies and the physicians are no longer RED FLAGGS. Both Alert and Sullivan could have easily verified this by using the PDMP, so what happen to the RED FLAG?????

These patients call us to ask when are we at Pronto Pharmacy getting back open because they have to pay much more for their meds under a hostile environment.

The ENTIRE TESTIMONY should be dismissed and the ISO order voided. (see)

_______________________________________________________

15. WHILE WE WERE NOT LOOKING

SO WHILE WE WERE ALL FOCUSED ON IRAN, TRUMP’S DRUG ENFORCEMENT AGENCY (DEA) WAS OUT ATTACKING BLACK OWN PHARMACIES…..

16. DEA’s Kourt of The Kangaroo

http://youarewithinthenorms.com/2019/12/23/deas-kourt-of-the-kangaroo-by-norman-j-clement-rph-dds/

17. From The New York Times: The Federal Agency That Fuels the Opioid Crisis
“The Drug Enforcement Administration has proved itself incompetent for decades.”  https://www.nytimes.com/2018/09/17/opinion/drugs-dea-defund-heroin.html

Transcript

DISCUSSION

THE OTHER SIDE OF THE SO-CALLED OPIOD EPIDEMIC 

The idea medically prescribed opioid medications (MPOM) or narcotic analgesic medications (NAM) cannot be use for chronic pain are simply not true and is misleading. Further the idea these medications are not to be used in combination with other medications such as those used to relieve anxiety; mood disorders or sleep are further in error. 

MPOM or NAM, when prescribe and use for long term chronic pain will result in dependency. It is the role of the Pharmacist to ensure the patient who is being treated for chronic pain on how to use of this class medications correctly to ensure their safety. 

These medications are safe when used correctly and like any medications control or non-control when taken beyond their therapeutic dose are dangerous and may result in death. More importantly, to this date unless is the case of extreme anaphylaxis there is no case in the  literature when any individual has succumbed to death when given a therapeutic dose. 

In fact, other medications may cause a higher level of mortality in therapeutic doses. Warfarin (an anti- coagulant) for example has an extremely narrow therapeutic index and cranial hemorrhage is somewhat common. Antibiotics, are too widely prescribed and create a need for newer and stronger antibiotics and will be the death of all human kind eventually. The CDC is well aware of these dangers. Anti-Neoplastic medications in the treatment of cancer are extremely toxic and what is considered “cure” is remission for just 5 years. 

DEA’s mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non- enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets. 

However, the Office of the Inspector General reports the inadequacies of the DEA in combating diversion, the major issues are the illicit drugs and not the prescribed medications. So once again the DEA is off target by targeting Healthcare Providers while largely ignoring the low-level diversion actors in the street. 

Healthcare Providers are assumed by DEA to be lacking due diligence if they don’t prove beyond a shadow of a doubt that they have addressed any red flags but in court hardly ever produce evidence of real diversion but rely on suspicions and glitzy presentations. 

In fact, DEA is the single most government agency who tactics have the increase cost of medication and healthcare all across America by mis-interpreting purpose and roles of medications needed to treat acute, chronic, neuropathic and psychological, pain. 

The DEA has been waging a campaign of disinformation to sway the public to a point prescribed narcotic analgesic medications are indeed drugs, dangerous drugs who dosages are red flags indicating abuse and trafficking contributing to the so-called Opioid crisis around America. 

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. 

Notably, DEA’s evidences always realize 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 a 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 to 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

RESPECTFULLY SUBMITTED

February 16, 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 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 15, 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

Respectfully Submitted

Norman J Clement

Norman J Clement pro. se

prontopharmacy@aol.com

FOR NOW,YOU ARE WITHIN

THE NORMS