Petition for Writ of Certiorari — Norman Clement, Petitioner v. Drug Enforcement Administration
Supreme Court briefOct 31, 2022
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FILED
OCT 3 1 2022
In the
Supreme Court of the United States
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NORMAN J CLEMENT,
Petitioners,
v.
DRUG ENFORCEMENT ADMINISTRATION,
Respondent.
On Petition for a Writ of Certiorari to the United States Court of
Appeals for the District of Columbia
PETITION FOR A WRIT OF CERTIORARI
NORMAN J CLEMENT, PRO SE
PO. BOX 280139, TAMPA FLORIDA 33682
(313) 510-3378
YWTN@UMICH.EDU
OCTOBER 7, 2022
PRO SE PETITIONER
Received"
NOV - 7 2022
SeSiiLsalg®
QUESTION PRESENTED
On May 25, 2022, a three-judge panel of the United States Court of Appeals District
of Columbia DEA Administrator’s decision to revoke Pronto Pharmacy’s DEA
registration interpreting 21 C.F.R. § 1306.04(a) to not require evidence of a
prescription’s illegitimacy before deciding it was dispensed in violation of the
regulation. Under this approach, even if a physician prescribed drugs in a good faith
effort to promote a patient’s well-being.
This vague regulation is fraught with misconceptions. In Gonzales, the Attorney
General thought he could interpret ‘legitimate medical purpose” under § 1306.04(a).
Gonzales v. Oregon, 546 U.S. 243 (2006). The Administrative Court explained,
however, he exceeded his limited authority under the Act. Id. More recently, the
Court. Ruan v. United States, 597 U.S.__ (2022) (slip op.), determine to whether
“knowingly” applied to “except as authorized” under the CSA brought the regulation
back before
This Petition raises a fourth misconception. In ignoring Gonzales, the DEA has
interpreted “legitimate medical purpose” so that a pharmacy violates its
corresponding responsibility whether or not there is evidence of a prescription’s
illegitimacy (see APP-25,97). Holiday CVS, Fed. Reg. 62316 (2012). This ultra vires
authority has allowed the DEA to discipline pharmacists for failing to resolve “red
flags” before filling a prescription. However “red flags” are guidelines created by
DEA in which the agency “lacks the authority to issue guidelines that
constitute advice relating to the general practice of medicine and further
lacks authority to promulgated new regulations regarding the treatment of
pain, (see APP-19-21) See Id. Sadly, when challenged in court, the DEA hides
behind the great deference awarded to administrative agencies. This Petition seeks
to fight this harmful deference and asks the Court:
1 .Whether a pharmacy violates its corresponding responsibility under 21 C.F.R. §
1306.04(a) by being required to operate beyond licensing requirement and training
and deny filling prescription(s) for a controlled substance issued by an authorized
prescribing provider, for a medical disease purpose(s) where the prescription’s
legitimacy remains undetermined?
2. Whether the record as a whole establishes by a preponderance of the evidence
base on an evidentiary standard of “red flag” as a guideline that Pronto Pharmacy's
DEA Certificate of Registration Number FP2302076 should be revoked and 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)?
3. We further ask this Court to determine whether a Pharmacists refusal to fill a
prescription for a ‘legitimate medical purpose” under the Pharmacists
“corresponding responsibility,” provision, constitute and violates the Eight
Amendment prohibition against cruel and usual punishment?
4. Whether it was the intent Congress for DEA to regulate the field and practice of
medicine and pharmacy auger deference awarded to administrative agencies ?
11
PARTIES TO THE PROCEEDINGS
Petitioners
•
• Pronto Pharmacy
*
Respondent
Drug Enforcement Administration
CORPORATE DISCLOSURE STATEMENT
Pursuant to Supreme Court Rule 29.6, neither Pronto Pharmacy is a publicly held
company, has a parent corporation, or has a publicly held company which owns 10
percent or more of its stock.
iii
LIST OF PROCEEDINGS
Administrative Law Judge
Department of Justice,
Drug Enforcement Administration
86 FR 647,14 (2021)
195app
Pronto Pharmacy LLC v. Drug Enforcement Administration, Defendant
Date Decision Issued: Nov. 18, 2021
Date Decision Effective: December 18, 2021
Direct Appeal
United States Court of Appeals for the District of Columbia No.: 21-1262
Pronto Pharmacy LLC, Plaintiff, v. Drug Enforcement Administration, Defendant
Date of Judgment: June 27, 2022
Date of Rehearing Denial: September 19, 2022
IV
TABLE OF AUTHORITIES - Continued
Page
QUESTION PRESENTED
1
PARTIES TO THE PROCEEDINGS
11
LIST OF PROCEEDINGS.
111
TABLE OF AUTHORITIES
Vll
OPINIONS BELOW...
1
JURISDICTION,
1
STATUTORY AND REGULATORY PROVISIONS INVOLVED...... 1
INTRODUCTION
2
•
An Overview of the Controlled Substances Act and the Authority Granted to
2
the Drug Enforcement Administration.
•
REFLECTING THE DISTINCT ROLES OF PRESCRIBERS AND
PHARMACIST, § 1306.04 IMPOSES LIABILITY ONLY ON PHARMACIST
WHO “KNOWINGLY” FILL AN ILLEGITIMATE
8
PRESCRIPTION.
•
FEDERAL LAW ENFORCEMENT AGENCIES ARE UNQUALIFIED TO
DETERMINE WHETHER DRUGS “HAVE A USEFUL AND LEGITIMATE
12
MEDICAL PURPOSE
•
B. EDUCATING AND HELPING THIS COURTS UNDERSTANDING, ALL
DRUG MEDICATION ARE DANGEROUS ESPECIALLY WHEN TAKEN
BEYOND THEIR THERAPEUTIC PRESCRIBED DOSE AND NOT ALL... 19
V
TABLE OF AUTHORITIES - Continued
Page
•
OPIOIDS ARE CREATED EQUAL, ESPECIALLY IN THE
20,21,23,
BODY,
•
ARGUMENT...US vs. LEVIN 973 F.2d 463 (6th Cir. 1992) Decided Aug 7,
23
1992
C. THE GOVERNMENT FAILED TO PROVE BY A PREPONDERANCE OF
THE EVIDENCE THAT THE PETITIONER DISPENSED PRESCRIPTIONS
,28
WITHOUT RESOLVING “RED FLAGS”
D. THE GOVERNMENT FAILED TO PROVE THAT THE APPELLANT
DISPENSED PRESCRIPTIONS IN THE FACE OF “UNRESOLVABLE RED
FLAGS,” OR THAT THE “RED FLAGS” PRESENTED WERE, IN FACT,
INHERENTLY “UNRESOLVABLE”........
E. THE GOVERNMENT FAILED TO PROVE THAT THE RESPONDENT
“MANUFACTURED,” RATHER THAN “COMPOUNDED,” SCHEDULE II
32
CONTROLLED SUBSTANCES
STATEMENT OF FACTS
11
SUMMARY OF THE ARGUMENT
13
REASONS FOR GRANTING THE PETITION
15
I.
THE REVOCATION OF PETITIONER’S REGIS- TRATION SHOULD BE
REVERSED BECAUSE A VIOLATION OF ITS CORRESPONDING RESPON
SIBILITY REQUIRES A DETERMINATION OF THE LEGITIMACY OF THE
16
PRESCRIPTIONS IT FILLED
CONCLUSION,
36
VI
TABLE OF AUTHORITIES - Continued
Page
STATUTES AND REGULATIONS
33
21 U.S.C. §§ 301-392, et seq. Sections 501, 502
5 U.S.C. § 553(b)(A)........................... ............ .
20 29 U.S.C. §
5 U.S.C § 706(2)(A); Morall v. DEA, 412 F. 3d 165,177 (D.C. Cir. 2005).... 13
801
802
812(b)
823(f)
824(a)
829
829(c)
(ii)
21 U.S.C. § 871
3, 21, 34 20 U.S.C. §
........9, 20 U.S.C. §
........ 9, 19 U.S.C. §
............ 3, 21 U.S.C. §
........... 3, 20 U.S.C. §
......... 2, 20 U.S.C. §
........8, 20 U.S.C. § 830(b)(3)(A)
18, 20, 21, 22, 34, 35
10 21 U.S.C. § 841(a)
3, 8, 34 20 U.S.C. §
28
§841(a)(l)
877.
1254(1)
13 27 U.S.C. §
1
i, 2, 3, 4, 7, 9,10,...............
21 C.F.R. § 1306.04(a)...
.. 19, 20, 21, 22, 23, 24, 26,
11, 12, 13, 14, 15, 16, 17,
28, 29, 30, 31, 32, 33, 34, 35, 36
27,
21uU.S.C. § § 823(F), 824 (a)(4); Masters Pharm., Inc v. DEA, 861 F. #d 206, 215
13
(D.C. Cir 2017)..... ........... ......... .............. ............ .
29 C.F.R. § 552.109(a)............................................................
29
FAC Rule 64B16-27.700. Pursuant to Rule 64B16-27.700,
29
vii
Final Rule: Redelegation of Functions;
Delegation of Authority to Drug
Enforcement Administration Official,
75 Fed. Reg. 4982-83.............................
3, 4, 34
CASES
Christoffel v. United States,
Federal Maritime Comm 'n v. Seatrain Lines,
TABLE OF AUTHORITIES - Continued
Page
George Pharmacy, Inc.; Decision and Order,
87 FR 211,45 (2022)........................................
5
Gonzales v. Oregon,
546 U.S243 (2006) .
i, 3, 5, 6, 8, 9, 18,
Gonzales v. Raich,
545 U.S. 1 (2005).
3
Health Fit Pharmacy; Decision and Order,
83 FR 243,48 (2018).....................................
5
In re Winship,
397 U.S. 358 (1970)
18, 21
Kisor v. Wilkie,
139 S. Ct. 2.....
400 (2019)
Paul J. Volkman,
73 FR 30,630 (2008)
Pronto Pharmacy LLC; Decision and Order, 86 FR 647,14
1, 5,12,13
(2021)
7, 8, 17, 21, 25,
5
viii
Ruan v. United States,
597 U.S. 20-1410 (2022)
i
Suntree Pharmacy and Suntree Medical
Equipment, LLC; Decision and Order,
85 Fed. Reg. 73753, 73754 (2020).... 6,11, 12, 13,
United States v. Cardiff, 344 U.S. 174, 73 S.Ct. 189, 98 L.Ed. 200
.xi, 27,
(1952)
factor 2 of § 823(e)
iv, 16
See Colautfci v. Franklin, 439 U.S. 379 (1979)
v, 3, 4, 16
see Kisor, 139 S. Ct. at 2415-16
•v, 4
U.S. V. Levin 973 F.2d 463 (6th Cir. 1992) Decided Aug 7,1992..5
Citing Lanzetta v. State of New Jersey, 306 U.S. 451, 59 S.Ct. 618, 83 L.Ed. 888
8
(1939));
Sorrells v. United States, 287 U.S. 485. 442, 53 S.Ct. 210. 212, 77 L.Ed. 413...........27
United States v. Jones, 570 F.2d 765, 769 (8th Cir. 1978).
United States v. Ragen, 314 U. S, 513, 314 U. 8. 524,................ .
i, 20
.............17
ix
TABLE OF AUTHORITIES - Continued
Page
DEA ADMIN. DECISION
Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24530 (2011);
Liddy’s Pharmacy, LLC, 76 Fed. Reg. at 48895;
East Main Street Pharmacy, 75 Fed. Reg. 66149, 66163 (2010);
Lincoln Pharmacy, 75 Fed. Reg. 65667, 65668 (2010);
Bob’s Pharmacy, 74 Fed. Reg. at 19601;
Carlos Gonzalez, 76 Fed. Reg. 63118, 63142 (2011) (citing
Holloway Distrib., 72 Fed. Reg. 42118, 42124 (2007)).
Wedge-wood Vill. Pharmacy v. DEA, 509 F 3d 541, 549 (d.C. Cir 2007)... 14
Wheatland Pharmacy, 78 FR 69441, 69445 (2013)...v, 6, 7. https://
www.federalregister.gov/d/2021-25133/p-87... vii, 20,
APPENDIX TABLE OF CONTENT
Opinion of the United States Court of Appeals for
the District of Columbia (September 19, 2022)......... la
Decision and Order of the United States Department
of Justice Drug Enforcement Administration (Filed November 9, 2021, Effective
December
21, 2021)...........................................................................
Respondent’s Proposed, Finding of Facts and Con-conclusion of Law
March 11, 2020
333app
X
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
(May 5, 2020)
195app
Petitioner’s Dispositive Motions to Vacate Administrative Judges Findings and
DEA Administrative Orders Restore CSA Registration of Pronto Pharmacy LLC
and Award Damages, Amend Index of Record
January 16, 2022.....App-110, February 03, 2022....App-182
Order of the United States Court of Appeals for
the District of Columbia Denying Petition for Rehearing En Banc (September
2022,)
Appl-2.
Regulatory and Statutory
Provisions Involved
3app
TABLE OF AUTHORITIES - Continued
Page
OTHER AUTHORITIES
Katie Adams,
DEA Takes Hard Stance On Pharmacies Administering Buprenorphine, BECKER’S
HOSPITAL REVIEW (Nov. 8, 2021), https:// www.beckershospitalreview.com/
opioids/ dea-takes-hard-stance-on-pharmacies- administering-hnprAnnrphins html
7
Matt Grant,
New Allegations Made On DEA’S Role In
Pain Prescription Denials, WESH 2 (Jul.
30, 2015, 5:59 PM), https://www.wesh. com/article/new-allegations-made-on-dea- srole-in-pain-prescription-denials/ 4443955#,
7
Walmart Press Center,
Xll
TABLE OF AUTHORITIES - Continued
Page
A Misguided Department of Justice Lawsuit
Forces Pharmacists Between Patients and Their Doctors (Dec. 22, 2020), https://
corporate, walmart.com/newsroom/2020/12/ 22/a-misguided-department-of-justice11
lawsuit-forces-pharmacists-between- patients-and-theirdoctors....................................... ....................—... ................
7
Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://
.23
nationalaffairs.com/publications/detail/the- truth-about-painkillers.
DEA EXHIBIT LETTERS
See supplement 5, exhibit 5-4D September 14,2022, US Court of Appeals DC ,
,x, 24, App72
letter dated November 04, 2019,
(See supplement 5exhibit 5-3e filed September 14,2022, US Court of Appeals
DC, Congresswoman Grace Meng, Member of Congress Sixty District of New York,
.x, 24, App 72
December 18, 2019)
(See supplement 5exhibit 5-6F, Letter dated February 12, 2021, from: Thomas W.
Prevoznik, DEA Deputy Assistant Administrator Diversion Control
Division, to: Richard A. Lawhem, Ph.D. 3691 Nestling Lane Fort Mill, South
,x, 24, App-73-74
Carolina 29708 lawhem@hotmail.com
https://vouarewithinthenonns.com/2022/09/24/nain-and-the-rules-ofx, 17
law/.
xiii
TABLE OF AUTHORITIES - Continued
Page
TABLE OF LAWS
UNITED STAES OF AMERICA, Plantiff
v.
Levin
No. 91-5034
United States Court of Appeals, Sixth Circuit
973 F.2d 463 (6th Cir. 1992) Decided Aug 7, 1992...iv,5.
United States Supreme Court in Raley v. State of Ohio, 360 U.S. 423, 79 S.Ct. 1267, 3 L.Ed.2d 1344
.27, 26
(1959).
United States v. Tran Trong Cuong, 18 F.3d 1132,1141 (4th Cir. 1994)..19
1
OPINIONS BELOW
The opinion of the U.S. Court of Appeals for the District of Columbia Circuit
appears in the Appendix at App.la and can be found at Norman Clement, pro se
Pronto Pharmacy LLc v. DEA, No. 21-1262, 2022 U.S. App. (District of Columbia
Circuit, May 25, 2033). (App.la). This opinion was not designated for publication.
The decision and order of the Department of Drug Administration appears in the
appendix at App. 17 and can be found in the Federal Register at Fed. Reg. 73753.
JURISDICTION
On May 25, 2022, a three-judge panel of the United States Court of Appeals District
of Columbia entered its opinion in Norman Clement and Pronto Pharmacy v. DEA,
No. 21-1262, 2022 U.S. App. (11th Cir. Feb. 14, 2022). (App.la). Petitioner Norman
Clement, Pronto Pharmacy LLC
filed a Petition for Panel Rehearing, or
alternatively, En Banc Rehearing, which the Court denied on September 27, 2022
(App.). This Court has jurisdiction pursuant to 28 U.S.C. § 1254(1).
STATUTORY AND REGULATORY PROVISIONS INVOLVED
Section 841(a)(1) of the Controlled Substances Act (“CSA”), 21 U.S.C. § 841(a)(1),
provides:
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful for any person
knowingly or intentionally—
(1) to manufacture, distribute, or dispense, or possess with intent to manufacture,
distribute, or dispense, a controlled substance[.]
2
21 C.F.R. § 1306.04(a)
A prescription for a controlled substance to be effective must be issued for a
legitimate medical purpose by an individual practitioner acting in the usual course
of his professional practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the prescription. An
order purporting to be a prescription issued not in the usual course of profes- sional
treatment or in legitimate and authorized 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 U.S.C. § 824
Denial, revocation, or suspension of registration included in the appendix at
App-1
INTRODUCTION
A.
An Overview of the Controlled Substances Act and
Granted to the Drug Enforcement Administration.
the Authority
The Controlled Substances Act (CSA) is a closed regulatory system enacted by
Congress, making it unlawful to manufacture, distribute, dispense, or possess any
controlled substance, except in a manner authorized by the Act. 21 U.S.C. § 801 et
seq.; Jones Total Health Care Pharmacy, LLC v. Drug Enft Admin., 881 F.3d 823,
827, 830 (11th Cir. 2018) (quoting Gonzales v. Raich, 545 U.S. 1, 13 (2005)). The Act
entrusts the Attorney General with the authority to develop regulations to monitor
3
and control provider registration for prescribing and dispensing controlled
substances. 21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262
(observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the
authority to register and deregister physicians ...”).
The Attorney General has delegated this authority to the Drug Enforcement
Administration (DEA) Administrator, under which the Administrator has developed
regulations to oversee pro- vider registration. 21 U.S.C. § 871; Gonzales, 546 U.S. at
262; Final Rule: Redelegation of Functions; Dele- gation of Authority to Drug
Enforcement Administration Official, 75 Fed. Reg. 4982 (Feb. 1, 2010).
One of these regulations includes 21 C.F.R. § 1306.04(a), which places a
corresponding responsibility on pharmacies to refuse to fill prescriptions that are
not issued for a legitimate medical purpose. 21 C.F.R. § 1306.04(a). Given that the
DEA Administrator draws his authority under the CSA from the Attorney General,
the Administrator can have no greater authority than he does. See Final Rule:
Redelegation of Functions; Delegation of Authority to Drug Enforcement
Administration Official, 75 Fed. Reg. at 4982-83. The Adminis- trator, however, has
exceeded his limited authority of overseeing provider registration and has instead
created a new category of “unauthorized prescriptions”. With-out notice, the DEA
Administrator has interpreted § 1306.04(a) so that prescriptions filled in the face of
unresolved “red flags” are not “issued for a legitimate medical purpose”; whether or
not the prescriptions are actually illegitimate. See Holiday CVS, LLC, d/b/a CVS/
Pharmacy Nos. 219 and 5195, 77 Fed. Reg. 62316, 62341 (2012) (declaring the “DEA
has interpreted the “legitimate medical purpose” feature of the corresponding
responsibility duty “as prohibiting a pharmacist from filling a prescription for a
controlled substance when he either knows or has reason to know that the
prescription was not written for a legitimate medical purpose...).
There, the DEA Administrator found that Holiday CVS violated its corresponding
responsibility under § 1306.04(a) solely on the basis that it filled controlled
substance prescriptions without resolving “red flags”. Id. at 62342-45. Holiday CVS
argued that these “red flags” were based on the testimony of one “expert” witness
and were not supported by case law, administrative decision, or published DEA
guidance. Id. at 62317-18. Relying on his—and the DEA’s—prior deci- sions,
Administrator simply responded that DEA precedent dictates the DEA interprets
the “legitimate medical purpose” feature of the corresponding responsibility duty as
4
prohibiting a pharmacist or pharmacy from filling prescriptions with unresolved
“red flags”. Id. at 62341.1 2 The Administrator’s decision, however, is indefensible
in light of the Court’s decision in Gonzales, 546 U.S. at 262. There, the Court
clarified the Attorney General’s —and by extension the DEA Administrator’s—
author- ity under the CSA is limited to registering physicians and scheduling drugs:
It would be anomalous for Congress to have so painstakingly described the Attorney
General’s limited authority to deregister a single physician or schedule a single
drug, but to have given him, just by implication, authority to declare an entire class
of activity outside “the course of professional practice,” and there- fore a criminal
violation of the CSA. (citation omitted)).
RED FLAGS
1. “ Red Flags” are not described in : 1) the CDC Guidelines ,
either the 2016, 2017, or the 2022 version, 2) HHS Best Pain
Practice
2. “ Red Flags” are not part of a generally accepted, nationally approved medical standard.
3. “ Red Flags” represent “ reasonable suspicion” and not, proof
beyond a reasonable doubt.
4. “ Red Flags” are arbitrary and capricious , because the
“ alleged red flags” do not proactively, clearly and
objectively, describe the prohibited conducts
5. “Red Flags” are necessary but not sufficient, to serve as
evidence beyond a reasonable doubt, of criminality.
6. “ Red Flags” falls below the knowing and intentional mens
5
rea, evidence standard, set under Euan. (Ruan v U.S. Supreme Court of the United
States, (No. 20-1410. Argued March 1, 2022—Decided June 27, 2022)
The question here in this case is the Rule of Law. The most fundamental concept of
DEA
our country, without which our society crumbles. The authority the
Administrator lays claim too does not arise out of the CSA or the Court’s prior
decisions. Instead, the DEA has systematically extended its authority through
decisions like Holiday CVS, LLC, 77 Fed. Reg. 62316, and this case, and in doing so,
has created a new category of “unauthorized prescriptions”—i.e., prescriptions that
bear the markers of unenumerated “red flags” that were not developed by noticeand-comment, statute, or medical expertise. In fact, An Administrative Law Judge
has the power to receive evidence and to issue subpoenas to compel the attendance
of witnesses and the production of materials “necessary” for the hearing. See 21
C.F.R. § 1316.52(d). However, DEA administrative revocation hearings do not
include the type of discovery process that is available to civil litigants in this Court
and are prevented from presenting witnesses such as the prescribing
practitioners.** As is found in Suntree Pharmacy and Suntree Medical Equipment,
LLC; Decision and Order, 85 Fed. Reg. at 73776-77 (on Petition for a Writ of
Certiorari to the US Supreme Court) at no point did the Acting Administrator
determine the legitimacy of the underlying controlled
1 The DEA Administrator cited to the following decisions: Sun & Lake Pharmacy, Inc., 76 Fed. Reg.
24523, 24530 (2011); Liddy’s Pharmacy, LLC, 76 Fed. Reg. at 48895; East Main Street Pharmacy, 75
Fed. Reg. 66149, 66163 (2010); Lincoln Pharmacy, 75 Fed. Reg. 65667, 65668 (2010); Bob’s
Pharmacy, 74 Fed. Reg. at 19601; Carlos Gonzalez, 76 Fed. Reg. 63118, 63142 (2011) (citing
Holloway Distrib., 72 Fed. Reg. 42118, 42124 (2007)).
2- Other decisions include: Paul J. Volkman, 73 Fed. Reg. 30,630 (2008) (discussing drug cocktails
issued by physician for oxycodone, benzodiazepines and carisoprodol, expert testimony of abuse
potential of these drugs, and red flag of patient travelling long distance to fill prescriptions); George
Pharmacy, Inc.; Decision and Order, 87 Fed. Reg. 211,45 (2022) (finding a pharmacy violated its
corresponding responsibility because it filled prescriptions with unresolved “red flags”); see e.g.,
Pronto Pharmacy, LLC; Decision and Order, 86 Fed. Reg. 647,14 (2021); Superior Pharmacy I
and Superior Pharmacy H; Decision and Order, 81 Fed. Reg. 313,09 (2016); The Medicine Shoppe;
Decision and Order, 79 Fed. Reg. 595,04 (2014); Health Fit Pharmacy; Decision and Order, 83 Fed.
Reg. 243,48 (2018).
6
substance prescriptions that Suntree Pharmacy filled, nor did any qualified
healthcare professional comment on whether the prescriptions were issued for a
legitimate medical purpose. Id. at 73774-75.
The Acting Administrator also never heard testimony from any patients and
prevented testimony from the physicians whom had DEA registrations and are
authorize to prescribe control substances for a legitimate medical purpose and the
usual course of professional practice for prescription Suntree Pharmacy filled. Id. at
73754. Instead, the Acting Administrator simply relied on “red flags” identified by
Dr. Gordon, a clinical hospice pharmacist for ProCare RX, working from home as a
consultant (i.e.. not a retail pharmacist), and used these “red flags” as a proxy to
conclude the prescriptions were illegitimate. Id. at 73754, 73774-75; R. 6 at 21; See
Br. at 15-20 (describing in detail Dr. Gordon’s testimony). To this day, the DEA has
never followed-up with or penalized the medical providers who prescribed these socalled “illegitimate” controlled substances that Sun- tree Pharmacy filled. (9)(10)
In the case of Pronto Pharmacy LLC, Suntree Pharmacy are similarly situated and
nexus that Dr. Donald Sullivan professors at the Ohio State University College of
Pharmacy working from home was used by DEA as the Pharmacy Expert
consultant and used “red flags” as a proxy to conclude the prescriptions were
'illegitimate.' (See Decision and Order, Fed. Reg.86 FR 64714 (2021) id. at https://
www.federalregister.gov/cl/2021-25133/p-87)
Similarly in this case, not only did the DEA Administrator fail to determine the
legitimacy of the prescriptions Pronto Pharmacy filled, but he also discouraged such
a determination by preventing Pronto Pharmacy from calling the physicians to
testify (see App.205-220). The Administrator further failed to gather testimony from
patients who were prescribed these controlled substances. All of the prescribing
physicians, dentist had DEA registrations and were authorize to prescribe control
substances for a legitimate medical purpose and the usual course of professional
practice for prescription, whom prescribed the controlled substances prescriptions
Pronto Pharmacy Lie., filled. See Pronto Pharmacy and Suntree Medical Equipment,
LLC; Decision and Order, 85 Fed. Reg. 73753, 73754 (2020) (App.l7a). Rather, to
streamline revocation, only one “expert”, Dr. Gordon, testified, providing a list of
DEA-created unresolved “red flags”. Id. at 73754-55. Indeed, Dr. Gordon even
admitted she developed this list of “red flags” based on DEA decisions and that she
7
was unable to cite to medical literature supporting any of the “red flags”. Transcript
at 21-311; AU Recommended Ruling, at 8-11 (App.l28a). Whether and to what
extent an agency can use a subjective non-statutory standard, “redflags,” compelling
pharmacist(s) to second guest the prescribing providers diagnosis, treatment and
licensing authority based on DEA’s own manufactured rules and misinterpretation
of laws, medical procedures guidelines, creating their own intrusion to regulate
medical science. Most-importantly, whether the record as a whole establishes by a
preponderance of the evidence base on an evidentiary standard of, “red flag” 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).
In the June 27, 2022 Ruan v United States opinion, the Court provided muchneeded clarity regarding when a physician can be subject to criminal conviction for
writing improper prescriptions for controlled substances.1 By narrowing the scope of
criminal liability, to requires proving beyond a reasonable doubt that the physician
knowingly or intentionally prescribed controlled substances without a legitimate
medical purpose. The “beyond a reasonable doubt” standard for conviction requires
that the jury must be virtually certain of the defendant’s guilt this decision will
benefited both physicians, pharmacist and patients, especially patients seeking
treatment for pain.
The great fear at this moment here is the United States Drug Enforcement
Administration (DEA) has operated unchecked, as a rogue sub agency of
government operating outside the rule of law. Creating their own medical science
(Auer-deference) seizing property using omnipotent authority of ill gotten gain over
the field of medicine and medical science.
Specifically, mis-identifying the dosages and purposes of legally and medically
prescribed FDA approved Narcotic Analgesic medications, “having a useful and
legitimate medical purposes,” to be re-defined as “illegitimate.” mis-labeling all as
“opioids.”
While, the original intent of Congress in the Controlled Substances Act (CSA) was
made clear Congress determined Federal law enforcement agencies are unqualified
to determine whether drugs “have a useful and legitimate medical purpose and are
necessary to maintain the health and general welfare of the American people.” 21
U.S.C. § 801(1).
8
“As a Law Enforcement agency, DEA is not a position to authorize or dictate what
a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it
comes to the practice of medicine because no such wavier exists. As the United
States’ component body charged with the management of controlled substances and
chemicals for scientific, medical research, and industrial applications; DEA
regulates the flow of control substances, not the practice of medicine, (see App 16-19
App 72,73,74,92,93)
The DEA lacks the authority to issue guidelines that constitute advice relating to
the general practice of medicine. The DEA has not promulgated 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
may be prescribed on a single prescription on the duration of treatment intended
with the prescribed controlled substance.’To (see App.375-380)
AND
B. REFLECTING THE DISTINCT ROLES OF PRESCRIBERS
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 inter- changeable, 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. 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.
9. The owner of Suntree Pharmacy is both a pharmacist and licensed practicing Attorney. Suntree
Medical LLC was a separate closed-door pharmacy that did not dispense retail prescriptions.
Suntree Medical had a separate DEA registration and was not in any way engaged in the conduct in
the Order to Show Cause.(https://www.wesh. com/article/new-allegations-made-on-dea- s-role-inpain-prescription-denials/ 4443955#)
9
The CSA recognizes pharmacists’ circumscribed role in dispensing controlled
substances. It provides that pharmacists may not dispense Schedule II con-trolled
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). OTSC warrants repeatedly refers to Pronto Pharmacy as
prescriber.(App.-375-380)
The regulations separately provide that such a prescription “may only be filled by a
pharmacist, acting in the usual course of his/her professional practice and either
registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.
Consistent with the division of responsibility between prescribers and pharmacists,
§ 1306.04 limits when pharmacists may be held liable for filling controlledsubstance 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 in legitimate
and authorized research is not a prescription within the meaning and intent of
section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a
purported prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to controlled
substances. 21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this
provision only if the pharmacist “knowingly filljs]” a “purported” prescription—i.e.,
a prescription that was not written “in the usual course of professional treatment.”
The purpose of the CSA’s regulations governing prescribing is to prevent physicians
from using their prescribing powers to engage in drug trafficking; for example, by
effectively selling prescriptions to individuals who misuse drugs. The Supreme
Court’s decision in Ruan v United States represented a critical step in remedying
these problems. Accordingly, the Court concluded that to convict a physician for
writing improper prescriptions, “the Government must prove beyond a reasonable
doubt that the defendant knew that he or she was acting in an unauthorized
manner or intended to do so.”
10
In other words, rather than simply showing that a physician’s prescriptions did not
conform to professional standards, prosecutors must prove the physician
intentionally wrote prescriptions without any legitimate medical purpose. The
Court acknowledged that deviating from prevailing standards, such as prescribing
pain medications for certain off-label uses or in unusually large doses, can be
relevant in determining whether a physician intended to act unlawfully. But these
practices should not establish criminal liability on their own. Bather, prosecutors
must show other evidence of a physician’s intention to act as a drug trafficker, such
as prescribing drugs with high potential for misuse without examining patients or
charging patients according to the volume of drugs prescribed, (see App249-253)
Here in Ruan, the Court categorically rejected the idea that physicians could be
convicted as drug traffickers merely by showing they prescribed outside the usual
course of practice, regardless of their intent. The Court observed that such a
standard would “criminalize a broad range of apparently innocent conduct” and risk
deterring physicians from using their best judgment to benefit patients.
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). (see App. 237-249)
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 fwas] revised to require knowledge.”
mHowever "red flags" are guidelines creating by DEA which, has staled to Congress and public that DEA "iaciis the
authority to issue guidelines that constitute advice relating to the general practice of medicine(see
APP-19-21,72,73,74,92,93). The DEA has not promulgated new regulations regarding the treatment ofpain,” this of
course is false.
11
m
STATEMENT OF FACTS
On August 23, 2019, a former Acting Administrator of the Drug Enforcement
Administration (hereinafter, DEA or Government), the DEA issued an Order to
Show Cause (“OSC”) to Pronto Pharmacy. R. 1. The OSC alleged that Pronto
Pharmacy filled prescriptions in contra- vention of its corresponding responsibility
under 21 C.F.R. § 1306.04(a). R. 1 at 2. Specifically, the OSC claimed that Pronto
Pharmacy violated this responsibility by “repeatedly filling] controlled substance
prescriptions that contained multiple red flags of diversion and/or abuse without
addressing or resolving those red flags and under circumstances indicating that the
pharmacists were willfully blind or deliberately ignorant of the prescriptions
illegitimacy.”
An administrative hearing was held from January, 28-29, 2020, following which, on
May 5, 2020, the Administrative Law Judge (“ALJ”) filed his Recommended
Rulings, Findings of Fact, Conclusions of Law and Decision. Pronto Pharmacy LLC;
Decision and Order, 86 FR 647,14 (2021). On November 9, 2021, the Administrator
rendered her decision, finding Pronto Pharmacy LLC had violated its corresponding
responsibility under § 1306 -04(a), and issuing an Order revoking Pronto
Pharmacy’s registration, effective November 18, 2021. Id. (App.l7a).
In her decision, the Administrator determined that Pronto Pharmacy actions of
filling “hundreds” of prescriptions in the face of “red flags” was egregious conduct
that necessitated revocation. At no point did the Administrator determine the
illegitimacy of the underlying controlled substance prescriptions that Pronto
Pharmacy LLC., filled, nor did any qualified healthcare professional comment on
whether the prescriptions were issued for a legitimate medical purpose.
Accordingly, nor did the Administrator conclude that the physicians were writing
improper prescriptions, or that prosecutors convicted the prescriber by using the
standard beyond a reasonable doubt or that the Petitioner knew that he or she was
acting in an unauthorized manner or intended to do so.”
In other words, rather than simply showing that a physician’s prescriptions did not
conform to professional standards, prosecutors must prove (or had proven) the
physician intentionally wrote prescriptions without any legitimate medical purpose.
The Court acknowledged that deviating from prevailing standards, such as
prescribing pain medications for certain off-label uses or in unusually large doses,
12
can be relevant in determining whether a physician intended to act unlawfully. But
these practices should not establish criminal liability on their own. Rather,
prosecutors must show other evidence of a physician’s intention to act as a drug
trafficker, such as prescribing drugs with high potential for misuse without
examining patients or charging patients according to the volume of drugs
prescribed. In this case the Administrator used “red flag” as a proxy to unjustly
manufacture an Order to Show Cause, to seize Pronto Pharmacy’s records, property
and money.(see App. 374-378)
Most, importantly, in the same way the Administrator used “red flags” as a proxy to
determine the illegitimacy of a controlled substance prescription (without actually
making such a determination; either by herself or via a medical expert), Instead,
the Acting Administrator simply relied on “red flags” identified by Dr. Donald L
Sullivan, consultant (i.e., not a retail pharmacist), and used these “red flags” as a
proxy to conclude the prescriptions were illegitimate, (see App-162-163,)
Pronto Pharmacy appealed the Administrator decision to the United States Court of
Appeals for the District of Columbia. It had jurisdiction to challenge the DEA
Administrator’s Order pursuant to 21 U.S.C. § 877, or the in the Eleventh Circuit
Court of Appeals pursuant to 21 U.S.C. § 877, in which Pronto Pharmacy’s principal
place of business is located. 21 U.S.C. § 877. (see App-333-373)
On May 25, 2022 a three Judge Panel issued its decision upholding the Acting
Administrator’s revocation of Pronto Pharmacy’s registration, finding the Petitioner
has not shown that the Drug Enforcement Administration (“DEA”) see decision
published November 18, 2021, (li)
10. The Acting Administrator’s factual findings were supported by “substantial evidence” and thus
conclusive, used the length of time the DEA has interpreted § 1306.04(a) as allowing the same as a
proxy for whether it should simply defer to the DEA’s interpretation. Relying on his—and the DEA’s
—prior deci- sions, the Administrator simply responded that DEA precedent dictates the DEA
interprets the “legitimate, medical purpose” feature of the corresponding responsibility duty as
prohibiting a pharmacist or pharmacy from filling prescriptions with unresolved “red flags”. Id. at
62341 ibid 1, 2
11. see decision published November 18, 2021, revoking Pronto Pharmacy, LLC’s registration to
dispense controlled substances, was “arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law.” pursuant to; 5 U.S.C § 706(2)(A); Morall v. DEA, 412 F. 3d 165, 177 (D.C. Cir.
2006). The DEA’s conclusion
13
that revocation was warranted because the pharmacy had committed acts rendering
its registration inconsistent with the public interest was supported was supported
by substantial evidence. See 21uU.S.C. § § 823(F), 824 (a)(4); Masters Pharm., Inc v.
DEA, 861 F. #d 206, 215 (D.C. Cir 2017). In a addition petitioner has not shown that
the DEA’s interpretation of the Controlled Substances Act 21 U.S.C. § 801, et seq.,
was “arbitrary, capricious or manifestly contrary to the statute, “Wedge-wood Vill.
Pharmacy v. DEA, 509 F 3d 541, 549 (d.C. Cir 2007), or that the DEA subjected
Pronto Pharmacy LLC to unfair or unequal treatment, (see App 334-338)
&
SUMMARY OF THE ARGUMENT
The DEA has set up a system of dictating medical through which encourages
Pharmacists to profiling patients by the Processes of "RED FLAGGING." The term
Red Flag used and enforced by DEA is both subjective, arbitrary and capricious and
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. Under this interpretation, a golf ball
can become a football and baseball bat can enforced as a hockey stick. The DEA
Administrator need not determine the underlying legitimacy of the prescriptions a
pharmacy filled, but rather, may use “red flags” as a proxy to presume
prescription was illegitimate.
The question we seek out as pharmacist here in is when does a golf ball become a
football, at what point in the game does a baseball bat become a hockey stick and at
what point does the umpire call a strike across the plate third down?
When does the referee call a prescription written for a “legitimate medical purpose
illegal so that a pharmacy violates its corresponding responsibility whether or not
there is evidence of a prescription’s illegitimacy? At what point on the mile marker
does a prescription written by a licensed authorized provider to treat a medical
disease of a disease state become illegal or can the Umpire convert the rules.of the
game into scienter as an financial incentive to issue more fines and expand his/her
authority?
14
In this 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).
Whether a pharmacy violates its corresponding responsibility under 21 C.F.R. §
1306.04(a) by being compelled to operate beyond their subject matter expertise and
knowingly fills a prescription for a controlled substance issued for a legitimate
medical purpose where the prescription’s legitimacy remains undetermined?
That these DEA policies are applied so arbitrarily and capriciously makes them
violate the right of patients to seek healthcare treatment for acute, chronic pain
care. This misguided thinking of “redflags” has led to abuses by the DEA, and the
needless suffering and deaths of thousand of chronic disease patients such as
Sarcardosis, Amyotrophic lateral Sclerosis, Sickle Cell (SCD) because pain has
been criminalized by this massive over-reach of the DEA. There are no amount of
words any healthcare providers can write in any petition when learning of the
needless suffering deaths of their chronic pain patients or love ones being subjected
to inadequate narcotic analgesic medication treatment because of fear being
targeted by DEA-DOJ as drug seekers and their doctors, “drug dealers in white
coats.” (see App 12, 21,17, 354,356)
This fear is real, my brother Walter R. Clement a 34 year veteran Detroit Police
Dept., passed September 19, 2022, peacefully and in horrific agonizing untreated
pain from ALS because his doctors feared over-prescribing. Then their is Gilinda
Spirits,
Dame-Fincher 63, Cleveland , OH., with the Kincaid Kindred
fwww kks4scd.org) whose suffered all her life of the horrific pain from Sickle Cell
Disease, (a condition exempt from the 2016 CDC Guidelines) a graduate of the
University of Cincinnati requires two units of blood every month to sustain her life,
requiring Oxycontin and being denied by pharmacies as a “Red Flag.”
Further knowing there are only twenty (20) Adult Sickle Cell hematology physician
specialist in all of America remaining to care for SCD adult patients because these
doctors whom are authorized to prescribe are targeted.
Finally, the DEA’s interpretation of § 1306.04(a) is not entitled to Auer deference
because this is an “extraordinary case” and there is no “clear congressional
15
authorization” supporting the authority the DEA has improperly acquired from its
interpretation. Specifically, under its interpretation, the DEA has declared an
entire class of activity—filling (i.e., dispensing under § 841(a)) a prescription for a
controlled substance with unresolved “red flags” whether or not the prescription
was issued for a legitimate medical purpose—a criminal violation of the CSA. The
Court, however, has recognized that the Attorney General’s— who the DEA draws
its power from—authority under the CSA is limited to registering physicians and
scheduling drugs. The CSA therefore contains no “clear congressional
authorization” supporting the DEA’s authority to criminalize an entire class of
activity.
Accordingly, the Court should not defer to the DEA’s improper interpretation of §
1306.04(a) and instead should enforce the regulation so that it reflects the Court’s
prior decisions, and the original intent of Congress’ not to dictate the practice of
medcine and does not “unjustly punish” pharmacies. The Court should therefore
hold that a violation of a pharmacy’s corresponding responsibility requires a
determination of the legitimacy of the prescriptions it filled, and further, that this
determination uncover prescriptions were “not issued for a legitimate medical
purpose”.
REASONS FOR GRANTING THE PETITION
SHOULD
I. THE REVOCATION OF PETITIONER’S REGISTRATION
BE REVERSED BECAUSE A VIOLATION OF ITS CORRESPONDING
RESPONSIBILITY REQUIRES A DETERMINATION OF THE LEGITIMACY
OF THE PRESCRIPTIONS IT FILLED.
The revocation of Pronto Pharmacy’s registration Decision and Order, 86 FR 647,14
(2021) should be reversed because it could not have violated its corresponding
responsibility under § 1306.04(a) unless it filled controlled substance prescriptions
that were not issued for a legitimate medical purpose. 21 C.F.R. § 1306.04(a); see
Ruan, 597 U.S.__ (slip op. at 3). (affirming “[w]e assume, as did the courts below
and the parties here, that a prescription is “authorized” and therefore lawful if it
satisfies this standard [issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice].”). The Supreme
Court’s decision in Ruan v United States represents a critical step toward
16
remedying these problems. The Court categorically rejected the idea that physicians
could be convicted as drug traffickers merely by showing they prescribed outside the
usual course of practice, regardless of their intent. The Court observed that such a
standard would “criminalize a broad range of apparently innocent conduct” and risk
deterring physicians from using their best judgment to benefit patients.
The plain language of the regulation supports pharmacies do not violate their
corresponding responsibility where they fill a prescription issued for a legitimate
medical purpose. Id. In other words, rather than simply showing that a physician’s
prescriptions did not conform to professional standards, prosecutors must prove the
physician intentionally wrote prescriptions without any legitimate medical purpose.
The Court acknowledged that deviating from prevailing standards, such as
prescribing pain medications for certain off-label uses or in unusually large doses,
can be relevant in determining whether a physician intended to act unlawfully. But
these practices should not establish criminal liability on their own. Rather,
prosecutors must show other evidence of a physician’s intention to act as a drug
trafficker, such as prescribing drugs with high potential for misuse without
examining patients or charging patients according to the volume of drugs
prescribed.
The DEA though is willfully blind of this requirement and has instead interpreted §
1306.04(a) to penalize pharmacies, like Pronto Pharmacy, Decision and Order, 86
FR 647,14 (2021) regardless of the underlying legitimacy of the prescriptions it
filled, so long as there are unresolved “red flags”. See Colautti v. Franklin, 439 U.S.
379 (1979) (12)
This is deeply unfair to both physicians, and pharmacist who could face draconian
penalties without any evidence that they intended to engage in criminal activity.
The risk has been particularly acute for both physicians who treat patients for pain
and pharmacist who fill such prescriptions relying upon the prescribers “good faith”
and having verified the legitimacy of each prescription through the Prescription
Drug Monitoring Program (PDMP). Identifying the “usual course of practice” for
treating pain is especially challenging because patients’ experiences of pain and
treatment needs are so varied. Moreover, although physicians are trained to trust
their patients (and patient self-report is the standard approach for assessing pain),
both physicians and pharmacist could be convicted for failing to detect that their
patients were misusing or diverting their prescribed drugs.
17
Given the Court’s decision in Gonzales, where it recognized § 1306.04(a) is
genuinely ambiguous, Auer deference is appropriate if the DEA’s interpretation of
the regulation is reasonable, and an independent inquiry of the character and
context of the DEA’s interpretation entitles it to controlling weight. 546 U.S. at 258
(“[a] 11 would agree, we should think, that the statutory phrase “legitimate medical
purpose” is a generality, susceptible to more precise definition and open to varying
constructions, and thus ambiguous in the relevant sense.”); see Kisor, 139 S. Ct. at
2415-16. However, the review, reveals the DEA’s interpretation is not entitled to
deference because it is unreasonable, thereby exceed- ing the zone of ambiguity
identified by this Court’s prior cases and the original intent of Congress. The DEA’s
interpretation were reasonable, is not entitled to controlling weight insofar as it
exceeds the authority Congress has granted under the CSA and falls short of the
agency’s “fair and considered judgment”, creating an “unfair surprise” to regulated
parties (13)
Here, the question we seek out before this body as pharmacist, under what law, rule
or authority does the Umpire have to dictate a golf ball as a football? At what point
during the game does a baseball bat become a hockey stick and the Umpire has
authority dictate and change the rules, regulations and procedures of the game into
scienter and criminal offenses ?
12. The viability determination requirement of § 5(a) is void for vagueness. Pp. 439 U. S.
390-397. Though apparently the determination of whether the fetus "is viable" is to rest upon the basis
of the attending physician's "experience, judgment or professional competence, "it is ambiguous
whether that subjective language applies to the second condition that activates the duty to the fetus,
viz., "sufficient reason to believe that the fetus may be viable."Pp. 439 U. S. 391-392. (b) The intended
distinction between "is viable" and "may be viable" is elusive. Apparently those phrases refer to
distinct conditions, one of which indeterminately differs from the definition of viability set forth in
Roe v. Wade, 410 U. S. 113, and Planned Parenthood of Central Missouri v. Danforth, 428 U. S. 52.
Pp. 439 U. 3. 392-394. (c) The vagueness of the viability determination requirement is compounded by
the fact that § 5(d) subjects the physician to potential criminal liability without regard to fault.
Because of the absence of a scienter requirement in the provision directing the physician to determine
whether the fetus is or may be viable,.......faith,” United States v. Ragen, 314 U. S. 513, 314 Li. S. 524,
and the perils of strict criminal liability are particularlyacute here because of the uncertainty of the
viability determination itself. Pp. 439 U. S. 390-397
13. httns://vouarewithinthenorms.com/2022/09/24/pain-and-the-rules-of-law/
18
A. DEA DISPLAYS LACK OF KNOWLEDGE AND OF IN
PHARMACEUTICAL MEDICAL PRACTICE
THE
The warrant issued identified as “red flags.” Items that are evidence of violations of
21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of
The intent of this law implies that it shall be
oxycodone and hydromorphone).
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 use the law with intent to imply a
licensed Pharmacist and medical professionals as a person that illegally distribute,
or dispense, a controlled substances, (see App 374-385)
This means that like 21 U.S.C. § 841(a), the DEA’s regulation § 1306.04(a) must
also require a healthcare professional with medical expertise to determine the
legitimacy of a controlled substance prescription, rather than simply identifying
“red flags” from which the then-Acting DEA Administrator may presume a
prescription’s legitimacy. See Gonzales, 546 U.S. at 266 (affirming “[t]he structure of
the CSA 0 conveys unwillingness to cede medical judgments to an executive official
[i.e., the then-Acting DEA Administrator] who lacks medical expertise.”)
The DEA 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 license pharmacist was in violations of 21 U.S.C. §§ 841(a)(1)
(possession with the intent to distribute and distribution of oxycodone and
The officers should be charged under Giglio. As a licensed
hydromorphone).
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 drug and authorized, (see App 382-396). Mr.Clement nor his staff or any
drug whole-saler was ever arrested or charged or brought before a grand jury.
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 United States u.
Binder, 26 F. Supp. 3d 656, 662-63 (E.D. Mich. 2014) (confirming where no expert
19
determination was made as to the suitability of treatment involved in a case, “red
flags” are insufficient); see also United States v. Tran Trong Cuong, 18 F.3d 1132,
1141 (4th Cir. 1994); United States v. Jones, 570 F.2d 765, 769 (8th Cir. 1978).
The DEA agents removed files with the intent of searching to discover items to
suggest a criminal act took place or is taking place. This is not implied within the
warrant and the act of looking to find a criminal act is not supported by probable
cause.
In this and other cases DEA Diversion Investigator falsely established diversion
based solely on the use of “red flag,” googles maps and performed absolutely no
follow up investigation as found in Wheatland Pharmacy, 78 FR 69441, 69445
(2013)(see app 376-380) to establish diversion or evidence that any patients had
diverted any prescription medication filled by pharmacist from Pronto Pharmacy
LLC. (see App 345-352)
Similar misconduct by DEA Diversion Investigation is on the record in
investigations of Sun Tree Pharmacy and Superior Pharmacy, Tampa, Florida.
Such acts to search to find without stated cause for the search is an investigative
function that violates the premise of a search warrant and violated the basis of
Probable Cause, and elements of Reasonable Suspicion. The search conducted was
not specific in nature whereby the agents confiscated items not specific to the
warrant. The removal of such documents and items serves no purpose of criminal
activity but only to developing a case beyond the scope and statues of the search.
The intent that a person and not a sold medication and criminalizing the job of a
licenses Pharmacist, (see App-21-27)
The Fourth Amendment was intended to create a constitutional buffer between U.S.
citizens and the intimidating power of law enforcement. The officers failed to
indicate within their search warrant the components of what was to be seized. The
officers exercised undue discretion when they choose to search and seize.
Therefore, the interest of the defendant was violated when the search and seizures
became "unreasonable" and not authorized by the warrant based upon probable
cause, to remove personal artifacts such as documents of academic research. This
binder contained copyrighted academic research.
B. FAMILIARIZING AND HELPING THIS COURTS UNDERSTANDING,
ALL DRUG MEDICATIONS ARE DANGEROUS ESPECIALLY WHEN
20
TAKEN BEYOND THEIR THERAPEUTIC PRESCRIBED DOSE AND NOT
ALL OPIOIDS ARE CREATED EQUAL, ESPECIALLY IN THE BODY
The DEA and the drug war system on physicians and pharmacist have fails to
recognize a peoples 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 subjective standard of "one-size-fits-all" mindset has
become the foundation of government-dictated medicine. And it’s very bad medicine
unless they sell “drugs, not for legitimate purposes but ‘primarily for the profits to
he derived therefrom' ” and are acting outside the usual course of medical care.
Theses deeply flawed policies that are being enacted as law all over the country are
based on the "one-size-fits-none" subjective unscientific concept of morphine
milligram equivalents (MME) - the maximum amount of an opioid medication than
is permitted per patient per day. 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.
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. (see App-128-134)
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
21
not only is the CDC chart flawed, but the MME is little more than a random
number.
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.
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. (14), (15),(16)
(1) MME is a deeply flawed science used by DEA as a way to calculate the total
amount of opioids, accounting for differences in opioid drug type and strength.
(2) 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.
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.
22
*
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 mis
interpreting the purpose and roles of medications needed to treat acute,
chronic, neuropathic and psychological pain.
(3) DEA has waged a subjective campaign of misinformation to persuade the public
that these medications are dangerous drugs whose dosages are “BED FLAGS”
indicating abuse and trafficking, which contributes to the so-called Opiod crisis in
America.
The DEA has become a rogue agency based on flawed science and subjective
misinterpretations of medical procedures (which is outside their Congressional
authority) that has lost their mission, using threats and intimidation such as;
1. Tactics of no-knock raids and arrest,
2. Forfeiture,
3. Threat of prison time
They impose their will onto the medical profession (muses, pharmacists, physicians,
dentists, and especially drug wholesalers) and their patients.
23
OFfOID tdes«irt ttf#aYC*u&. yinge ncaotf?
CONVERSION FACTOR
Codeine
Fentanyl transdermal (in meg/hr)
0.15
2.4
Hydrocodone
I
4
Hydromorphone
Methadone
1-20 mg/day
4
21-40 mg/day
41-60 mg/day
8
10
i 61-80 mg/day
12
Morphine
1
Oxycodone
1.5
Oxymorphone
3
|
14. Josh Bloom, PhD, “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-equivalentsunscientific-15561
15. h2ps://www.acsh.org/profile/josh-hloom
16. Sally Satel, MD, “The Truth About Painkillers” National Affairs, Nr 47, Spring 2021. https://
ARUGUMENT
H. U.S. v. Levin 973 F.2d 463 (6th Cir. 1992) Decided Aug 7,1992
In Levin, the undisputed evidence established that the government issued letters
which were circulated to the defendant stating the government's approval of the
activity charged in the indictment the United States Supreme Court in Raley v.
State of Ohio, 360 U.S. 423, 79 S.Ct. 1257, 3 L.Ed.2d 1344 (1959). Holding that
24
"convicting a citizen for exercising a privilege which the State had clearly told him
was available to him" was "the most indefensible sort of entrapment by the State"
and violated due process (3) (see App-16-17)
In this case we previously demonstrated in Dispositive Motions, Addendums and
Supplements (see App-110, App 168-170) the DEA issued letters to Citizens,
Providers, a US Congress Member stating:
“The DEA lacks the authority to issue guidelines that constitute advice
relating to the general practice of medicine(see APP-19-21). The DEA has
not promulgated 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 may be prescribed on
a single prescription on the duration of treatment intended with the
prescribed controlled substance.” (See App-73-74 exhibit 5-4D September
14, 2022, US Court of Appeals DC , letter dated November 04, 2019, from:
Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control
Division, to: Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and
Regulatory Affairs National Association of Chain Drug Storesl776 Wilson
Boulevard Suite 200 Arlington, Virginia 22209) (see App-73-74 also App-15 thru
App-21). However, “red flags” are guidelines that constitute advice in medicine.
DEA’s , letter to Congresswoman Grace Meng,
“As a Law Enforcement agency, DEA is not a position to authorize or dictate what
a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it
comes to the practice of medicine because no such wavier exists....” (See APP- 72,
73,74) exhibit 5-3e filed September 14, 2022, US Court of Appeals DC,
Congresswoman Grace Meng, Member of Congress Sixty District of New York,
December 18, 2019).
DEA’s, letter to Richard Lawhern,
“ 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-
25
registered practitioner authorized by DEA to do so, to treat patients according to his
or her professional medical judgement in accordance with a standard of medical
practice that is generally recognized and accepted in the United States.
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...”
(See APP-92-93, exhibit 5-6F, Letter dated February 12,2021, from: Thomas W.
Prevoznik, DEA Deputy Assistant Administrator Diversion Control
Division, to: Richard A. Lawhem, Ph.D. 3691 Nestling Lane Fort Mill, South
Carolina 29708 lawhem@hotmail.com) (17)
In sum, the district court concluded from the undisputed extrinsic evidence, initially
introduced during the court's pretrial hearing addressing the defendants' 12(b)
motion to dismiss the indictment, including the HCFA letters, that the sales
inducements did not constitute criminal activity in violation of § 1395nn(b')(l)(B),
and that the defendants and those similarly situated could not, as a matter of law,
have formulated the necessary intent to participate in a criminal act in violation of
§ 1395nn(b)(l)(B). (17),(18)
Though the burden of proof is not the same for § 1306.04(a) given the regulation
does not impose criminal liability, the “near equivalence” of the regulation supports
that, like § 841(a), each of the regulation’s elements must be proven, including that
a pharmacy filled a prescription for a controlled substance that was not issued for a
legitimate medical purpose.? 21 C.F.R. § 1306.04(a). To be sure, in Gonzales, the
Court observed that though the Attorney General argued he was interpreting
‘legitimate medical purpose” as it pertained to § 1306.04(a), given the regulation’s
“near equivalency” to the statutes found in the CSA, the Administrator was in fact
trying to interpret the statutes—power that Congress has yet to entrust to the
Attorney General. 546 U.S. at 257, 262 (acknowledging “[a]n agency does not
acquire special authority to interpret its own words when, instead of using its
expertise and experience to formulate a regulation, it has elected merely to
paraphrase the statutory language”).
"l
26
The Court explained that if the Attorney General could interpret § 1306.04(a) so
that he could determine what class of activity was and was not medically legitimate
(i.e., outside the course of professional practice), he would have the power to
criminalize the actions of DEA registered physicians. Id. at 262 ((advising “[i]t
would be anomalous for Congress to have so painstakingly described the Attorney
General’s limited authority to deregister a single physician or schedule a single
drug, but to have given him, just by implication, authority to declare an entire class
of activity outside “the course of professional practice,” and therefore a criminal
violation of the CSA.” (citation omitted)); (is)
The letters of DEA Thomas W. Prevoznik, DEA Deputy Assistant
Administrator Diversion Control Division, act as a command exercising a
privilege. The Court reaffirmed its pronouncements in Raley v. State of Ohio, in
United States v. Laub, 385 U.S. 475, 87 S.Ct. 574, 17 L.Ed. 2d 526 (1967), where it
stated: Ordinarily, citizens may not be punished for actions undertaken in good
faith reliance upon authoritative assurance that punishment will not attach. As this
Court said in Raley v. State of Ohio, 360 U.S. 423. 438, 79 S.Ct. 1257, 1268, 3
L.Ed.2d 1344, we may not convict ” a citizen for exercising a privilege which the
State clearly had told him was available to him." As Raley emphasized, criminal
sanctions are not supportable if they are to be imposed under "vague and
undefined" commands (citing Lanzetta v. State of New Jersey, 306 U.S. 451, 59
S.Ct. 618, 83 L.Ed. 888 (1939)); or if they are "inexplicably contradictory" (citing
United States v. Cardiff, 344 U.S. 174, 73 S.Ct. 189, 98 L.Ed. 200 (1952); and
certainly not if the Government’s conduct constitutes " active misleading language".
Thus we have based our argument here that the DEA Administrator has attained
“omnipotent powers” not granted by Congress and has been wrongfully excersizing
the use of their ill-attained authority to regulate the practice of medicine by
criminalizing good faith medical mistakes being freely able to move the goal post
backward and forward generate rules policy and law without proper notice or
hearing required by Congress See 21 U.S.C. § 903., and further act as the Federal
equivalent of a state medical board overseeing the general practice of medicine
while they have lacked the authority to issue guidelines that constitute advice
relating to the general practice of medicine.”...dictating what a doctor prescribes to
a patient, promulgating regulations regarding the treatment of pain, imposing
specific quantitative minimum or maximum limit (a subjective standard of 90MME)
on the amount of medication that may be prescribed on a single prescription on the
duration of treatment intended with the prescribed controlled substance, simply
27
“The DEA lacks the authority to issue guidelines that constitute advice relating to
the general practice of medicine, (see App. 16-19 App. 72,73,74,92,93)
17. The assignment of error confronting this appellate review was initially resolved by the United
States Supreme Court in Raley v. State of Ohio, 360 U.S. 4.23, 79 S.Ct. 1257, 3 L.Ed.2d 1344 (1959).
In that action defendants had been convicted for refusing to answer certain questions before the
TJnamerican Activities Commission of the State of Ohio". The defendants had invoked the privilege
against self-incrimination after various commission members, including the chairman, erroneously
advised them that the enabling legislation extended them the right against self- incrimination.
Subsequently, defendants were indicated in the state court for exercising the privilege. They were
convicted. The conviction was affirmed by the Supreme Court of Ohio.
18. In reversing the defendants* conviction, the United States Supreme Court concluded that: “the
judgments of convictions rendered below violate the Due Process Clause of the Fourteenth
Amendment. . . . [Hjere the Chairman of the Commission, who clearly appeared to be the agent of
the State in a position to give such assurances, apprised three of the appellants that the privilege in
fact existed, and by his behavior toward the fourth obviously gave the same impression. . . . [Hjere
the crime said to have been committed hv the appellants, as defined by the State Supreme Court,
was simply that of declining to answer any relevant question on the ground of possible self
While there is no suggestion that the Commission had any intent to deceive the
incrimination
appellants, we repeat that to sustain the judgment of the Ohio Supreme Court on such a basis after
the Commission had acted as it did would be to sanction the most indefensible sort of entrapment by
the State — convicting a citizen for exercising a privilege which the State clearly had told him. was
available to him. Cf. Sorrells v. United States, 287 U.S. 435, 442, 53 S.Ct. 230, 212, 77 L.Ed. 413. “
19. A state may not issue commands to its citizens, under criminal sanctions, in language so vague
and undefined as to afford no fair warning of what conduct might transgress them. Lametta v. State
of New Jersey, 306 U.S. 451, 59 S.Ct. 618, 83 L.Ed. 888. Inexplicably contradictory commands in
....United States v. Cardiff, 344 U.S. 174, 20. This means that like 21 U.S.C. § 841(a), the DEA’s
regulation § 1306.04(a) must also require a healthcare professional with medical expertise to
determine the legitimacy of a controlled substance prescription, rather than simply identifying “red
flags” from which the then-Acting DEA Administrator may presume a prescription’s legitimacy. See
Gonzales, 546 U.S. at 266 (affirming “[tjhe structure of the CSA Q conveys unwillingness to cede
medical judgments to an executive official [i.e., the then-Acting DEA Administrator] who lacks
medical expertise.”)
28
C. THE GOVERNMENT FAILED TO PROVE BY A PREPONDERANCE OF
THE EVIDENCE THAT THE PETITIONER DISPENSED PRESCRIPTIONS
WITHOUT RESOLVING “RED FLAGS”
The regulation at the heart of this case, 21 C.F.R. § 1306.04(a), provides: “A
prescription for a controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual course of his
professional practice.” The DEA has developed a range of regulations to monitor
and control provider registration for prescribing and dispensing controlled
substances. One such regulation, 21 C.F.R. § 1306.04(a), places a corresponding
responsibility on pharmacists and pharmacies to refuse to fill prescriptions that are
not issued for a legitimate medical purpose. In this case the DEA has interpreted §
1306.04(a) so that a pharmacy violates its corresponding responsibility if it fills
controlled substance prescriptions without resolving “red flags”.
Under this interpretation, the DEA Administrator need not determine the
underlying legitimacy of the prescriptions a pharmacy filled, but rather, may use
“red flags” as a proxy to presume a prescription was illegitimate. Supreme Court
9-0 Ruan-Khan vs United States could not be met to establish criminal negligence
and falsely established diversion based solely on the use of “red flags “and
performed absolutely no investigation in Ruan v. United States holding that
“§841(a)(l) and § 1306.04(a) require the government to provide that a practitionerdefendant either:
(1) subjectively knew a prescription was issued not for a legitimate medical
purpose; or
(2) issued a prescription that was objectively not in the usual course of
professional practice.” Going strictly by “pill,” numbers is not enough to
support a prosecution. The government must prove that a doctor prescribed
controlled substances for no ‘legitimate medical reason” to impose criminal
liability as a violation of Section 841(a) of the Controlled Substances Act.
United States v. Outler, 659 F.2d (see Ruan v. United States, App-14)
29
Although § 1306.04(a) has been held genuinely ambiguous, the DEA’s interpretation
of the regulation is not entitled to the [Auer] deference customarily awarded to an
agency when it interprets its own regulation. This is because Auer deference is only
appropriate where an agency’s interpretation of its genuinely ambiguous regulation
is reasonable and an independent inquiry into the character and context of the
agency’s interpretation entitles it to controlling weight.
The Government’s expert, Dr. Sullivan, testified at length that the prevailing
professional standard of care applicable to the Petitioner requires the Petitioner
and its pharmacists to conduct a prospective drug utilization review and attempt to
resolve “red flags” — i.e., indicia of diversion or abuse - before filling (or refusing to
fill) a prescription for controlled substances. Dr. Sullivan opined that there are
many options available to a pharmacist to address “red flags,” including, inter alia,
speaking with, observing, or even conducting a physical examination of the patient,
communicating with the prescriber, and reviewing PDMP data. He also emphasized
that there is no “one size fits all” approach to conducting a prospective drug
utilization review, as each patient and prescription may present different
circumstances that the pharmacist, in the exercise of his or her independent
professional judgment regarding whether a prescription was issued for a legitimate
medical purpose, must consider. Dr. Sullivan was adamant that, whatever efforts a
pharmacist may make to resolve “red flags,” the prevailing standard of professional
care absolutely and unequivocally requires that the pharmacist must document his
efforts somewhere, whether in the pharmacy’s patient record management system
(a/k/a, the “patient profile”) or, notably, on the face of the prescription itself. It is in
this regard that the Government’s first contention falls short.
It is beyond peradventure that the Government seized data from the Petitioner
during the execution of the OSC. It is also unquestionable that these data included
images of the actual prescriptions filled by the Petitioner during the relevant time
period. Indeed, in the pre-hearing phase of this proceeding, the parties extensively
briefed this Tribunal on the whereabouts of the prescription image data seized by
DEA.
The Petitioner alleged that when the DEA eventually returned Petitioner’s
computer equipment several months after the initial seizure, the Petitioner
discovered that the data were corrupted and/or rendered inaccessible in its
computer system and certain items of hardware had been destroyed while in DEA
custody. Through these pre-hearing
proceedings, it became clear that the
Government was able to obtain images of the actual prescriptions filled by the
30
Petitioner. In fact, the Government included excerpts of certain prescription images
in the demonstrative exhibit it used extensively at the hearing.
Remarkably, though it clearly had these documents in its possession, the
Government did not seek to introduce any of the original prescriptions, or even
electronic images thereof, into evidence at the hearing. The Government’s expert
also testified that he had not reviewed any of the actual prescriptions or images
thereof, and had not asked the DEA to provide those documents to him for review.
Instead, the Government relied solely upon PDMP data - spreadsheet reports that
DI Albert testified were generated from the PDMP and/or E-FORSCE databases.
The Government’s exclusive reliance on PDMP data and its expert’s review thereof
to prove that “red flags” were not resolved was insufficient for at least one glaring
reason: its own expert testified that the prevailing standard of professional care
required the Petitioner to document the resolution of “red flags” in one of two places
- either in the “patient profile” (i.e., in the Appellant’s patient management
computer system), or on the face of the prescription itself. It would confound logic to
conclude, as the Government invites us to do, that the evidence demonstrates that
Appellant failed to resolve “red flags” when the record is utterly devoid of even so
much as a single, actual prescription. Stated differently, if the Petitioner had the
option to document resolution of “red flags” on the face of the prescriptions, but
there is no record evidence before this Tribunal to suggest whether the Respondent
documented resolution of “red flags” on the prescriptions (i.e., because there are no
prescriptions in evidence), then it cannot be said that the Appellant, in fact, failed
to document its resolutions or attempted resolutions of “red flags.” At best, the
likelihood that the Petitioner resolved the “red flags” is equal to the likelihood that
it failed to do so. We reach this conclusion because, as noted above, only half of the
relevant evidence on this question is before us. To prove a factual assertion by a
preponderance of the evidence, the Government must, at a minimum, show that it
is more likely that not that the Petitioner failed to resolve the “red flags” in
question. It has not done so.
The DEA has developed a range of regulations to monitor and control provider
registration for prescribing and dispensing controlled substances. One such
regulation, 21 C.F.R. § 1306.04(a), places a corresponding responsibility on
pharmacists and pharmacies to refuse to fill prescriptions that are not issued for a
legitimate medical purpose.
31
In this DEA has interpreted § 1306.04(a) so that a pharmacy violates its
corresponding responsibility if it fills controlled substance prescriptions without
resolving “red flags”. Under this interpretation, the DEA Administrator need not
determine the underlying legitimacy of the prescriptions a pharmacy filled, but
rather, may use “red flags” as a proxy to presume a prescription was illegitimate.
Although § 1306.04(a) has been held genuinely ambiguous, the DEA’s interpretation
of the regulation is not entitled to the [Auer] deference customarily awarded to an
agency when it interprets its own regulation. This is because Auer deference is only
appropriate where an agency’s interpretation of its genuinely ambiguous regulation
is reasonable and an independent inquiry into the character and context of the
agency’s interpretation entitles it to controlling weight.
Further the DEA’s interpretation of § 1306.04(a) is unreasonable given the “near
equivalence” of the regulation to the statutes in the CSA. This “near equivalency”
means that it is these statutes the DEA has interpreted and not the regulation—
power Congress has not entrusted to the DEA. The DEA’s interpretation is also
unreasonable because it is inapposite given the Court’s characterization of willful
blindness, which requires the existence of the fact a defendant is found willfully
blind of. Here, that fact being whether the prescriptions Pronto Pharmacy filled
were not issued for a legitimate medical purpose.
A state may not issue commands to its citizens, under criminal sanctions, in
language so vague and undefined as to afford no fair warning of what conduct might
transgress them. Lanzetta v. State of New Jersey, 306 U.S. 451, 53 S.Ct. 618, 83
L.Ed. 888. Inexplicably contradictory commands in statutes ordaining criminal
penalties have, in the same fashion, judicially been denied the force of criminal
sanctions. United States v. Cardiff, 344 U.S. 174,
D. THE GOVERNMENT FAILED TO PROVE THAT THE RESPONDENT
“MANUFACTURED,” RATHER THAN “COMPOUNDED,” SCHEDULE II
CONTROLLED SUBSTANCES
The other theory advanced by the Government is that the Appellant engaged in
illegal “manufacturing” of Schedule n controlled substance, as opposed to
permissible “compounding” of those materials. Applying the legal framework of the
CSA, the Government thus contends that under factor 2 of § 823(e), the Respondent
has not complied with applicable federal, state and local law. Accordingly, before
32
turning to a consideration of the evidence before us, we must consider the
requirements of applicable federal, state, and local law. (see. APP-52-54)
The Appellant is registered with the DEA to “dispense” Schedule II controlled
substances. The CSA defines “dispense” to mean “to deliver a controlled substance
to an ultimate user or research subject by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a controlled substance
and the packaging, labeling or compounding necessary to prepare the substance
for such delivery.” 21 U.S.C. § 802(10) (emphasis supplied), (see. APP 138-150)
The statute also defines the term “manufacture” to mean “the production,
preparation, propagation, compounding, or processing of a drug or other substance,
either directly or indirectly or by extraction from substances of natural origin, or
independently by means of chemical synthesis or by a combination of extraction and
chemical synthesis, and includes any packaging or repackaging of such substance or
labeling or relabeling of its container; except that such term does not include
the preparation, compounding, packaging, or labeling of a drug or other
substance in conformity with applicable State or local law by a
practitioner as an incident to his administration or dispensing of such
drug or substance in the course of his professional practice. 21 U.S.C. §
802(15) (emphasis supplied), (see App 30-35)
The CSA does not supply a definition of “compounding.” However, because the CSA
refers to the “compounding ... of a drug ... in conformity with applicable State or
local law,” we can look to State law to supply the relevant definition.
Under Florida law, “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.” FAC Rule 64B16-27.700. Pursuant to Rule 64B16-27.700,
compounding specifically includes the following three (3) activities:
•
The preparation of drugs or devices in anticipation of prescriptions
based on routine, regularly observed prescribing patterns.
33
•
The preparation pursuant to a prescription of drugs or devices which are not
commercially available.
•
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.
FAC Rule 64B16-27.700(1) (emphasis supplied).
Another federal law also provides guidance regarding the circumstances under
which a pharmacist may compound drugs. The Federal Food, Drug, and Cosmetic
Act (hereinafter, the “FDCA”) imposes certain requirements upon those who
produce drugs for human use. See 21 U.S.C. §§ 301-392, et seq. Sections 501, 502,
and 505 of the act set forth the obligations of human drug producers with respect to
the implementation of current good manufacturing practices, drug labeling and
directions for use, and the approval of new drug applications or abbreviated new
drug applications. 21 U.S.C. §§ 351, 352, 355.
However, a licensed pharmacist in a State licensed pharmacy who compounds
human drug products is exempt from the aforementioned requirements of the FDCA
if certain conditions are met. 21 U.S.C. § 353a(a). Specifically, there are two (2)
circumstances in which the compounding exemption applies, to wit•
If the drug is compounded by a licensed pharmacist in a State licensed
pharmacy or a Federal facility, or a licensed physician, on the prescription
•
order for an individual patient made by a licensed physician or other licensed
practitioner authorized by state law to prescribe drugs, or
•
If the drug is compounded by a licensed pharmacist or licensed physician in
limited quantities before the receipt of a valid prescription order for
such individual patient if the compounding is based on a history of the
licensed pharmacist or licensed physician receiving valid
prescription orders for the compounding of the human drug product,
and the orders have been generated solely within an established
34
•
relationship between the licensed pharmacist or licensed physician
and either such patient for whom the prescription order will be
provided or the physician or other licensed practitioner who will
write such prescription order.
21 U.S.C. § 353a(a)(2)(A) (emphasis supplied).
The latter practice described above, known as “anticipatory compounding,” can be
beneficial not only because larger batch sizes can increase efficiency and reduce the
likelihood of human error associated with small batch compounding, but also
because the limitations set forth in the statute serve to distinguish licensed
pharmacists practicing permissible “compounding” under 503A of the FDCA from
conventional manufacturers, who generally produce larger quantities of drugs that
are distributed without a prescription.
With all of the foregoing framework in mind, it would be fair to summarize the
distinction between “manufacturing” and “compounding,” for purposes of applying
the CSA in the instant proceeding, as follows:
•
“manufacturing” means the production of drugs, but does not include
“compounding” in conformity with State and local law.
Neither the CSA nor the FDCA expressly defines “compounding,” but Florida law
supplies the definition:
Under Florida law, “compounding” is the incorporation of ingredients to
create a finished drug product for dispensing to a patient, and specifically
includes, inter alia, anticipatory compounding and preparation of
commercially available products from hulk, (see APP-145-158, 374-378)
•
Anticipatory compounding may be practiced, in compliance with each of the
federal and state laws referenced herein, by a licensed pharmacist in a State
licensed pharmacy so long as the conditions of 21 U.S.C. § 353a(a)(2)(A) are
satisfied, (see App 136-144, 368-373) (see OTSC App- 381-383)
Turning to the evidence before us, we cannot conclude that the Appellant was
engaged in “manufacturing” as that term is defined by the CSA. The evidence
35
included approximately 51 pages of batch records for limited quantities of two (2)
different strengths of hydromorphone, a Schedule II controlled substance. GE 5, 6.
DI Albert was unable to identify the signatures and initials contained on these
batch records and did not compare the number of doses of capsules reflected in the
batch reports to the amount of drugs dispensed by the Appellant. There was no
evidence that Appellant produced significantly large quantities of any drug, nor was
there any evidence that Appellant sold or wholesaled any drug, in any quantity, to
any distributor or reseller (such as would be expected in the case of a traditional
drug manufacturer, whose business model typically involves the distribution of
drugs to third parties without a prescription). (App. 137-139)
There was also no evidence to suggest that the single drug compounded by
Appellant was not compounded in anticipation of receipt of valid prescriptions
based upon established historical relationships with patients to whom the drug was
prescribed and providers who prescribed it.
In fact, the evidence of record demonstrates that the Appellant dispensed a
significant amount of hydromorphone, and Dr. Sullivan testified about the
dispensing of this drug by Appellant on several occasions. In short, the evidence
appears to suggest that the Petitioner’s Pronto Pharmacy engaged in permissible
anticipatory compounding in compliance with applicable federal and state law. (see
APP-137-138) Such practice is, according to the CSA, not encompassed within the
definition of “manufacturing ” 21 U.S.C. § 802(15).
In order to prosecute a pharmacist does the DEA have the authority to move the
goal post backward and forward, redefine a golf ball as a football, change the rules
of the game while in the game, to regulate the practice of medicine and pharmacy
by unenumerated “red flags,” not developed by notice and comment, statues or
medical expertise and enforcing such authority thru forfeiture laws, revocations
certificates of registration while, “lacking the authority to promulgate rules.” (see
APP-139,149,150, see also App 16-19, App 72,73,74,92,93)
t'
36
CONCLUSION
For the foregoing reasons, the revocation of Pronto Pharmacy’s registration should
be reversed and the Court should grant Petitioner’s writ of certiorari as the decision
in this case by this Court will have far-reaching effects on the professions of
Medicine, and Pharmacy. The Petitioner is a Pharmacist Not a Street Drug Dealer.
Respectfully submitted
Norman J Clement, pro se
Pronto Pharmacy LLC
P.O. Box 280139
Tampa FI. 33682
vwtn@umich.edu or Drontonharmacv@aol.com
OCTOBER 26, 2022
APPENDIX TABLE OF CONTENTS
Opinion of the United States Court of Appeals for
the District of Columbia (September 19, 2022)......... la
Decision and Order of the United States Department
of Justice Drug Enforcement Administration (Filed November 9, 2021, Effective
December
21, 2021)
Respondent’s Proposed, Finding of Facts and Con-conclusion of Law
March 11, 2020
333app
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
195app
(May 5, 2020)
Petitioner’s Dispositive Motions to Vacate Administrative Judges Findings and
DEA Administrative Orders Restore CSA Registration of Pronto Pharmacy LLC
and Award Damages, Amend Index of Record
January 16, 2022.....App-110, February 03, 2022..... App-182
Order of the United States Court of Appeals for
the District of Columbia Denying Petition for Rehearing En Banc (September
Appl-2.
2022,)
Regulatory and Statutory
Provisions Involved
3app
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.