NORMAN J. CLEMENT RPH., DDS.,
WITH CONTRIBUTION FROM
JACK FOLSON RPH, WALTER R. CLEMENT MS., MBA., RICARDO FERTIL PHARMD, NORMAN L.CLEMENT PHARM-TECH, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BERES E. MUSCHETT, BS., STRATEGIC ADVISOR
THE CONGRESS MUST DEFUND THE DRUG ENFORCEMENT AGENCY
THE MANIFESTO OF THE NORTH STAR PROJECT
When you see THROUGHOUT LIFE most of your friends, colleagues, and classmates who are of degree being defiled, sanctioned, terminated, harassed, arrested, jailed, and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do
Then at some point, you are compelled to ask yourself when
ENOUGH IS ENOUGH.
At some point in your life, you have to say and proclaim enough is enough and what are you going to do about it.
Then we must stand and fight as soldiers together or die like mice.
ENOUGH IS ENOUGH.
To me, that idea of an Administrative Judge Federal showing such destain to a Respondent would so overturn nearly 200 years of medical and pharmaceutical practice make this court worthy of oversight and disillusionment
WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY TO THE UNITED STATES HOUSE COMMITTEE ON THE JUDICIARY, UNITES STATES HOUSE OVERSIGHT ON OVERSIGHT SUBCOMMITTEE ON GOVERNMENT OPERATIONS AND UNITED STATES SENATE COMMITTEE ON THE JUDICIARY TO DEFUND AND DISBAND THIS AGENCY OF GOVERNMENT.
ENOUGH IS ENOUGH.
THE CONGRESS MUST DEFUND THE DEA
THIS PRESENTATION CONTAINS MUST SEE VIDEOS WHICH SUPPORTS THE NARRATIVE OF THIS ARTICLE
The DEA has acted as an unregulated medical agency policing medical facilities and medical practices without legal standards and grounds and the DEA Administration Court System body, which operates within the Department of Justice (DOJ), like a runaway unconstitutionally entity, and immune to all laws of governance of all courts within the Justice System.
Therefore, it is incumbent for Chair of the Subcommittee of Federal Court Operation, Congressman Hank Johnson of Georgia’s 4th district to give Oversight on the DEA Court System which operates outside the Federal Rules Evidence and of Civil Procedures.
On May 5, 2020, Mark D. Dowd, U.S. Administrative Law Judge, in the matter of Pronto Pharmacy, LLC Docket No. 19-42 issues RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION OF THE ADMINISTRATIVE LAW JUDGE in a rambling decision of 148 pages, to be found so ridicules it overturned nearly 200 years of medical and pharmacy law(s) and protocols.
THE HOUSE JUDICIARY COMMITTEE MUST BEGIN OVERSIGHT THIS COURT SYSTEM
Yet, it is further clear, on this day U.S. Administrative Law Judge Mark D. Dowd, was so busy trying to be a bigot, so busy trying to be a racist, so busy trying to be the toughest man on the Federal bench he forgot how to be fair. You Are Within The Norms has decided to publish the last 50 pages of Judge Dowd’s decision in which the respondent never spoke one word.
One can never prevail in any court system or environment, even when supported with science and facts, against bias and prejudice, or when privilege is permitted to take the stand. Yet still, it is not Judge Mark D. Dowd, bias/racism that is troublesome, it is his stupidity in his recommended ruling, findings of facts, the conclusion of law which eviscerates nearly two hundred years of medical and pharmacy law and protocols.
THE PAINFUL DISCUSSION OF BEING UNDERESTIMATED, UNDERVALUED AND MARGINALIZED
Let it be clear the poor training and limited comprehension, lack of understanding of pharmaceutical science, pharmacy law, and pharmacy protocols of DI Richard James Albert are deliberate, yet essential, and purposefully crafted by his handlers to perform his mission. Richard James Albert does not perform without their command. His handlers more than understand they can prevail with him in spight of their dismissiveness toward medical science and protocols. DI Albert could never be used successfully against a large Chain Drug Store or a Jewish, or White-owned pharmacy because the quality of his knowledge and training would quickly be exposed in a legal proceeding.
However, DI Richard James Albert can prevail against a Black-owned Pharmacy despite any facts or laws we present because the built-in institution of racial injustice, particularly within the Judicial System or in the field of medical science, sports, politics, or the military, will default to all knowledgeable, educated Black persons as arrogant and uppity. We see this in our history, particularly in the United States, when one is right and dares to challenges the morae within the system. (1)
Arrogance is rate-limiting, defined all by a preconceived standard of what we are expected to know and further based on a preconceived level of knowledge, expectation, and skill of what one should have obtained. This is likely an eighth-grade education. Anything beyond that becomes suspicious, surprise, unearned, and requires further examination of one’s credentials, instead of being well versed, you are detested. Arrogance stops one in their tracks to be undervalued, underestimated, and marginalized. (1) This is a reality that all Black professionals face, especially those who are licensed in any profession, which we only quietly discuss this among ourselves.
YET, THE PEOPLE AREN’T AS STUPID AS THE DEA THINKS WE ARE!
The authors of this article have learned one thing:
” in America, you either stand for something or nothing at all.”
If standing against DEA’s abuses by redefining medical science procedures, their lies, and deceptions perpetrated by this Federal Institution (DEA), then we are one more set of uppity arrogant Black N-Word SOB’s the DEA, DOJ, or anyone else just don’t have to like.
Because we stand and rise against to oppose this system of injustice, which treats licensed Black pharmacists as common drug dealers, we will put an end to the United States Drug Enforcement as an agency of Government, through Congressional Oversight and wisdom and put an end automatically defining degree people of color as arrogant. We have learned from our ancestors, “just to sit still would be a sin:”
“There is no human activity you can ever perform that will ever lift the shroud of this racial constructs in this system the restraint is the color of your skin”
COMPOUNDING IS NOT MANUFACTURING NEVER HAS AND NEVER WILL BE!!
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Compounding is defined in several ways according to the Guidelines for Compounding Practices we quote these definitions verbatim from Chapter 795 of the United States Pharmacopeia (USP)
Compounding can be as simple as the addition of a liquid to a manufactured drug powered or as complex as the preparation of a multicomponent parenteral nutrition solution. In general, compounding differs from manufacturing in that compounding involves a specific practitioner-patient-pharmacist relationship, the preparation of a relatively small quantity of medications, and different conditions of sale.
Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders, on the basis of routine, regularly observed prescribing patterns. (2)
MANUFACTURING INCLUDES THE PREPARATION AND THE PROMOTION OF A COMMERCIALLY AVAILABLE PRODUCT
“Manufacturing is the production, preparation, propagation, conversion, and/or processing of a drug or device, either directly or indirectly, through extraction from substances of natural origin or indecently through means of chemical or biological synthesis; the terms include any packaging or repackaging of the substances(s) or labeling or relabeling of its container and the promotion and marketing of such drug devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.” (2)
GUIDELINES FOR DISTINGUISHING BETWEEN COMPOUNDING AND MANUFACTURING ARE AS FOLLOWS:
“Pharmacists may compound, in reasonable quantities, drug preparations the are commercially available in the mar place if a pharmacist-patient-prescriber relationship exists and a valid prescription is presented.
Pharmacists may compound nonprescription medications in commercially available dosage forms or in alternative dosage form to accommodate patients’ needs called by individual state boards of pharmacy.”
“Pharmacists may compound drugs in limited quantities prior to receiving a valid prescription, on the basis of history receiving valid prescription that has been generated solely within an established pharmacist-patient prescriber relationship, and provided that the prescriptions are maintained on file for all such preparations dispensed at the pharmacy.”
“The pharmacist should not offer compounded medications to other pharmacies for resale; however, a practitioner may obtain compounded medications to administer to patients, but it should be labeled with the following: “For Office Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by a hospital to contract compounding pharmacies.”
“Compounding pharmacies and pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services.”
Judge Mark Dowd’s decision of May 5, 2020, has been labeled ridiculous by Pronto Pharmacy Attorney Dale Sisco and more than demonstrates his incompetents and fails as a Juris. Most importantly, had Judge Dowd simply took a look at the DEA website under 21 USC 1301.13 which he deliberately goes out of his way to misinterpreted this law:
” A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.“
DEA’s argument, has been Pronto Pharmacy compounding of control medications was concluded as manufacturing and Pronto Pharmacy needed a separate manufacturing registration. This was because their retail registration license does not cover for manufacturing. The chart of guidelines more than contradicts all DEA assertions made by both DI Albert and his handlers against Pronto Pharmacy.
The DEA Diversion Investigator Richard James Albert prepared a warrant that “opinion based on a red flag that Pronto Pharmacy engaged in manufacturing-controlled substances. Albert’s actions and those of his handlers (The crew) were both deliberate fabrications of the laws and distortion of truths in order to shut Pronto Pharmacy down. Specifically, these are the assumptions purposely perpetrated by The Crew that crimes were being committed within the Pronto Pharmacy to justify the removal of their Control Substance Registration Certificate.
Pronto Pharmacy LLC is a licensed retail community pharmacy by law and permitted under this license to compound control medications. The below chart demonstrates Richard James Albert nor his handlers comprehended existing laws and/or rules guiding the practicing of Pharmacy; DEA Judge Mark Dowd was just as complicit in their ignorants.
More specifically control medications and this chart under (iv) practitioners, hospitals retail pharmacies are permitted under their DEA Federal Registry certificate to process Schedule medications II-V. This chart specifically outlines:
“A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture.“
DEA WEBSITE UNDER 21USC 1301.13
|(iv) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution)||Schedules II–V||New–224 Renewal–224a||731||3||May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound, or mixture. A retail pharmacy may perform central fill pharmacy activities.|
Yet, more, troublesome these guidelines are from the DEA’s own website under 21 USC 1301.13 under certificate new license and renewal (224&224a) and the cost for this license is $731.00 and it is good for 3 years. The importance is DI Albert didn’t appear to know any of laws, nor does it appear searched for any laws and his handlers, Aimee Hickerson, Susan Langston, John Beerbower kept him ignorant of the laws.
JUDGE MARK DOWD’S 48 PAGE RULING
Analysis of Unlawful Manufacturing Allegation
“Finally, the Government alleges that the Respondent engaged in “manufacturing” controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing the manufacture of controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28. Specifically, the Government alleges that the Respondent compounded oxycodone and hydromorphone capsules in such large quantities that this activity constituted manufacturing rather than permissible compounding for individual patients. Id.
DEA regulations require registrants to obtain a separate registration for each regulated business activity in which they engage. 21 C.F.R. § 1301.13(e). Section 1301.13(e) provides ten separate business activities, to include manufacturing and dispensing.44 Id. at (e)(1)(i), (iv). Each business activity is “deemed to be independent of each other.” 21 U.S.C. § 1301.13(e). In other words, a registration for one activity does not authorize the registrant to engage in another activity. Id. To engage in both dispensing and manufacturing, a registrant would need to apply for and obtain separate registrations for each activity. No person or entity may engage in a regulated business activity “until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person [or entity].” 21 C.F.R. § 1301.13(a).”
JUDGE MARK DOWD’S Pre-posed Opinion as written from 101 thru 137. NOTE: (this is verbatim from his Pre-posed opinion included are his typo which we did not correct)
“Requiring separate registrations for manufacturing and dispensing is more than mere formality. In fact, the CSA imposes stricter requirements on manufacturers than dispensers, not to mention a different standard for issuing a sanction. Wedgewood Village Pharm., 71 Fed. Reg. 16593, 16594 (2006); compare 21 U.S.C. § 823(a) (setting forth six public interest factors for manufacturers of
44 Although not relevant to this case, the other business activities include distributing, reverse distributing, research (Schedule I), research (Schedules II-V), narcotic treatment programs, importing, exporting, and chemical analysis. 21 U.S.C. § 1301.13(e)(1).”
“Schedule I and II controlled substances), with 21 U.S.C. § 823(f) (establishing five similar, yet different, public interest factors for practitioners, which includes pharmacies engaged in dispensing). Additionally, the CSA imposes higher standards for recordkeeping, reporting, and security on manufacturing than it does on dispensing. 71 Fed. Reg. at 16594. Manufacturers are also required to obtain a registration annually, whereas dispensers are only required to obtain a registration every three years. Id. (citing 21 U.S.C. § 822(a)(1)-(2)).”
” The Respondent is registered with the DEA as a “retail pharmacy.” GX 1. Pursuant to this registration, the Respondent may dispense controlled substances in Schedules II-V. Id.; 21 C.F.R. § 1301.13(e)(1)(iv). The Respondent’s registration as a retail pharmacy authorizing it to engage in the regulated activity of dispensing does not permit the Respondent to manufacture controlled substances; thus, any manufacturing it performed would be unlawful. To prevail on its claim that the Respondent manufactured controlled substances, the Government must show by a preponderance of the evidence that the Respondent engaged in an activity that met the CSA’s definition of “manufacturing.”
“Although the CSA does not define what the term “to compound” means, it does define “manufacture.” Wedgewood Village Pharm. v. DEA, 509 F.3d 541, 543 (D.C. Cir. 2007) (noting the CSA does not define “compounding”). “[T]he term ‘manufacture’ means 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.” 21 U.S.C. § 802(15) (emphasis added). Importantly, the CSA includes compounding in its definition of manufacturing. Id. Not all compounding, however, is considered to be manufacturing. The definition of manufacturing “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.” Id. Stated differently, compounding does not require a registration to manufacture so long as the compounding (1) conforms to State and local laws, and (2) is conducted “as an incident to [the] administration or dispensing” of the compounded drug.
The critical question here is whether the Respondent compounded controlled substances as an incident to dispensing them. If so, then its activity qualified for the exemption to manufacturing and the Respondent would be properly registered. If not, however, then its compounding activity would be considered manufacturing, for which it is not registered. In Wedgewood, the Agency framed this question as whether the pharmacy compounded “as an adjunct to dispensing controlled substances.” 71 Fed. Reg. at 16594. If the pharmacy compounded “as an adjunct to dispensing controlled substances to specific patients,” Wedgewood continued, then the pharmacy would be exempt from the definition of manufacturing. Id. The Agency concluded “that to be exempt from the definition of manufacturer under the CSA a DEA practitioner registrant must be engaged in compounding controlled substances on an individual patient basis. That is, a pharmacy must receive a prescription for a specific patient from a physician or other individual practitioner and must deliver or dispense that medication to the patient.” Id. at 16595. A pharmacy may avoid the regulatory requirements associated with manufacturing, including the requirement to obtain a separate registration, so long as the pharmacy compounds “for a specific patient on a patient by patient basis.” Id. at 16596.
In reaching this conclusion, the Agency turned to the traditional definition of compounding articulated by the Supreme Court in Thompson v. Western States Medical Center. 71 Fed. Reg. at 16595-96 (citing 535 U.S. 357 (2002)). In that
case, the Supreme Court defined compounding as “a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.” 535 U.S. 357, 361 (2002) (emphases added). The critical element of this definition, that compounding is done on a patient-by-patient basis after having received a prescription, is also found in the Fifth Circuit’s view of compounding.45 The Agency also found support for its conclusion in the legislative history of the Food, Drug, and Cosmetic Act (FDCA).
Like the CSA, the FDCA exempts compounding pharmacies from manufacturing requirements. 71 Fed. Reg. at 16595 (citing 21 U.S.C. § 353a). Around the time Wedgewood was decided in 2006, the Food and Drug Administration (FDA) had expressed concerns, however, that some pharmacies were circumventing manufacturing requirements by mass-producing drugs in a manner that appeared at first blush to be compounding, but was in fact manufacturing. Id.; see also Wedgewood Village Pharm., 509 F.3d at 543 (noting the same concern). A House Conference Report concerning the Food and Drug Administration Modernization Act of 1997, the law which amended the FDCA at 21 U.S.C. § 353a to exempt compounding from certain requirements, states that “[i]t is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so
45 The Fifth Circuit defined compounding as “the process whereby a pharmacist combines ingredients pursuant to a physician’s prescription to create a medication for an individual patient.” Prof. & Pat. For Customized Care v. Shalala, 56 F.3d 592, 593 (5th Cir. 1995). This process, the Fifth Circuit added, is typically needed when a medication is not commercially available. Id. In another case, the Fifth Circuit stated that compounding is a process designed “to create a medication to meet the unique needs of an individual . . . patient.” Med. Ctr. Pharm. v. Mukasey, 536 F.3d 383, 387 (5th Cir. 2008). According to the American Pharmacists Association, as cited in Mukasey, pharmacists compound “patient-specific medication.” Id.
as to prevent manufacturing under the guise of compounding.” 71 Fed. Reg. at 16595 (quoting 1997 U.S.C.C.A.N. 2880).
By citing this portion of the FDCA’s legislative history, the Agency made clear that it shares the FDA’s concern about one of the challenges of regulating compounding and manufacturing; namely, that a pharmacy could compound on such a large scale that its operation would, in essence, be akin to that of a manufacturer. Based on this concern shared between two federal agencies charged with regulating pharmaceuticals, it is understandable why in Wedgewood the Agency chose to limit the manufacturing exemption to compounding conducted on an individual patient basis after the pharmacy receives a prescription. 71 Fed. Reg. at 16595-96.
The view that compounding is exempt from the definition of manufacturing only when it is conducted pursuant to a prescription for a particular patient is also consistent with the CSA’s definition of “dispense” as well as the language “incident to” in the definition of “manufacture.” Under the CSA, “dispense” means “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) (emphases added). The fact that the definition of “dispense” includes “compounding necessary to prepare the substance” for delivery, and the fact that compounding “incident to” dispensing exempts a pharmacy’s activity from the definition of “manufacture,” shows that the CSA drafters contemplated compounding as “an incident to” dispensing when needed to prepare a substance for delivery to a patient pursuant to the patient’s prescription. Compounding large quantities of a substance in anticipation of receiving prescriptions for that substance would not be “necessary to prepare the substance for” delivery pursuant to a patient’s prescription.
Furthermore, the reference to compounding as “necessary” in the definition of “dispense,” combined with the “incident to” clause in the manufacturing exemption, illustrates that the CSA drafters intended compounding to be dependent on dispensing, and for dispensing to be dependent on receipt of a valid prescription. In other words, the logical sequence of events is that (1) a pharmacy receives a prescription, (2) in some cases compounding will be “necessary” to prepare that prescription, and (3) because compounding is necessary to prepare the substance for dispensing, (4) it is viewed as incidental46 to the act of dispensing, and (5) therefore, the necessary act of compounding to fill that prescription is exempt from the definition of manufacturing. 21 U.S.C. §§ 802(10), (15). But it would only be exempt to the extent that it was necessary to prepare a substance for delivery pursuant to a prescription. Id
The thrust of the Respondent’s argument is that because the CSA does not define compounding, the appropriate question is whether the Respondent complied with Florida law and other federal laws. Resp’t PHB, at 37-38. The Respondent argues that it engaged in anticipatory compounding (i.e., compounding before receiving a prescription), which is permissible under Florida law and the FDCA. Id. at 37-41. Florida law provides that lawful compounding includes “[t]he preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.” Fla. Admin. Code r. 64B16-27.700(1)(a).
46 As pointed out by the Government, the view that the phrase “incident to” implies that compounding is dependent on dispensing is also consistent with the Black’s Law Dictionary definition of “incident to” as “dependent on, subordinate to, [or] arising out of.” Gov’t PHB, at 43. Perhaps this is the reason why the CSA drafters declined to define “compounding”: because they viewed it only as an accessory to dispensing. In other words, they viewed compounding as a necessary, but limited, means to an end, to be performed only in relation to dispensing and dependent on dispensing. Under this approach, the CSA allows pharmacies to compound on an as-needed basis in order to engage in their primary activity of dispensing, but any compounding that is not done as a means of engaging in an activity that meets the definition of “dispense” would fall under the definition of “manufacture”; thus, triggering the requirement to be registered as a manufacturer and to meet stricter standards.
The Respondent also argues that it complied with the anticipatory compounding provision of the FDCA. Section 353a of Title 21, United States Code, governs pharmacy compounding under the auspices of the FDA. Thompson, 535 U.S. at 362; Allergan USA v. Imprimis Pharm., Inc., No. 8:17-cv-01551-DOC-JDE, 2019 WL 4545960, at *5 (C.D. Cal. March 27, 2019). This section falls under the FDCA. Allergan USA, 2019 WL 4545960, at *5. This section of the FDCA, commonly referred to as Section 503A, exempts certain compounded drug products from the FDCA’s “new drug” approval requirements. United States v. Conigliaro, 384 F. Supp. 3d 145, 160 (2019). This provision resolves issues arising from the question of whether a compounded medication qualifies as a “new drug” requiring FDA approval. Mukasey, 536 F.3d at 389. Section 503A also establishes “safety and quality standards” for compounding ingredients (21 U.S.C. §§ 353a(b)(1)(A)- (B)); prohibits pharmacists from producing “carbon copies of commercially available drug products” (21 U.S.C. § 353a(b)(1)(D)); and prohibits pharmacists from “soliciting customers,” or advertising or promoting particular compounded drugs (21 U.S.C. § 353a(c)). Conigliaro, 384 F. Supp. 3d at 160.(SEE: CLICK ON BELOW VIDEO)
In order to receive Section 503A’s exemption from “new drug” approval requirements, the compounded drug product must meet certain criteria, the most relevant of which requires the compounding to be done “in response to a valid prescription” or that the compounding be limited to situations where a professional relationship already existed between the patient, pharmacist, and prescriber. Conigliaro, 384 F. Supp. 3d at 160 (citing 21 U.S.C. § 353a(a)). In essence, Section 503A allows compounding in only two scenarios: (1) after receiving a prescription, or (2) before receiving a prescription if the pharmacist has previously received valid prescriptions issued within the same established relationship between the pharmacist, patient, and prescriber. Allergan USA, 2019 WL 4545960, at *5. For ease of reference, the second scenario will be referred to as anticipatory
The fact that the Respondent may have complied with the anticipatory
compounding allowance under the FDCA, as the Respondent argues, does not mean that its conduct also complied with the CSA.47 In fact, meeting the criteria for permissible compounding under the FDCA only means that the Respondent is
47 I am not making any finding about whether the Respondent violated (or complied with) the FDCA. As the Government points out in its post-hearing brief, the FDA, the agency tasked with implementing the FDCA, is responsible for ensuring the safety and effectiveness of new drugs for their intended purposes. Gov’t PHB, at 44 (citing Am. Pharm. Ass’n v. Weinberger, 377 F. Supp. 824, 830 (D.D.C. 1974)). The DEA, in contrast, is the federal agency charged with enforcing the CSA and combatting the “unlawful diversion” of controlled substances. Id. (citing id.). By establishing the FDA and DEA, Congress manifested its intent to create two distinct institutions responsible for regulating drugs. Weinberger, 377 F. Supp. at 830. On the one hand, the FDA is responsible for “determining which new drugs should be permitted to enter the flow of commerce.” Id. On the other hand, once a drug is approved to enter the marketplace, the DEA is responsible for ensuring that a particular class of drugs, controlled substances, is not diverted outside the lawful chain of distribution from manufacturer to patient. Id.; see also Gonzales v. Raich, 545 U.S. 1, 13 (2005) (stating that in enacting the CSA, Congress created “a closed regulatory system” to curb “the diversion of drugs from legitimate to illicit channels”).
There is, undoubtedly, overlap between the scope of FDA’s and DEA’s authority. Weinberger, 377 F. Supp. at 831. In a broad sense, both agencies are responsible for protecting the public from unsafe or dangerous drugs. Weinberger, 377 F. Supp. at 831. These are similar regulatory missions. And yet, it is important to keep in mind, as the D.C. District Court explained in Weinberger, that the FDA ensures a drug is safe before entering the market, while the DEA protects the public from the diversion of controlled substances after entering the stream of commerce. 377 F. Supp. at 830-31.
Given this distinction, it is understandable why the Agency has stopped short when it comes to interpreting the FDCA or holding respondents accountable for violating the FDCA. For example, in Wedgewood, the Agency stressed that it did “not rely on FDA’s position” when applying the CSA’s “compounding” provisions, even though its interpretation happened to be consistent with FDA guidelines and statutes. 71 Fed. Reg. at 16596. In two other DEA cases, the Agency explicitly stated that it lacked the authority to interpret the FDCA or to declare violations of the FDCA. Paul Weir Battershell, N.P., 76 Fed. Reg. 44359, 44368 n.27 (2011); Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49989 (2010). First in Bui, then reinforced in Battershell, the Agency emphasized that the “DEA is not charged with administering the [FDCA]”; therefore, any attempt to “definitively interpret” the FDCA would be outside the scope of its delegated authority. Id. Similarly, this lack of authority to interpret the FDCA “bars the Agency from deciding whether Respondent violated the statute.” Battershell, 76 Fed. Reg. at 44368 n.27. Simply put, the issue of whether a registrant violated the FDCA is “outside of the Agency’s authority to adjudicate.” Bui, 75 Fed. Reg. at 49989.
Although the Agency has stated that interpreting or declaring violations of the FDCA is outside its authority, the extent to which violating the FDCA may be considered under Factor Five is another matter. In Battershell, the Agency noted that the respondent’s plea agreement established that he violated the FDCA and that evidence of such violation could “be considered under factor five” for the “purpose of assessing the likelihood of Respondent’s future compliance with the CSA.” 76 Fed. Reg. at 44368 n.27 (citing Wonderyears, Inc., 74 Fed. Reg. 457, 458 n.2 (2009) (stating unlawful conduct related to non-controlled drugs is relevant in determining whether the respondent can be trusted to comply with the CSA)). Although a violation of the FDCA adjudicated in another forum could be analyzed under Factor Five to evaluate the Respondent’s likelihood of following the CSA, the Government has not advanced any such theory in this case. In fact, the Government’s only Factor Five allegation is that the Respondent’s business consisted almost exclusively of dispensing controlled substances to patients presenting numerous red flags. Gov’t PHB, at 39- 40. Because the Government has not argued that the Respondent’s compounding should be assessed under the FDCA in a Factor Five analysis, I will not consider whether the Respondent violated or complied with the FDCA under Factor Five. David W. Bailey, M.D., 81 Fed. Reg. 6045, 6046 n.2 (2016) (stating no findings may be made under Factor Five unless the Government specifically advances a theory under that factor).
exempt from satisfying the FDA’s “new drug” approval process. It does not mean that the Respondent is exempt from the CSA’s definition of manufacturer.
The same is true with respect to Florida law. Although the Respondent’s practice of anticipatory compounding may have been permissible under Florida law, that fact alone does not automatically render the practice in accord with the CSA’s definitions. While I agree with the Respondent that part of the CSA’s manufacturing exemption includes “conformity with applicable State or local law,” the CSA also requires that compounding be done “as an incident to . . . dispensing” in order to be exempt from the definition of manufacturer. 21 U.S.C. § 802(15). And as already shown, anticipatory compounding is inconsistent with the phrase “as an incident to . . . dispensing.” Id. It is also inconsistent with the Agency’s view of permissible compounding articulated in Wedgewood. 71 Fed. Reg. at 16595.
The Respondent’s post-hearing arguments address neither Wedgewood nor the “incident to” language in the CSA’s definition of manufacture. The Respondent’s primary argument is that both Florida law and the FDCA allow anticipatory compounding, and that “the evidence appears to suggest that the Respondent engaged in permissible anticipatory compounding in compliance with applicable federal and state law.” Resp’t PHB, at 41. I reject the Respondent’s argument that it can seek refuge under Florida’s anticipatory compounding allowance for three reasons. First, I recognize that consistent with Gonzales v. Oregon, the Agency typically looks to the standards of practice in the registrant’s state of registration as the appropriate benchmark against which to evaluate the registrant’s conduct. See 546 U.S. 243, 270 (2006) (noting the CSA “manifests no intent to regulate the practice of medicine generally” and that the CSA rests “upon a functioning medical profession regulated under the States’ police powers”); Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10090 (2009) (explaining the DEA looks to state standards to evaluate whether a bonafide doctor-patient relationship was formed).
Deference to state standards of medicine is based, in part, on the Supreme Court’s finding that the CSA “conveys unwillingness to cede medical judgments to an executive official,” such as the U.S. Attorney General, “who lacks medical expertise.” Oregon, 546 U.S. at 266. Deciding to limit compounding to an activity dependent on dispensing, as the CSA does, is not, however, a medical judgment that requires medical expertise, in the same way that determining proper medical treatment is a medical judgment requiring medical expertise. Defining what is and is not manufacturing is wholly different than interfering with a state’s police power to regulate the practice of medicine.
Second, while compounding is generally a matter left to state regulators, drug manufacturing remains subject to federal authority. Prof. & Pat. For Customized Care, 56 F.3d at 593. Accordingly, the CSA views anticipatory compounding as a form of manufacturing. And while registrants are obligated to follow state law, they are also obligated to follow the CSA, which includes its registration requirements. Nothing in the Florida law cited by the Respondent exempts the Respondent from the CSA’s requirement to obtain appropriate DEA registration before engaging in certain regulated activities as the CSA defines them. And as already discussed, the CSA considers compounding (even if conducted in compliance with state law) to be manufacturing unless it is an incident to dispensing.
Third, federal law typically trumps state law. “The Supremacy Clause unambiguously provides that if there is any conflict between federal and state law, federal law shall prevail.” Gonzalez v. Raich, 545 U.S. 1, 29 (2005). I view the conflict here as analogous to the conflict between state and federal regulation of marijuana. While many states have relaxed their restrictions around the cultivation, use, and sale of marijuana, that drug remains a schedule I controlled substance under the CSA. While Florida law may permit anticipatory compounding, that conduct meets the definition of manufacturing under the CSA, and therefore, triggers federal
obligations on top of state obligations, such as obtaining the proper federal registration.
The Respondent also argues that the evidence fails to show that the Respondent sold any of the drugs it compounded to a distributor or reseller, “as would be expected in the case of a traditional drug manufacturer.” Id. The CSA’s definition of manufacture, however, does not depend on to whom the drugs are sold after being created. 21 U.S.C. § 802(15). The CSA’s definition of manufacture focuses on how the drug is created, not the manufacturer’s business model for selling it. Id. Consequently, the Respondent can still be held accountable for manufacturing controlled substances without the proper registration regardless of the fact that it sold its compounded drugs directly to patients rather than to distributors or wholesalers.
This brings us to the evidence of record. The clearest evidence that the Respondent manufactured, rather than compounded for individual patients, comes from the closing inventory conducted by DI Albert and Mr. Clement, Sr., in September 2018. Tr. 52, 54, 56, 165-66; GX 7. The closing inventory documented the number of controlled substances the Respondent had on hand at the time. Id. DI Albert observed Mr. Clement, Sr., conduct the inventory and Mr. Clement, Sr., signed off on it. Tr. 56, 166.
The closing inventory shows that on September 10, 2018, the Respondent had 3,546 compounded capsules of hydromorphone 8 mg on hand and 574 compounded capsules of oxycodone 30 mg on hand. GX 7, p. 1. These capsules were sitting in a safe when they were counted. Tr. 56. Several thousand capsules sitting in a safe is not consistent with compounding for an individual patient’s therapeutic needs as an incident to dispensing. It is consistent with manufacturing capsules in bulk and storing them until a prescription is presented.
The Respondent argues that no evidence of record proves that it “produced significantly large quantities of any drug.” Resp’t PHB, at 41. Whether the 4,120
capsules stored in the Respondent’s safe on September 10, 2018, constitutes a “significantly large” quantity is beside the point. Whether the Respondent produced a large or small amount of compounded capsules, however, is relative, and my finding on this allegation has nothing to do with the amount of capsules produced. In fact, the Agency has instructed that “volume alone does not show that [a registrant’s] activity is manufacturing rather than compounding.” Wedgewood, 71 Fed. Reg. at 16597. While volume can be one relevant factor to consider,48 the distinguishing factor is whether the pharmacy compounded “on an individual patient basis” as an adjunct to dispensing. Id. at 16594-95, 16597. And as already noted, storing over four thousand compounded capsules in a safe is not consistent with compounding “on an individual patient basis” as an adjunct to dispensing. Id. It is, in effect, manufacturing.
This is especially true when the Respondent typically filled only two to four prescriptions per day. Tr. 508. The rough math shows that four thousand compounded capsules could be enough for two weeks of dispensing. Considering that a month’s supply of oxycodone would be roughly 112 tablets (GX 18, p. 6) and a month’s supply of hydromorphone would be roughly 120 tablets (GX 44, p. 6), the Respondent had enough oxycodone capsules on hand to fill approximately 5 prescriptions and enough hydromorphone capsules on hand to fill about 29 prescriptions. Together, this would approximate the number of prescriptions the Respondent typically saw over the course of two
weeks. This lends further support to my conclusion that the amount of compounded capsules the Respondent had on
48 Based on Dr.Sullivan’testimony,theGovernmentarguedthat“theextremevolumeofRespondent’scompounding indicated that it was not being done in response to the individualized patient needs.” Gov’t PHB, at 47. Compounding only 30 capsules would still be manufacturing if not done for an individual patient. Four thousand capsules, however, raises far more suspicions than 30 would. Thus, I have considered the amount of compounded capsules, and I find that it further supports my conclusion that the Respondent was manufacturing rather than compounding on a patient-by-patient basis. Per Wedgewood, however, the volume of compounding alone is not outcome determinative. 71 Fed. Reg. at 16597.
hand on September 10, 2018, is not consistent with compounding for individual patients as an incident to dispensing. Rather, it is consistent with manufacturing.
In addition to the closing inventory, the Government also points to statements made by Mr. Clement, Sr., in 2012. Gov’t PHB, at 46. In May 2012, during execution of an administrative inspection warrant (AIW) at the Respondent pharmacy, TFO Shearer interviewed Mr. Clement, Sr., the Respondent’s owner. Tr. 183. Mr. Clement, Sr., was not in custody at the time and was free to leave. Id. In the interview, Mr.Clement, Sr., told TFO Shearer about his process for manufacturing oxycodone and hydromorphone in capsules. Tr.183-84. Mr. Clement, Sr., told TFO Shearer that he could buy a 100 gram bottle of oxycodone powder for $1,100, enough to manufacture about 6,000 dosage units. Tr. 185. Tablets of oxycodone purchased from commercial distributors cost roughly $2-$10 per pill. Id. In other words, $1,100 worth of powder could produce at least $12,000 worth of dosage units. Mr. Clement, Sr., told TFO Shearer that he manufactured thousands of capsules per batch because it was cost effective. Tr. 184- 85. The batch records that TFO Shearer reviewed in 2012 documented that Mr. Clement, Sr., produced thousands of pills in each batch. Id. Mr. Clement, Sr., also told TFO Shearer that he persuaded patients to take capsules even if they did not want them because capsules have the same effect as tablets.49 Tr. 185-86.
Although these statements were made in 2012, they demonstrate that the Respondent had a system in place to compound thousands of capsules at a time. Tr. 184-85. These statements also demonstrate that the Respondent’s motive for mass-compounding thousands of capsules per batch was cost effectiveness, rather than patients’ unique therapeutic needs. Tr. 184-86. These statements provide
49 While reliable hearsay statements may be admissible in these administrative proceedings, Mr. Clement, Sr.’s, statements to TFO Shearer in 2012 are not hearsay. They enjoy enhanced credibility as they would qualify as statements by a party opponent and would, therefore, be excluded from the definition of hearsay. Fed. R. Evid. 801(d)(2).
additional support to the conclusion that the Respondent’s compounding was cost- driven rather than patient-driven, and that the Respondent was, therefore, manufacturing and not compounding as the CSA understands those terms.
The Government also points to the batch records obtained pursuant to the 2017 subpoena. Gov’t PHB, at 46; Tr. 27. A batch record documents the production of a controlled substance and lists the ingredients in the controlled substance. Tr. 33. The batch record is created by the person who makes the substance. Id. The batch records indicate how many capsules were used in the production of each batch. Tr. 38, 40-41. The batch records in Government Exhibit 5 document the production of hydromorphone 8 mg. The batch records in Government Exhibit 6 document the production of oxycodone 30 mg. The hydromorphone batch records show that the Respondent “compounded” from 600 to 2,400 capsules per batch, with 1,200 capsules being the most frequently occurring quantity. See generally GX 5. The oxycodone batch records show that the Respondent “compounded” from 600 to 1,800 capsules per batch, with 1,200 capsules being the most frequently occurring quantity. See generally GX 6. These numbers are consistent with the number of compounded capsules found during the 2018 closing inventory and with Mr. Clement, Sr.’s, statements to TFO Shearer in 2012. These numbers are also consistent with manufacturing rather than compounding on an individualized patient basis.
Furthermore, the Respondent’s dispensing records also demonstrate that the patients for whom the Respondent compounded oxycodone and hydromorphone did not have valid therapeutic needs for compounded medication. Dr. Sullivan explained that compounding is only done when necessary “to meet the individual, unique therapeutic needs of a patient.” Tr. 231. Compounding would be necessary, he continued, if the patient had an allergy to the commercially available version or if the patient needed a unique dose or strength that was not available in the mass-
produced product. Tr. 230-31. Dr. Sullivan’s testimony on this topic is consistent with case law. As already noted, the Fifth Circuit described compounding as a process designed “to create a medication to meet the unique needs of an individual . . . patient.” Mukasey, 536 F.3d at 387. The Fifth Circuit further noted that compounding is necessary to create “patient-specific medication.” Id. The Supreme Court has observed that one reason why a pharmacist would need to compound patient-specific medication is if the patient is allergic to an ingredient in the commercially manufactured drug. Thompson, 535 U.S. at 361. Other reasons, the Fifth Circuit has also recognized, include “diluted doses for children and altered forms of medications for easier consumption.” Prof. & Pat. For Customized Care, 56 F.3d at 593.
Dispensing records, however, show that the Respondent dispensed both commercially manufactured tablets and compounded capsules to the same patient. The fact that the Respondent dispensed both commercially available tablets and compounded capsules of the same controlled substances to the same patients indicates that the patients lacked “unique therapeutic needs” for the compounded version. Tr. 231, 256. For example, the Respondent dispensed seven prescriptions of oxycodone 30 mg tablets to patient A.G. from June 2017 to August 2018. ALJ Ex. 42, p. 11. During that same time period, the Respondent also dispensed to A.G. three prescriptions of oxycodone 30 mg compounded capsules. Id. A note dated March 13, 2017, in A.G.’s profile states that a doctor approved dispensing medication to A.G. in compounded capsules. GX 15, p. 1; ALJ Ex. 42, p. 13. After March 2017, however, the Respondent continued dispensing both tablets and compounded capsules to A.G. ALJ Ex. 42, p. 11. Thus, even if a doctor approved of A.G. taking compounded capsules, it was not for a therapeutic or medical reason since he continued to alternate between capsules and tablets.
In another example, the Respondent dispensed both tablets and compounded capsules to patient R.G. to fill the same oxycodone prescription. GX 49; Tr. 325- 26. Dr. Sullivan opined that R.G. clearly had no valid therapeutic need for compounded capsules since he also took the tablet form of the same drug. Tr. 326. Patient R.G. also received oxycodone in capsules on 15 occasions from June 2017 to September 2018, and in tablets on 2 occasions during the same time period. ALJ Ex. 42, p. 45. As Dr. Sullivan observed, the fact that the Respondent dispensed oxycodone to R.G. in both capsule and tablet forms, and dispensed capsules and tablets together on one occasion, demonstrates that the Respondent was not compounding for R.G. in response to a unique therapeutic need for compounded capsules. Tr. 325-26. Furthermore, no profile for any of the patients documents an allergy that would have necessitated compounded capsules. Tr. 339; GX 15, 20, 23, 26, 29, 32, 35, 38, 41, 47, 51.
Dr. Sullivan pointed out numerous other instances where the Respondent’s dispensing history demonstrated that patients lacked legitimate therapeutic justification for compounded capsules.
From January 2018 to December 2018, the Respondent dispensed compounded capsules of hydromorphone 8 mg to A.H. on eight occasions: January 4; February 15; March 5; April 3; May 2; August 16; September 11; and December 5. ALJ Ex. 42, pp. 15-16; GX 19; GX 21. The Respondent then dispensed tablets of hydromorphone 8 mg to A.H. on the following five occasions in 2019: January 22; February 15; February 27; March 14; and April 18. Id. The fact that the Respondent dispensed capsules of hydromorphone to A.H. on eight occasions in 2018 and then tablets of hydromorphone on five occasions in 2019 demonstrates that A.H. had no unique therapeutic justification that required the Respondent to compound hydromorphone capsules for him. Tr. 255- 56, 258-59, 269.
Dr. Sullivan noted a lack of therapeutic justification to compound hydromorphone for B.S. since he received hydromorphone in both tablets and capsules. Tr. 274. From August 2017 to August 2018, the Respondent filled 12 hydromorphone prescriptions with compounded capsules for B.S.: August 22, 2017; September 27, 2017; October 18, 2017; November 15, 2017; December 12, 2017; January 4, 2018; January 29, 2018; February 28, 2018; March 26, 2018; April 23, 2018; May 22, 2018; and August 24, 2018. ALJ Ex. 42, p. 19; GX 24. On February 5, 2019, the Respondent filled a hydromorphone prescription for B.S. with tablets. ALJ Ex. 42, p. 20; GX 22. The fact that the Respondent dispensed hydromorphone tablets to B.S. in 2019 shows that B.S. had no unique therapeutic justification that required the Respondent to compound hydromorphone capsules for him on 12 occasions in 2017 and 2018. Tr. 255-56, 258-59, 269, 274.
The Respondent dispensed oxycodone capsules and tablets to C.R., indicating that there was no valid therapeutic reason for the Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59, 269, 274, 279-80. On July 19, 2017, and October 26, 2017, the Respondent filled oxycodone prescriptions for C.R. with compounded capsules. ALJ Ex. 42, p. 23; GX 27. The Respondent then filled four oxycodone prescriptions for C.R. with tablets: March 6, 2018; April 19, 2018; July 12, 2018; and August 28, 2018. Id.
Dr. Sullivan observed that J.M. alternated between tablets and capsules of oxycodone, demonstrating that there was no valid therapeutic need for the Respondent to compound oxycodone capsules for her. Tr. 290. First, the Respondent dispensed oxycodone tablets to J.M. on January 25, 2018, and then filled J.M.’s next oxycodone prescription with compounded capsules on March 1, 2018. ALJ Ex. 42, p. 30; GX 33; Tr. 290. The next month the Respondent switched back to oxycodone tablets on April 4, 2018, followed by oxycodone capsules on April 19, 2018, and then switched back again to tablets on May 16, 2018. Id. The fact that
the Respondent alternated between dispensing oxycodone tablets and capsules to J.M. demonstrates that there was no valid therapeutic reason for the Respondent to compound oxycodone capsules for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290.
Dr. Sullivan observed that the Respondent dispensed oxycodone tablets and compounded capsules to M.M. Tr. 295, 297. From June 2017 to August 2018, the Respondent filled 14 oxycodone prescriptions for M.M. with compounded capsules. Tr. 295, 297; ALJ Ex. 42, pp. 33-34; GX 34; GX 36. From January 2019 to April 2019, the Respondent filled five oxycodone prescriptions for M.M. with tablets. Id. The fact that the Respondent dispensed compounded oxycodone capsules to M.M. for over a year and then switched to dispensing oxycodone tablets to her for several months demonstrates that there was no valid medical reason for the Respondent to have compounded oxycodone for her. Tr. 255-56, 258-59, 269, 274, 279-80, 290, 295, 297.
Dr. Sullivan observed that the Respondent compounded hydromorphone capsules for N.B. without any apparent therapeutic justification. Tr. 302. From June 2017 to August 2018, the Respondent filled twelve hydromorphone prescriptions for N.B. with compounded capsules. ALJ Ex. 42, p. 37; GX 39.
Dr. Sullivan pointed out that the Respondent compounded hydromorphone capsules for R.B. without any apparent medical justification. Tr. 311, 319-20. From June 2017 to January 2019, the Respondent filled 14 hydromorphone prescriptions for R.B. with compounded capsules. GX 40; GX 43; ALJ Ex. 42, pp. 41-42. At least three of those prescriptions were originally written for tablets and were substituted for capsules by the Respondent. Tr. 319-20; GX 44, pp. 6-7. The Respondent then dispensed hydromorphone tablets to R.B. on three occasions from February to April 2019. ALJ Ex. 42, p. 42; GX 40. The fact that the Respondent dispensed tablets and capsules of hydromorphone to R.B., switching prescribed
tablets to capsules, demonstrates that there was no valid therapeutic reason for the Respondent to compound hydromorphone for R.B. Tr. 311, 319-21.
Lastly, Dr. Sullivan noted that the Respondent compounded capsules of hydromorphone for R.L. without any apparent medical justification. Tr. 331; ALJ Ex. 42, p. 49; GX 52. From June 2017 to September 2018, the Respondent filled 14 hydromorphone prescriptions for R.L. with compounded capsules. Id.
In sum, the evidence paints a picture of a pharmacy mass-compounding bulk quantities of oxycodone and hydromorphone in thousands of capsules per batch. The evidence further reveals the Respondent’s motive for doing so: profit rather than patient need.
The evidence shows that the Respondent’s “compounding” was not incidental to the act of dispensing. Because the Respondent’s “compounding” was not conducted “on an individual patient basis” after having received a prescription, it is not exempt from the CSA’s definition of “manufacture.” Wedgewood, 71 Fed. Reg. at 16595. This is true regardless of whether the Respondent complied with Florida law and the FDCA, since it must also comply with the CSA’s registration requirements. Thus, the Respondent engaged in manufacturing thousands of controlled substance dosages over a period of several years without the proper registration. For these reasons, the Government’s allegation that the Respondent illegally manufactured controlled substances is SUSTAINED. ALJ Ex. 1, pp. 8-10, ¶ 20-28.
Government’s Burden of Proof and Establishment of a Prima Facie Case Based upon my review of each of the allegations by the Government, it is necessary to determine if it has met its prima facie burden of proving the requirements for a sanction pursuant to 21 U.S.C. § 824(a). At the outset, I find that the Government has demonstrated and met its burden of proof in support of revocation through its case that the Respondent has failed to resolve red flags of
diversion and to document the resolution of red flags of diversion in accordance with Florida law and the usual course of professional practice in Florida. Furthermore, the Government has additionally demonstrated that the Respondent unlawfully manufactured controlled substances without the proper registration. Inasmuch as the Government has established by a preponderance of the evidence that the Respondent violated state and federal laws relating to controlled substances on numerous occasions and committed such other conduct which may threaten the public health and safety, it has met its prima facie burden of proving that the requirements for a sanction pursuant to 21 U.S.C. § 824(a) are satisfied.
PUBLIC INTEREST DETERMINATION: THE STANDARD
Pursuant to 21 U.S.C. § 823(f) (2006 & Supp. III 2010), the Acting Administrator50 may revoke a DEA Certificate of Registration if persuaded that
maintaining such registration would be inconsistent with the public interest. Evaluation of the following factors have been mandated by Congress in determining whether maintaining such registration would be inconsistent with “the public interest”:
(1)The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2)The [registrant’s] experience in dispensing, or conducting research with respect to controlled substances.
(3)The [registrant’s] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety. 21 U.S.C. § 823(f).
“These factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D.,
50 This authority has been delegated pursuant to 28 C.F.R. §§ 0.100(b) and 0.104 (2008). 120
68 Fed. Reg. 15227, 15230 (2003). Anyone or a combination of factors may be relied upon, and when exercising authority as an impartial adjudicator, the Agency may properly give each factor whatever weight it deems appropriate in determining whether a registrant’s registration should be revoked. Id. (citation omitted); David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 16422, 16424 (1989). Moreover, the Agency is “not required to make findings as to all of the factors,” Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall, 412 F.3d at 173, and is not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (holding that the Administrator’s obligation to explain the decision rationale may be satisfied even if only minimal consideration is given to the relevant factors, and that remand is required only when it is unclear whether the relevant factors were considered at all). The balancing of the public interest factors “is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest.”Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 462 (2009).
Factors Two and Four: Experience in Dispensing, and Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances
The Government seeks the revocation of the Respondent’s COR based primarily on conduct most appropriately considered under Public Interest Factors Two and Four.51 The Government has also raised one allegation under Factor Five.
51 21 U.S.C. § 823(f)(2), (4). There is nothing in the record to suggest that a state licensing board made any recommendation regarding the disposition of the Respondent’s DEA COR (Factor One). Likewise, the record contains no evidence that the Respondent has been convicted of (or charged with) a crime related to controlled substances (Factor Three).
Factor Two: Experience in Dispensing Controlled Substances
Factor Two requires consideration of the Respondent’s experience in dispensing controlled substances. The plain language of Factor Two dictates that a registrant’s prior experience in the regulated activity must be considered. The Agency has acknowledged that even a considerable level of benign or even commendable experience could be easily outweighed by evidence demonstrating that continued registration was inconsistent with the public interest.52
The Respondent did not offer specific direct evidence, either documentary or testimonial, relating to experience in dispensing. Although the Government has proved misconduct which could be considered under Factor Two and Factor Four, I will only weigh that misconduct under Factor Four to avoid double-counting the same violations under multiple factors.
Factor Four: Compliance with Applicable Federal, State, or Local Laws Relating to Controlled Substances
Evidence is considered under Factor Four when it reflects a respondent’s compliance (or non-compliance) with laws related to controlled substances. Established violations of the CSA, DEA regulations, or other laws regulating controlled substances at the state or local level are cognizable under Factor Four. As DEA has held in the past, a registrant’s “ignorance of the law is no excuse” for actions that are inconsistent with responsibilities attendant upon a registration. Daniel A. Glick, D.D.S., 80 Fed. Reg. 74800, 74809 (2015) (quoting Sigrid Sanchez, M.D., 78 Fed. Reg. 39331, 39336 (2013) (citing Patrick W. Stodola, 74 Fed. Reg. 20727, 20735 (2009) and Hageseth v. Superior Ct., 59 Cal. Rptr. 3d 385, 403 (Ct.
52 See,e.g.,PaulJ.Caragine,Jr.,63Fed.Reg.51592,51560(1998)(“[E]venthoughthepatientsatissueareonlya small portion of Respondent Pharmacy’s patient population, his prescribing of controlled substances to these individuals raises serious concerns regarding [his] ability to responsibly handle controlled substances in the future.”); Med. Shoppe-Jonesborough, 73 Fed. Reg. at 386 (finding that the misconduct outweighed the fact that only a relatively small portion of the respondent’s patient population was involved).
App. 2007) (a “licensed health care provider cannot ‘reasonably claim ignorance’ of state provisions regulating medical practice”))). Under Agency precedent, “[a]ll registrants are charged with knowledge of the CSA, its implementing regulations, as well as applicable state laws and rules.” Id. at 74809 (internal citations omitted). Standard of Care as to Charged Violations
Prescriptions for controlled substances may only 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). Although “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” Id. This “prohibits[s] a pharmacist from filling a prescription for a controlled substance when she either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” Wheatland Pharm., 78 Fed. Reg. 69441, 69445 (2013) (internal quotations, alterations omitted). This “standard of care refers to that generally recognized and accepted in the medical community rather than a standard unique to the practitioner.” Rene Casanova, M.D., 77 Fed. Reg. 58150, 58161 (2012) (citing Robert L. Dougherty, M.D., 76 Fed. Reg. 16823, 16832 n.11 (2011) (internal citations omitted)). While “state law is a relevant factor in determining whether a practitioner is acting in the ‘usual course of professional practice,’ it is appropriate in the context of an inquiry under federal law to also consider ‘generally recognized and accepted medical practices’ in the United States.” Id. (citing Bienvenido Tan, M.D., 76 Fed. Reg. 17673, 17681 (2011)).
A pharmacy’s standard of care for dispensing controlled substances is governed by federal and state law, as well as standards of practice accepted within the state. “A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.” 21 C.F.R. § 1306.06. Under Florida law, a pharmacy is required to conduct a prospective drug
use review before filling or refilling any prescription for controlled substances. Fla. Admin. Code r. 64B16-27.810. Florida law also requires pharmacies to question suspicious prescriptions and to only fill a prescription if the pharmacy can validate the prescription’s medical legitimacy. Fla. Admin. Code r. 64B16-27.831. Florida law also requires pharmacies to maintain a patient record system. Fla. Admin. Code r. 64B16-27.800. Dr. Sullivan explained that under Florida law, pharmacies must document information relevant to resolving red flags in the patient record system. Tr. 209, 453-55, 489. He further noted that a patient record system is synonymous with a patient profile. Tr. 209. The Agency has previously interpreted Florida law as requiring pharmacies to document information in the patient profile that they would need to resolve red flags. Trinity II, 83 Fed. Reg. at 7330. Failure to document information pertinent to red flag resolution in the patient profile would violate Florida law and, therefore, be outside the usual course of professional practice in Florida.
While violations of state law are cognizable under Factor Four, Agency precedent provides that “the mere fact that a violation of a state rule occurs in the context of the dispensing of controlled substances does not necessarily mean that the violation has a sufficient nexus to the CSA’s core purpose of preventing the diversion and abuse of controlled substances.” Fred Samimi, M.D., 79 Fed. Reg. 18698, 18710 (2014). There must be a nexus between the state law that has been violated and the CSA’s purpose of preventing drug abuse and diversion. Id. Therefore, the inquiry is twofold: it must be determined whether the Respondent’s conduct violated the particular state law alleged and whether that state law has a nexus with the CSA’s purpose of preventing drug abuse and diversion. See Judulang v. Holder, 565 U.S. 42 (2011) (actions of a regulatory agency must bear a rational relationship to the purposes of the statute it is charged with enforcing); Tony T. Bui, M.D., 75 Fed. Reg. 49979, 49989 (2010) (holding that in order for a registrant’s
“conduct to be actionable, there must be a substantial relationship between the conduct and the CSA’s purposes of preventing drug abuse and diversion, and that the conduct may constitute a threat to public health and safety”); see also Paul Weir Battershell, N.P., 76 Fed. Reg. 44359 n.27 (2011) (to same effect).
This condition is met here. The Florida laws that the Respondent violated share the CSA’s purpose of combatting the diversion of controlled substances. Similar to DEA regulations, Florida law defines a valid prescription as one “based on a practitioner-patient relationship” and “issued for a legitimate medical purpose.” Compare Fla. Admin. Code r. 64B16-27.831(1)(a), with 21 C.F.R. § 1306.04(a). Furthermore, Florida law places a priority on the medical legitimacy of controlled substance prescriptions. Florida pharmacies are required to confirm the medical legitimacy of a controlled substance prescription before filling it. Fla. Admin. Code r. 64B16-27.831(2)-(3). Florida law even provides steps the pharmacy should take in its process to validate the prescription. Id. If a pharmacy is unable to resolve the concerns raised by a controlled substance prescription, the pharmacy should refuse to fill it. Id. at 64B16-27.831(2)(c). The same regulation also requires Florida pharmacies to report prescribers suspected of diversion to the Florida Department of Health. Id. at 64B16-27.831(4).
Florida law also specifies that before dispensing medication, pharmacies should be on the lookout for signs of clinical abuse or misuse of prescriptions drugs. Fla. Admin. Code r. 64B16-27.810(1)(g). In addition to looking out for signs of abuse, Florida pharmacies are also required to maintain a patient record system for the purpose of documenting information relevant to resolving red flags of diversion or abuse. Id. at 64B16-27.800; Tr. 209, 453-55, 489.
The objectives of these Florida laws are to ensure prescriptions for controlled substances are issued for legitimate medical purposes; to impose on pharmacies a process to confirm the medical legitimacy of controlled substances before dispensing
them; to be on guard for evidence that drugs are being abused or misused; and to memorialize findings relevant to red flag investigation in the patient’s records. These objectives demonstrate the same fundamental purpose of the CSA to ensure controlled substances remain within legitimate channels.
The Government has also raised allegations involving a pharmacy’s corresponding responsibility under 21 C.F.R. § 1306.04(a). The DEA has consistently interpreted a pharmacist’s corresponding responsibility “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.’” Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 381 (2008) (quoting Medic-Aid Pharmacy, 55 Fed. Reg. 30043, 30044 (1990)). In short, a pharmacist has a “corresponding responsibility under Federal law” to dispense only lawful prescriptions. Liddy’s Pharmacy, L.L.C., 76 Fed. Reg. 48887, 48895 (2011) (citation omitted). The regulation does not require the pharmacist to practice medicine, but instead, imposes a responsibility upon the pharmacist “not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows [or has reason to know] that the issuing practitioner issued it outside the scope of medical practice.” E. Main St. Pharmacy, 75 Fed. Reg. 66149, 66157 (2010) (quoting United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)).
Providing further guidance concerning a pharmacist’s corresponding responsibility the DEA has held:
[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a “reasonable professional,” there is a duty to “question the prescription.” Ralph J. Bertolino, d/b/a/Ralph J. Bertolino Pharmacy, 55 Fed. Reg. 4729, 4730 (1990). Though initially framed as a “reasonable professional” standard, the Agency has considered the duty to discharge the corresponding responsibility by evaluating the circumstances in light of what would
be considered suspicious by a “reasonable pharmacist.” East Main Street Pharmacy, 75 Fed. Reg. 66149, 66165; see also Winn’s Pharmacy, 56 Fed. Reg. 52559, 52561 (1991). Accordingly, a pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid. Id. Because Agency precedent limits the corresponding responsibility to circumstances which are known or should have been known,
Sun & Lake Pharmacy, Inc., 76 Fed. Reg. 24523, 24530 (2011), it follows that, to show a violation of a corresponding responsibility, the Government must establish that: (1) the Respondent dispensed a controlled substance; (2) a red flag was or should have been recognized at or before the time the controlled substance was dispensed; and (3) the question created by the red flag was not resolved conclusively prior to the dispensing of the controlled substance. See Sun & Lake Pharmacy, 76 Fed. Reg. at 24532 (Finding that pharmacy violated corresponding responsibility where it took no steps to resolve red flags prior to dispensing controlled substances.). The steps necessary to resolve the red flag conclusively will perforce be influenced by the nature of the circumstances giving rise to the red flag.
Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 & 5195, 77 Fed. Reg. 62316, 62341 (2012).
Further, to establish a violation of a pharmacist’s corresponding responsibility, the Government must establish the requisite degree of scienter. Hills Pharmacy, L.L.C., 81 Fed. Reg. 49816, 49835 (2016) (citing JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 Fed. Reg. 28667, 28669 (2015)). To establish scienter, the Government can show that a pharmacist violated his or her “corresponding responsibility” by filling a prescription while knowing that it lacked a legitimate medical purpose. Hills Pharmacy, L.L.C., 81 Fed. Reg. at 49835. In the case before me, however, the Government presented no evidence that one of the Respondent’s pharmacists filled a prescription with actual knowledge that the prescription was not legitimate. Absent actual knowledge, the Government can
establish scienter by showing that a pharmacist was “willfully blind (or deliberately ignorant) to the fact that the prescription lacked a legitimate medical purpose.” Id. To establish willful blindness, it is necessary to show that a pharmacist subjectively believed that there was a high probability that the prescription lacked a legitimate medical purpose and that the pharmacist deliberately avoided learning the truth. Id. Here, the Government argues that the Respondent’s failure to document the resolution of numerous red flags when it filled many prescriptions establishes that the Respondent was willfully blind as to the medical legitimacy of those prescriptions. Gov’t PHB, pp. 34-35.
The Government has introduced a preponderance of evidence to prove that the Respondent dispensed numerous controlled substance prescriptions for at least eleven patients. Those prescriptions raised classic red flags of drug abuse and/or diversion, to include early fills, travelling long distances, paying in cash, dangerous drug cocktails, and highest strength of the medication, among others. The Government also introduced the patient profiles for each of these eleven patients, as well as twelve hardcopy prescriptions for two of the patients. The profiles contain insufficient information, and in some cases no information, that would have enabled the Respondent to sufficiently resolve the suspicion raised by the prescriptions.
The evidence reveals a concerning pattern of a pharmacy that repeatedly ignored its state-mandated obligation to document information needed to resolve red flags in a patient record system. This concerning pattern demonstrates that regardless of the obvious signs of drug abuse and diversion that are well-known to the pharmacy community, and firmly-established in DEA precedent, the Respondent repeatedly dispensed controlled substances and rarely, if ever, documented any information in response to those red flags in the patient record. And when the Respondent documented information, it was always insufficient to resolve all the concerns raised by the prescription.
With respect to the twelve prescriptions in evidence, the Government has further demonstrated a violation of the Respondent’s corresponding responsibility under 21 C.F.R. § 1306.04(a). While I declined to sustain the Government’s allegation that the Respondent violated its corresponding responsibility with respect to prescriptions not in evidence, the other sustained violations are more than enough for the Government to establish its prima facie burden justifying sanction. The Government has proven this violation through documentary evidence and testimony from its expert witness.
Furthermore, the Respondent failed to rebut or discredit the Government’s case. The Respondent did not introduce any documentary evidence and it only offered the testimony of a single witness, who failed to convincingly rebut the Government’s evidence. In light of the record as to this factor, I find that the Government has overwhelmingly proven that the Respondent failed to comply with federal and state law with respect to resolving and documenting resolution of red flags of drug abuse and/or diversion, and with respect to its corresponding responsibility for the prescriptions in evidence.
Furthermore, I find that the Government has sponsored a preponderance of evidence to show that the Respondent engaged in unlawful manufacturing of controlled substances without the proper DEA registration, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). Thus, the Government has introduced evidence against the Respondent with respect to two aspects of the controlled drug supply chain, dispensing and manufacturing. The totality of this evidence demonstrates a concerning lack of compliance with applicable federal and state law that poses a significant risk of diversion and threatens public health and safety. This evidence further demonstrates a lack of commitment on the Respondent’s part with respect to its federal and state controlled substance obligations. Therefore, I find that this factor significantly favors revoking the Respondent’s registration.
Factor Five: Such Other Conduct Which May Threaten the Public Health and Safety
The Government argues that in addition to weighing the misconduct committed on a patient-by-patient basis, the Tribunal should also consider that the “Respondent’s business consisted almost entirely of dispensing controlled substances to customers who exhibited one or more significant red flags.” Gov’t PHB, p. 39 (emphasis in original). To support this allegation, the Government contends that nearly all of the Respondent’s customers paid cash and nearly all of them lived over 100 miles from the pharmacy. Id., pp. 39-40. The Government adds that controlled substances, specifically schedule II narcotics, constituted a grossly disproportionate percentage of the Respondent’s overall dispensing. Id., p. 40. Thus, the Government urges that in addition to the “specific violations relating to specific patients” under Factors Two and Four, it is appropriate to “consider the pervasiveness of Respondent’s misconduct” under Factor Five. Id., p. 39. This is the only misconduct the Government has alleged under Factor Five.
As I announced at the hearing, however, I will not sustain any allegations based solely on statistical grounds.53 Tr. 18, 218. Although Dr. Sullivan suggested that the high number of patients provided compounded medication alone was proof positive that the subject compounding could not have been legitimate, Tr. 336-37, I don’t accept that the law of averages alone may sustain the Government’s burden of proving Respondent’s subject alleged failures. Even if the Respondent’s business consisted entirely of dispensing controlled substances to cash-paying patients who
53 Due Process notice concerns may be implicated in allegations of “guilt” by statistical analysis. The essential requirements of due process “are notice and an opportunity to respond” before a person is deprived of a protectable property interest. Cleveland Bd. of Educ. v. Loudermill, 470 U.S. 532, 542, 546 (1985). Where a single misfeasance can justify sanction, does the allegation on the basis of a statistical overview provide the respondent with sufficient notice of charges in which to defend? See Pope v. U.S. Postal Service, 114 F.3d 1144, 1148-49 (1997) (concluding an employee’s due process right to notice was not violated where, among other things, “the administrative judge required the Postal Service to break down the charges into multiple specifications, each directed to a specific act of misconduct, which helped alleviate due process notice concerns”).
lived over 100 miles from the pharmacy, that fact alone would only be grounds for sanction if the Government proved Respondent violated its corresponding responsibility or dispensed controlled substances outside the usual course of professional practice by failing to resolve and document red flags. This Tribunal believes these evaluations must necessarily be individualized to specific prescriptions. Statistical analysis may be an important tool in focusing attention on particular practitioners warranting further investigation, and it may be evidence in support of an ultimate conclusion that an individual prescription was improperly compounded or dispensed, but it does not, in itself, constitute proof positive of any violations.54 Accordingly, this Tribunal is not convinced that evidence of statistical probability constitutes proof positive of actionable misconduct, even under the catch-all provision of Factor Five.
In the alternative, the Government has introduced evidence pertaining to eleven patients, sustaining its burden with respect to those patients by focusing on each dispensing event individually. That evidence has been evaluated under Factor Four. For these reasons, I decline to consider any conduct under Factor Five.
Acceptance of Responsibility
With the Government’s prima facie burden having been met as to violations of the corresponding responsibility under 21 C.F.R. § 1306.04(a) with respect to twelve prescriptions; dispensing controlled substances outside the usual course of professional practice in violation of 21 C.F.R. § 1306.06 for failing to document red flag resolution in compliance with state law; and unlawfully manufacturing controlled substances without the proper DEA registration in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e), an unequivocal acceptance of responsibility
54 What would such a finding look like, “on average, the evidence proves that the Respondent must have prescribed at least a single compounded medication improperly”?
stands as a condition precedent for the Respondent to prevail. George Mathew, M.D., 75 Fed. Reg. 66138, 66148 (2010).
This feature of the Agency’s interpretation of its discretionary authority under the CSA has been sustained on review. MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 2011). Accordingly, the Respondent must present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility incumbent with such registration. Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008); Samuel S. Jackson, 72 Fed. Reg. 23848, 23853 (2007). As past performance is the best predictor of future performance, DEA has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for its actions and demonstrate that it will not engage in future misconduct. ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995); Medicine Shoppe, 73 Fed. Reg. at 387; see also Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) (reasoning that “admitting fault” is “properly consider[ed]” by DEA to be an “important factor” in the public interest determination). Likewise, in making the public interest determination, “this Agency places great weight on a registrant’s candor, both during an investigation and in [a] subsequent proceeding.” Robert F. Hunt, 75 Fed. Reg. 49995, 50004 (2010); Hoxie, 419 F.3d at 483.
Although correcting improper behavior and practices is very important to establish acceptance of responsibility, conceding wrongdoing is critical to reestablishing trust with the Agency. Holiday CVS, L.L.C., 77 Fed. Reg. 62316, 62346 (2012); Daniel A. Glick, D.D.S., 80 Fed. Reg. 74800, 74801 (2015).
The Respondent has not unequivocally accepted responsibility for the proven violations. In fact, the Respondent has not tendered any acceptance of responsibility at all, whether equivocal or unequivocal. The Respondent’s owner and pharmacist-in-charge never testified at the hearing in order to accept responsibility. Instead, the Respondent’s sole witness, a pharmacy tech, never admitted that the Respondent. (SEE: CLICK ON BELOW VIDEO)
committed any wrongdoing. The Respondent’s post-hearing brief is silent on this issue. Resp’t PHB, p. 29, ¶ (i); p. 32, ¶ (ii); p. 36, ¶ (iii).
The Respondent took the similar approach in its opening statement, arguing that the Government has failed to satisfy its burden; accusing the DEA of never intending to clearly or objectively evaluate the evidence; attacking the credentials of the Government’s expert; claiming that the Respondent exercised appropriate judgment when dispensing the relevant controlled substance prescriptions in compliance with Florida law; and complaining about the so-called “ivory tower aspirational” standard the DEA is imposing on its conduct. Tr. 503-05. In other words, the message from the Respondent’s post-hearing brief and its opening statement is that it has done nothing wrong. These sentiments are inconsistent with a registrant that is remorseful for misconduct and determined to regain the Agency’s trust. By failing to accept responsibility, the Respondent has failed to overcome the Government’s prima facie case. In addition to failing to accept responsibility, the Respondent has also failed to offer any evidence of remediation.
Egregiousness and Deterrence
While a registrant must accept responsibility and demonstrate that it will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 Fed. Reg. 10083, 10094 (2009); Southwood Pharm., Inc., 72 Fed. Reg. 36487, 36504 (2007). The egregiousness and extent of an applicant’s misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 Fed. Reg. 19386, 19387-88 (2011) (explaining that a respondent can “argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation”); Paul H. Volkman, 73 Fed. Reg. 30630,
30644 (2008); see also Gregory D. Owens, 74 Fed. Reg. 36751, 36757 n.22 (2009). I find that the proven misconduct is egregious and that deterrence considerations weigh in favor of revocation. The proven misconduct involves repeated instances of dispensing high-strength schedule II controlled substances despite the presence of well-known signs of drug abuse and diversion. The proven misconduct also involves repeat instances of failing to follow state law and state standards of practice with respect to documenting red flag resolution in the patient profile. Continuously dispensing high-strength schedule II opioids, sometimes dangerously combined with high-strength benzodiazepines, to patients who raised multiple red flags of diversion, and failing to document any investigation into those red flags in the patient profiles, constitutes egregious misconduct because it allowed for the potential of unchecked diversion of controlled substances into illegitimate channels.
Finding that the Respondent’s proven misconduct is egregious is warranted
despite the fact that I only weighed the Government’s evidence under Factor Four. The public interest factors are considered separately and any one or combination of factors may be considered when weighing the evidence. Robert A. Leslie, M.D., 68 Fed. Reg. at 15230 (citation omitted). It is not necessary that a sanction be supported by findings under each factor. Hoxie v. DEA, 419 F.3d at 482; Morall, 412 F.3d at 173. It is also not required to discuss consideration of each factor in equal detail, or even every factor in any given level of detail. Trawick v. DEA, 861 F.2d at 76. The balancing of the public interest factors “is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest.” Jayam Krishna-Iyer, M.D., 74 Fed. Reg. at 462. Thus, I find that sanction is justified and that the Respondent’s conduct was egregious even though the evidence was only weighed under a single
In addition to the severity of the Respondent’s dispensing misconduct, the
Respondent also unlawfully manufactured thousands of capsules of schedule II controlled substances without being registered with the DEA as a manufacturer. As noted earlier, registered manufacturers of controlled substances are held to higher standards than practitioners with respect to recordkeeping, reporting, security, and frequency of renewing registration. Thus, manufacturing controlled substances without the DEA’s blessing enabled the Respondent to produce thousands of dosage units of controlled substances over several years in the absence of regulatory monitoring. As with unlawful dispensing, unlawful manufacturing is an egregious violation and warrants the revocation of registration.
I further find that deterrence considerations weigh in favor of revocation. Allowing the Respondent to retain its COR despite the proven misconduct would send the wrong message to the regulated community. Imposing a sanction less than revocation would create the impression that registrants can maintain DEA registration despite repeatedly failing to resolve and document the resolution of red flags in accordance with state law, and despite engaging in a regulated activity without obtaining approval from the DEA to engage in that activity. Revoking the Respondent’s COR communicates to registrants that the DEA takes all failings under the CSA seriously and that severe violations will result in severe sanctions.
Advice of Counsel
When the DEA executed an AIW at the Respondent in September 2018, the Respondent’s owner and pharmacist-in-charge, Mr. Clement, Sr., refused to speak to DI Albert upon advice of counsel to not answer any questions. Tr. 168, 173, 177. The Respondent has an absolute right to seek advice of counsel, and no adverse inference from obtaining advice of counsel may be drawn. It does not provide,
however, any defense to actions taken, including failing to eventually respond to DEA inquiries following consultation with counsel, or lack of cooperation with the DEA’s investigation.
Loss of Trust
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Acting Administrator that he can be entrusted with the responsibility commensurate with such a registration. Medicine Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008).
There is no evidence that suggests the Respondent has learned any lessons from its misconduct. As just discussed, the Respondent does not appear to believe it has done anything wrong. And the Government’s evidence proves violations that occurred within the past few years, allowing a significant lapse of time for the Respondent to reform its ways.
These actions do not engender trust. The Respondent’s failure to accept responsibility and present remediation evidence has convinced this Tribunal that the DEA cannot trust Respondent with the obligations of a DEA registration. Furthermore, on two occasions the Respondent exhibited a lack of trustworthiness. First, in May 2017, the Respondent’s owner directed his wife to ask a DEA Diversion Investigator to leave the pharmacy during an inspection. Tr. 27. Secondly, during execution of an AIW in September 2018, the Respondent’s owner refused to answer the same Diversion Investigator’s questions upon advice of counsel. Tr. 168, 173, 177. As just noted, the Respondent is entitled to rely upon the advice of counsel; however, relying on advice of counsel cannot serve as a defense to actions taken, such as refusing to cooperate with the DEA’s investigation. Both of these instances demonstrate a concerning reluctance on the Respondent’s
part to work with the DEA in correcting its transgressions. If the DEA cannot trust the Respondent to cooperate with its investigators, it is hard to trust that it will take its duties under the CSA seriously. See Satinder Dang, M.D., 76 Fed. Reg. 51424, 51425 (2011) (noting the ALJ determined a respondent’s lack of cooperation with DEA investigators weighed against the respondent); Kimberly Maloney, N.P., 76 Fed. Reg. 60922, 60929 n.25 (2011) (noting respondent’s cooperation with investigators weighed in her favor). Thus, I find that the Respondent has lost a significant amount of trust and has failed to overcome that loss of trust by demonstrating to the Agency that it can be relied upon to lawfully discharge it’s COR obligations.
Considering the entire record before me, the conduct of the hearing, and observation of the testimony of the witnesses presented, I find that the Government has met its burden of proof and has established a prima facie case for revocation. Furthermore, I find that the Respondent has not accepted responsibility, or presented sufficient evidence demonstrating that the Agency can entrust it with a COR.
Therefore, I recommend that the Respondent’s DEA COR No. FP2302076 should be REVOKED, and that any pending applications for modification or renewal of the existing registration, and any applications for additional registrations, be DENIED.
Signed: May 5, 2020
Mark M. Dowd
MARK M. DOWD
U.S. Administrative Law Judge
Certificate of Service
This is to certify that the undersigned, on May 5, 2020, caused a copy of the foregoing to be delivered to the following recipients: (1) John Beerbower, Esq., Counsel for the Government, via email to the DEA Government Mailbox at firstname.lastname@example.org; and (2) Dale R. Sisco, Esq., Sisco-Law, Counsel for the Respondent, via email at email@example.com.
Bella A. Mapeso
Bella Mapeso, Secretary
Office of Administrative Law Judges
Judge Mark D. Dowd may be in legal circles a great juris in the field of medicine and pharmacy he is but a fool and needs to step down immediately and earn a living as an Uber Driver.
PHARMACY COMPOUNDING WHILE BLACK!!!
The DEA investigation was an act of brazen misconduct against a licensed retail pharmacy that is licensed by law to compound medications. These cases are not only about bad science but bad law and poor training. Diversion Investigator Richard Albert prepared a warrant that was “opinion based on a red flag,” that Pronto Pharmacy engaged in manufacturing-controlled substances. This is an assumption that a crime was committed within the Pronto Pharmacy, wherein a licensed pharmaceutical company by law, that can compound medication. Diversion Investigator wrote,
ILLEGAL MANUFACTURING :
Between January 2018 and May 2019, the Respondent was engaged in manufacturing controlled substances, as that term is defined in the CSA, without a separate DEA registration authorizing it to manufacture controlled substances, in violation of 21 U.S.C. § 841(a)(1) and 21 C.F.R. § 1301.13(e). ALJ Ex. 1, ¶ 20-28.
“In addition, the Government previewed that its evidence will show that the Respondent unlawfully manufactured controlled substances, specifically oxycodone and hydromorphone, without a manufacturer’s registration.”
To support this allegation, the Government intended to show that in May 2012 the Respondent’s owner, Mr. Norman J. Clement, Sr., told DEA investigators that he compounded oxycodone and hydromorphone because it was cheaper than obtaining them from distributors.
THE MANUFACTURING OF OXYCODONE
Pronto Pharmacy does not manufacture Oxycodone nor Hydromorphone, which is a far more complex process. Pronto would have to:
- Acquire large tons of harvested opium paste from Tasmania, India, or Afghanistan, transporting these volumes to Tampa, Fl., for processing.
- Process the opium paste, large volumes of agents, reagents, equipment, and space would be needed, notwithstanding the fact that to bring the product Oxycodone and Hydromorphone to a pharmaceutical-grade that meets FDA purity standards.
- The water bill and electrical bill at Pronto Pharmacy would be enormous.
The manufacturing of Oxycodone into a bulk product is an extremely complex procedure and would involve: (see google scholar manufacture Oxycodone footnote 4)
Oxycodone is manufactured in high yields and with high purity using codeine or salt of codeine as the starting material. The manufacturing process involves the following steps:
- (a) codeine or a codeine salt (e.g., codeine phosphate) is converted into the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine,
- (b) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeine resulting from step (a) is oxidized to yield the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone;
- (c) the intermediate N-carboalkoxy- or N-carboaryloxynorcodeinone resulting from step (b) is enolized with a base and the resultant enolate is thereafter methylated to yield the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine;
- (d) the intermediate N-carboalkoxy- or N-carboaryloxynorthebaine resulting from step (c) is reduce to yield thebaine;
- (e) the thebaine resulting from step (d) is oxidized to yield the intermediate 14-hydroxycodeinone; and
- (f) the intermediate 14-hydroxycodeinone resulting from step (e) is hydrogenated to yield oxycodone.
THERE WAS NOT ONE SINGLE CAPSULE EVER MANUFACTURED AT PRONTO PHARMACY
1. There is not one piece of equipment that the DEA seized from Pronto that was used in manufacturing. All equipment taken was for compounding
2. All medications compounded was purchase from two wholesalers (Fagron and B&B)
3. There is not a single controlled substance compounded for encapsulation at Pronto Pharmacy which was manufactured at the pharmacy or by a Pronto pharmacist and/or their technicians.
Here are the containers. ( see below)
4. The containers of powders were obtained from B&B Pharmaceutical and were recorded into the CSOS system which reported back to the DEA and wholesalers. Therefore, Richard James Albert should have known this but chose to falsify his warrant in order to put Pronto out of business and its owners in prison.
DEA MOVING THE GOAL POST BACKWARD AND FORWARD AND SETTING QUOTAS
We see this early in the case of Pronto Pharmacy when Diversion Investigator Richard James Albert (DI Albert) came upon compounding, and when he could not repeatedly find anything wrong with the pharmacy’s records His handlers instructed him to redefine this long-standing pharmaceutical methodology as manufacturing.
It is more than clear that the DEA Diversion Investigators were operating in absent the law based on mis-facts, lies, distortions. DEA has learned well. When there is no evidence of wrongdoing, DI Richard James Albert’s handlers cleverly instructed him to redefine the meaning of pharmaceutical procedures to accomplish their goals. The Diversion Investigator’s charges and findings were easily scientifically debunked.
It became clear from his court testimony he did not understand compounding or its procedures. But likely learned from his handlers like Amy Hickerson, who was guiding him on how to divert both meanings to convince a Federal Administrative Judge to secure a warrant to shut Pronto Pharmacy LLC down. Additionally, he testified that he did not “know or understand the law(s) or how any law applies to the practice of Pharmacy. Florida Statue 499.1.2 states the wholesaler must assess the purchases of control medication by an individual pharmacy.
YOU’RE WITHIN THE NORMS
1) Joseph Madison “The Black Eagle” XM 126, THE URBAN VIEW, Thank you Joe, if i’m a celebrity then let it be for Obamacare which saved my life from Invasive Early Stage Colon Cancer through an eye exam 2016.
2) Good compounding practice applicable to state-licensed pharmacies. In: Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. Park Ridge, Ill: National Association of Boards of Pharmacy; 1993;C-1-C-5.