Case 4:20-cv-00817-SDJ Document 1 Filed 10/22/20 Page 1 of 54 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`SHERMAN DIVISION
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`WALMART INC.,
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`Plaintiff,
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`v.
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`U.S. DEPARTMENT OF JUSTICE;
`ATTORNEY GENERAL WILLIAM P.
`BARR; U.S. DRUG ENFORCEMENT
`ADMINISTRATION; ACTING
`ADMINISTRATOR TIMOTHY J. SHEA,
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`Defendants.
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`Walmart Inc. (Walmart) seeks a judicial declaration to resolve a dispute with the U.S.
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`CIVIL ACTION NO.:
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` COMPLAINT FOR DECLARATORY
`RELIEF
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`
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`Department of Justice (DOJ) and the U.S. Drug Enforcement Administration (DEA) about the
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`obligations of pharmacists and pharmacies under the Controlled Substances Act (CSA).
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`DOJ and DEA are placing pharmacists and pharmacies in an untenable position by
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`threatening to hold them liable for violating DOJ’s unwritten expectations for handling opioid
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`prescriptions—expectations that are directly at odds with state pharmacy and medical practice
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`laws, the expert judgment of federal health agencies, and even DEA’s own public statements.
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`When a patient presents a pharmacist with an opioid prescription written by a doctor who is
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`licensed by a state medical board and credentialed by DEA to prescribe controlled substances, the
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`pharmacist must make a difficult decision. The pharmacist can accept the doctor’s medical
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`judgment and fill the opioid prescription, or second-guess the doctor’s judgment and refuse to fill
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`it—a decision the pharmacist must make without the benefit of a medical license, examining the
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`patient, or having access to medical records.
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`Either decision puts the pharmacist and pharmacy at great risk. On the one hand, a
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`pharmacist who fills a facially valid opioid prescription risks federal investigation, civil liability,
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`or even criminal prosecution should DOJ and DEA claim in hindsight that a prescription the
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`pharmacist believed was valid should not have been filled. On the other hand, a pharmacist who
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`refuses to fill such a prescription risks having her license stripped for the unauthorized practice of
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`medicine, not to mention the potential harm to patients in need of their medicine.
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`These risks are not hypothetical. Walmart pharmacists have refused to fill hundreds of
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`thousands of problematic opioid prescriptions, and Walmart has blocked thousands of concerning
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`doctors from having their opioid prescriptions filled at any Walmart pharmacy. Because of this,
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`Walmart and its pharmacists face state investigations and lawsuits for interfering in medical
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`practice—that is, for going too far by refusing to fill opioid prescriptions. And DOJ now has stated
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`it will sue Walmart for not going far enough by continuing to fill opioid prescriptions of certain
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`licensed doctors—many of whom are still authorized by DEA to prescribe opioids to this day.
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`DOJ’s legal contentions about the duties of pharmacists and pharmacies cannot be found
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`anywhere in the text of the CSA or in any DEA regulation. At most, DOJ has stitched this untested
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`position together from scattered and informal letters and PowerPoint presentations by DEA
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`officials. But these documents are not law, as DOJ has recently reaffirmed in rules and other
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`public statements. In any event, DEA’s opioid “guidance” is often inconsistent or even
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`irreconcilable with other DEA statements, with the expert judgment of federal health agencies, and
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`with state practice of medicine and pharmacy laws.
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`Congress entrusted DEA—not pharmacists and pharmacies—with the responsibility, tools,
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`and legal authority to strip unscrupulous doctors of their prescribing privileges. But DOJ’s own
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`Inspector General has described DEA’s significant and repeated failures to vet doctors before
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`letting them prescribe opioids or to revoke the credentials of suspicious doctors. DOJ and DEA
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`should not be allowed to outsource to pharmacists and pharmacies the job DEA has failed to do.
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`The agencies’ insistence on doing so continues to expose pharmacists and pharmacies to liability
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`for improperly interfering with the doctor-patient relationship.
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`To resolve this untenable dilemma, declaratory relief is appropriate and necessary.
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`INTRODUCTION
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`1.
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`The United States is in the throes of a public health crisis arising from the abuse of
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`opioids. Opioids are addictive, prone to abuse, and readily available in illegal forms, such as
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`heroin and synthetic fentanyl. At the same time, the federal government’s Health and Human
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`Services Pain Management Best Practices Inter-Agency Task Force has determined that tens of
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`millions of Americans rely on legal prescription opioids to treat acute or severe chronic pain,
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`including pain arising from cancer as well as terminal or degenerative illnesses. The Food and
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`Drug Administration (FDA) long ago approved opioid medications for these purposes, and doctors
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`throughout the country lawfully prescribe them.
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`2.
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`Congress tasked DOJ and its sub-agency DEA with primary responsibility for
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`preventing drug abuse. With respect to illegal opioids—the chief cause of opioid overdose
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`deaths—DEA’s and DOJ’s duty is to keep those drugs off the streets and to find and punish the
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`criminals who push them.
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`3.
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`Through the CSA, Congress similarly entrusted DEA with the responsibility for
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`regulating legal opioids. DEA is responsible for enforcing the CSA in a way that preserves
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`legitimate patients’ access to pain-relief medications prescribed by their doctors while preventing
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`diversion, misuse, and abuse. As such, Congress has charged DEA with regulating every step in
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`the opioid supply chain:
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`• DEA must set production quotas to limit the quantity of legal opioids that enter the
`supply chain each year.
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`• DEA must approve and renew—or reject and revoke—manufacturers’ registrations
`to produce opioids.
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`
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`• DEA must approve and renew—or reject and revoke—distributors’ registrations
`before they may distribute opioids to licensed pharmacies and health care
`providers.
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`• DEA must approve—or reject—doctors’ initial registrations before they may
`prescribe opioids, and renew—or decline to renew—their registrations upon
`application every three years. DEA must also revoke registrations when
`appropriate in the public interest.
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`• DEA must approve and renew—or reject and revoke—pharmacies’ registrations
`before their pharmacists may dispense opioids to patients.
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`In carrying out these regulatory tasks, DEA must consider whether a given registration advances
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`“the public interest.” And if DEA determines, at any time, that continued registration would not
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`be or is no longer in the public interest, it may—and should—deny or revoke the registration or
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`decline its renewal.
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`4.
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`DEA requires as a condition of registration that each registrant play a role in
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`ensuring the integrity of the opioid supply chain. Manufacturers and distributors must report to
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`DEA any “suspicious orders” they identify. Doctors must exercise professional care to prescribe
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`opioids only for a legitimate medical purpose. And pharmacists must refuse to fill prescriptions
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`they know to be forged, altered, or not written for a legitimate medical need. The system is set up
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`so that DEA can protect the public by robustly enforcing the CSA against any improper conduct
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`anywhere along the supply chain, including by revoking or declining to renew the registrations of
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`bad actors. Every registrant necessarily relies on DEA’s endorsement when it interacts with other
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`DEA-registered entities in the supply chain. For example, in deciding whether to fill an opioid
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`prescription, pharmacists confirm whether the doctor is registered by DEA to prescribe controlled
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`substances.
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`5.
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`Watchdog agencies have meticulously catalogued, however, myriad ways in which
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`DEA has failed to safeguard the public from improper diversion of prescription opioids. Even as
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`the abuse of legal opioids climbed over the last decade, DEA authorized manufacturers to produce
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`ever-increasing quantities of the drugs, and largely abandoned its most potent enforcement tools
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`against bad actors. Most egregiously, despite years of complaints about the conduct of certain
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`doctors, DEA not only allowed those doctors to continue prescribing opioids, but in many
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`instances renewed their registrations. DEA also refused to provide any clear rules to distributors
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`on how they should detect and report “suspicious orders” from their customers. And DOJ’s own
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`Inspector General concluded that when suspicious orders were reported, DEA had ignored and
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`discarded the reports with no investigation or follow-up.
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`6.
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`In the shadow of their own profound failures, DOJ and DEA now seek to
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`retroactively impose on pharmacists and pharmacies unworkable requirements that are not found
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`in any law and go beyond what pharmacists are trained and licensed to perform. And because
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`these new, unsupported expectations directly conflict with the requirements of state regulators who
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`oversee the practice of pharmacy and medicine, pharmacists are left between the proverbial “rock
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`and a hard place.”
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`7.
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`By law, pharmacists presented with an opioid prescription cannot interfere with the
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`doctor-patient relationship by usurping the doctor’s professional judgment—and understandably
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`so, because they are not doctors, do not examine or diagnose patients for purposes of dispensing
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`opioid medications, and do not have access to patients’ medical records. Pharmacists accordingly
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`lack the tools needed to second-guess doctors’ judgments about questions that remain vigorously
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`debated in the medical field (and even within the government’s law enforcement and health
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`agencies), such as the appropriate dosing for particular patients or the necessity of particular
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`combinations of medicines.
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`8.
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`In fact, when they refuse to fill opioid prescriptions, pharmacists and pharmacies
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`have been reprimanded, investigated, and even sued by state boards of pharmacy and medicine,
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`national medical associations, doctors, and patients. State regulators, in particular, contend that
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`state laws regulating the practices of pharmacy and medicine prohibit pharmacists from second-
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`guessing doctors, and particularly from doing so on a categorical rather than prescription-by-
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`prescription basis. Meanwhile, physician organizations such as the American Medical Association
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`maintain that doctors’ judgments should be paramount.
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`9.
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`Nevertheless, Defendants assert that the CSA and its regulations require
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`pharmacists—and pharmacies’ corporate headquarters—to insert themselves into the doctor-
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`patient relationship. DOJ and DEA now contend that it is not enough for a pharmacist to refuse to
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`fill prescriptions he or she knows to be illegitimate—even though the laws they rely on impose
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`liability only based on what is within a pharmacist’s knowledge. Instead, Defendants’ position
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`would require that every time a patient presents a facially valid prescription for an opioid
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`medication—a prescription written by a DEA-registered doctor who has examined the patient and
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`knows the patient’s medical history—the pharmacist must second-guess the doctor’s medical
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`judgment.
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`10.
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`Defendants’ position also would effectively impose liability if a pharmacy’s
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`corporate headquarters does not override its pharmacists’ judgments whether to fill prescriptions
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`(and the judgments of the doctors who write them) by blocking all prescriptions written by
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`particular doctors across the whole pharmacy chain.
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`11.
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`Defendants’ position is an attempt to effectively shift to pharmacists duties that
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`Congress has assigned to DEA and that state law assigns to state medical boards. DEA is charged
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`with revoking or refusing to renew doctors’ registrations to prescribe controlled substances if they
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`write medically unnecessary prescriptions. DEA has the legal authority to conduct investigations
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`and even revoke credentials on an emergency basis. And state medical boards police standards of
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`medicine and may suspend or revoke doctors’ licenses if they violate their professional obligations.
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`Under Defendants’ view, however, pharmacists must reexamine every doctor’s diagnosis to
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`confirm that the prescription written by the doctor was medically proper for the patient in question,
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`and then categorically block those doctors that pharmacists deem suspect.
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`12.
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`These supposed duties find no basis in the text of DEA’s own regulations, much
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`less the statutes that Congress enacted. On the contrary, Defendants can piece them together only
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`from scattered letters, PowerPoint presentations, and other materials that are—at best—informal
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`“guidance.” Under its own rules, however, DOJ is not permitted to use guidance like this as the
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`basis for enforcement actions. And DOJ has likewise forsworn lawsuits that seek to impose
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`penalties for violating “rules” announced only after the conduct at issue. DEA could have
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`promulgated regulations dictating how pharmacists and pharmacies should evaluate opioid
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`prescriptions, and pharmacists and pharmacies would have complied. But DEA never did.
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`Defendants’ threatened suit based on sub-regulatory guidance and post hoc asserted obligations
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`cannot be squared with DOJ’s formal renunciations of just such unlawful tactics.
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`13.
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`DOJ’s and DEA’s current position is also impossible to square with DEA’s own
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`prior positions and those of other expert federal agencies. DEA has emphasized that the decision
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`to fill a prescription depends on the prescription-by-prescription judgment of licensed medical
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`professionals. DEA, The Pharmacist’s Manual 42 (2020); DEA, Dispensing Controlled
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`Substances for the Treatment of Pain, 71 Fed. Reg. 52716, 52716–23 (Sept. 6, 2006) (Dispensing
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`Controlled Substances). That position comports with the views of medical experts at the
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`Department of Health and Human Services (“HHS”), Centers for Disease Control and Prevention
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`(“CDC”), and Centers for Medicare & Medicaid Services (“CMS”). See, e.g., HHS, Draft Report
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`on Pain Management Best Practices (2019), available at https://www.hhs.gov/ash/advisory-
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`committees/pain/reports/2018-12-draft-report-on-updates-gaps-inconsistencies-recommendations
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`/index.html; CDC, CDC Advises Against Misapplication of the Guideline for Prescribing Opioids
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`for Chronic Pain (Apr. 24, 2019), https://www.cdc.gov/media/releases/2019/s0424-advises-
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`misapplication-guideline-prescribing-opioids.html (highlighting the need for “individualized
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`assessment of the benefits and risks of opioids given the specific circumstances and unique needs
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`of each patient”). But DOJ and DEA are now attempting to invent post hoc rules—not found in
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`the CSA or its regulations—that would outlaw certain categories of prescriptions and essentially
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`impose strict liability based on the government’s Monday-morning quarterbacking.
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`14.
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`Unfortunately, Defendants’ attempt to rewrite the CSA and restructure the practice
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`of medicine has placed pharmacists and pharmacies—including Walmart and its pharmacists—in
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`a very difficult position.
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`15. Walmart is a retailer that serves a diverse array of communities. As a relatively
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`small part of its business—but in keeping with its mission to provide its customers with a one-stop
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`shopping experience—Walmart operates more than 5,000 in-store pharmacies in the United States.
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`16. Walmart has always encouraged its pharmacists to exercise their professional
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`judgment and refuse to fill opioid prescriptions that they do not believe to be legitimate. In fact,
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`Walmart pharmacists have refused to fill hundreds of thousands of opioid prescriptions. Walmart
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`also has adopted innovative opioid-stewardship programs and partnered with law enforcement
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`agencies, including DEA, to help root out corrupt doctors and put them behind bars.
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`17.
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`In an atmosphere of government pressure, including DOJ’s unethical threats of
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`criminal sanctions meant to leverage a huge civil settlement, Walmart accelerated its
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`implementation of doctor-blocking policies. But Walmart’s good-faith efforts have not satisfied
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`Defendants, and at the same time have been met with inquiries, lawsuits, threats, and investigations
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`from doctors, patients, legislators, and state boards of medicine and pharmacy, who believe
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`Walmart’s actions go too far in blocking dispensing of prescription opioids.
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`18.
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`Despite these efforts, DOJ and DEA have stated they will file a civil complaint
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`against Walmart for not going far enough in blocking doctors by refusing to fill their prescriptions.
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`This threat is based on legal theories that have no basis in statute or regulation. DOJ will seek
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`civil penalties against Walmart for its licensed pharmacists’ filling of prescriptions for pain
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`medications approved by the FDA, written by licensed and registered doctors, presented by
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`individual patients as medically necessary, and filled by pharmacists in their exercise of their
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`professional judgment on a case-by-case basis. There is no allegation that these prescriptions were
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`forged or altered, or that pharmacists were taking kickbacks or had inappropriate relationships with
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`patients or doctors. Defendants’ threatened action would be unprecedented.
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`19.
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`Defendants’ effort to regulate through litigation only compounds the untenable
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`dilemma faced by pharmacists across the United States. On the one hand, a pharmacist who fills
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`a facially valid opioid prescription is at risk of federal investigation, civil liability, or even criminal
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`prosecution. On the other hand, a pharmacist who refuses to fill such a prescription is at risk of
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`having her license stripped for the unauthorized practice of medicine, not to mention the potential
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`harm to patients in need of their medicine. Those risks become particularly acute where the
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`pharmacist (or a chain of pharmacies), in accord with Defendants’ demands, blocks a given
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`doctor’s prescriptions entirely.
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`20.
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`DOJ’s threatened lawsuit also underscores the extent to which Defendants seek to
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`make up for their own regulatory shortcomings by imposing liability on Walmart and its
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`pharmacists. For example, of the hundreds of specific doctors that DOJ has identified to Walmart
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`as having written problematic prescriptions that Walmart’s pharmacists allegedly should not have
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`filled, nearly 70% continue to have active DEA registrations to this day. In other words,
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`Defendants want to blame Walmart for continuing to fill purportedly bad prescriptions written by
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`doctors that DEA and state regulators enabled to write those prescriptions in the first place and
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`continue to stand by today.
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`21.
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`Neither Walmart nor its pharmacists caused the opioid crisis. Walmart and its
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`pharmacists never marketed opioids, nor did they mislead the public and the medical community
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`(including pharmacists) about the dangers of opioids. Walmart never shipped opioid medications
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`to any rogue independent or internet pharmacies; it distributed only to itself. Unlike DEA, DOJ,
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`and state medical boards, Walmart and its pharmacists had no say in determining whether opioids
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`should be approved as safe and effective, what conditions they should be approved as treatment
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`for, the quantity of opioids produced in this country, or the circumstances in which they are
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`prescribed. Nor have Walmart or its pharmacists had a role in credentialing doctors or approving
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`and renewing their state licenses or DEA registrations. And of course, Walmart pharmacies and
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`pharmacists never wrote opioid prescriptions at all.
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`22.
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`Even though Walmart and its pharmacists did not cause the opioid crisis, they
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`remain devoted to trying to combat it while serving their customers’ legitimate medical needs. But
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`Walmart and its pharmacists should not be held responsible for the government’s failures to
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`address the opioid crisis, and should not be subject to Defendants’ threats to enforce unwritten
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`laws and regulations, conflicting duties, and contradictory guidance.
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`23.
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`To end the unacceptable uncertainty caused by Defendants’ conduct, Walmart
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`reluctantly files this action to obtain a declaration resolving its disputes of law with Defendants
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`and clarifying its legal rights and duties under the CSA and its implementing regulations.
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`JURISDICTION AND VENUE
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`24.
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`This Court has jurisdiction over the subject matter of this civil action under 28
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`U.S.C. §§ 1331 and 2201 because the claims arise under the laws of the United States.
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`25.
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`Venue is proper in this judicial district under 28 U.S.C. § 1391(e) because this is
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`an action against officers and agencies of the United States and a substantial part of the events
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`giving rise to the claims occurred in this judicial district. Specifically, the U.S. Attorney’s Office
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`for this judicial district initially led the investigation into Walmart, and that investigation focused
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`primarily on conduct within this judicial district.
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`THE PARTIES
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`26.
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`Plaintiff Walmart Inc. (Walmart) is a Delaware corporation with its principal place
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`of business in Bentonville, Arkansas.
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`27.
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`Defendant U.S. Department of Justice (DOJ) is an executive department of the
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`United States federal government.
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`28.
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`Defendant William Barr is the Attorney General of the United States, the principal
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`officer of DOJ. He is sued in his official capacity.
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`29.
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`Defendant U.S. Drug Enforcement Administration (DEA) is a component law
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`enforcement agency under DOJ.
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`30.
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`Defendant Timothy Shea is the Acting Administrator of DEA, the principal officer
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`of that agency. He is sued in his official capacity.
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`FACTUAL ALLEGATIONS
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`I.
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`OPIOIDS, THEIR SUPPLY CHAIN, AND THEIR REGULATORY SCHEME.
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`31.
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`Opioids are chemical substances,
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`including morphine, hydrocodone, and
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`oxycodone, that provide pain relief. Many opioids have long been approved by the FDA as safe
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`and effective for medical use and are regulated under the CSA. Illegal forms of certain opioids
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`exist, such as heroin and illegally imported synthetic fentanyl.
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`32.
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`The prescription opioid supply chain includes manufacturers, distributors, doctors,
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`and dispensers (pharmacies and other entities who ultimately provide the medications to patients
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`with prescriptions written by licensed medical professionals). Public agencies, including FDA and
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`DEA, are tasked by law with tightly controlling every aspect of the supply chain, including by
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`limiting manufacture of prescription opioids and registering and regulating the doctors,
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`distributors, and dispensers. Regulatory oversight occurs at every step in the chain.
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`33.
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`The CSA, 21 U.S.C. § 801 et seq., provides the primary framework governing the
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`manufacture, distribution, and dispensing of controlled substances. It establishes registration
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`requirements for participants in the opioid supply chain, id. § 822, and sets forth unlawful acts that
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`may give rise to civil or criminal liability, id. § 842. DEA has issued regulations interpreting the
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`CSA.
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`34. Manufacturers make, market, and sell opioids. Production is limited, however, by
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`DEA, which (in consultation with FDA and other interested parties like the manufacturers
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`themselves) sets annual aggregate production quotas (“APQs”) that determine the amount of
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`controlled substances that may be produced each year. 21 C.F.R § 1303.11. In setting APQs,
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`DEA is charged with limiting production of controlled substances, including prescription opioids,
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`to the amount necessary for the “estimated medical, scientific, research and industrial needs of the
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`United States, for lawful export requirements, and for the establishment and maintenance of
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`reserve stocks.” Id. § 1303.11(a). Opioids cannot legally be produced without DEA approval;
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`DEA therefore establishes the total quantity of prescription opioids available in any given year.
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`DEA has been widely criticized for failing to impose proper limits on the national supply of
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`opioids.
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`35.
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`Some manufacturers are alleged to have aggressively promoted prescription
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`opioids directly to doctors as a safe, non-addictive method for treating pain. These marketing
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`efforts are alleged to have had an effect on prescribing practices, but for many years DEA did little
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`or nothing to stop them. See, e.g., Nat’l Inst. of Health, Opioid Overdose Crisis (May 28, 2020),
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`https://www.drugabuse.gov/drug-topics/opioids/opioid-overdose-crisis (describing misleading
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`claims
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`about
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`addictiveness); HHS, About
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`the Epidemic
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`(Sept.
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`4,
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`2019),
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`https://www.hhs.gov/opioids/about-the-epidemic/index.html (same).
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`36. Manufacturers do not, however, ship their products directly to doctors or
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`pharmacies. Instead, they rely on distributors who ship pharmaceuticals, including prescription
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`opioids, to dispensers. Wholesale distributors ship opioids to all kinds of pharmacies, including
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`to those located in hospitals, independent and internet pharmacies, and certain medical practices.
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`37.
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`To prevent diversion through distribution channels, distributors are expected to
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`“know their customers” to ensure that those customers are legitimate pharmacies. Distributors are
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`therefore required, as a condition of CSA registration, to “design and operate a system to disclose
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`to the registrant suspicious orders of controlled substances” and “inform” local DEA officials of
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`“suspicious orders when discovered.” 21 C.F.R. § 1301.74(b). Federal investigations have shown
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`that for many years, however, DEA did not use or maintain suspicious order reports submitted by
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`distributors. DOJ, Office of the Inspector Gen., Review of the Drug Enforcement Administration’s
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`Regulatory and Enforcement Efforts to Control the Diversion of Opioids (Sept. 2019), at 31.
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`38.
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`For a period of time, Walmart, like other national chain pharmacies, self-distributed
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`controlled substances, including opioids, by buying them from manufacturers and shipping them
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`to its own pharmacies—and only to its own pharmacies. Walmart and a number of other national
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`chain pharmacies no longer self-distribute prescription opioids, but instead rely on third-party
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`distributors.
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`39.
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`Doctors play the central role in the prescription opioid supply chain. Doctors
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`conduct medical exams, review medical histories, and directly interact with their patients before
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`prescribing controlled substances. Their integrity is essential to the regulatory scheme. Doctors
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`are registered by DEA (to whom they must reapply for renewal every three years) and licensed by
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`the relevant state medical boards to prescribe controlled substances.
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`40.
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`DEA has stated that “the overwhelming majority of American physicians who
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`prescribe controlled substances do so for legitimate medical purposes.” DEA, Dispensing
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`Controlled Substances, 71 Fed. Reg. at 52719.
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`41.
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`Of course, as in any field, there are bad actors—doctors who do not undertake
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`appropriate medical scrutiny before providing a prescription. Both DEA and state medical boards
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`retain oversight of these doctors and have the authority and responsibility to revoke their ability to
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`prescribe controlled substances. See, e.g., 21 C.F.R. § 1301.36. Federal law empowers DEA with
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`regulatory tools such as subpoenas, investigatory resources, and the legal authority to suspend on
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`an emergency basis or revoke a doctor’s registration. See, e.g., 21 C.F.R. §§ 1301.31–46,
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`1316.41–68. But DEA has failed in its responsibility to deny prescribing privileges to doctors who
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`abuse them, even allowing a multitude of doctors that DOJ and DEA now contend should not have
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`had any of their prescriptions filled to maintain their DEA registrations and continue writing opioid
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`prescriptions.
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`Case 4:20-cv-00817-SDJ Document 1 Filed 10/22/20 Page 15 of 54 PageID #: 15
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`II.
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`PHARMACISTS’ ROLE IN THE OPIOID SUPPLY CHAIN.
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`42.
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`The role of the pharmacist in this regulatory framework is an important but limited
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`one. Pharmacists do not prescribe opioids, and they cannot dispense them to anyone other than
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`patients with prescriptions written by state-licensed and DEA-registered doctors. They apply their
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`own professional judgment to the facts before them in light of their training, education, and
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`experience.
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`43.
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`The rules governing the dispensing of controlled substances, including prescription
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`opioids, are set out in part in 21 C.F.R. § 1306.04(a). That section provides:
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`A prescription for a controlled substance to be effective must be issued for a
`legitimate medical purpose by an individual practitioner acting in the usual course
`of his professional practice. The responsibility for the proper prescribing and
`dispensing of controlled substances is upon the prescribing practitioner, but a
`corresponding responsibility rests with the pharmacist who fills the prescription.
`An order purporting to be a prescription issued not in the usual course of
`professional treatment or in legitimate and authorized research is not a prescription
`within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the
`person knowingly filling such a purported prescription, as well as the person issuing
`it, shall be subject to the penalties provided for violations of the provisions of law
`relating to controlled substances.
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`44.
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`As that regulation makes clear, it is the “prescribing practitioner” (the doctor) who
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`bears primary responsibility for ensuring that controlled substances are properly prescribed (“for
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`a legitimate medical purpose” and “in the usual course” of a practitioner’s professional practice).
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`45.
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`That allocation of responsibility makes sense. The patient’s doctor is the one who
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`has been licensed by the state medical board to practice medicine, has been authorized by DEA to
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`prescribe controlled substances, has the capacity to examine the patient and access her complete
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`medical history, and is best positioned by virtue of the doctor-patient relationship to accurately
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`assess the patient’s treatment needs and any accompanying risks.
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`46.
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`By contrast, pharmacists are not doctors. Pharmacists cannot examine or diagnose
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`a patient who has received a prescription for opioid medication. They cannot obtain or review the
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`Case 4:20-cv-00817-SDJ Document 1 Filed 10/22/20 Page 16 of 54 PageID #: 16
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`patient’s full medical file. Nor can they access the patient’s full prescription history at other
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`pharmacies. Instead, a pharmacist’s knowledge of the situation is generally limited to the four
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`corners of the prescription, the patient’s history at that particular pharmacy, any of the patient’s
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`information available to the pharmacist in the state Prescription Drug Management Program, a
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`brief interaction with the patient, and any follow-up or inquiry that the pharmacist may conduct by
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`contacting the prescribing doctor’s office. Indeed, pharmacists are not permitted to practice
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`medicine and would be disciplined for doing so.
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`47.
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`Nevertheless, pharmacists have an important role to play when filling prescriptions.
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`As the