The medicine shoppe v. Loretta lynch, et al.: Pharmacists and prescribing physicians are equally liable

After reading the article in the required reading: “The medicine shoppe v. Loretta lynch, et al.: Pharmacists and prescribing physicians are equally liable.” Discuss the following:

  1. Identify and discuss the duties and responsibilities of a pharmacist toward a patient.
  2. Based upon your research and assessment of the case, did the pharmacist perform the required duties and uphold patient rights?
  3. Is the pharmacy at fault? Why or why not?
  4. What is the impact of the pharmacist’s actions on the patient and community?
  5. What precautions can be taken to ensure these types of incidents by allied professionals don’t happen to others? Should there be more regulations in place?

Length: Submit a 3-page paper.

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

ABSTRACT

[…]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

prescriptions.3

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

Registrants.19

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

complexity.22

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

Decision.43

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

appears suspicious.64

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

Medical Marijuana

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

statutory language.71

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

Lethal Injection

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

Factual Background

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

practice.”1’09

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

practitioners.110

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

Conclusion

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

criminal prosecution.122

The author would like to acknowledge Marla Durben Hirsch, Esq. for her tireless commitment to editing this article

in preparation for publication.

Footnote

Endnotes

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

Submission DEA-18.

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

Submission, DEA-21.

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

include:

Heroin (diacetylmorphine)

LSD (Lysergic acid diethylamide)

Marijuana (cannabis, THC)

Mescaline (Peyote)

MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”)

GHB (gamma-hydroxybutyric acid)

Psilocybin

Methaqualone (Quaalude)

Khat (Cathinone)

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

Submission DEA-81.

21 Ibid, at DEA – 93.

22 Ibid.

23 Ibid.

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

http://www.justice.gov/sites/default/files/doj/ pages/attachments/20l5/02/06/fyl4.

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

(2014).

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).

45 Ibid.

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].

51 Ibid.

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).

59 Ibid.

60 Moore, 423 U.S. at 423.

61 Ibid

62 Ibid

63 Ibid.

64 Gonzales v. Raich (previously Ashcroft v, Raich), 545 U.S. 1 (2005). California voters passed Proposition 215 in

1996, legalizing the medical use of marijuana. Defendant A. age I Raich used homegrown medical marijuana,

which was legal under California law but illegal under federal law. Angel Raich’s physician had stated that, without

marijuana, Angel’s life is threatened by excruciating pain. Raich sued to enjoin enforcement of the CSA against him

claiming that doing so would violate the Commerce Clause, the Due Process Clause of the U.S. Const, amend. V,

the U.S. Const, amend. IX, the U.S. Const, amend. X, and the doctrine of medical necessity.

65 U.S. Const, amend. X.

66 Supra n. 18.

67 Gonzales v. Oregon, 546 U.S. 243 (2006), at 244.

68 21 U.S.C. §824(a) (4), 822(a)(2).

69 21 U.S.C. §823(f).

70 21 U.S.C. §903.

71 Id. at 244.

72 See Gregory v. Ashcroft, 501 U.S. 452, 461, (1991) (holding that states’ police powers grant them exclusive

authority to set licensing standards).

73 In 1994, the state of Oregon enacted by ballot measure the Oregon Death with Dignity Act, the country’s first law

authorizing physician-assisted suicide. Alexander DeLuca, M.D. Addiction, Pain, &Public Health. Affirmation of

States’ Authority to Define “Legitimate Medical Purpose” Citing David B. Brushwood. J.D; American Journal of

HealthSystems Pharmacy; 63(5); 2006, posted: 2006-03-18.

74 Moore, 423 at 138-39.

75 Stone S. The investigation and prosecution of professional practice cases under the Controlled Substances Act.

Drug Enforcement (newsletter). 1983, page 21.

76 See United States v. Collier, 478 F.2d 268, 27172 (5th Cir. 1973) (citing Doe v. Bolton, 410 U.S. 179, 93 S.Ct. 739,

747, 35 L.Ed.2d 201 (1973).

77 Linder v. United States, 68 U.S. (5) at 18, 45 S.Ct. (446) at 449, (69 L.Ed. 819 (1925)).

78 August, 984 F.2d at 713 (6th Cir. 1992).

79 Ibid.

80 21 C.F.R. §1308.13(c)(l)(iii), 21 U.S.C. §§829(b), 841(a)(1).

81 In 2006, the Supreme Court ruled in Hill v, McDonough, 437 F. 3d 1084 that death row inmates in the United

States could challenge the constitutionality of states’ lethal injection procedures through a federal civil rights

lawsuit. Since then, numerous death row inmates have brought such challenges in the lower courts, claiming that

lethal injection as currently practiced violates the ban on “cruel and unusual punishment” found in the Eighth

Amendment to the United States Constitution.” Memorandum of Intended Decision (Morales)” (PDF). Death

Penalty Clinic, UC Berkeley Schoolof Law. 2006-12-15,

82 Ibid.

83 United States v. Rosen, 582 F.2d 1032, 1033 (5th Cir. 1978).

84 Ibid.

85 United States v. August, 984 F.2d 705,713 (6th Cir. 1992).

86 United States v. Behrman, 258 U.S. 280, 42 S. Ct. 303,66 L. Ed. 619 (1922); United States v. Warren, 453 F.2d

738 (2d Cir. 1972), Cert, denied, 406 U.S. 944, 92 S.Ct. 2040, 32 L.Ed.2d 331 (1972); United States v. Brandenburg,

155 F.2d 110 (3d Cir. 1946).

87 United States v. Abdallah, 149 F 2d 219 (2d Cir. 1945), Cert, denied, 326 U.S. 724, 66 S.Ct. 29,90 L.Ed. 429

(1945).

88 Warren, 453 F.2d 738; White v. United States, 399 F.2d 813 (8th Cir. 1968); Brown v. United States, 250 F.2d 745

(5th Cir. 1958), cert, denied, 356 U.S. 938, 78 S.Ct. 779, 2 L.Ed.2d 812 (1958); Brandenburg, 155 F.2d 110.

89 Abdallah, 149 F.2d 219.

90 Warren, 453 F.2d 738.

91 Brandenburg, 155 F.2d 110.

92 United States v. Larson, 507 F.2d 385 (9th Cir. 1974).

93 United States v. Banee, 479 F.2d 484 (10th Cir. 1973); United States v. Larson, 507 F.2d 385. United States v.

Rosen, 582 F.2d 1032 (5th Cir. 1978).

94 In the Matter of The Medicine Shoppe Fed. Reg. / Vol. 79, No. 191 / Thursday, October 2, 2014 / Notices 59504

to 59517.

95 The DEA’s statistics reflect that the combination of these three drugs has the effect of heroin and is highly

addictive. From the Pharmacist’s Manual, USDOJ DEA. There were additional red flags, including missing

prescriber signatures, missing patient addresses and DEA numbers that were missing or incorrect.

96 See Pet. Br. at 4. The Medicine Shoppe v, Loretta Lynch, etal. 14-223 (2014).

97 Ibid.

98 See Pet. Br. at 4.

99 I bid.

100 See Recommended Findings of Fact, Conclusions of Law and Decision of the Administrative Law Judge to the

DEA Deputy Administrator, Thomas M. Harrigan. (citing 21 U.S.C. §824(a) &21 U.S.C. §823(f)). 79 Fed. Reg. 101

pgs. 59504-59517 – in the Matter of The Medicine Shoppe; Decision and Order (October 2,2014).

101 Id. at 59505.

102 Pharmacy Reporting Form and Memo on Changes to Policy, available at http://nmms. org/ news/ 2013 /pha

rmacy-reporti ng- form- a ndmemo-changes-policy-go.

103 http://ecfr.gov/cgi-bin/text-idx?node=se 39.1.95 2_11.

104 See Gregory v. Ashcroft, 501 U.S. 452, 461, (1991) (holding that states’ police powers grant them exclusive

authority to set licensing standards).

105 Supra note 73.

106 See The Medicine Shoppe v. Loretta Lynch, et al. 14-223 (2014) Pet. Br. at 4.

107 Moore, 423 at 138-39.

108 Medicare defines “medical necessity” as services or items reasonable and necessary for the diagnosis or

treatment of illness or injury or to improve the functioning of a malformed body member. If Medicare or other

payors determine that services were medically unnecessary after payment has already been made, they treat it as

an overpayment and demand that the money be refunded, with interest. Moreover, if a pattern of such claims can

be shown and the physician knows or should know’ that the services are not medically necessary, the physician

may face large monetary penalties, exclusion from the federal healthcare programs, and criminal prosecution.

Nancy W. Miller, Esq. “What is Medical Necsssity?” Physician’s News Digest. August 2002.

http://chiro.org/documentation/FULL/ What_is_Medical_N eeessity.html.

109 See Holiday CVS, L.L.C., djb/a CVS Pharmacy Nos, 219 and 5195, 77 Fed. Reg. 62,316, 62,340-41 (Oct. 12,

2012) (interpreting 21 C.F.R. §1306.04(a) limiting a pharmacist’s duty to determine the legitimacy of a

prescription).

110 Ibid.

111 The Medicine Shoppe, 14-1223 Resp. Br. 10.

112 Ibid.

113 The Medicine Shoppe, 14-1223 Resp. Br. 10 (citing Ralph J. Bertolino, d/b/a Ralph J. Bertolino Pharmacy, 55

Fed. Reg. 4729, 455 Fed. Reg. 4729,4730 (1990).

114 http://texas-defense-lawyer.com/Articles/ The-Medicine-Shoppe-v-DEA-14-1223-1.

115 Ibid.

116 United States v. Morton Salt Co., 338 U.S. 632, 642-643 (1950).

119 Ibid,

118 http://kevirnnd.com/blog/2012/04/futuremedicine-aspirirg-young-doctors.html.

119 Advanced Practice Nurses’ Use of Prescription Drug Monitoring Program Information, Steven D. LeMire, PhD;

Sarah G. Martner; Cheryl Rising, RN, Journal for Nurse Practitioners. 2012;8(5):383.

120 Ibid.

121 This concern is evident from the “specific issues and questions that have been raised on a recurring basis by

physicians [and pharmacists] who seek guidance on the subject of dispensing controlled substances for the

treatment of pain.” P/uxrmacj Reporting Form and Memo on Changes to Policy on Good Faith Dispensing of

Controlled Substances, New Mexico Medical Society, May 2013. http:// nmms.org/ news/ 2013.

122 See United States v. Pawan Kumar Jain, 2:14-cr-01261-RB, In the United States District Court, District of New

Mexico, Las Cruces Division.

AuthorAffiliation

Jeffrey C. Grass, JD, MS, ACLM

Jeffrey C. Grass &Associates

Plano, TX

AuthorAffiliation

Jeffrey C. Grass, JD, MS, FCLM, is former US Navy JAG. He was awarded Navy? Commendations and Naval

Achievement medals for meritorious service. He has represented physicians and pharmacists for more than 22

years. He maintains a national practice and has appeared before the U.S. Supreme Court, the U.S. Fifth Circuit

Court of Appeals and the U.S. Court of Appeals for the DC Circuit.

Mr. Grass is a Fellow of the American College of Legal Medicine and a Member of the State Bar College of Texas.

He also sits on the Advisory Board for The Champion Magazine, a monthly publication of the National Association

of Criminal Defense Lawyers. Mr. Grass is a member of the American Bar Association s Committees on Criminal

Justice and Healthcare. Jeffrey may be reached at (972) 422-9999, Fax: (972) 423-2646, or [email protected] DETAILS

Subject: Prescription drugs; Drug stores; Attorneys general; Physicians; Professional practice;

Pharmaceuticals; Substance abuse treatment; Medicine; Criminal liability;

Pharmacists; Regulation; Criminal investigations

Location: United States–US

Publication title: The Health Lawyer; Chicago

Volume: 28

Issue: 3

Pages: 28-37

Number of pages: 10

Publication year: 2016

Publication date: Feb 2016

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