The Criminalization of Pain – In 2022, DOJ is Aggressively Investigating and Prosecuting MDs, NPs and PAs for Violations of the Controlled Substances Act

Criminalization of Pain – In 2022-Liles parker

(April 19, 2022): Despite our government’s best efforts, opioid overdose deaths in America are continuing to spiral out of control. According to the U.S. Centers for Disease Control and Prevention (CDC), during the period April 2020 through April 2021, the number of overdose deaths were more than 30% higher than the previous year. While many of these overdose deaths can be attributed to the wrongful diversion of otherwise legal opioid pain medications, most of these overdose deaths have been attributed to fentanyl, a synthetic opioid that is currently the leading cause of death among Americans between the ages of 18 and 45. To address this problem, the government has been taking steps to curb the illicit importation and illegal use of fentanyl. Nevertheless, federal prosecutors have continued to aggressively prosecute alleged violations of the Controlled Substances Act. Even though the government has gone out of its way to reaffirm its position that physicians should not be reluctant to provide legitimate pain relief, [1] the government’s opioid abuse enforcement efforts have had a significant chilling effect on physicians’ pain medication prescribing practices. This has often made it difficult for patients with a long-established history of chronic pain to obtain relief.[2] In this article, we examine the standards applied by prosecutors and the courts when physicians and other qualified practitioners [3] are alleged to have illegally prescribed controlled substances.

I. Early History of Our Country’s Efforts to Regulate Addictive Drugs:

During the 19th century, addictive substances such as opium and cocaine were largely unregulated in the United States. In fact, as late as the 1890s, it was possible to buy cocaine through the Sears & Roebuck catalogue.[4] Notably, when the impact of addictive substances became apparent in the early 20th century, our government didn’t focus its efforts on prohibiting the use of opiates. Instead, it took steps to curb the use of opiates through taxation. With the passage and enactment of The Harrison Narcotics Tax Act of 1914, the government weighed in for the first time to regulate and tax the production, importation and distribution of opiates and coca products.[5]

II. Enactment of the Controlled Substances Act

With the advent of the 1960s, there were fundamental changes in our society. One consequence of this liberated period was the adoption of a new drug culture among young Americans. In response, the Nixon Administration took action to address this new threat to the safety and welfare of our citizens. Congress passed and the President subsequently enacted the Comprehensive Drug Abuse Prevention and Control Act of 1970.” [6] Title II of this statute is known as the Controlled Substances Act.” [7] The agency primarily responsible for enforcing the Controlled Substances Act is the Drug Enforcement Administration (DEA).[8] As set out in the Controlled Substances Act, the term “Controlled Substance” is defined as:

. . . a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this title. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1954." [9]

Importantly, the Controlled Substances Act does not apply to all prescription drugs. It only applies to a narrow subset of drugs – “Controlled Substances” -- which have been deemed to justify the imposition of additional restrictions. The DEA has estimated that only 10% of all drug prescriptions written in the United States are for controlled substances.[10] The Controlled Substances Act restricts the use of controlled substances to legitimate medical, scientific, research and industrial purposes. Due to their potential for abuse and in light of the safety risks presented if they are misused or diverted, controlled substances are highly regulated. Among its various provisions, the Controlled Substances Act makes it unlawful for any person to knowingly and intentionally manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance.[11]

 

The only persons who may lawfully manufacture, distribute and dispense controlled substances under the Controlled Substances Act are qualified practitioners who have obtained a DEA registration authorizing them to do so.[12] Under the Controlled Substances Act, these registered persons are permitted to write prescriptions for certain controlled substances in the course of professional practice.” [13]

 

Under the Controlled Substances Act, controlled substances have been categorized as schedules I through V, based on their medical use and their potential for abuse and dependence. The lower the schedule, the greater the risk to the public. Therefore, schedule I substances are considered to pose the greatest risk and are subject to the highest amount of scrutiny and restrictions. In contrast, schedule IV and V substances are considered to pose the least amount of risk. The following chart illustrates the differences between schedules I through V:
Schedule Controlled Substances Act Statutory Provision List of Scheduled Substances
I Pursuant to 21 U.S.C. § 812(b)(1), a substance will be placed in schedule I based on specific findings made by the Administrator that “(A) The drug or other substance has a high potential for abuse. (B) The drug or other substance has no currently accepted medical use in treatment in the United States. (C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.” Examples include heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4- methylenedioxymethamphetamine (MDMA).

See 21 C.F.R. § 1308.11(b)-(f) (complete listing of schedule I drugs and substances).

II Pursuant to 21 U.S.C. § 812(b)(2), a substance will be placed in schedule II based on specific findings made by the Administrator that “(A) The drug or substance has a high potential for abuse. (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. (C) Abuse of the drug or other substance may lead to severe psychological or physical dependence.” Examples include morphine, codeine, and opium.

See 21 C.F.R. § 1308.12 (b)-(g) (complete listing of schedule II drugs and substances).

III Pursuant to 21 U.S.C. § 812(b)(3), a substance will be placed in schedule III based on specific findings made by the Administrator that “(A) The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. (B) The drug or other substance has a currently accepted medical use in treatment in the United States. (C) Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence.” Examples include morphine combination products containing not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, non-narcotic ingredients in recognized therapeutic amounts, and products containing not more than 90 milligrams of codeine per dosage unit with an equal or greater quantity of an isoquinoline alkaloid of opium.

See 21 C.F.R. § 1308.13 (b)-(g) (complete listing of schedule III drugs and substances).

IV Pursuant to 21 U.S.C. § 812(b)(4), a substance will be placed in schedule IV based on specific findings made by the Administrator that “(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. (B) The drug or other substance has a currently accepted medical use in treatment in the United States. (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.” Examples include alprazolam, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, and triazolam.

See 21 C.F.R. § 1308.14 (b)-(f) (complete listing of schedule IV drugs and substances).

V Pursuant to 21 U.S.C. § 812(b)(5), a substance will be placed in schedule V based on specific findings made by the Administrator that “(A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV. (B) The drug or other substance has a currently accepted medical use in treatment in the United States. (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.” Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams

See 21 C.F.R. § 1308.15 (b)-(e) (complete listing of schedule V drugs and substances).

III. Regulatory Restrictions on the Prescription of Controlled Substances

In addition to meeting the requirements of the Controlled Substances Act, there are a number of regulatory restrictions on the prescription of controlled substances that have been placed on qualified practitioners. Most notably, regulations issued by the Attorney General require that for a controlled substance prescription to be lawful, it “must be issued for a legitimate medical purpose” by an individual practitioner acting in the “usual course of his professional practice.”[14] Both of these prongs must be met in order for a controlled substance prescription to be legitimately issued by a qualified practitioner. Conversely, to convict a registered practitioner for a violation of 21 U.S.C. § 841(a), the government must only show that one of these prongs have not met.[15] While there is agreement among the circuits with respect to the two prongs that must be met in order for a controlled substance prescription to be lawful. there is a wide divergence between the circuits with respect to the scienter that must be shown in order for the government to prove a violation of the Controlled Substances Act.

A. What does it mean for a prescription to be issued for a “Legitimate Medical Purpose”?

Circuit courts have addressed violations of the “legitimate medical purpose” requirements very differently. For example, in several of the circuits, the government must prove that a defendant knew that he or she was issuing a prescription for no “legitimate medical purpose.” [16]

Aside from the scienter requirement, it can be difficult to definitively set out what constitutes a “legitimate medical purpose.” [17] Commenting on what is meant by the Controlled Substances Act’s “legitimate medical purpose” requirement, the Supreme Court has noted that this requirement ‘‘ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse.’’ The Supreme Court further stated: ‘‘As a corollary, the provision also bars doctors from peddling to patients who crave the drugs for those prohibited uses.’’[18]

In contested cases, the issue of whether a physician’s prescribing practices were for a legitimate medical purpose is often the key to whether the government prevails. In many cases, it ultimately ends up as a battle between expert witnesses, with the defendant’s expert asserting that the prescriptions for controlled substances were both proper and within the applicable standard of care, while the prosecution’s expert will likely argue that the prescriptions were not for a legitimate medical purpose and therefore fell well outside of what would be considered an acceptable level of practice.

B. What does it mean for a prescription to be issued in the “Usual Course of Professional Practice”?

While the several circuits have required the “legitimate medical practice” prong to have a scienter element, these circuits still hold a registered practitioner strictly liable for ensuring that a controlled substance prescription is within the “usual course of professional practice.” In contrast, the remaining circuit courts require that the government prove that the defendant knowingly or intentionally acted "outside the scope of professional practice." [19]

With respect to what is meant by the prong “outside the scope of professional practice,” the federal government has left the overall regulation of medicine to the oversight of the states. This prong has been interpreted to mean that a prescription must be “in accordance with a standard of medical practice generally recognized and accepted in the United States.” [20] The DEA has further commented that:

"While the CSA is one component of the overall regulation of the practice of medicine in the United States, it bears emphasis that the CSA does not regulate the practice of medicine as a whole. Therefore, although DEA is the agency responsible for administering the CSA, DEA does not act as the Federal equivalent of a State medical board overseeing the general practice of medicine. State laws and State licensing bodies (such as medical licensing boards) collectively regulate the practice of medicine." [21]

Unfortunately, neither the Controlled Substances Act, DEA regulations, nor case holdings have more precisely explained what is meant by the phrase "in the usual course of professional practice." Instead, courts many have merely focused on the fact that the bad conduct in a particular case is typically sufficient to show that a practitioner was well outside of what could be considered a practitioner’s scope of professional practice. For example, as the 6th Circuit noted in United States v. August:

There are no specific guidelines concerning what is required to support a conclusion that an accused acted outside the usual course of professional practice. Rather, the courts must engage in a case-by-case analysis of evidence to determine whether a reasonable inference of guilt may be drawn from specific facts.[22]

Similarly, as the 5th Circuit noted in United States v. Rosen:

"A majority of cases [in which physicians were alleged to have dispensed controlled substances without a legitimate medical purpose] have dealt with facts which were so blatant that a statement of clear-cut criteria in a form useful in other cases would have been superfluous to the decision. We are, however, able to glean from reported cases certain recurring concomitance of condemned behavior."[23]

C. Can a practitioner argue that there he or she had “good faith” belief that the actions fell within the “Usual Course of Professional Practice”?

One of the questions that practitioners sometimes ask when facing a Controlled Substances Act prosecution is whether it is a proper defense to argue that their prescribing decisions were made in “good faith,” in a sincere, albeit mistaken belief that their actions fell within the usual course of professional practice. There is at least some early precedent for permitting a defendant to at least raise good faith type defenses when challenging the prosecutions narrative that the defendant’s conduct falls outside of the usual course of professional practice.[24]

Unfortunately, there is a lack of consensus among the circuit courts with respect to whether jury instructions may consider a defendant’s belief that he or she acted in good faith. For example, in the 7th [25] and 9th [26] circuits, if a defendant practitioner is able to show that he or she subjectively held a sincere, good faith belief that the prescribing practices were appropriate, then the defendant would be eligible to have the court issue a jury instruction that the defendant would not be guilty of intentionally or knowingly issuing controlled substance prescriptions outside of the usual course of professional practice. In contrast, the 10th circuit has taken a strict liability approach with respect to the “usual course of professional practice” prong of the regulation. The 10th circuit takes the position that in a 21 U.S.C. § 841(a) prosecution, these terms speak for themselves and whether a violation has occurred is a question of fact for the jury. A defendant’s sincere, good faith belief that his prescribing practices fell within the usual course of professional practice isn’t relevant. The jury is solely required to determine whether the conduct fell outside of the usual course of professional practice.

IV. Implications with Respect to Malpractice or Irregular Controlled Substances Prescribing Practices.

As previously discussed, neither of the phrases must be issued for a legitimate medical purpose” nor usual course of his professional practice,” have been further defined in the Controlled Substances Act or in DEA regulations. This uncertainty has made it quite difficult to parse out whether certain conduct may be the basis of civil or criminal liability. This is especially troubling when you consider the fact that some jurisdictions don’t permit a defendant to instruct a jury on the differences between:

  • Possible Criminal Conduct. Prescribing practices that would qualify as illegal drug dealing, distribution, or trafficking.
  • Possible Non-Criminal Conduct. Prescribing practices that may constitute medical malpractice.
  • Possible Non-Criminal Conduct. Prescribing practices that do not conform or possibly challenge what the government considers to be the appropriate standard of care.
For example, a practitioner who improperly prescribes controlled substances for a condition that would not be considered “legitimate,” may have just made a bad medical decision, more akin to medical malpractice rather than a criminal violation of the Controlled Substances Act.

 

Focusing on the second prong to be met, there are a number of situations which may warrant deviating from what would normally be considered the usual course of professional practice. As one clinician found after testing patients for cytochrome P450-2D6 (CYP-2D6) genetic abnormalities:

"The clinical history of these persons is quite typical, and I share this information to help practitioners identify pain patients who may have a genetic defect of CYP-2D6. They will likely not respond to some opioids. These patients may require high dosages of opioids or may be falsely accused of drug-seeking behavior." [27]

It is also worth noting that every day physicians prescribe medications to patients that are meant to be used in an “off-label” fashion. Prescribing a medication in an off-label fashion means that the drug has been approved by the Food and Drug Administration (FDA) for a specific disease or symptom BUT the prescriber has determined that a patient may benefit from treatment with this drug for a non-FDA approved condition. Arguably, the prescribing of a drug in an off-label fashion would fall outside of the usual course of professional practice. Despite the fact that off-label prescribing is widespread, the government has effectively prohibited the off-label prescribing of controlled substances. While these medications are only supposed to be ordered for FDA approved purposes, there are a number of examples where controlled substances are being used in an off-label fashion for medical indications that are not FDA approved and would be considered to be outside the usual course of professional practice.[28]

 

Ultimately, the approach taken by some circuit courts effectively precludes a defendant from arguing that the conduct at issue is not a criminal violation of the Controlled Substances Act, despite the fact that conduct may constitute medical malpractice or an improper deviation from the usual course of professional practice.

V. What are the Primary Investigative Tools Used by Law Enforcement to Identify Aberrant Prescribing Patterns?

A. Data Analysis of Prescribing Patterns

Both state and federal law enforcement agencies now heavily rely on an analysis of prescription claims data when identifying physicians and others whose prescribing practices are unusual when compared to those of their peers. To be clear, the fact that a physician’s overall volume of prescriptions for opioids or benzodiazepines appears to be excessive is not definitive proof of wrongdoing. Nevertheless, once a physician has been identified as an outlier, an audit or investigation of his or her prescribing practices will almost surely ensue, regardless of the fact that the physician may have a pain management or psychiatry practice.

B. State Prescription Drug Monitoring Programs (PDMPs)

Every state has implemented a prescription drug monitoring program (PDMP). Essentially, the PDMP is a statewide electronic database that is used to track controlled substance prescriptions ordered by physicians and other registered practitioners. It also tracks the controlled substances filled by a given pharmacy. Perhaps most importantly, it is used to track the various prescriptions for controlled substances issued to a specific patient. The PDMP greatly assists prescribers and pharmacies in monitoring possible drug contraindications and helps guard against patients engaging in doctor-shopping.

prescription drug monitoring program - lilesparker

C. State Licensure Board Actions

State licensure boards work closely with state and federal law enforcement agencies to ensure that both parties are notified when a prescribing practitioner has been identified as engaging in improper or illegal controlled substances practices. Once an adverse action is taken (e.g. the suspension of a physician’s license or the revocation of a physician’s DEA registration), that information is reported to the National Practitioner Databank (NPDB). After receiving notice of the adverse action, private payors and hospitals often initiate their own actions (e.g. terminate a practitioner’s participation status in a plan or revoke the practitioner’s hospital privileges).

D. Pharmacist Reports / Pharmacy Records

After a registered practitioner prescribes controlled substances, the prescription is typically filled by a licensed pharmacist. It is important to keep in mind that pharmacists have their own legal obligations under the Controlled Substances Act to only fill prescriptions that are for a “legitimate medical purpose.” From a practical standpoint, this means that pharmacists are required to use their professional judgment and exercise due diligence (such as checking the state PDMP) prior to filling a controlled substance prescription. As set out in the latest version of the DEA’s “Pharmacist Manual”:

"To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a corresponding responsibility rest with the pharmacist who fills the prescription."[29]

A pharmacist knowingly filling an improper controlled substance prescription, as well as the registered practitioner issuing it, can be subject to the penalties provided for violations of both the Controlled Substances Act and applicable regulations. For example, in a recent 2022 California case, a San Diego pharmacy agreed to pay $105,000 to resolve allegations that it illegally dispensed opioids and other dangerous drugs to patients without resolving “red flags” that indicated that the prescription may be invalid. Examples of “red flags” that may indicate that a prescription does not meet the Controlled Substances Act and / or DEA regulations (and is therefore invalid), include:

  • Excessive Dosage Amounts. Prescriptions for controlled substances that exceed acceptable guidelines, in terms of frequency and or dosage amounts are a red flag for the pharmacist, especially since dispensing high dosages increases the risk that patients will divert opioids.
  • Dangerous Combinations of Drugs. Pharmacists must check to ensure that there are no contraindications that could pose a safety risk to a patient. For example, does the PDMP show that the patient is already on another opioid? Has the patient been prescribed opioids and benzodiazepines at the same time? Is the patient currently taking or has been prescribed opioids, benzodiazepines, and muscle relaxants?
  • Doctor Shopping Behavior. Pharmacists must be vigilant to guard against patients who have seen multiple practitioners and received multiple prescriptions for controlled substances or been prescribed other drugs that may be contraindicated.
  • Early Requests for Refill. If a pharmacist is asked by a patient to fill a prescription for a controlled substance before the prior prescription should have run out, it may be an indication that the patient has taken the drug more frequently than was prescribed.

As Randy S. Grossman, U.S. Attorney for the Southern District of California stated in connection with a recent Controlled Substances Act enforcement case brought against a pharmacy:

"Pharmacies are the last line of defense protecting the public from addictive opioids and other controlled substances. . . This office will pursue pharmacists who carelessly disregard red flags, opting instead to rubberstamp questionable prescriptions. We will continue to use all available tools to combat the serious opioid epidemic."

VI. Registered Practitioners Should Also Exercise Special Care When Prescribing Benzodiazepines

The government’s current focus on improper controlled substance prescribing practices isn’t limited to only opioids. The prescribing practices of practitioners ordering benzodiazepines (sometimes called "benzos") are also under law enforcement’s microscope. Simply put, benzos work to calm or sedate a person, induce sleep or relieve anxiety. This occurs by raising the level of inhibitory neurotransmitters in the brain. Common benzodiazepines include diazepam (Valium), alprazolam (Xanax), and clonazepam (Klonopin), among others. These classes of drugs fall under schedule IV of the Controlled Substances Act. For example, in a recent Massachusetts case, law enforcement investigated the prescribing practices of a licensed, registered psychiatrist for almost a year. Using undercover agents, investigators found that the psychiatrist was allegedly providing prescriptions for Adderall or Xanax to individuals in exchange for $200 in cash, typically with little to no medical examination. Many of the patients used Medicaid to pay for the prescriptions that the psychiatrist wrote for them. The psychiatrist has been charged with health care fraud and controlled substances offenses related to the illegal distribution of prescription medication.

VII. How Do Prosecutors Distinguish Between Good and Bad Physicians?

There are limits to how registered physicians and other qualified practitioners may exercise their prescribing authority. Physicians and other registered practitioners who illegally prescribe opioids or benzos are typically prosecuted under 21 U.S.C. § 841(a)(1). Notably, this is typically the same criminal statute as that used to prosecute traditional drug dealers.[30]

When bringing a case against a physician holding a DEA registration authorizing him or her to prescribe controlled substances, a prosecutor must show that the physician acted outside their scope of professional practice and without a legitimate medical purpose.[31] For example, in an early case rendered relatively shortly after the passage of the Controlled Substances Act, the Supreme Court held that a doctor is criminally liable for unlawfully distributing a controlled substance when acting as “a drug pusher,” and “not as a physician.” [32] In a more recent holding by the Supreme Court, the Court held that the Controlled Substances Act “bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood.”[33]

The message here is quite clear, if a registered practitioner deviates from his or her duty to provide legitimate, medically necessary care and engages in conduct that constitutes illegal drug dealing or distribution, such conduct will constitute a violation of the Controlled Substances Act and will be prosecuted to the fullest extent of the law.

VIII. Reducing Your Level of Risk Under the Controlled Substances Act

Despite the fact that neither the Controlled Substances Act nor DEA regulations describe what constitutes a "legitimate medical purpose. . . in the usual course of professional practice," law enforcement requires that registered physicians and other practitioners fully comply with these directives. There are a number of questions that law enforcement may ask when trying to determine whether your controlled substance prescribing practices meet these requirements. These questions include, but are not limited to the following:

  • Has the practitioner prescribed an inordinately large quantity of controlled substances?
  • Has the practitioner pre-signed prescriptions for controlled substances and issued prescriptions for patients who were not evaluated by a physician?
  • Does it appear that paid “runners” are bringing sham patients to a practice?
  • How does the practitioner’s prescribing practices compare to those of his or her peers in the area?
  • Is there a bona fide doctor / patient relationship that has been established or is this merely a subterfuge to prescribe controlled substances?
  • Is there evidence that a proper physical examination of the patient was given?
  • Did the practitioner advise the patient to fill prescriptions at different drug stores or to avoid going to certain pharmacies?
  • Does it appear that the practitioner has ignored “red flags” that would suggest that the practitioner should stop writing controlled substance prescriptions, change those prescriptions and / or counsel patients accordingly?
  • Is there evidence that the practitioner knew that the patient was giving the drugs to someone else or selling the drugs?
  • Is there evidence that the practitioner has written prescriptions for controlled substances in exchange for sexual favors?
  • Is there evidence that the practitioner is effectively selling controlled substance prescriptions?
  • Is the practitioner prescribing controlled drugs more frequently or in higher dosages than would be consistent with legitimate medical treatment?
  • Is there evidence that the controlled substance prescriptions were issued to patients with medical conditions that do not warrant that type of treatment.
  • Has the practitioner permitted allowed nonmedical personnel to prescribe commonly abused painkillers, such as oxycodone?
  • Has the practitioner pre-signed prescriptions for opioids, to be completed by staff members of the clinic and delivered to patients not seen by the practitioner?
  • Has the practitioner prescribed dangerous combinations of drugs known to heighten the risk of overdose and death?

IX. Final Thoughts

Banks and financial institutions have implemented a complex set of due diligence procedures that are intended to prevent money laundering activities. These are commonly referred to as "Know Your Customer" [34] requirements. Registered physicians and practitioners prescribing controlled substances, along with the pharmacists tasked with filling these prescriptions, need to adopt an analogous due diligence approach before ordering and filling prescriptions for controlled substances. An effective compliance program can go a long way towards helping you stay within the four corners of the law.

Are your controlled substance prescribing practices currently being audited or investigated? If so, give us a call. We can provide an assessment of your case and advise you of your options.

Robert W. Liles, Esq. is Managing Partner at the health law firm, Liles Parker PLLC. With offices in Washington, DC, Houston, TX, and Baton Rouge, LA, our attorneys represent health care providers and suppliers around the country in connection with DEA administrative appeals and DOJ prosecutions of Controlled Substances Act violations. Should you have any questions, please call us for a free consultation. Robert can be reached at: 1 (800) 475-1906.

  • [1] Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52715, 52716 (Sep. 6, 2006).
  • [2] The Washington Post (May 31, 2018), https://www.washingtonpost.com/graphics/2018/local/impact-of-americas-opioid-crackdown
  • [3] Under 21 U.S.C. § 802(21), the term “practitioner” means “a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.”
  • [4] Cockburn, Alexander; Jeffrey St. Clair (1998). Whiteout: The CIA, Drugs and the Press. (Page 71).
  • [5] The full title of the Act is “An Act to provide for the registration of, with collectors of internal revenue, and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes." Public Law No. 223, 63rd Cong., approved December 17, 1914.
  • [6] Pub.L. 91–513, 84 Stat. 1236, enacted October 27, 1970
  • [7] The Controlled Substances Act is codified at 21 U.S.C. § 841. Within a relatively short period of time, the U.S. Drug Enforcement Administration (DEA), a component of the U.S. Department of Justice (DOJ), was established in 1973 and is primarily responsible for enforcing federal drug laws.
  • [8] The DEA is a component of the U.S. Department of Justice (DOJ). The DEA was established in 1973 by President Nixon through his issuance of Executive Order 11727 on July 6, 1973.
  • [9] Pub.L. 91–513, 84 Stat. 1236, 1243.
  • [10] See DEA, Dispensing of Controlled Substances to Residents at Long Term Care Facilities, 75 Fed. Reg. 37,463, 37,464 (June 29, 2010).
  • [11] 21 U.S.C. § 841(a)(1).
  • [12] 21 U.S.C. § 822.
  • [13] Physicians and other qualified providers must first be registered with the Attorney General to qualify to write prescriptions for controlled substances. See 21 U.S.C. §§ 802(21), 822(b); 21 C.F.R. § 1306.03.
  • [14] 21 C.F.R. § 1306.04(a)
  • [15] The circuit courts generally cite United States v. Moore, 423 U.S. 122 (1975), along with 21 C.F.R. § 1306.04(a).
  • [16] United States v. Norris, 780 F.2d 1207, 1209 (5th Cir. 1986). United States v. Tobin, 676 F.3d 1264, 1283 (11th Cir. 2012).
  • [17] Drug Enforcement Admin., Practitioner's Manual, Appendix B (2006), DEA Office of Diversion Control website, available at: https://www.in.gov/dhs/files/DEA_Practicioner_Manual.pdf
  • [18] Gonzalez at 274.
  • [19] United States v. Sabean, 885 F.3d 27, 45 (1st Cir. 2018); United States v. Wexler, 522 F.3d 194, 206 (2d Cir. 2008); United States v. Li, 819 F. App'x 111, 118 (3d Cir. 2020) (unpublished); United States v. Hurwitz, 459 F.3d 463, 478, 480 (4th Cir. 2006); United States v. Jones, 825 F. App'x 335, 339 (6th Cir. 2020); United States v. Kohli, 847 F.3d 483, 490 (7th Cir. 2017); United States v. Smith, 573 F.3d 639, 649–50 n.4 (8th Cir. 2009); United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006).
  • [20] United States v. Moore, 423 U.S. 122, 139 (1975) (quoting jury instruction).
  • [21] Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52715, 52719 (Sep. 6, 2006).
  • [22] United States v. August, 984 F.2d 705, 713 (6th Cir.1992).
  • [23] United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978).
  • [24] United States v. Moore, 423 U.S. 122, 124 (1975).
  • [25] United States v. Kohli, 847 F.3d 483, 489 (7th Cir. 2017);
  • [26] United States v. Hayes, 794 F.2d 1348, 1351 (9th Cir. 1986).
  • [27] Edwards A. Non-responsive Pain Patients with CYP-2D6 Defect. Pract. Pain Manag. 2010;10(5).
  • [28] For instance, despite the fact that morphine has never received an FDA indication for pain treatment in children, it is extensively used for this indication in hospitalized pediatric patients. Wittich, Christopher M et al. “Ten common questions (and their answers) about off-label drug use.” Mayo Clinic proceedings vol. 87,10 (2012): 982-90, citing, Shah S.S., Hall M., Goodman D.M. Off-label drug use in hospitalized children [published correction appears in Arch Pediatr Adolesc Med. 2007;161(7):655] Arch Pediatr Adolesc Med. 2007;161(3):282–290].
  • [29] Drug Enforcement Admin., Pharmacist’s Manual (2020), Page 40.
  • [30] Jamie A. Peña & Peter A. McNeilly, Investigating and Prosecuting Opioid Diversion and Tampering Cases Involving Medical Professionals and Institutional Healthcare Providers, 64 U.S. ATT’Y BULL. 115, 124 (Nov. 2016).
  • [31] United States v. Moore, 423 U.S. 122, 124 (1975); See 21 C.F.R. § 1306.04(a) (“a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”).
  • [32] United States v. Moore, 423 U.S. 122, 126, 143 (1975).
  • [33] Gonzales v. Oregon, 546 U.S. 243, 270 (2006).
  • [34] In response to the terrorist attacks on September 11, 2001, Congress passed, and President Bush enacted the “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot Act)”, Public Law 107–56. 107th Congress (Oct. 26, 2001) The USA Patriot Act is a complex piece of legislation that was intended to provide law enforcement with the tools it needed to prevent money laundering and future terrorist activities. Among its various provisions, the USA Patriot Act formally introduced a set of anti-money laundering procedures that banks and financial institutions must follow to meet their compliance obligations.