Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis
Released: 2018-12-18T00:00:00

T he alarming rise in drug overdose deaths involving opioids over the past two decades has prompted the federal government to examine the causes of the public health crisis, identify possible solutions to counteract the problem, and take actions to address the crisis. The primary federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the Controlled Substances Act (CSA or the act), which is administered and enforced by the Drug Enforcement Administration (DEA) in the U.S. Department of Justice. The CSA provides the legal regime through which the federal government (1) regulates and facilitates the lawful production, possession, and distribution of controlled substances, including opioids; (2) prevents diversion of these substances from legitimate purposes; and (3) penalizes unauthorized activities involving controlled substances.

The regulatory framework under the CSA relies primarily on a registration system: the act requires persons who handle controlled substances (such as drug manufacturers, wholesale distributors, exporters, importers, health care professionals, hospitals, pharmacies, and scientific researchers) to register with the DEA and comply with the terms and conditions of the registration. Through this registration mechanism, the CSA creates a "closed system" of distribution in which distribution may lawfully occur among registered handlers of controlled substances, referred to under the act as "registrants." To monitor the amount of particularly dangerous drugs that enters this distribution system, the CSA requires the DEA to establish a quota system that restricts the total amount of certain controlled substances that may be annually produced or manufactured.

In order to minimize theft and diversion and to help the DEA monitor the flow of controlled substances in the United States, the CSA and its implementing regulations subject registrants to strict requirements regarding recordkeeping, maintaining the security of their controlled substance inventories, and reporting certain information to the DEA. The "closed system" of distribution, along with registrant compliance with the CSA's regulatory requirements, helps to ensure that a particular controlled substance is always accounted for by a DEA-registered entity, from its creation until it is dispensed to a patient or is destroyed. Note that patients are not required to register with the DEA because the controlled substances in their possession "are no longer part of the closed system of distribution and are no longer subject to DEA's system of corresponding accountability."

A registrant's failure to meet its obligations under the CSA can result in a controlled substance being diverted from legitimate channels. For example, "[d]istributors that blindly sell pharmaceutical controlled substances to rogue pharmacies, and practitioners who issue prescriptions without a legitimate medical purpose are diverting." Such diversion can contribute to drug abuse and addiction, which, in turn, increase the number of overdose deaths and emergency room visits, two defining features of the current opioid epidemic. In addition, some users who abuse prescription opioids may also start using cheaper and potentially easier to obtain illicit opioids such as heroin, which provide similar euphoric effects.

The CSA provides civil and criminal penalties for any unlawful manufacture, distribution, importation, exportation, or possession of controlled substances. Such violations may include (1) "regulatory" offenses committed by registrants who do not adhere to their responsibilities under the CSA, thereby increasing the risk of diversion, and (2) illicit trafficking or possession crimes that occur outside the "closed system" of authorized controlled substance distribution that primarily involve nonregistrants.

This report first provides a brief overview of the opioid epidemic and then describes in greater detail the current federal legal regime governing opioids and other controlled substances under the CSA and its implementing regulations. After that, the report examines DEA actions taken that are specifically targeted at addressing opioid abuse and describes recently enacted laws amending the CSA that impact the opioid regulatory system, including the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act ( P.L. 115-271 ), enacted by the 115 th Congress. The report concludes by discussing other legislative options that the 116 th Congress could consider to amend the CSA further to address the opioid epidemic.

Brief Background on the Opioid Epidemic29

The Centers for Disease Control and Prevention (CDC) has declared that the nation "is in the midst of an opioid overdose epidemic," citing statistics that show the number of overdose deaths involving opioids (including prescription opioids and illegal opioids such as heroin and nonpharmaceutical fentanyl) has more than quadrupled since 1999, and on average 115 Americans now die each day from an opioid overdose. Former Attorney General Jeff Sessions referred to the opioid epidemic as "the deadliest drug crisis in American history," and President Trump in October 2017 directed the Secretary of Health and Human Services to declare the crisis a national public health emergency.

The CSA defines the term "opioid" to mean "any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability." Opioids can include prescription pain relief drugs such as hydrocodone, oxycodone, codeine, morphine, and fentanyl, as well as illegal drugs such as heroin and nonpharmaceutical (illicitly produced) fentanyl. While doctors may prescribe U.S. Food and Drug Administration (FDA)-approved opioids to patients to alleviate their pain, particularly following surgery or injury or for serious health conditions such as cancer, some individuals may choose to abuse opioids for nonmedical reasons (such as to experience feelings of relaxation or to get "high") or by taking them in a higher dosage or through different means than prescribed by their doctor (such as by snorting or injecting the substance into a vein). The CDC has estimated that more than 40% of all opioid overdose deaths in the United States in 2016 involved an FDA-approved prescription opioid.

How the opioid epidemic occurred, and who is responsible for fueling it, are complicated questions, though reports have suggested that many parties are likely involved to some extent, including pharmaceutical manufacturers and distributors, doctors, health insurance companies, rogue pharmacies, and drug dealers and addicts. The National Institute on Drug Abuse has described the origins of the opioid overdose crisis as follows:

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.

The President's Commission on Combating Drug Addiction and the Opioid Crisis also cited excessive prescribing of opioids since 1999 as a significant contributor to the proliferation of opioids. The commission identified several other factors that have influenced the current opioid crisis, including large scale production and distribution of addictive opioids, widespread availability of illicit heroin and fentanyl, unethical physician prescribing practices and rogue pharmacies that fill those illegitimate prescriptions, and a lack of education for medical professionals and patients in prescribing and using opioids, respectively.

Overview of the CSA

This section provides a general overview of the CSA's closed system of distribution that regulates opioids and other types of controlled substances, including the schedules in which the substances are placed and the regulatory requirements and obligations that registrants must satisfy, such as (1) registering with the DEA, (2) keeping accurate and complete records of controlled substance inventories and transactions, (3) implementing security measures to safeguard controlled substances from theft or diversion, (4) reporting certain information to the DEA (including suspicious controlled substance orders), (5) meeting production quotas, and (6) prescribing controlled substances only for legitimate medical purposes.

Scheduling of Controlled Substances

The CSA places various plants, drugs, and chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic steroids) into one of five schedules based on the substance's medical use, potential for abuse, and safety or dependence liability. Opioids are types of narcotic drugs. To restrict access to chemicals used in the illicit manufacture of certain controlled substances, the CSA also regulates specified "listed chemicals." Furthermore, the CSA regulates controlled substance "analogues," which are substances that are not controlled but have chemical structures substantially similar to those of controlled substances found in Schedule I or II.

The order of the five schedules in which controlled substances are categorized reflects substances that are progressively less dangerous and addictive. Schedule I contains substances, such as the hallucinogen lysergic acid diethylamide (LSD) and the illicit opioid heroin, that have "a high potential for abuse" with "no currently accepted medical use in treatment in the United States" and that cannot safely be dispensed under a prescription. Schedule I substances may be used only for bona fide, federal government-approved research studies. In contrast, schedules II, III, IV, and V include substances that have recognized medical uses, such as prescription opioids like oxycodone, codeine, and morphine, and may be manufactured, distributed, prescribed, dispensed, and possessed in accordance with the CSA.

The CSA provides an administrative mechanism for substances to be controlled (added to a schedule); decontrolled (removed from the scheduling framework altogether); and rescheduled or transferred from one schedule to another. Federal rulemaking proceedings to add, delete, or change the schedule of a drug or substance may be initiated by the DEA, the U.S. Department of Health and Human Services (HHS), or by petition by any interested person. The DEA Administrator must request from HHS a scientific and medical evaluation and recommendation as to whether the drug or substance should be controlled or removed from control. The DEA Administrator then must evaluate all of the relevant data and make a final determination as to whether the drug or substance should be controlled or removed entirely from control.

In making such determination, the DEA Administrator is required to consider statutory factors such as the drug's actual or relative potential for abuse; scientific evidence of its pharmacological effect; the current state of scientific knowledge regarding the drug or substance; the risk to the public health from the drug; and whether the substance is an immediate precursor of a substance already controlled under the act. After the DEA Administrator makes this determination, he must make specific findings concerning the drug or substance that dictate the schedule in which the drug or substance will be placed.

For example, in 2009, the DEA requested from HHS an evaluation and recommendation concerning whether to reschedule hydrocodone combination products (HCPs) such as Vicodin® from Schedule III to Schedule II. After evaluating the scientific and medical evidence showing, among other things, significant diversion of HCPs and the health and safety risks created by people who abuse HCPs, HHS then recommended to DEA that HCPs should be reclassified to the more restrictive Schedule II, In 2014, DEA published a final rule that administratively reschedules HCPs from Schedule III to Schedule II, thereby subjecting anyone who manufactures, distributes, or dispenses HCPs to the more stringent regulatory requirements (and administrative, civil, and criminal sanctions) that are applicable to Schedule II controlled substances.

Congress may also change the scheduling status of a drug or substance at any time through enactment of legislation. For example, Congress passed the Synthetic Drug Abuse Prevention Act of 2012 that permanently added two synthetic cathinones (central nervous system stimulants) to Schedule I of the CSA, along with cannabimimetic substances (commonly referred to as synthetic marijuana).

Emergency or Temporary Scheduling

The CSA authorizes the DEA Administrator to place a drug or substance that is not currently controlled, on a temporary basis, into Schedule I when he finds such scheduling "necessary to avoid an imminent hazard to the public safety." The DEA Administrator may not issue a temporary scheduling order until 30 days after he notifies both the public and the HHS Secretary of his intent to issue the temporary scheduling order and of his justification for issuing the order. Furthermore, the DEA Administrator must consider the HHS Secretary's comments regarding the temporary order. A drug or substance may be temporarily scheduled for two years and possibly longer—up to an additional year—if formal scheduling procedures have been initiated. As discussed below in the report, DEA has exercised its emergency scheduling authority eight times to control seventeen substances structurally related to the opioid fentanyl by placing them temporarily in Schedule I.

Scheduling in Order to Satisfy International Treaty Obligations

Treaty obligations may require the DEA Administrator to control or reschedule a substance if existing controls under federal law are less stringent than those required by a treaty. The United States is a party to three United Nations drug control treaties that impose certain international obligations relating to the manufacture, distribution, use, and possession of controlled substances, including the Single Convention on Narcotic Drugs of 1961, which was designed to establish effective control over international and domestic traffic in narcotics, coca leaf, cocaine, and marijuana. The United States is also party to the Convention on Psychotropic Substances of 1971, which was designed to establish similar control over stimulants, depressants, and hallucinogens. Finally, the United States is a party to the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which requires parties, among other things, to control precursor chemicals used in the illicit manufacture of drugs and to take measures to combat money laundering crimes related to drug trafficking.

Who Must Register with the DEA?

The CSA requires any person who seeks to manufacture, distribute, dispense, or conduct research involving any controlled substance (such as drug manufacturers, wholesale distributors, physicians, hospitals, pharmacies, and scientific researchers) to obtain a registration from the DEA, unless they are exempt. Registrations specify the extent to which the DEA has authorized registrants to manufacture, possess, distribute, or dispense controlled substances. The DEA currently regulates more than 1.73 million registrants. The CSA authorizes the DEA Administrator to charge reasonable fees relating to the registration and control of the manufacturing, distribution, and dispensing of controlled substances under the act.

The CSA directs the DEA Administrator to register an applicant if the Administrator determines that, among other things, it would be consistent with the "public interest" to do so. The CSA provides several criteria that the DEA Administrator must consider in assessing whether registering an applicant is consistent with the "public interest." The criteria differ depending on the substance involved and whether the applicant is a manufacturer, distributor, or practitioner, but include general factors such as those relating to public health and safety and compliance with state and local laws. Manufacturers and distributors of controlled substances must obtain a registration from the DEA annually, and those who dispense controlled substances must obtain registrations that may not be issued for less than one year or more than three years. The registration of an individual terminates when the person dies, ceases legal existence, or discontinues business or professional practice. A registration cannot be transferred to someone else unless the Administrator provides his express, written consent for such a transfer to occur.

In some instances, applicants must apply for several separate registrations in order to comply with the CSA. For example, separate registrations are generally required for each principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, or dispensed. For example, a physician who is regularly engaged in dispensing controlled substances at one location must register to dispense controlled substances at other locations if he chooses to dispense controlled substances at these other locations.

Exceptions to the Registration Requirement

The CSA allows for exceptions and also exempts certain individuals from some or all of its regulatory requirements. For example, individuals exempted from registration requirements include, among others, officers or employees of the DEA, officers of the U.S. Customs Service, offers or employees of the FDA, and any other federal officers who are authorized to possess, import, or export controlled substances in the course of their official duties. Officers or employees of any state, or political subdivision of a state, who are engaged in enforcement of state or local laws relating to controlled substances, are also exempt from registering with the DEA. A person who has lawfully obtained, and who possesses, a controlled substance for his own legitimate medical use (a patient) is also not required to register.

In addition, only those actually engaged in activities relating to manufacturing, distributing, and dispensing controlled substances are required to obtain registration, but related or affiliated persons who are not engaged in such activities are not required to register. For example, a stockholder or parent corporation of a corporation that manufactures controlled substances is not required to obtain registration, nor are employees of a registered manufacturer, distributor, or dispenser.

The DEA Administrator may, by regulation, waive the registration requirement for certain manufacturers, distributors, or dispensers, if he finds it consistent with the public health and safety.

Regulatory Obligations of Registrants Under the CSA

The CSA imposes specific obligations on registrants in an effort to reduce the potential diversion of controlled substances out of legitimate distribution channels. In particular, the CSA imposes legal duties relating to (1) recordkeeping by registrants, (2) measures ensuring the secure storage of controlled substances handled by registrants, (3) reporting certain information to the DEA, (4) prescribing and dispensing controlled substance medications by registered doctors and pharmacists, and (5) the quantity of controlled substance that may be produced by manufacturers.

Recordkeeping

All registrants are required by the CSA to maintain complete and accurate inventories and records of all regulated transactions involving controlled substances and listed chemicals. For example, a registrant must make a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by the registrant. Furthermore, inventories must be available for inspection by the DEA for at least two years. The CSA declares that it is unlawful for any person to "refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required" by the CSA. It is also unlawful for any person knowingly or intentionally "to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed" under the CSA.

In certain circumstances, the CSA recordkeeping provisions do not apply. For example, the provisions do not apply to the prescribing or administering of a controlled substance listed in Schedules II-V by practitioners acting in the lawful course of their professional practice unless such substance is prescribed or administered in the course of maintenance or detoxification treatment of an individual. As discussed below, this has implications for the drugs typically used in the treatment of opioid addiction, two of which are controlled substances, while the other is not.

Security Measures

For the purposes of ensuring the secure storage and distribution of controlled substances and listed chemicals, all applicants for DEA registration and registrants must generally "provide effective controls and procedures to guard against theft and diversion of controlled substances." DEA regulations also detail specific security requirements for different types of applicants and registrants. For example, nonpractitioners (i.e., manufacturers, distributors, and narcotic treatment programs) are required to store Schedule I and II substances in electronically monitored safes, steel cabinets, or vaults that meet or exceed certain specifications. Licensed practitioners must store controlled substances in a "securely locked, substantially constructed cabinet" and must notify the DEA of the theft or significant loss of any controlled substances within one business day of discovering such loss or theft. Furthermore, all practitioners are prohibited from hiring employees who have been convicted of a drug-related felony or who have had a DEA registration denied or revoked. DEA regulations recommend that nonpractitioners carefully screen individuals before hiring them as employees, to ensure that job applicants do not have convictions for crimes or have not engaged in unauthorized use of controlled substances.

Reporting

The CSA requires manufacturers, distributors, and pharmacies to report periodically to the DEA every sale, delivery, disposal, or dispensing of any controlled substance. Registered pharmacies that are authorized to dispense controlled substances by means of the internet must also report to the DEA Administrator the type and total quantity of each controlled substance that the pharmacy has dispensed each month via the internet. In addition, the CSA requires manufacturers, distributors, and dispensers of controlled substances (1) to design and operate a system (that is compliant with applicable federal and state privacy laws) that will alert the registrant of suspicious orders of controlled substances, and (2) upon discovering a suspicious order or series of orders, to inform the DEA Administrator and the Special Agent in Charge of the DEA Field Division Office. The CSA defines "suspicious orders" as those that may include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

Manufacturers and distributors of Schedule I and II drugs must file reports with the DEA through the Automated Reports and Consolidated Orders System (ARCOS), which is an automated drug reporting system that allows the agency to "monitor[] the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.... " Certain narcotics listed in Schedules III and IV are also covered by the ARCOS reporting requirements. According to the DEA, U.S. attorneys and DEA investigators may use ARCOS controlled substances transaction information "to strengthen criminal cases in the courts."

Quotas

The CSA includes a production quota system that requires the DEA to establish the total amount of each basic class of Schedule I and II controlled substances and certain listed chemicals that may be manufactured in a given calendar year, in order "to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks." The DEA establishes this quota, referred to as the aggregate production quota (APQ), for approximately 200 Schedule I and II controlled substances. The DEA assigns individual production quotas to controlled substance manufacturers that prevent the APQ from being exceeded. The CSA allows a registrant to apply for an increase in his individual manufacturing quota if it is necessary "to meet his estimated disposal, inventory, and other requirements during the remainder of that year."

By regulation, the DEA Administrator must consider the following factors in making his APQ determinations: (1) the total disposal of the controlled substance during the current year and two preceding years; (2) trends in the national rate of new disposal of the controlled substance; (3) total inventories (actual or estimated) of "the class and all substances manufactured from the class [of controlled substances listed in Schedule I or II];" (4) projected demand for a particular controlled substance; (5) the extent of any diversion of the controlled substance in the class; (6) relevant information obtained from the Department of Health and Human Services and from the states; and (7) other relevant factors affecting the use of controlled substances including changes in the currently accepted medical use of a controlled substance, the economic and physical availability of the raw materials necessary to produce a controlled substance, and recent unforeseen emergencies (i.e., natural disasters).

A registrant may not manufacture a Schedule I or II controlled substance or a specified listed chemical that is (1) not expressly authorized by his registration and by the individual quota assigned to him by the DEA, or (2) in excess of that quota.

Prescription Requirements

The CSA provides specific requirements that practitioners and pharmacists must observe when prescribing and dispensing controlled substances in Schedules II-V to patients for legitimate medical purposes. As noted, controlled substances classified as Schedule I drugs are deemed to have no accepted medical purpose in the United States, and thus they may only be used for research, and may not be prescribed or dispensed to patients. DEA regulations hold both the prescribing practitioner and the pharmacist who fills the prescription responsible for ensuring that the controlled substance is properly prescribed and dispensed. A DEA manual prepared for pharmacists to help them understand their obligations under the CSA explains that

A pharmacist is required to exercise sound professional judgment when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted along with the issuing practitioner, for knowingly and intentionally distributing controlled substances.

Practitioners

Under the CSA, only licensed medical practitioners are authorized to prescribe controlled substances listed in Schedules II-V to patients. A prescription for a controlled substance must be "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." A pharmacist may not dispense to a patient a Schedule II controlled substance without a written prescription from a practitioner, except in certain cases where the practitioner administers the controlled substance directly to the patient. However, in the case of an "emergency situation," a practitioner may orally authorize a pharmacist to fill a prescription for a Schedule II controlled substance. Controlled substances in Schedules III-V may be dispensed by a pharmacy pursuant to either a written or oral prescription, including a facsimile of a written prescription. These substances may also be administered or dispensed directly by the practitioner in the course of his professional practice without a prescription. Practitioners are permitted to sign and transmit electronic prescriptions for controlled substances, assuming that the electronic prescription complies with detailed requirements set forth in the applicable federal regulations.

Pharmacists

Pharmacists may partially fill a prescription for Schedule II substances under certain circumstances, such as pursuant to a request by the patient or the practitioner who wrote the prescription. Pharmacists are prohibited from refilling prescriptions for Schedule II substances. A pharmacist may fill or refill prescriptions for controlled substances in Schedules III and IV, however, up to five times within six months after the date on which the prescription was issued, unless the prescribing practitioner authorizes a renewal of the prescription. A pharmacy may process electronic prescriptions for controlled substances if the pharmacy uses a computer application that complies with several requirements specified in the applicable federal regulations. A controlled substance that is a prescription drug may not be delivered, distributed, or dispensed by means of the internet without a "valid prescription," which the CSA defines as a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one medical evaluation of the patient in the physical presence of the practitioner.

What Are the Potential Consequences for Violating the CSA?

The CSA contains a variety of criminal sanctions for illicit possession, manufacture, and distribution of controlled substances that occurs outside the closed system of distribution. For example, the CSA outlaws "simple possession" of a controlled substance (referring to a person knowingly or intentionally possessing a controlled substance) "unless such substance was obtained directly, or pursuant to" a valid prescription issued by a medical practitioner, "or except as otherwise authorized by" the CSA. The CSA also prohibits any person from knowingly or intentionally acquiring or obtaining possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge. It is unlawful for any person knowingly or intentionally to "traffic" in controlled substances; illegal drug trafficking generally refers to distributing or dispensing, or to possessing with intent to distribute or dispense, a controlled substance, unless the particular activity is authorized by law. The CSA's criminal penalties for trafficking in controlled substances vary depending on whether the individual is a first-time offender or a repeat offender, the type of substance involved, and the quantity of the type of substance involved. For example, a federal drug trafficking offense committed by a first-time offender involving a Schedule II substance such as codeine is punishable by a term of imprisonment of up to 20 years and a fine of up to $1,000,000. For a second offense, the fine increases to $2,000,000 and the maximum imprisonment term increases to 30 years.

The focus of this report, however, is on the CSA penalty provisions specifically applicable to persons registered with the DEA. The CSA sets forth certain "regulatory" offenses involving listed chemicals, failure to comply with CSA requirements and obligations that registrants must satisfy as a condition of registration, and other prohibited acts by registrants who manufacture, distribute and dispense controlled substances.

For example, a registrant authorized to distribute or dispense any controlled substance is prohibited from distributing, dispensing, or manufacturing controlled substances in a manner that is not authorized by his particular registration. As noted above, registrants may not refuse or negligently fail to maintain accurate records of controlled substances, and may not refuse to furnish such records when required to do so by law enforcement officials (such as the requirement that registrants report to the DEA any "suspicious orders of controlled substances)." It is unlawful for registrants to prohibit law enforcement officials from entering their premises for inspections authorized by the CSA. Similarly, practitioners and pharmacists may not dispense or distribute a controlled substance drug in violation of the CSA's statutory prescription requirements.

The CSA also proscribes certain acts committed by a registrant related to the manufacture and distribution of controlled substances and listed chemicals. Registrants may not knowingly or intentionally (1) distribute Schedule I and II substances without a valid order form; (2) use an invalid registration number during the course of handling or acquiring controlled substances; (3) furnish false or fraudulent material information in a record or report required by the act; or (4) present false or fraudulent identification when receiving a listed chemical. Registrants who violate the aforementioned provisions may be subject to injunctive or declarative actions filed by the Attorney General in federal district court in addition to the general penalties described in the next paragraph. Manufacturers may also not produce Schedule I or II controlled substances or specified listed chemicals that are not expressly authorized by their registration or in excess of the individual production quotas assigned to them by the DEA.

Registrants who fail to adhere to the CSA's regulatory requirements or who engage in certain prohibited acts may face administrative consequences, civil and criminal fines, and even the possibility of imprisonment. The CSA provides that violations of its regulatory requirements generally do not constitute a crime and that "imposition of a civil penalty ... shall not give rise to any disability or legal disadvantage based on conviction for a criminal offense," unless the violation was committed knowingly , in which case the CSA authorizes imprisonment of up to one or two years.

State Regulation of Controlled Substances

In addition to federal oversight of controlled substances and registrants who handle them, Congress has permitted state governments to regulate the use of controlled substances under their own state controlled substances acts. The U.S. Supreme Court has stated that the CSA "manifests no intent to regulate the practice of medicine generally" and has observed that its "structure and operation ... presume and rely upon a functioning medical profession regulated under the States' police powers" that may be used "to protect the health, safety and welfare of their citizens." For example, all states have prescription drug monitoring programs (PDMPs) that maintain statewide electronic databases of prescription controlled substances dispensed to patients within their jurisdictions; such information may be used by those working in law enforcement, professional licensing bodies, and health care to identify patterns of prescribing, dispensing, or receiving controlled substances that could indicate abuse or diversion. States may also subject certain controlled substance medications to stricter regulation than the CSA requires. For example, the states of Oregon and Mississippi have passed laws that require anyone to obtain a prescription for drugs containing pseudoephedrine (a nasal decongestant commonly found in over-the-counter cold, allergy, and sinus medications), which is an important ingredient in producing illicit methamphetamine, whereas the substance is regulated as a listed chemical under the CSA that does not require a prescription to dispense.

The operation of several provisions of the CSA depends on state laws and state regulatory bodies. For example, if a physician wants to obtain a DEA registration to dispense controlled substance medications, he must first be "authorized to dispense ... controlled substances under the laws of the State in which he practices." In addition, the DEA Administrator must be satisfied that issuing the applicant a registration would be "[]consistent with the public interest," a determination that requires the DEA Administrator to consider several statutory factors, including the "recommendation of the appropriate State licensing board or professional disciplinary authority"; the applicant's previous convictions for federal or state controlled substances offenses; and the applicant's "[c]ompliance with applicable State, Federal, or local laws relating to controlled substances." Despite the latitude that Congress has given to states to regulate controlled substances, however, the CSA nevertheless generally preempts, or overrides, state laws regarding controlled substances when "there is a positive conflict between" a CSA provision and "that State law so that the two cannot consistently stand together."

DEA's Legal Authorities for Enforcing the CSA

The DEA's Office of Diversion Control is responsible for preventing, detecting, and investigating violations of the CSA involving controlled pharmaceuticals while also "ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs." The Office of Diversion Control also manages the regulation of registrants, promulgates regulations concerning the handling of controlled substances, and establishes controlled substance production quotas. The Assistant Attorney General for the DOJ's Criminal Division conducts, handles, or supervises all criminal and civil litigation to enforce the CSA. Several federal courts have held that the CSA does not contain an express or implied cause of action provision under which private parties or state, local, or tribal governments may sue registrants for noncompliance with their CSA obligations, noting instead that the CSA expressly authorizes only the Attorney General and the U.S. Department of Justice to enforce federal controlled substances laws.

Investigations

The DEA can conduct a variety of investigations to monitor and ensure registrant compliance with the CSA and its implementing regulations. As mentioned earlier, registrants may not prevent law enforcement officials from entering their premises for any inspections authorized by the CSA. The three types of investigations that the DEA may undertake can be classified as regulatory, complaint, and criminal. Regulatory investigations can include scheduled inspections of registrants, usually every two, three, or five years, although such inspections generally are directed at manufacturers, wholesale distributors, and importers/exporters rather than physicians and pharmacies (who receive such oversight from state regulators). The DEA may initiate complaint investigations after it has received a tip about potential diversion by the registrant or if the DEA has identified any unusual drug transactions involving the registrant. Finally, the DEA may conduct criminal investigations regarding potential criminal activities involving diversion of controlled substances. Criminal investigations can be directed at either registrants or nonregistrants, such as an individual suspected of stealing drugs from a pharmacy or one who is trafficking in unlawfully obtained controlled substances. Following an investigation of a registrant that reveals violations of the CSA and its implementing regulations, the DEA can take certain enforcement actions, as discussed in the following section.

Enforcement Actions

The DEA has discretion to initiate enforcement actions to seek a variety of administrative, civil, and criminal penalties against a registrant who is not in compliance with the CSA, depending on the severity of the offense and taking into consideration factors such as whether the registrant has previously violated a CSA regulatory requirement. This section focuses on the administrative actions that the DEA may take against a registrant or an applicant for registration.

Letter of Admonition or Informal Hearing

A noncompliant registrant could face several types of corrective actions. For example, the DEA can issue a warning letter referred to as a Letter of Admonition (LOA) to a registrant suspected of conduct inconsistent with his obligations under the CSA and its implementing regulations. The DEA can also hold an Informal Hearing (IH) concerning the registrant; either administrative action "provide[s] registrants an opportunity to recognize and acknowledge their infractions, and immediately correct them."

Administrative Proceedings to Deny, Revoke, or Suspend a Registration

The DEA Administrator has the authority to deny, revoke, or suspend registrations under certain circumstances. However, before the DEA Administrator can take such an action, the agency must generally provide the applicant or registrant with notice and an opportunity to demonstrate why the registration should not be denied, revoked, or suspended. This notice is referred to as an Order to Show Cause or OTSC. Such an order provides the basis for the proposed denial, revocation, or suspension (including an identification of the laws or regulations that the applicant or registrant is alleged to have violated) and also notifies the applicant or registrant of the opportunity to submit to the DEA a corrective action plan (CAP). The OTSC instructs the applicant or registrant to appear at a hearing before a DEA Administrative Law Judge (ALJ) that must be conducted in accordance with the Administrative Procedure Act (APA). If the registrant submits a CAP, the DEA Administrator is required to determine "whether denial, revocation, or suspension proceedings should be discontinued."

After examining the evidence and arguments submitted by the parties, the ALJ is required to submit a report to the DEA Administrator that explains his recommended ruling, findings of fact, conclusions of law, and decision regarding the proposed denial, revocation, or suspension. "As soon as practicable after" receiving the ALJ's record and report, the DEA Administrator is required to publish in the Federal Register a final order in the proceeding that adopts, modifies, or rejects the ALJ's recommended decision. The CSA also provides that if the DEA Administrator suspends or revokes an existing registration, all controlled substances owned or possessed by the registrant may "be placed under seal ... until the time for taking an appeal has elapsed or until all appeals have been concluded.... " Once a revocation order becomes final (meaning all judicial appeals have been exhausted), these controlled substances "shall be forfeited to the United States" and "[a]ll right, title, and interest in such controlled substances ... shall vest in the United States.... "

Immediate Suspension Orders

Simultaneously with the institution of administrative proceedings to revoke or suspend a registration (or at any time after the DEA Administrator issues an OTSC notifying the registrant that the DEA is taking action to revoke or suspend a registration), the DEA Administrator may exercise emergency power to suspend immediately any existing registration for a limited time period in order to avoid "an imminent danger to the public health or safety." This agency action is often referred to as an "immediate suspension order" (ISO), and does not require the DEA to provide the registrant with prior notice or a formal hearing. The CSA specifies that the suspension "shall continue in effect until the conclusion of [the] proceedings [to revoke or suspend the registration on a final basis], including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction."

Prior to the enactment into law of the Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA) of 2016, the CSA did not expressly define the phrase "imminent danger to the public health or safety," and, as a result, courts held that the DEA Administrator possessed "significant discretion" to determine when the continued registration of a registrant constituted such a threat. As an example of the latitude that courts afforded the DEA Administrator's imminent danger finding, a federal district court permitted the DEA to rely on pharmacy controlled substances sales data from 2008 to support an ISO issued in early 2012.

The EPAEDEA amended the CSA to provide, for the first time, a statutory definition of the phrase "imminent danger to the public health or safety," which limits the DEA Administrator's discretion to issue an ISO and creates new evidentiary requirements that he must satisfy before issuing such an order. Under the EPAEDEA, the DEA's authority to issue an ISO depends on the agency's ability to prove two things: (1) "an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur" due to the failure of the registrant to comply with the CSA's requirements, including those obligating the registrant "to maintain effective controls against diversion," and (2) the probability that such a threat will occur without an immediate suspension of a registration, which the statute requires to be a "substantial likelihood." Some have suggested that the legislative changes made by the EPAEDEA considerably weaken the power of the DEA to issue an ISO against a distributor or manufacturer, although others have argued that the addition of a statutory definition of "imminent danger to the public health or safety" was necessary in order to prevent "a completely subjective determination made solely by the DEA" that "summarily eliminate[s] the registrant's ability to handle controlled substances before any due process hearing."

In response to the ISO, a registrant could seek immediate judicial review of the ISO in federal court, arguing that the DEA acted arbitrarily and capriciously in violation of the APA. However, a registrant faces a difficult burden in convincing a court to enjoin the DEA's enforcement of the ISO pending resolution of the revocation or suspension proceedings. In order to obtain such preliminary injunctive relief, a registrant "must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest." The CSA provides that a reviewing court must use a "substantial evidence" standard in considering the DEA's findings of facts with respect to an ISO, though a court applies the APA's arbitrary and capricious standard of review when considering the DEA's reason for deciding to adopt, modify, or reject the ALJ's recommendation concerning an ISO. A federal appellate court has explained its review of the DEA's issuance of an ISO under the APA as follows: "To uphold DEA's decision, ... we must satisfy ourselves that the agency examined the relevant data and articulated a satisfactory explanation for its action including a rational connection between the facts found and the choice made."

A registrant served with an ISO could also request "an expedited administrative hearing" before an ALJ on the merits of the revocation or suspension at a time before that indicated in the OTSC. DEA regulations specify that the DEA Administrator "shall" grant the request for an earlier hearing and "fix a date for such hearing as early as reasonably possible."

DEA's Response to the Opioid Abuse Crisis

This section describes selected DEA actions intended to help alleviate the opioid crisis.

DEA Actions Against Registrants

As discussed earlier in this report, the CSA provides the DEA with a variety of criminal, civil, and administrative tools to hold manufacturers, distributors, pharmacies, and physicians accountable for actions that violate the CSA's regulatory requirements. The DEA has used these authorities in connection with the opioid crisis. For example, in February and March 2018, the DEA "surged its enforcement and administrative resources" to target prescribers and pharmacies suspected of diverting large amounts of opioid drugs, resulting in 147 revoked registrations and 28 arrests. In addition, in July 2017, CVS Pharmacy Inc. agreed to a $5 million settlement payment as well as an administrative compliance plan with the DEA, to resolve the federal government's allegations that nine of its pharmacies in the Eastern District of California had failed to keep and maintain accurate records of its controlled substances, in violation of the CSA's recordkeeping requirements. In early 2016, CVS also paid $8 million to the United States to settle allegations that certain CVS pharmacies in Maryland had dispensed controlled substances, including the opioids oxycodone, fentanyl, and hydrocodone, in violation of the CSA by failing to comply with their duty to ensure that the prescriptions were issued for legitimate medical purposes. In 2013, Walgreens agreed to pay $80 million in civil penalties to resolve DEA administrative actions and civil penalty investigations concerning "an unprecedented number of record-keeping and dispensing violations" occurring at six Walgreens pharmacies and a Walgreens drug distribution center in Florida that allegedly resulted in oxycodone and other prescription opioids to be diverted. As part of this settlement, Walgreens agreed to several terms and conditions, including ending its practice of "compensat[ing] its pharmacists based on the volume of prescriptions filled."

The DEA has also focused its attention on wholesale distributors of prescription opioids, which ship the drugs from drug manufacturers to pharmacies, and their compliance with the CSA's recordkeeping and reporting requirements. Several DEA investigations into these wholesale distributers resulted in civil penalty settlements. In January 2017, one of the largest U.S. drug distributors, McKesson Corporation, agreed to pay a $150 million civil payment to resolve DEA allegations that it had, in violation of CSA regulatory requirements, "failed to design and implement an effective system to detect and report 'suspicious orders' for controlled substances distributed to its independent and small chain pharmacy customers." The federal government alleged that "[f]rom 2008 until 2013, McKesson supplied various U.S. pharmacies an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic." In addition to the monetary penalty, the settlement requires McKesson to (1) suspend for several years sales of controlled substances from a number of its distribution centers, (2) agree to certain "enhanced compliance obligations" that include periodic auditing and staffing and organization improvements; and (3) accept the oversight of an independent monitor to assess the company's adherence with the compliance terms.

Another major pharmaceutical drug distributor, Cardinal Health, Inc., agreed in December 2016 to pay $44 million to the federal government to settle allegations that it had failed to notify the DEA when it filled unusually large and frequent orders for controlled substances requested by pharmacies located in Maryland, Florida, and New York, and that it had failed to maintain effective controls against diversion. The settlement agreement between Cardinal Health and the federal government included an admission by the company that "from January 1, 2009 to May 14, 2012, it failed to report suspicious orders to the DEA as required by the CSA."

In 2014, the DEA took an administrative action to revoke the registration of Masters Pharmaceuticals, Inc. (Masters), a bulk supplier of prescription medications to many U.S. pharmacies, after concluding that the company had not satisfied its legal obligation to monitor and report to the DEA suspicious orders for controlled substances. Masters had previously entered into a settlement agreement with the DEA in 2009 in which Masters agreed to pay $500,000 and implement a compliance system to detect suspicious orders of controlled substances and prevent the substances from being diverted into illegal channels. However, in the years following the settlement, the DEA grew to suspect that Masters's employees were not detecting and reporting to the DEA suspicious orders of oxycodone products. In 2013, the DEA issued an Order to Show Cause why Masters's registration should not be revoked, in light of allegations that Masters had ignored its duty to report suspicious orders after its computer system had flagged controlled substance orders that were unusual in size, frequency, or pattern. The DEA Administrator concluded that Masters's repeated violations of the suspicious orders reporting requirement warranted revocation of its registration to distribute controlled substances. Masters challenged the DEA's revocation decision in federal court, arguing among other things that the DEA's factual conclusions were not supported by the record. In June 2017, the U.S. Court of Appeals for the D.C. Circuit denied Masters's petition for review, seeking to overturn the DEA's final order, after the court found "no prejudicial error in DEA's decision."

In addition to these actions against distributors, the DEA has also investigated opioid manufacturers for their failure to report suspicious orders of controlled substances that occurred downstream in the drug supply chain. In July 2017, the DEA confirmed it had reached a $35 million civil penalty settlement with Mallinckrodt LLC, a drug manufacturer that is one of the largest makers of the highly addictive generic pain reliever oxycodone. This settlement resolved allegations that the company committed several violations of the CSA from 2008 until 2011 by supplying to drug distributors that, in turn, supplied pharmacies and pain clinics, "an increasingly excessive quantity of oxycodone pills without notifying DEA of these suspicious orders." The DEA described this settlement as "groundbreaking" in part because it is the first time the DEA has been able to hold a drug manufacturer responsible for detecting and reporting suspicious orders relating to downstream sales between its distributor customers and the distributors' customers (pharmacies). This settlement agreement also apparently contains the first public statement of the DEA's position that "controlled substance manufacturers need to go beyond 'know your customer' to use otherwise available company data to 'know your customer's customer' to protect these potentially dangerous pharmaceuticals from getting into the wrong hands." Under the settlement, Mallinckrodt agreed to analyze data it collects involving "chargebacks," which are reimbursements the company offers to their drug distributor customers based on the distributor's discounted sale of its drugs to pharmacies and pain clinics, in order to monitor and report to the DEA any suspicious orders of oxycodone placed by the distributor's customers. Commentators have argued that the legal basis of the DEA imposing an obligation on a drug manufacturer to "know your customer's customer," and its ability to hold the company "responsible for what happens to its drugs once the distributors send them to their customers," may be uncertain. Moreover, one observer has characterized the DEA's action as "creat[ing] ... a new requirement by announcing it in a press release" and has argued instead that such a change needs to be made in accordance with notice and comment rulemaking requirements under the APA. As of the date of this report, the DEA's position that manufacturers "need to go beyond 'know your customer'" practices has not been challenged in court.

Emergency Scheduling of Illicit Fentanyl

Fentanyl is a powerful synthetic opioid analgesic that mimics the effects of morphine and heroin, but is 50 to 100 times more potent. Pharmaceutically produced fentanyl is a Schedule II prescription drug that may be used by patients to manage severe pain after surgery, for example, and can be administered via injection, in lozenges, or transdermal patch.

Most fentanyl overdoses do not involve prescription fentanyl, but rather nonpharmaceutical fentanyl that is illicitly produced in clandestine laboratories located abroad, in particular in Mexico and China. A recent investigation by a Senate subcommittee revealed that "many Americans are purchasing fentanyl and other illicit opioids online and having them shipped here through the international mail system." Such illicit fentanyl can be mixed with other opioids such as heroin to increase its effects, and can be sold as a powder or as tablets that are "intended to mimic the appearance of prescription opioid medications such as oxycodone or hydrocodone. According to the 2018 National Drug Threat Assessment published in October 2018 by the DEA, fentanyl "is a major contributor to the continuing epidemic of drug overdose deaths" in the United States and "[s]ynthetic opioids are now involved in more deaths than any other illicit drug." In July 2018, then-Attorney General Sessions announced the formation of "Operation Synthetic Opioid Surge," an initiative in which the Justice Department will be focusing its prosecutorial priorities on "every readily provable case involving the distribution of fentanyl, fentanyl analogues, and other synthetic opioids, regardless of drug quantity," within 10 areas of the nation that are experiencing some of the highest drug overdose death rates.

However, making the problem more difficult for the federal government in stopping illicit fentanyl traffickers are "[o]verseas chemical manufacturers, aided by illicit domestic distributors, [who] currently attempt to evade regulatory controls by creating structural variants of fentanyl that are not directly listed under" the CSA. The DEA has stated that fentanyl-related compound "[m]anufacturers and distributors will continue to stay one step ahead of any state or federal drug-specific banning or control action by introducing and repackaging new products that are not listed as such in any of the controlled substance schedules." Since 2015, DEA has exercised its emergency scheduling authority eight times to control 17 substances structurally related to fentanyl by placing them temporarily in Schedule I. In February 2018, the DEA issued a broader temporary scheduling order that attempts to schedule all fentanyl-related substances that are not otherwise controlled in any schedule, by creating a definition of a new class of substances that is structurally related to fentanyl by virtue of one or more specified modifications to the substance's formulation. It remains to be seen whether the DEA's attempt to schedule proactively an entire class of illicit fentanyl substances simultaneously, including substances that have not yet been introduced into the U.S. market by drug traffickers, will be subject to a legal challenge under the APA, claiming the DEA's action to be inconsistent with its emergency scheduling authority under the CSA.

Aggregate Production Quotas for Certain Schedule II Opioids

As discussed previously in this report, the DEA limits the quantity of Schedule I and II controlled substances (referred to as aggregate production quotas, or APQs) that may be produced in a given calendar year. According to the Acting Assistant Administrator of the DEA's Diversion Control Division, "since 2014, DEA has observed a decline in prescriptions written for certain Schedule II opioids," including oxycodone, hydrocodone, fentanyl, and morphine. In November 2017, the DEA responded to the decreased demand for these drugs when it released the 2018 APQs, which reduce by nearly 20% (compared to the 2017 levels) the amount of prescription opioids that can be manufactured in 2018. According to a DEA spokesperson, this decrease in APQs "can be attributed to combined local, state, and federal activities and interventions, including creating new partnerships, enforcing current regulations, and dissemination of provider education and guidance documents.... " Several organizations representing hospitals, anesthesiologists, and pharmacists have raised their concerns to the DEA that the new APQs could exacerbate the problem they are experiencing with "critical shortages" of injectable opioid medications, including morphine, fentanyl, and hydromorphone, which are used to treat the pain needs of patients undergoing interventional procedures (such as colonoscopy or cardiac catheterization) and surgeries. These organizations suggest that the DEA "temporarily reallocate or revise APQ to allow other manufacturers to supply product until the shortages resolve," and also note that their request is "specific to these injectable medications and does not extend to other dosage forms or opioid products."

In August 2018, the DEA released proposed APQs for 2019 that would require further reductions in the quantity of Schedule II opioids that may be manufactured in the United States in 2019. The proposed 2019 APQ for Schedule I and II controlled substances "decreases manufacturing quotas for the most six frequently misused opioids for 2019 by an average ten percent as compared to the 2018 amount," including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.

Congressional Actions Addressing the Opioid Epidemic

Existing legal authorities supplied DEA with the tools for the agency's efforts to combat opioid abuse as described in the previous section. In recent years, Congress has also taken action to address perceived deficiencies in the federal regulatory regime governing opioids. To date, the most comprehensive legislative response to the overprescribing and abuse of opioids is the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act ( P.L. 115-271 ) (the SUPPORT for Patients and Communities Act, or the SUPPORT Act) that President Trump signed into law on October 24, 2018. Title III, subtitle B of the SUPPORT Act contains provisions that amend the CSA in various ways to address the opioid epidemic, as described in the following sections.

Expanding Disposal Options for Unwanted Opioid Medication

Young adults and teenagers who seek to abuse prescription opioids may find access to expired or unwanted controlled substance medication from their parents' medicine cabinets or even the trash. One approach to addressing the prescription opioid abuse problem is to reduce the availability of such drugs by having patients properly dispose of their unwanted opioid medications that have accumulated in their homes. For example, patients may want to get rid of their expired or unused drugs by returning them to pharmacies or giving them to their prescribing physicians. Yet, when Congress originally drafted the CSA, "it did not account for circumstances in which controlled substances were lawfully dispensed to and possessed by an ultimate user but not fully used." To make it easier and more convenient for patients to dispose of unwanted controlled substances, including opioid medications, Congress enacted the Secure and Responsible Drug Disposal Act of 2010 (Disposal Act). The Disposal Act amended the CSA to allow a patient to deliver controlled substances to an entity that is authorized by federal law to dispose of them, provided that such disposal occurs in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances. These implementing regulations, issued by the DEA in September 2014, substantially expand the options and opportunities available to patients for safe and secure disposal of their unwanted prescription opioid and other controlled substance medication.

The DEA regulations governing secure disposal of controlled substances allow three primary options for patient disposal of controlled substances. The first option is for federal, state, tribal, or local law enforcement agencies to conduct periodic drug "take-back" events to collect controlled substances from unwanted users; private entities or community groups may also partner with law enforcement to hold community take-back events. Second, DEA-registered manufacturers, distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, or retail pharmacies that wish to become collectors of unwanted controlled substances for disposal purposes must seek authorization from DEA to do so. Authorized collectors may then conduct "mail-back" programs that utilize the mail system for convenient transfer of the unwanted controlled substances, although the physical packages in which the drugs are shipped must comply with certain requirements (for example, tamper-resistance and tracking numbers) that DEA has specified. The third option permits law enforcement agencies or authorized collectors to manage, maintain, and empty secure collection receptacles at their DEA registered location. A long-term care facility may also dispose of controlled substances on behalf of its residents (or former residents) by using on-site collection receptacles that are installed, managed, and maintained by authorized retail pharmacies or hospitals/clinics with an on-site pharmacy. Finally, the regulations provide requirements that collectors must follow regarding methods of destroying controlled substances and destruction procedures, in order to render the collected controlled substances "non-retrievable."

Congress also enacted prescription drug disposal and take-back provisions as part of the Comprehensive Addiction and Recovery Act (CARA) of 2016. Section 201 of CARA authorizes the creation of a grant program at the Department of Justice addressing the problems of opioid addiction and abuse, through which the Attorney General may award grants to states, units of local governments, and Indian tribes to fund their activities relating to opioid abuse, including "[d]eveloping, implementing, or expanding a prescription drug take-back program." Section 203 of CARA requires the Attorney General, in coordination with the DEA Administrator, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, to coordinate with "covered entities" to expand or make available disposal sites for unwanted prescription drugs. The law defines "covered entities" to include state, local, or tribal law enforcement agencies, drug manufacturers and distributors, retail pharmacies, narcotic treatment programs, hospitals or clinics with an onsite pharmacy, and long-term care facilities.

Congress included two chapters relating to drug disposal in the SUPPORT for Patients and Communities Act that was enacted in October 2018. The first chapter addresses the difficulties faced by home hospice employees regarding disposal of pharmaceutical controlled substances. Under the Disposal Act of 2010, a member of a hospice patient's household may dispose of an unused controlled substance medication after the patient dies, but a home hospice employee cannot do so unless authorized by law (such as state law). Chapter 3 of subtitle B, title III of the SUPPORT Act, referred to as the "Safe Disposal of Unused Medication Act," amends the CSA to allow an employee of a "qualified hospice program" to dispose of a controlled substance after (1) the death of a person receiving hospice care, (2) the expiration of the controlled substance, or (3) a modification in the plan of care of the hospice patient if the employee is the physician of the person receiving hospice care and has a DEA registration. This chapter also requires the Comptroller General of the United States, head of the Government Accountability Office (GAO), to study and report to Congress, not later than 18 months after the SUPPORT Act's enactment on October 24, 2018, on the federal requirements applicable to the management and disposal of controlled substances in the home, as well as the challenges encountered by select qualified hospice programs regarding the disposal of controlled substances.

Chapter 6 of subtitle B, title III of the SUPPORT Act, referred to as the "Access to Increased Drug Disposal Act of 2018," addresses the relatively low number of pharmacies and other DEA-registered entities eligible to collect unused prescription drugs for disposal who have voluntarily sought DEA authorization to become registered collectors. This chapter does not directly amend the CSA but instead provides the Attorney General (acting through the Assistant Attorney General for the Office of Justice Programs) with authority to make grants to states in an effort to increase participation rates of eligible collectors as authorized collectors. A state seeking a grant award under this chapter must submit an application that (1) designates a single state agency responsible for complying with the conditions of the grant, (2) describes a plan to increase the participation of eligible collectors as authorized collectors, and (3) explains how the state will select eligible collectors to be served under the grant. The Attorney General is required to award these grants to five states, and at least three of these states must be "in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General."

Increasing Flexibility With Respect to Medication-Assisted Treatment for Opioid Addiction

Certain prescription drugs may be used to treat opioid abuse and facilitate recovery from addiction; this type of practice is commonly referred to as "medication-assisted treatment" or MAT. Currently, the main prescription drugs used in MAT are methadone, buprenorphine, which are controlled substances under the CSA, and naltrexone, which is not scheduled under the CSA. The CSA requires any practitioner wanting to administer and dispense methadone (a Schedule II substance) for the purpose of maintenance treatment or detoxification treatment to obtain annually a separate DEA registration for that purpose, referred to as a "Narcotic Treatment Program" or NTP registration. (NTPs are also regulated by the Substance Abuse and Mental Health Services Administration (SAMHSA) in the Department of Health and Human Services, as well as by state methadone authorities). However, a practitioner may apply for and receive a waiver from this separate registration requirement (commonly known as a "DATA waiver") if the controlled substance to be used for addiction treatment outside of a NTP is a Schedule III, IV, or V substance, such as buprenorphine (a Schedule III drug). If a medical professional wishes to prescribe the third type of drug used in MAT, naltrexone, he need not be registered with the DEA to do so because naltrexone is not a controlled substance under the CSA.

One section of CARA amended the CSA to expand temporarily the types of practitioners who may, without being separately registered with the DEA as a NTP, dispense buprenorphine or other narcotic drug in Schedule III, IV, or V, for treating opioid dependence outside of a NTP. Prior to CARA, only "qualified physicians" were permitted to dispense such narcotics for these purposes; CARA temporarily (until October 1, 2021) expands the categories of practitioners to include a qualifying nurse practitioner or physician assistant. The DEA issued a final rule, effective January 22, 2018, that implemented the changes made to the CSA by CARA. Note that CARA did not make any changes to who may dispense methadone.

Congress included several provisions relating to MAT in the SUPPORT Act. Chapter 1 of subtitle B, title III of the SUPPORT Act amends the CSA by removing the time limit imposed by CARA during which nurse practitioners and physician assistants may dispense controlled substances for maintenance and detoxification treatment under a DATA waiver, effectively making CARA's temporary authority permanent. This chapter also allows clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives to obtain DATA waivers until October 1, 2023.

In addition, the SUPPORT Act addresses issues relating to controlled substances that require a physician to administer them to a patient by injection or implantation in a medical office. For example, buprenorphine is a schedule III controlled substance prescribed for treatment of opioid use disorders that may require administration via injection or implantation. However, under the CSA prior to its amendment by the SUPPORT Act, a pharmacist was prohibited from dispensing a controlled substance to anyone other than the ultimate user; as such, the pharmacist could not give a particular controlled substance prescribed for a patient directly to that patient's physician. The SUPPORT Act amends the CSA by allowing a pharmacy, under specified conditions, to deliver a controlled substance to a practitioner, pursuant to a prescription, to be administered by the practitioner to the patient by injection or implantation for the purpose of maintenance or detoxification treatment. The physician must administer the controlled substance to the patient within 14 days after the physician has received the controlled substance. The Attorney General, in coordination with the Secretary of Health and Human Services, may reduce the number of days within which the physician must administer the controlled substance if such reduction will reduce risk of diversion or protect public health; however, the Attorney General cannot make a modification that is less than seven days. The SUPPORT Act requires the GAO to study and submit a report to Congress on access to and potential diversion of controlled substances administered by injection or implantation not later than two years after the Act's enactment.

Providing Manufacturers and Distributors Certain ARCOS Data

As discussed previously in this report, manufacturers and distributors of Schedule I and II drugs must report their controlled substances transactions to the DEA through the Automated Reports and Consolidated Orders System (ARCOS). Chapter 7 of subtitle B, title III of the SUPPORT Act, referred to as the "Using Data to Prevent Opioid Diversion Act of 2018," is intended "to provide drug manufacturers and distributors with access to anonymized information through ARCOS to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates." This chapter amends the CSA to require the DEA Administrator to make certain data available to registered manufacturers and distributors through the ARCOS system on a quarterly basis; it covers the total number of registrants that distribute controlled substances to a pharmacy or practitioner registrant and the total quantity and type of opioids distributed to each pharmacy and practitioner registrant. These provisions impose an affirmative obligation on manufacturers and distributors to review this ARCOS information and establish new civil and criminal penalties for failure to do so. Furthermore, these provisions provide that the DEA Administrator may consider a failure of a manufacturer or distributor to review this information in determining whether to initiate administrative actions against the registrant for noncompliance with CSA requirements.

The legislation also requires the Attorney General to submit to Congress within one year of enactment of the act a report that provides information about how the Attorney General is using data in ARCOS to identify and stop suspicious activity.

Adding Considerations for DEA Opioid Quotas

Chapter 8 of subtitle B, title III of the SUPPORT Act, referred to as the "Opioid Quota Reform Act," amends the CSA by adding statutory considerations for the DEA in establishing annual production quotas (APQ) for schedule I and II controlled substances. In establishing the annual medical, scientific, and research need for a controlled substance, the DEA Administrator may, if he determines it will help to address "overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production quota," or a procurement quota that he has set by regulation, "in terms of pharmaceutical dosage forms prepared from or containing the controlled substance." In addition, in establishing annual quotas for the production of fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone, the SUPPORT Act requires the DEA Administrator to estimate the amount of diversion of these particular controlled substances that occurs in the United States and then make appropriate reductions from the quota the DEA Administrator would have otherwise established had such diversion not been considered.

Strengthening Requirements to Detect and Report Suspicious Orders

Prior to being amended by the SUPPORT Act, the statutory text of the CSA did not require registrants to design and operate a system to disclose to them any suspicious orders of controlled substances and to report such orders to the DEA; rather, such requirements appeared in DEA regulations. The CSA's definitions section also lacked a definition of the term "suspicious order." Chapter 9 of subtitle B, title III of the SUPPORT Act, referred to as the "Preventing Drug Diversion Act of 2018," adds a statutory definition of "suspicious order" to the CSA that essentially adopts the language of the existing regulatory definition. These provisions also add a new section to the CSA entitled "Suspicious Orders," which requires a DEA registrant to take essentially the same actions as those required under the DEA regulation: (1) to design and operate a system (that is compliant with applicable federal and state privacy laws) that will alert the registrant of suspicious orders of controlled substances, and (2) upon discovering a suspicious order or series of orders, to inform the DEA Administrator and the Special Agent in Charge of the DEA Field Division Office. The SUPPORT Act provisions also require the DEA Administrator, within a year of the act's enactment, to establish a centralized database for storing suspicious orders reports; if a registrant submits a suspicious order to this database, the registrant is considered to have complied with the notification requirement mentioned above. The DEA Administrator must share information regarding suspicious orders for prescription controlled substances in a state with an entity designated by the governor or chief executive officer of that state.

The SUPPORT Act also establishes a maximum criminal fine of $500,000 for registered manufacturers or distributors of opioids who intentionally fail to report suspicious orders for opioids.

Other Legislative Proposals That the 116th Congress Could Consider to Amend the CSA

The 116 th Congress may consider legislation to amend the CSA beyond the changes made by the SUPPORT Act. These potential additional amendments to the CSA may resemble opioid legislation introduced, but not enacted to date, in the 115 th Congress. Legislative proposals introduced in the 115 th Congress include the following:

Changes to the DEA's Authority to Deny, Revoke, or Suspend a Registration, and to Issue Immediate Suspension Order s . The DEA Opioid Enforcement Restoration Act of 2017 ( H.R. 4095 ) would repeal the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (EPAEDEA) ( P.L. 114-145 ), discussed above in the section describing the DEA's authority to issue "immediate suspension orders," and would restore the sections of the CSA amended by such act as if it had not been enacted into law. This bill would thus delete the definition of "imminent danger to the public health or safety" that the EPAEDEA had added to the CSA provision governing the DEA Administrator's power to suspend immediately an existing registration for a temporary period of time to avoid such a harm, thereby returning to the DEA significant discretion in interpreting this phrase that is a necessary finding to support an immediate suspension order. The bill would also remove the option afforded by the EPAEDEA for the registrant or applicant to submit a "corrective action plan" to the DEA prior to the agency's denial, revocation, or suspension of his registration. The Opioid Immediate Suspension Order Act of 2017 ( H.R. 4073 ) would also delete the statutory definition of "imminent danger to the public health or safety" for purposes of immediately suspending a registration but, unlike H.R. 4095 , the bill would not disturb the "corrective action plan" provision that P.L. 114-145 had added to the CSA. Establishing a n Opioid Prescription Limit . Current federal law does not restrict the particular quantity of opioids that may be prescribed by a practitioner. The Opioid Addiction Prevention Act of 2017 ( S. 892 ) would, among other things, amend the CSA to prohibit the DEA Administrator from registering, or renewing the registration of, a practitioner who is licensed under state law to prescribe controlled substances in schedule II, III, or IV, unless the practitioner certifies to the DEA that he will not prescribe any schedule II, III, or IV opioid for the initial treatment of "acute pain" (except opioids approved by the FDA for treating drug addiction) in an amount greater than a seven-day supply of the drug (with no refills allowed), or exceeding an opioid prescription limit established under state law, whichever is lesser. The bill would define "acute pain" to mean "pain with abrupt onset and caused by an injury or other process that is not ongoing" and excludes chronic pain, pain associated with cancer, hospice or other end-of-life care, or pain being treated as part of palliative care. The CARA 2.0 Act of 2018 ( S. 2456 ) would also impose a supply limitation on opioid prescriptions, requiring practitioners to certify, as a precondition for DEA registration or renewal of registration, that they will not prescribe any opioid (other than an addiction-treatment opioid) for the initial treatment of acute pain in an amount exceeding a three-day supply. Medical Education and Prescriber Education Initiatives . 358 The Safer Prescribing of Controlled Substances Act ( S. 1554 ) would, among other things, amend the CSA to require physicians, dentists, and scientific investigators who wish to dispense or conduct research with controlled substances to complete training that provides them with information concerning best practices for pain management (including alternatives to prescribing controlled substances), responsible prescribing of opioids, methods for diagnosing and treating substance use disorders, and tools to manage diversion of controlled substances such as prescription drug monitoring programs and the use of drugs to treat opioid overdoses. The bill would also make such required training a precondition to the DEA's granting or renewing the registration of these types of practitioners. The Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 ( H.R. 2063 ) would impose similar practitioner education requirements as a condition for registration to prescribe or dispense opioids, though the specifics of the training differ from S. 1554 . Increasing Penalties for Fentanyl Trafficking. Several bills, including the Stop Trafficking in Fentanyl Act of 2017 ( H.R. 1354 ), the Comprehensive Fentanyl Control Act ( H.R. 1781 ), the Stop Trafficking in Fentanyl Act of 2018 ( S. 2481 ), and the Ending the Fentanyl Crisis Act of 2018 ( H.R. 5459 , S. 2635 ), would reduce the quantity (in grams) of fentanyl that triggers mandatory minimum sentences for anyone who, in violation of the CSA, knowingly or intentionally manufactures, distributes, or dispenses fentanyl or fentanyl analogues (or possesses such substances with intent to engage in these prohibited activities). Under current law, a trafficking offense involving 400 grams or more of a mixture or substance containing a detectable amount of fentanyl, or 100 grams or more of a mixture or substance containing a detectable amount of a fentanyl analogue, is punishable by a te rm of imprisonment of at least 10 years and up to life in prison (or a minimum sentence of 20 years to life in prison, if death or serious bodily injury results from the use of the trafficked fentanyl). The bills would reduce these quantities to 20 grams and 5 grams, respectively. In addition, under current law, a drug trafficking offense involving 40 grams or more of a mixture or substance containing a detectable amount of fentanyl, or 10 grams or more of a mixture or substance containing a detectable amount of a fentanyl analogue, is punishable by a term of imprisonment of at least 5 years but not more than 40 years (or a minimum of 20 years to life in prison, if death or serious bodily injury results from the use of the trafficked fentanyl). The bills would reduce these quantities to 2 grams and 0.5 grams, respectively.