THE MEDICINE SHOPPE V. LORETTA LYNCH, ET AL.: PHARMACISTS AND PRESCRIBING PHYSICIANS ARE EQUALLY LIABLE Grass, Jeffrey C, JD, MS, ACLM . The Health Lawyer ; Chicago Vol. 28, Iss. 3, (Feb 2016): 28-37.
ProQuest document link
[…]Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled Substances
Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R. § 1306.04(a) (2014) on
the grounds that these standards exceed the United States Attorney General’s and the DEA’s statutory authority
under the CSA.7 On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without
comment, thereby leaving open the question of whether or not the United States Attorney General may expand the
professional duty of pharmacists to require they either endorse or overrule the medical judgment of the prescribing
physician. FULL TEXT
On November 3, 2011, the Dmg Enforcement Administration (“DEA”) conducted an inspection of The Medicine
Shoppe, a small family-owned pharmacy in San Antonio, Texas. DEA Diversion Investigators (“Dis”) seized
prescriptions filled by patients of a local physician who was under investigation for possible dmg diversion. On
October 7, 2013, the DEA Deputy Administrator issued an Order to Show Cause (“OTSC”) to revoke The Medicine
Shoppe’s controlled substances Certificate of Registration (“COR”) on the grounds that the pharmacy had filled
prescriptions written by the target physician that were not for a “legitimate medical purpose.”1 The DEA alleged
that The Medicine Shoppe’s pharmacists failed to exercise their “corresponding responsibility,” along with the
physician, “to assure that its prescription for controlled substances was issued for a legitimate medical purpose”
and “in the practitioner’s usual course of professional practice” under DEA regulation.
The Medicine Shoppe responded that the pharmacists had known the patients and the prescribing physician for
many years and had contacted the prescribing physician’s office to verify the prescriptions before filling them.2
The Medicine Shoppe argued that therefore it had complied with the requirements of their pharmacists’
professional licenses and absent clear evidence of diversion, the pharmacists were obliged to fill the
On October 2nd, 2014 the DEA revoked The Medicine Shoppe’s COR.4 The Medicine Shoppe then filed a Petition for
Review with the United States Court of Appeals for the District of Columbia Circuit, which has original jurisdiction
for appeals of DEA Orders under the Administrative Procedure Act (“APA”).5 The Medicine Shoppe appealed on the
grounds that imposing a “corresponding responsibility” on pharmacists to ensure that controlled substances are
prescribed for a “legitimate medical purpose'” requires them to make medical judgments beyond their education
and training.6 Moreover, should the DEA disagree with a physician’s medical judgment and the medical necessity
of a prescribed medication, pharmacists who now share a “corresponding responsibility,” along with the physician,
“to assure that its prescription for controlled substances was issued for a legitimate medical purpose” will be
subject to the same civil and criminal liability for the physician, despite authenticating the order with the
prescribing doctor, as required by state law.
Accordingly, Petitioners challenged the DEA’s interpretation of “legitimate medical purpose” under the Controlled
Substances Act (“CSA”) and the “corresponding responsibility” standard under DEA Regulation 21 C.F.R.
§1306.04(a) (2014) on the grounds that these standards exceed the United States Attorney General’s and the
DEA’s statutory authority under the CSA.7
On December 16, 2015, the Court denied The Medicine Shoppe’s petition for review without comment, thereby
leaving open the question of whether or not the United States Attorney General may expand the professional duty
of pharmacists to require they either endorse or overrule the medical judgment of the prescribing physician.
The Backdrop of Expanding DEA Enforcement
The DEA has declared prescription drug abuse to be the Nation’s fastest-growing dmg problem.8 It is of particular
concern because legally obtained substances can lead to addiction or death.9 One source of this problem is
medical offices acting as “pill mills” and brick and mortar pharmacies working together promoting the illegal sale
of pharmaceuticals.lu In response to this epidemic, the DEA has stepped up its enforcement efforts against
pharmacies suspected of diverting pharmaceutical medicines.11 In doing so, the DEA has broadened the legal
standard delineating licit from illicit dispensing of controlled substances.12
Controlled Substance Registration
The CSA and its implementing regulations “establish federal requirements regarding both illicit and licit controlled
substances.”13 A “controlled substance” is defined as “a drug or other substance, or immediate precursor, included
in Schedule I, II, III, IV, or V.”14 Under the framework of the CSA, enacted in 1970, “all controlled substance
transactions take place within a ‘closed system’ of distribution established by Congress.”15 Accordingly, the DEA
“requires all businesses that import, export, manufacture, or dispense controlled substances; all health care
practitioners entitled to give out, administer, or prescribe controlled pharmaceuticals; and all pharmacies
authorized to fill prescriptions, to register with the DEA.”16 The DEA has the unique dual responsibility to not only 1
) ensure the supply of pharmaceutical controlled substances for legitimate purposes, but also 2) prevent the
diversion of these substances to illicit users/abusers.1′ The DEA administers this provision of the CSA by issuing a
COR that authorizes a central individual or entity (s) (“Registrants”) to dispense controlled substances in
Schedules II thru V of the CSA.18 According to the most recent tally by the Department of Health and Human
Services Office of Inspector General (“OIG”), in March 2014 the DEA had 1.5 million active retail and wholesale
The DEA actively monitors these Registrants through a system of scheduling, quotas, recordkeeping, reporting,
and security requirements.20 The DEA also uses criminal and regulatory tools to identify and determine who is
most likely involved in the illicit distribution of controlled substances.21 The DEA initiates criminal investigations
of those suspected of criminal violations of the CSA. Criminal prosecutions are coordinated with an Assistant
United States Attorney or state District Attorney. Criminal cases vary widely in resource requirements and
Administrative Inspection Warrants
Compliance inspections of pharmacies are carried out by the DEA Office of Diversion Control to ensure that the
pharmacies have sufficient measures in place to prevent the diversion of controlled substances.23
Noncompliance is determined primarily by investigating complaints about the dispensing practices of
pharmacies.24 The DEA’s compliance review system includes web sites that monitor the prescribing and
dispensing of controlled substances by physicians and pharmacies 2s For example, the DEA uses the Automated
Reports and Consolidated Order System (“ARCOS”) to identify high volume purchasers of narcotic controlled
substances.20 Signs of suspicious circumstances are termed “red flags.”27 Red flags can constitute evidence of
diversion from “legal and medically necessary uses towards uses that are illegal and typically not medically
authorized or necessary.”28 If red flags are detected but left unresolved, the DEA will issue an Administrative
Inspection Warrant (“AIW”). An AIW is an administrative search warrant that allows DEA Dis access to either a
medical practice or pharmacy for the purpose of conducting compliance audits.29
Pharmacists* Duty to Identify and Resolve Red Flags
Individual pharmacists are now required to do more than just “verify the validity and authenticity of a prescription,”
as has historically been the case under state and federal law as well as DEA decisional history.30 Pharmacists
must also “resolve all red flags” before filling the prescription.31
Under this new regime, A pharmacist who “knowingly fills an order that is not intended for a legitimate medical
purpose, as well as the physician issuing it, will be subject to the penalties provided for violations of the provisions
of law relating to controlled substances under the CSA.”32 “Knowingly” includes circumstances that are known or
should have been known to the pharmacist who may not “close [his or her] eyes and thereby avoid positive
knowledge of the real purpose of the prescription, upon verifying that a physician issued it.”33 Keeping oneself
unaware of facts that would render him or her liable in order to avoid civil or criminal liability is termed “willful
blindness,” “ignorance of the law,” or “contrived ignorance” and is not a defense under the law.34 Committing
multiple violations of a pharmacist’s “corresponding responsibility” can mean administrative or criminal
prosecution resulting in the revocation of a pharmacy’s COR, loss of the pharmacist’s professional license, and
possibly criminal prosecution under state or federal controlled substances statutes.35
Revoking Certificates of Registration and Orders to Show Cause
If the Registrant is believed to be non-compliant, the DEA may initiate an OTSC hearing as to why the Registrant’s
COR should not be revoked, suspended, or application for one denied.36 This authority is derived from an
amendment to the CSA in 1984, which “gives the United States Attorney General the power to revoke the federal
registrations of physicians and pharmacists for the purpose of addressing the severe problem of diversion of
dmgs of legitimate origin into the illicit market.”3′ If the DEA deems the violation to be egregious enough to pose
an “imminent threat to public health or safety,” the DEA may issue an immediate suspension order that summarily
revokes the Registrant’s authorization to prescribe or dispense controlled substances.08 OTSC hearings and
immediate suspension orders are collectively known as “Registrant Actions.”39 Since the DEA grants a COR to a
pharmacy and not the pharmacist, this legal action refers to the practices of the store, although the actual parties
being scrutinized are the pharmacy owners and the registered pharmacists operating it.40
Once the DEA Administrator issues an OTSC, the Registrant may either allow the DEA Administrator to issue a
Final Decision and Order modifying or revoking the pharmacy’s COR or request an OTSC due process hearing.41 If
the Registrant wants a hearing, a DEA Administrative Law Judge (“ALJ”) hears evidence presented by DEA Counsel
and the Registrant. The ALJ will make findings as to whether or not a preponderance of the evidence submitted
shows the Registrant’s continued registration is “inconsistent with the public interest.”42 The ALJ will then issue
his or her Findings of Fact, Conclusions of Law and a Recommended Decision to the DEA Administrator. The DEA
Administrator may agree or disagree with the recommendation of the ALJ and will render his or her final Decision
and Order adopting, modifying or rejecting the ALJ’s Findings of Fact, Conclusions of Law and a Recommended
Pharmacists “Corresponding Responsibility”
The DEA Administrator’s decision to allow a pharmacy to continue dispensing controlled substances depends, in
part, on whether it has acted responsibly in filling prescriptions. DEA regulations require pharmacists have a
“corresponding responsibility,” along with the physician, “to assure that a prescription for a controlled substance
“was issued for a legitimate medical purpose” and “in the practitioner’s [physician’s] usual course of professional
practice.”44 An order purporting to be a prescription issued not in the usual course of professional treatment or a
legitimate medical purpose 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.45 In
other words, the DEA make pharmacists as equally responsible as the prescribing doctor that medications the
pharmacy dispenses are necessary for treating a patient’s medical condition.46
Controlled Substances Must Be for a “Legitimate Medical Purpose”
Although the “legitimate medical purpose” standard has existed for more that 90 years, the phrase is not defined in
the CSA, and this omission invites conjecture about its meaning.4” For the most part, “legitimate medical purpose”
has been construed by the federal courts and DEA decisional history to require that dispensing controlled
substances be done “in accordance with a standard of medical practice recognized and accepted in the United
States.”48 However, the United States Attorney General and state legislatures have repeatedly been at odds when
the DEA has interpreted its statutory authority under the CSA in a way that enables it to control healthcare policy49
For example, at issue in The Medicine Shoppe case was whether the DEA may interpret this phrase to decide
medical standards of care and require pharmacists to judge whether prescribed medications are necessary to treat
a patient’s medical condition.50
Federal Pre-emption v. State Police Powers
Since medical standards of care are traditionally determined by the states, a tension has developed between
federal and state enforcement in discerning whether a practice is for a “legitimate medical purpose” or “illegitimate
nonmedical purpose.”61 More particularly at issue in The Medicine Shoppe case is whether the United States
Attorney General may expand the professional duty of pharmacists to require that they either endorse or overrule
the medical judgment of the prescribing physician. Under Texas state law, and the law of most other states,
pharmacists have the duty to “exercise sound professional judgment with respect to the accuracy and authenticity
of any prescription drug order dispensed. If the pharmacist questions the accuracy or authenticity of a prescription
drug order, the pharmacist shall verify the order with the practitioner before dispensing.”52 “A prescription drug
order may not be dispensed or delivered if the pharmacist has reason to suspect that the prescription drug order
may have been authorized in the absence of a valid patient-practitioner relationship, or otherwise in violation of the
practitioner’s standard of practice [.]”S3 Historically, the DEA’s interpretation of pharmacists’ duty under the CSA is
to require they verify the validity and authenticity of the prescription with the prescriber and to deny the order if it
However, the DEA contends that it has the authority to expand the professional duty of pharmacists to require they
either endorse or overrule the medical judgment of the prescribing physician even if contrary to state law. The
United State’s Attorney General interprets the CSA’s preemption provision, 21 U.S.C. 903, as clearly demonstrating
that “Congress expressly intended that there would be a dual system of Federal-State regulation of controlled
substances,” which reflects that this field of regulation was to be shared by the federal and state governments.55
This provision reiterates what is inherent in the Supremacy Clause of the United States Constitution – that no state
may enact a law relating to controlled substances that present a “positive conflict” with the CSA. The DEA cites the
preceding language of the CSA as its authority to make a determination, independent of state regulators, whether
the Registrant’s continued authority to handle controlled substances would follow the public interest.56 Yet,
expanding this interpretation in a way that grants the United States Department of Justice the power to determine
medical necessity has consistently put the federal government at odds with the states’ ability to regulate the use
and dispensing of controlled substances.
Conflicting Applications of the “Legitimate Medical Purpose” Standard
Chronic Pain Management
In United States v. Moore, the United States Supreme Court upheld the conviction of a physician alleged to have
“knowingly or intentionally, dispensed or distributed [methadone] by prescription, and who did so other than in
good faith in the usual course of a professional practice and in accordance with a standard of medical practice
generally recognized and accepted in the United States.”57
However, the Court clarified that the CSA extends only to issues related to a practitioner’s federal registration and
“extends no further.”58 In so doing, the Moore Court limited the DEA’s authority to regulate transactions within “the
legitimate distribution chain.”59 Therefore, the holding in Moore did not interpret the CSA to “authorize the DEA to
set standards of care, but rather reserves those questions for the States.”60 Nor did the Court extend the ruling to
impose an independent duty or “corresponding responsibility” for the medical necessity of the prescribed
medications on pharmacists.61 The Court observed that these were medical standards of care that have
traditionally been relegated to the states and applied to the prescribing practitioner.62 Therefore, scrutiny of
pharmacy practice by the DEA had historically been limited to issues concerning the manner in which controlled
substances are stored and distributed.63
However, the authority of the United States Attorney General to set healthcare policy under the doctrine of
preemption was embraced by the United States Supreme Court in Gonzales v. Raich (previously Ashcroft v. Raich).
In Raich, the Court held that the United States Congress may criminalize the production and use of medical
marijuana even where the states approve its use as medically necessary and for a “legitimate medical purpose.”64
Here, the Court acknowledged Congressional intent to criminalize the possession and use of marijuana for all
purposes as a Schedule I controlled substance.65 Consequently, federal law and the United States Attorney
General’s enforcement of the CSA preempt state law under the Commerce Clause of the United States Constitution
when Congress has manifested its clear intention to do so.66
Death with Dignity
Yet a year later, the Court in Gonzales v. Oregon expressly limited the DEA’s role in evaluating the medical
usefulness of a prescription drug. The Gonzales Court held that “the states, not the DEA, have the authority to
determine what orders have been issued for a ‘legitimate medical purpose.'”0′ The Court said that the authority
delegated by the United States Attorney General permits the DEA to deny, suspend, or revoke a registration that
would be “inconsistent with the public interest.”68 In determining consistency with the public interest, the Attorney
General must consider five factors, including the state’s recommendation, compliance with state, federal, and local
law regarding controlled substances, and public health and safety.69 The CSA explicitly contemplates a role for
the states in regulating controlled substances. However, the Gonzales Court found substantial limitations in the
implementation of the CSA by the DEA in this regard.i0 Justice Kennedy, writing for the Court, stated:
The CSA and this Court’s case law amply support the conclusion that Congress regulates medical practice insofar
as it bars doctors from using their prescriptionwriting powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood. Beyond this, the Act manifests no intent to regulate the practice of
medicine generally, which is understandable given federalism’s structure and limitations. The CSA’s structure and
operation presume and rely upon a functioning medical profession regulated under the States’ police powers. The
Federal Government can set uniform standards for regulating health and safety. In connection with the CSA,
however, the only provision in which Congress set general, uniform medical practice standards, 42 U.S.C.
§2990bb2a, strengthens the understanding of the CSA as a statute combating recreational drug abuse and also
indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit
Consequently, the Gonzales Court adhered to a policy of “continuing to give deference to the opinions of the state
licensing authorities.”72 By ruling for the state of Oregon, the Supreme Court is requiring that states, through their
legislatures, professional licensing boards, and citizen initiatives, will continue to decide what uses of medications
are for a legitimate medical purpose.70
Furthermore, the Gonzales Court and its progeny reveal a reluctance to grant the DEA the absolute authority to
impose upon pharmacists civil or criminal liability arising from a “corresponding responsibility with physicians that
controlled substances are intended for a legitimate medical purpose” unless there is direct evidence that the
pharmacist had actual knowledge that the prescribing physician is diverting drugs. That means that the
pharmacist knew that the doctor has “knowingly or intentionally, dispensed or distributed by prescription, other
than in good faith in the usual course of professional practice and in accordance with a standard of medical
practice recognized and accepted in the United States.”74 Therefore, “[a]cts of prescribing or dispensing of
controlled substances that are done within the course of the registrant’s professional practice are, for purposes of
the Controlled Substances Act, lawful. It matters not that such acts might constitute terrible medicine or
malpractice. They may reflect the grossest form of medical misconduct or negligence. They are nevertheless
legal.”71 Moreover, “[i]n making a medical judgment concerning the right treatment for an individual patient,
physicians require a certain latitude of available options,”76 Hence, “[w]hat constitutes Bona fide medical practice
must be determined upon consideration of the evidence and attending circumstances.”7′ However, under the guise
of treatment, a physician cannot prescribe, and a pharmacy cannot sell drugs to a dealer nor distribute drugs
intended to cater to cravings of an addict.’8 Congress did not intend for doctors to become drug pushers. This
general principle does not diminish the difficulty in the application of the legal standards set forth for the proper
prescribing and dispensing of controlled substances.’9
Because sodium thiopental is a Schedule III drug, the CSA requires a qualified medical practitioner to write a
prescription for the drug before it may be dispensed.80 As lethal injection has become the near exclusive method
of execution in this country, challenges to capital punishment will migrate from federal U.S. Constitutional
amendment VIII challenges involving cruel and unusual punishment to whether the drugs used have been
dispensed and administered for a “legitimate medical purpose.”81 Based on this position, the DEA can no longer
consistently hold that it should not regulate the drugs used in lethal injections.82
Clear Examples of Illicit Purposes
Decisions in the Fifth Circuit and Sixth Circuit have provided some, but not much guidance to pharmacists as to
how they define “legitimate medical purpose,” but mostly these decisions tell stakeholders what is not considered
a legitimate medical purpose. In United States v. Rosen, the Court of Appeals observed that “[a] majority of cases
[in which physicians were alleged to have dispensed controlled substances without a legitimate medical purpose]
have dealt with facts which were so blatant that a statement of clear-cut criteria in a form useful in other cases
would have been superfluous to the decision.”83 The Rosen Court did, however, “glean from reported cases certain
recurring concomitance of condemned behavior to include conclusive evidence of wrongdoing such as providing
multiple prescriptions to individuals in fictitious names to avoid detection; trading drugs for sexual favors or
money; or, physicians who sell prescriptions to drug dealers or abusers; and evidence of illicit sales.”84
In United States v. August, the Court of Appeals for the Sixth Circuit stated that “there are no specific guidelines
concerning what is required to support a conclusion that an accused acted outside the usual course of
professional practice…. [Rather, the courts] “must engage in a case-by-case analysis of evidence to determine
whether a reasonable inference of guilt may be drawn from specific facts.”85 The August Court’s holding
essentially declared that the judiciary was no more qualified than the DEA to say what a “legitimate medical
purpose” is, but could say in particularly blatant cases what it is not by including a few condemned behaviors that
are so flagrant as to warrant concern. For example, ( 1 ) an inordinately large quantity of controlled substances
was prescribed;86 (2) large numbers of prescriptions were issued;8′ (3) no physical examination was given;88 (4)
the physician warned the patient to fill prescriptions at different drug stores;89 (5) the physician issued
prescriptions for a patient known to be delivering the dmgs to others;90 (6) the physician prescribed controlled
dmgs at intervals inconsistent with legitimate medical treatment;91 (7) the physician involved used street slang
rather than medical terminology for the dmgs prescribed;92 (8) there was no logical relationship between the
dmgs prescribed and treatment of the condition allegedly existing; and (9) the physician wrote more than one
prescription on occasions to spread them out.93
The Medicine Shoppe v, Loretta Lynch, et, aL
As noted above, The Medicine Shoppe Pharmacy is a small, familyowned, franchised pharmacy located in San
Antonio, Texas. In October 2011, the DEA executed an AIW in connection with its investigation of a local physician.
Neither the Pharmacist-In-Charge (“PIC”) nor the pharmacy itself had ever been the subject of a complaint.94
On October 7, 2013, two years after the AIW was executed, the DEA Deputy Administrator issued an OTSC to revoke
The Medicine Shoppe’s COR. The grounds for the OTSC were that the pharmacy, two years prior, filled
prescriptions written by the physician under investigation and that these prescriptions should not have been filled
because they presented unresolved red flags. According to the DEA, the prescriptions presented red flags because,
among other things, they were written for the “holy trinity dmg cocktail” of hydrocodone, Xanax and Soma (a
muscle relaxant), and were suspicious for that reason.95 The Medicine Shoppe responded that its pharmacists
had known the patients and the prescribing physician for many years.96 Moreover, the PIC explained that before
filling the prescriptions, the pharmacist contacted the prescribing physician’s office to verify the authenticity of the
order, the identity of the patient, the physician’s contact information and DEA number and the drug dosages. The
doctor confirmed this information.9′ Therefore, The Medicine Shoppe’s pharmacists maintained that they had
complied with their professional duty within the parameters of their education, training and the scope of their
professional licenses.98 Moreover, the pharmacists insisted that absent clear evidence of diversion, the pharmacy
was obligated to fill the order.99
On January 7, 2014, an OTSC hearing was held in San Antonio, Texas, before the DEA’s ALJ. Under her review of the
evidence presented by the parties, the ALJ recommended the revocation of The Medicine Shoppe’s COR, and “to
deny any pending applications for renewal or modification of such registration.”100 On October 2, 2014 DEA
Deputy Administrator Thomas Harrigan issued his Final Decision and Order, revoking The Medicine Shoppe’s DEA
COR on the basis that its continued registration would be “inconsistent with the public interest.”101 The Deputy
Administrator’s Order was premised upon his finding that The Medicine Shoppe’s pharmacists had failed to
exercise their “corresponding responsibility,” along with the physician, “to assure that its prescription for controlled
substances was issued for a legitimate medical purpose” and “in the practitioner’s usual course of professional
The Medicine Shoppe then filed a Petition for Review with the United States Court of Appeals for the District of
Columbia Circuit challenging this ruling on three principal grounds: 1) whether the manner in which the DEA
currently imposes on pharmacies a “corresponding responsibility with physicians” exceeds its authority under the
CSA; 2) whether the DEA requires pharmacists to act beyond the scope of their state-issued professional licenses
by requiring them to make judgments about the medical necessity of the controlled substances being prescribed
by practitioners; and 3) whether the “legitimate medical purpose” standard is inconsistently defined and applied by
the DEA, thus resulting in arbitrary enforcement actions.100
On December 16, 2015, the Appeals Court denied The Medicine Shoppe’s Petition for Review without comment or
memorandum, resulting in the current state of the law.
The DEA Exceeds Its Authority Under the CSA
The Medicine Shoppe unsuccessfully argued that the DEA exceeds its statutory authority under the CSA by
interpreting the “legitimate medical purpose” provision of the CSA to grant the United States Attorney General the
power to (1) impose medical standards of care for physicians; and (2) impose a “corresponding responsibility” on
pharmacists as well as the prescribing doctors. This interpretation continues to grant the DEA the same broad
authority allowed by the United States Supreme Court in Moore and Raich but rejected in Gonzales, which adhered
to a policy of “continuing to give deference to the opinions of the state licensing authorities.”104
The Medicine Shoope advocated that the states, through their legislatures, professional licensing boards, and
citizen initiatives, should continue to decide what uses of medications are for a legitimate medical purpose.105
Furthermore, The Medicine Shoppe attempted to persuade the Court of Appeals that it follow the Gonzales Court
and its progeny’s reluctance to grant the DEA the absolute authority to impose upon pharmacists civil or criminal
liability arising from a “corresponding responsibility with physicians that controlled substances are intended for a
legitimate medical purpose” unless there is direct evidence that the pharmacist had actual knowledge that the
prescribing physician was diverting drugs.106 That means that the pharmacist knew that the physician has
“knowingly or intentionally, dispensed or distributed by prescription, other than in good faith in the usual course of
a professional practice and in accordance with a standard of medical practice generally recognized and accepted
in the United States.”10′ The Court did not accept these arguments, arguably permitting the federal government to
make medical judgments concerning medical necessity beyond setting standards for regulating health and safety
combating drug abuse. This authority would presumably allow the Department of Justice to make determinations
concerning medical necessaity in other areas of law where “medical necessity” is the benchmark for eligibility of
benefits and also criminal prosecution.108
The DEA Requires Pharmacists to Act Beyond the Scope of Their State License
The Medicine Shoppe argued that the DEA regulation imposing a “corresponding responsibility” on pharmacists to
ensure that controlled substances are prescribed for a “legitimate medical purpose” requires they act beyond the
scope of their stateissued professional licenses and make judgments about the medical necessity of the
controlled substances being prescribed by practitioners. This corresponding responsibility requires pharmacists
and pharmacy owners to do more than just verify the authenticity of a prescription for controlled substances;109
they must now make judgments about the medical necessity of the controlled substances being prescribed by
Although The Medicine Shoppe contended that this standard requires pharmacists take affirmative action beyond
their education, training and professional license, the DEA maintained that its regulation requires no pharmacist to
exercise, overrule, or second-guess a physician’s medical judgment.111 Rather, it requires a reasonable
assessment, within the pharmacist’s competence, of whether the prescribing practitioner has exercised medical
judgment.112 The DEA further explained that “a pharmacist must exercise professional judgment when filling a
prescription issued by a physician” and may not reasonably claim that, when presented with a prescription that
raised suspicion, state law required its pharmacists to “close [their] eyes and thereby avoid positive knowledge of
the real purpose of the prescription” upon verifying that a physician issued it.”113 The Court of Appeals agreed
with the DEA.114
The DEA’s “Legitimate Medical Purpose” Standard is Vague and Arbitrary
The Medicine Shoppe also argued, unsuccessfully, that the “legitimate medical purpose” standard is vague and
arbitrary because its is not grounded upon any particular medical standard of care establishing what constitutes
proper prescribing, negligent prescribing and criminal dmg diversion under the CSA and DEA regulations.113
However, the DEA has refused to set such standards, stating its policy is that “the government can investigate
merely on suspicion that the law is being violated, or even just because it wants assurance that it is not.”116 The
DEA further asserted that “it would be incorrect to suggest that DEA must meet some arbitrary standard or
threshold evidentiary requirement to commence an investigation of a possible violation of the [CSA].”117
As a result, some stakeholders fear that the Court of Appeals decsion clears the way for the DEA to insert itself
into the sensitive equation of the physician-patient relationship, requiring federal law enforcement to make
medical and scientific interpretations that should be made by state regulatory authorities.118 This fear has
increased the risk of a chilling effect on prescribers and pharmacists to provide needed medicines.119 This
concern is especially true for the treatment of pain.120
Best Practices for Pharmacies
The CSA, when introduced over 40 years ago, was a much-needed attempt to stem the abuse of licit and illicit
drugs in American society. The numerous amendments to the CSA since then exemplify the difficulties in defining
and controlling such a vast and complex problem. The challenges faced in determining the diversion of
prescriptive controlled substances in such a way as not to negatively affect the practice of medicine and
treatment of pain especially proves to be no less difficult a task. A fresh perspective on the matter is needed to
provide better guidance. This change should be considered in light of the relatively long period that has passed
since this subject was last addressed by the courts, the vast improvements in technology and our increased
understanding of the effects drugs have on the human body. The Medicine Shoppe121 provides some guidance to
pharmacists and pharmacy owners in understanding their “corresponding responsibility to assure that [their]
prescriptions for controlled substances are issued for a legitimate medical purpose” and “in the practitioner’s usual
course of professional practice.”
Pharmacists need to remain vigilant in the war against dmg abuse and pill mills and decline to fill prescriptions for
controlled substance that are suspicious. Pharmacies and the pharmacists operating them are not immune from
administrative, regulatory? or criminal prosecution under the CSA solely because they have verified a prescription
with the prescribing doctor. Rather, they are expected to dispense drugs for the bona fide treatment of a patient’s
disease. In doing so, they must exercise sound professional judgment when evaluating the legitimacy of a
controlled substance prescription. Pharmacists must “resolve all red flags” before filling the prescription. The law
does not require pharmacists to dispense every medication, especially if the order is suspicious. To the contrary,
pharmacists who deliberately ignore red flags that give them a reason to believe the medication does not serve a
legitimate medical purpose may be prosecuted, along with the issuing practitioner, as a dmg trafficker. The price is
steep; drug trafficking is a felony offense, which may result in the loss of one’s COR, professional license or even
The author would like to acknowledge Marla Durben Hirsch, Esq. for her tireless commitment to editing this article
in preparation for publication.
1 The DEA sought revocation despite the fact neither the Pharmacist-In-Charge (“PIC”) nor the pharmacy itself had
ever been the subject of a prior complaint or investigation under 21 U.S.C. §812 (2012). In the Matter of die
Medicine Shoppe Federal Register / Vol. 79, No. 191 / Thursday, October 2, 2014 / Notices 59504 to 59517.
2 See The Medicine Shoppe v. Loretta Lynch, et al. 14-223 (2014) Pet. Br. at 4. On January 7, 2014, an OTSC
hearing was held in San Antonio, Texas, before the DEA’s ALJ. Pursuant to her review of the evidence presented by
the parties, the ALJ issued her Recommended Findings of Fact, Conclusions of Law and Decision of the
Administrative Law Judge to the DEA Deputy Administrator, Thomas M. Harrigan. The ALJ recommended the
revocation of The Medicine Shoppe’s COR under 21 U.S.C. §824(a), and “to deny any pending applications for
renewal or modification of such registration under 21 U.S.C. §823(f).” 79 Fed. Reg. 191 (Jan. 2,2014) pgs. 59504-
59517 – In the Matter of the Medicine Shoppe; Decision and Order (October 2, 2014).
3 See The Medicine Shoppe v. Loretta Lynch, et al. 14-223 (2014) Pet. Br. at 4.
4 Deputy Administrator Harrigan issued his final Decision and Order, Docket No. 14-01 revoking The Medicine
Shoppe’s DEA Certificate of Registration (“COR”) BT8599891 under 21 U.S.C. §§823(f), 824(a), on the basis that its
continued registration would be “inconsistent with the public interest,” 21 U.S.C. §59505.
5 5 U.S.C. §551 (2012) et seq.
6 Pet. Br. At 15-17, The Medicine Shoppe: Decision and Order | Insurance News Net,
http://insurancenewsnet.com/oarticle/ 2014/10/02/the-medicine-shoppe-decisionand-order (last accessed
August 19, 2015).
7 The Medicine Shoppe v, Loretta Lynch, et. al. 14-1223 (D.C. Cir. 2014). Pet. Br. 11-16.
8 U.S. Department of Justice Drug Enforcement Administration FY 2014 Performance Budget Congressional
9 Denisco, R. A. “A pharmacist who knowingly fills a prescription that is not intended for a legitimate medical
puipose, as well as the physician issuing it, shall be subject to the penalties provided for violations of the
provisions of law relating to controlled substances under the Federal Controlled Substances Act (“CSA”),” Chandler,
R. K., &Compton, W. M. (2008), Addressing the Intersecting Problems of Opioid Misuse and Chronic Pain
Treatment. Experimental and Clinical Psychopharmacology, 2 6(5), 417-428.
10 U.S. Department of Justice Drug Enforcement Administration FY 2016 Performance Budget Congressional
11 The DEA’s Diversion Control Program (“DCP”) is responsible for enforcing the CSA and its regulations pertaining
to pharmaceutical controlled substances and listed chemicals.
12 “Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in
Medicaid,” Centers for Medicare &. Medicaid Services (Baltimore, MD: January 2012), p. 1. “Drug diversion” is best
defined as the diversion of licit drugs for illicit purposes.
13 21 U.S.C. §801 et seq.
14 21 U.S.C. §802(6).
15 “‘file DEA was established in 1973 to serve as the primary agency responsible for the enforcement of federal
drug laws.” Controlled Substances Act, DEA Diversion Control Program Pharmacist’s Manual.
16 21 U.S.C. §801 et sap and 21 C.F.R. pt. 1300 (2014) et seq.
17 Controlled Substances Act, DEA Diversion Control Program Pharmacist’s Manual.
18 U.S, Department of Justice Drug Enforcement Administration FY 2015 Performance Budget Congressional
Submission, DE A-79. No prescriptions may be written for Schedule 1 substances, and they are not readily
available for clinical use. Schedule I drugs are those that have a high potential for abuse. The drug or other
substance has no currently accepted medical treatment use in the United States. There is also a lack of accepted
safety for use of the drug or substance under medical supervision. The Substances listed in DEA Schedule 1
LSD (Lysergic acid diethylamide)
Marijuana (cannabis, THC)
MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”)
GHB (gamma-hydroxybutyric acid)
Bath Salts (3,4-methylenedioxypyrovalerone or MDPV)
NOTE: Tetrahydrocannabinol (THC, marijuana) is still considered a Schedule I drug by the DEA, even though some
states have legalized marijuana for personal, recreational, or medical use.
19 The Drug Enforcement Administration’s Adjudication of Registrant Actions, Evaluation, and Inspections Report
1-2014-003. p. 2.
20 U.S. Department of Justice Drug Enforcement Administration FY 2016 Performance Budget Congressional
21 Ibid, at DEA – 93.
24 I bid.
25 According to the National Alliance for Mode 1 State Drug Laws (NAMSDL), a Prescription Drug Monitoring
Program (PDMP) is a statewide electronic database which collects designated data on substances dispensed in
the state. The PDMP is housed by a specified statewide regulatory, administrative or law enforcement agency. The
housing agency distributes data from the database to individuals who are authorized under state law to receive the
information for purposes of their profession.
26 Ibid, at DEA-12.
27 See United States v. Ilayayev, 800 E Supp. 2d 417, 2011 U.S. Dist. LEXIS 87012 (E.D.N.Y., 2011) (holding that red
flags are sufficient for the DEA to issue an OTSC).
28 “Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in
Medicaid,” Centers for Medicare &Medicaid Services (Baltimore, MD: January 2012), p. 1.
29 21 C.F.R. §1316.07, Requirement for administrative inspection warrant; exceptions.
30 See Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 Fed. Reg. at 62,340-41 (interpreting 21
C.F.R. §1306.04(a) limiting a pharmacists’ duty to determine the legitimacy of a prescription).
31 A Pharmacist’s Obligation: Corresponding Responsibility and Red Flags of Diversion By Larry Cote on August
11, 2013, posted in DEA Compliance.
32 21 C.F.R. §1306.04(a).
33 The Medicine Shoppe, 14-1223 Resp. Br. 10 (citing Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55
Fed. Reg. 4729, 4730 (1990) (interpreting pharmacists’ duty under 21 U.S.C. §§823,824).
34 Luban, David. Contrived Ignorance (1999), Vol. 87 Georgetown Law Journal, 957.
35 In other words, DEA regulations make pharmacists liable, with prescribing physicians, for both negligent and
criminal acts. The CSA is found in Trtle 21 of United States Code (21 U.S.C.) 801-971 and the DEA regulations, Title
21, C.F.R Parts 1300 to End 21 U.S.C. §812.
36 https://oig.justice.gov/reports/20 14/ el403-summary.pdf.
37 S. Rep. No. 98-225 at 260, 261-62, 1984 U.S.C. C.A.N. at 343-344) (granting authority to the Attorney General to
delegate regulatory authority to the DEA).
38 21 U.S.C. §§823 &824, https://www.oig. justice.gov/reports/2014/e 1403.pdf.
39 FY 2014 Annual Performance Report and FY 16 Annual Performance Report available at
40 ARTICLE: DRUG DIVERSION ADMINISTRATIVE REVOCATION AND APPLICATION HEARINGS FOR MEDICAL AND
PHARMACY PRACTITIONERS: A PRIMER FOR NAVIGATING MURKY, DRUG-INFESTED WATERS, 78 Alb. L. Rev. 327
41 DEA Regulation 21 C.F.R. §1307.37(c) states: “OTSC shall call upon registrant to appear before the
Administrator and contain a statement of the legal basis for such hearing and for the denial, revocation, or
suspension of the registration and a summary of the matters of fact and law asserted.”
42 21 U.S.C. §824.
43 SENATE STAFF ANALYSIS AND ECONOMIC IMPACT STATEMENT, available at
http://leg.state.fl.us/data/session/2001/ S ena te/bi lls/a na lysis/pdf/2001 s1042.
44 21 C.F.R. 1306.04(a).
46 A P/iarmacist’s Obligation: Corresponding Responsibility and Red Flags of Diversion by Larry Cote on August
11, 2013, posted in DEA Compliance.
47 Colin Miller, Death by Any Other Name: The Federal Government’s Inconsistent Treatment of Drugs Used in
Lethal Injections and Physician-Assisted Suicide, 17 J.L. &Health 217 (2002-2003).
48 See United States v. Moore, 423 U.S. 122, 139 ( 1975 ) (quoting jury instructions).
49 U.S. Const, amend. X. In United States constitutional law, police power is the capacity of the states to regulate
behavior and enforce order within their territory1 for the betterment of the health, safety, morals, and general
welfare of their inhabitants. Controversies over the exercise of police power arise when its exercise by the federal
government conflicts with the rights of the states, or when its exercise by federal or state authorities conflicts with
individual rights and freedoms. Willrich, Michael (2012). Pox. New York: Penguin, p. 302. ISBN 978-0-14-312078-0.
50 Dispensing Controlled Substances for the Treatment of Pain. FR Doc E6-14517 [Fed. Reg.: September 6, 2006
(Volume 71, Number 172)] [Notices] [Page 52715-52723].
52 Tex. Admin.Code (TAC) Title 22, Part 15 TSBP Rule §291.29(a).
53 Ibid.at §291.29(b)(2), Professional Responsibility of Pharmacists.
54 77 Fed. Reg. at 62,340-41.
55 21 U.S.C. 903 states: “No provision of this subchapter shall be construed as indicating an intent on the part of
Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any
State law on the same subject matter which would otherwise be within the authority of the State.”
56 21 C.F.R. 1306; DEA Policy Statement: Dispensing Controlled Substances for the Treatment of Pain; Notice
[Docket No. DEA286P] Fed. Reg. / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Notices at 52716-52717.
Mark P. Koch, D.O., 79 Fed. Reg. 18,714,18,719 (Apr. 3,2014).
57 United States v. Moore, 423 U.S. 122 (1975), 423 U.S. at 138-39.
58 Moore, 423 U.S. at 141 (citing H.R.Rep. No. 91-1444, p. 3).
60 Moore, 423 U.S. at 423.