DEA Toolkit - Washington Society of Addiction Medicine

DEA Toolkit

A Guidance for Health Professionals Dispensing or Prescribing Controlled Substances

Developed with a grant provided by Millennium Laboratories

INTRODUCTION

Guidance contained in this document is for informational purposes and shall not constitute legal advice. Nor shall any policies or practices be considered current should revisions or changes occur. Always check any information against multiple sources and consider this a starting point.

Compliance with regulatory obligations can be confusing and generate fear among physicians. In many cases, we don’t know what our obligations are. Administrative inspections by the DEA have gained much attention recently. This guidance document has been created for members of the Washington Chapter of the American Society of Addiction Medicine, with grant support from Millennium Laboratories.

This document is designed to assist physicians treating patients with Schedule II drugs, dispensing buprenorphine in their office either through witnessed inductions, or through the drug company sponsored patient assistance program. It is also of use for any provider providing maintenance treatment for Opioid dependence with buprenorphine or Methadone.

The document begins with an interview with regional DEA field officers. A former persecutor Ron Friedman, who now works as a defense attorney, has contributed an original article. Bellevue based psychiatrist Berry Edwards has also contributed an editorial. The remainder of the public domain documents was sourced from the DEA.

The contributors hope this guidance will assist you in gaining a greater understanding of what is otherwise a confusing area. Michael Schiesser MD President-Elect Washington Chapter American Society of Addiction Medicine Contents:

1. Interview with DEA Officials –Michael Schiesser MD 2. DEA Inspection Preparation and Sample Log 3. Increased Scrutiny of Pain Physicians-Ron Friedman 4. DEA Audits OBOT providers – H Berryman Edwards MD 5. Definitions Title 21 sec 802 6. Sample Criminal Cases A-C 7. DEA Practitioner Manual 8. Title 21 Recordkeeping 9. Title 21 Exceptions to recordkeeping 10. Title 21 Inspections 11. Title 21 Dispensing 12. Title 21 Maintenance Therapy 13. DEA 2008 annual report 14. Methadone and Buprenorphine 15. 2006 DEA report on Rx Drugs 16. Treatment of Pain in Opioid Dependent Patients-Federal Register 17. Title 21 Unlawful Distribution 18. Title 21 Changes in Opioid Dependence 19. Title 21 CII and Fraud 20. Title 21 Locum Docs 21. Title 21 Multiple Rx’s 22. Title 21 Schedule II drugs

The Following interview occurred on 2/16/10 by Michael Schiesser MD with Seattle DEA regional field agents: Q: Are DEA Agents required by law to perform “audits” unannounced? DEA: Unannounced visits are not law, but are DEA policy. The DEA feels that this is the best means of gaining a snapshot of what the physician is doing day to day in their practice. Q: When The DEA arrives, how do I know this is an administrative inspection, and not a criminal investigation? DEA: There are several ways. If you have not been engaging in illegal activity, then there is no probable cause to trigger a criminal investigation. But many doctors worry that if, for example, a staff member is using their prescription pad and producing fraudulent prescriptions, then maybe the DEA would confuse the situation even though they were innocent. If the DEA produces “Form 82”, then the reason for the visit is by definition an administrative inspection, not a criminal investigation. Q: What happens first when they arrive? DEA: The most current policy is to ask for the office manager, to minimize disruption to the MD, and provide the receptionist a card, but not flashing a badge. Agents are to conduct themselves in a low key manner and will not actively work to attract attention, other than the interaction with the receptionist. Q: What if the doctor is not in the office? DEA: They will seek to return at the earliest availability of the physician, however, they may also work with the office manager to inspect records and ask questions. Q: What is form 82? DEA: Form 82 gives the agents the consent of the doctor or their staff to conduct the inspection? Typically it is the first order of business with the physician or office manager. Q: Can the office manager sign form 82? DEA: Yes Q: If the office manager and the physician are not available, do they have to wait in the waiting room? DEA: No, they can come back later the same day, or wait in an area that is more private if this is preferable to staff.

Q: Does the DEA have a right to inspect a physician’s office who has no evidence of misconduct? DEA: Yes, under the Controlled Substances Act, for DEA registrants. Q: What happens if the staff or physician refuse to sign form 82? DEA: By Federal Law it is an automatic probable cause for a judge to issue a warrant for an administrative inspection. Q: What is the difference between an administrative inspection, and a criminal investigation? DEA: A criminal investigation occurs when there is compelling evidence a physician is diverting medication. A criminal investigation would not begin with form 82. Q: Is failure to comply with recordkeeping a crime? DEA: It is a civil offense, with fines, under 21.842. It can be cited as a criminal offense, but typically only enforced in the context of egregious behavior. Q: Are DEA agents required to read us our Miranda rights? DEA: In the usual course of an administrative inspection, no. However, if in the context of an administrative inspection, the registrant self-incriminates or confesses to a crime, and that individual was considered an immediate threat to public safety, then detainment and Miranda rights would be considered. This is never occurred with Buprenorphine administrative inspections. Q: Can the necessary medication logs, dispensing dates, etc be reviewed with ancillary staff, not the physician? DEA: Yes, this is currently the preferred means of conducting the audits to minimize time-loss for the physician. Q: Why do the DEA agents ask “chit-chat” with the doctor, are they sizing the doctor up to look for suspicious patterns? DEA: The DEA will ask questions of the physician to help inform the DEA and other agencies of trends in illegal drug use. e.g. “How many patients are heroin abusers vs. prescription opiates. Q: Is it ok to request to not discuss questions that don’t seem of direct material relevance to the administrative inspection? DEA: The doctor has the right to request to limit questions to what is directly relevant to his/her recordkeeping with respect to controlled substances.

Q: What options does a physician have, in dealing with an agent they feel is acting in a manner that is unprofessional? DEA: Contact regional DEA field agent director Ruth Carter at [email protected] or on her cell phone 206-553-1258 Q: Do agents have the right to review patient records DEA: Yes, it does not require a court order, although if it is necessary to review patient records, the DEA may request a court order to more thoroughly document the “need to know” prior to viewing patient records. Q: Is it ok to ask the DEA to wait to perform the audit until I am represented by counsel? DEA: It is the physician’s right to be represented by counsel, but by declining form 82, it is federal law to automatically issue a warrant for administrative inspection, where probable cause to issue the warrant is declining form 82. In the opinion of DEA field officers, this incurs expense and perhaps unnecessarily adds complexity to the inspection. Q: If the doctor has not consulted with a lawyer and has had an inspection, under what circumstance might the doctor might want to get a lawyer? DEA: If there was something uncovered in the inspection that raised the question of diversion. Q: Do Doctor’s get fined for one time offenses of poor record keeping in the absence of any obvious problems beyond that? DEA: Not typically, but the doctor needs to add office processes to correct the record keeping problems.

Keeping a Log Michael Schiesser MD

The DEA performed an administrative audit recently in the office where I designed many of the administrative procedures pertaining to tracking meds dispensed in office. The distinction of “prescriber” vs. “dispenser" is critical, as your obligations if you store meds in your office is greater than if you merely prescribe. When the DEA arrived, they asked that form 82 be signed. When the agents arrived, we had a three ring binder ready for the sake of organization and inspection. Sections included:

1. Reckitt Benckiser Client Assistant Program instructional materials for practices. 2. Dispensing Log (see that page), (printed from computer spreadsheet) 3. Patient applications for program 4. DEA Certificates with “X” registration 5. Written verifications from CSAT that you can treat 30 vs 100 patients. 6. Relevant DEA regulations. 7. *Periodic “counts” of patients performed at various intervals 8. *Office policies pertaining to these issues.

The audit included:

1. Review of the above materials 2. Inspection of supply of Buprenorphine, and the mode of security. 3. Reconciliation of dispensed records with supply. 4. Interview of office manager 5. Interview of prescriber

The inspection was brief and having the materials on hand was useful in reducing anxiety. *Our office policy is that a patient is considered under our care for the duration of the patient’s prescription, plus 15 days. For example, a patient prescribed 1 bid #14 is expected to return in one week. If the patient fails to return, our policy is designed to explicitly define the patient’s care term to be 15 days after their expected follow up date.

Increased Scrutiny of Medical Providersa Cause for Refl ection and Diligence

By Ronald J. Friedman February 22, 2010

1. Increased Scrutiny

Th ere can be little doubt that we are witnessing, on a nationwide basis, increased scrutiny of medical providers, especially those involved in pain management practices. Medical periodicals note this trend, and off er a variety of explanations for it. On one end of the spectrum are those who believe that going after doctors and medical facilities with increased fervor is simply the government’s way of funding our increasingly unaff ordable health care system. At the other end are practitioners who believe that the Drug Enforcement Administration (“DEA”) and state regulators are simply opposed to their professions and their reliance on the dispensing of highly addictive and powerful narcotics as a means of treating pain.

Rather than subscribe to either of these viewpoints, I believe the trend to be a result of several factors. Th ese factors include the increasing prevalence and availability of highly addictive controlled substances in our society and the widespread abuse of such substances. Th ose controlled substances most abused include oxycodone, hydrocodone, morphine, fentanyl and other newly-formulated synthetic opiates utilized to treat both long-term and short-term pain conditions. Other contributing factors to the increased scrutiny include the Medicaid and Medicare costs attributable to such patients, the costs of such addictive medications and the frequent lack of clarity in the profession as to what may constitute a proper dose. Th ere is debate over when it is appropriate to even prescribe such medications. For example, are such medications appropriate for the treatment of common or chronic headaches? Should such medications be dispensed by primary care physicians and dentists or only those especially trained in pain care treatment? Also contributing are simple statistics. Th e National Drug Intelligence Center notes in a 2009 National Prescription Drug Assessment that overdoses and deaths due to the use of prescription opioids have increased more than 100 percent in the last fi ve years. Th e estimated costs to public and private medical insurers attributable to such abuses exceeds $72 billion per year, much of which is passed on to consumers through higher insurance premiums. In addition, over the last ten years, while the population of the United States has increased at a rate of about 14 percent, the number of prescriptions for controlled substances has increased more than 500 percent in the general population. Sales of oxycodone products have also increased more than 500 percent during this same period. Studies refl ect that over 80 percent of those abusing prescription drugs began by obtaining those drugs pursuant to a written prescription.

Th e fact that there have been numerous instances where doctors themselves have been detected unlawfully diverting such substances and committing records violations regarding such substances has also contributed to this increased scrutiny. Further, genuine debate remains in medical and governmental circles as to the best way to treat opioid drug dependency through products such as buprenorphine and methadone or through some other form of enforced or volitional drug abstinence. Add to this such highly publicized cases as that of Dr. Conrad Murphy, recently charged in the State of California with criminal manslaughter for causing the death of pop star Michael Jackson through administering the powerful anesthetic propofol to Jackson as a sleep aid, and you have the makings of a wave of interest in the actions and prescribing practices of pain practitioners and primary care doctors who prescribe such

KNOW THE LANDSCAPE®

INCREASED SCRUTINY OF MEDICAL PROVIDERS A CAUSE FOR REFLECTION AND DILIGENCE By Ronald J. Friedman February 22, 2010

medications. Th is governmental interest can be expected to continue to rise as the federal government increasingly creates health care fraud task forces and utilizes anti-diversion resources designed to detect fraud, waste, abuse and criminal conduct by medical professionals.

All of this makes it an appropriate time for physicians engaged in pain practices and general practitioners engaged in dispensing such medications to pause, refl ect and take whatever steps are necessary to ensure that they are in compliance with law. It is noted that in January 2010, an otolaryngologist (Dr. Capener) who had been charged with 52 counts of health care fraud in federal court in California was acquitted of those charges, but he was denied his claim for attorneys fees and damages sustained in his occupation as a result of the government putting him through a costly federal trial.

Prior to entering the private practice of law, I served as a federal prosecutor with the United States Attorneys Offi ce in Seattle, presiding over several such prosecutions of physicians. All of these prosecutions, investigated by the DEA and other federal and state authorities, resulted in the conviction of the physician involved.

Regardless of the reason, or myriad of reasons, for increased scrutiny of medical providers dispensing pain medications, any such practitioner should pause to consider how physicians in this area have gotten into trouble. One also needs to understand the laws involved. Th rough such understanding, adequate legal counsel and adequate medical training specifi c to the pain management area, one can learn what needs to be learned and lessen the prospect that the DEA will ever come knocking at your offi ce door. And if they do, you will have the confi dence of knowing that the DEA will be pleased with the record-keeping procedures in place and fi nd you to be a physician in full compliance with the law.

2. Unlawful Diversion and Record Keeping

Title 21, United States Code, Section 843(a)(3), commonly known as the “unlawful diversion statute,” makes it a federal felony to knowingly and intentionally acquire, or aid and abet someone else in acquiring, a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge. Th is off ense is punishable by up to four years imprisonment and a $250,000 fi ne.

Within the last few years, this statute resulted in the felony conviction within the State of Washington of a Seattle psychiatrist who was splitting oxycodone prescriptions with his patients, a University of Washington surgery resident who was delivering blank scripts to friends so they could use such scripts to unlawfully acquire oxycodone, and a dentist and anesthesiologist who were unlawfully ordering into their respective clinics quantities of hydrocodone for their mutual use and writing scripts for each other to satisfy their addictions to the substance.

Th e federal “unlawful diversion statute” is violated virtually every time a medical professional diverts a controlled substance, whether for his or her own personal use or some other purpose. It includes taking controlled substances for which you do not have a lawful prescription from your practice, place of employment, or any other lawful supply. It includes writing prescriptions for medical reasons that are not legitimate or are based on inadequate medical examination, and fi lling prescriptions you know to be unlawful. It includes actions you knowingly take to help others improperly obtain drugs, such as providing illegitimate scripts to others or prescribing drugs with no reasonable medical purpose other than to satisfy the patient’s desire for the drug. Indeed, it includes a myriad of fact patterns, too many to recount, wherein controlled substances are purposefully removed from a lawful supply by a medical professional for anything other than legitimate reasons. Unfortunately, what is “legitimate” may remain a question for a jury to someday consider and may, indeed, be a battle of competing medical experts, as was the case with Dr. Capener.

Rather than being prosecuted for felony diversion, at times these cases are charged as simple unlawful possession cases, a federal misdemeanor. Within the last several months, a family practice physician in the Seattle area who was

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unlawfully diverting meperidine from his place of work for his own personal use and a Bellevue dermatologist who was writing himself prescriptions for oxycodone, in an alias name, were convicted of unlawful possession of a controlled substance, in violation of Title 21, United States Code, Section 844, the federal misdemeanor statute. Even though it was treated as a misdemeanor, the convictions had a very serious impact upon the doctors involved, including suspension and/or revocation of their DEA licenses, a signifi cant monetary fi ne and a period of probation.

During the summer of 2009, following a DEA investigation, a Seattle osteopath, was convicted of failing to maintain records of receipt and distribution of a controlled substance in violation of Title 21, United States Code, Sections 842(a)(5) and 842(c)(2)(A), a federal misdemeanor. Title 21, United States Code and implementing federal regulations require that all licensed medical practitioners maintain records of all controlled substances received and dispensed by them in their practices. Examining such records for accuracy is one of the fi rst tasks DEA Agents and Investigators will perform when they visit and audit your practice to see whether you are in conformity with law. Failure to maintain proper records may be charged as a misdemeanor, as above, or as a felony pursuant to Title 21, United States Code, Section 843(a)(4)(A). Section 843(a)(4)(A) makes it a felony off ense to knowingly and intentionally furnish false material information or omit material information from a report or record required to be kept under law relating to the dispensing of controlled substances. Every time such a record is falsifi ed or material information is omitted, this statute is violated. Th is off ense is punishable by up to four years imprisonment, a $250,000 fi ne, and a one year period of supervised release. Th e DEA insists upon examining such records and is legally authorized to examine them to ensure full accountability as to the dispensing of controlled substances. Th is right to examine by the DEA is a right you acknowledge in receiving the lawful privilege of a DEA license to dispense such substances. In examining the records of the Seattle osteopath, the DEA found signifi cant discrepancies between what controlled substances were being received and what was being lawfully dispensed. Th e doctor was sentenced to one year probation, 100 hours of community service and fi ned $10,000.

3. Lessons Learned and Emergent Trends

Controlled substances are subject to federal regulation, and the possession and distribution of such drugs are governed by federal law. Federal record-keeping requirements are imposed upon all who are authorized to dispense controlled substances (Title 21, United States Code, Section 827(a)(3)). Th ese requirements impose a legal duty upon drug dispensers to maintain accurate and up-to-date records of all distributions of controlled substances. Th ese records are subject to audit and administrative inspection by the DEA (Title 21, United States Code, Section 880). Th ese record-keeping requirements provide the DEA with an independent means to monitor drug distributions and to detect

controlled substances being unlawfully diverted. In addition, Title 21, Code of Federal Regulations contains detailed requirements as to the records that need to be maintained by physicians and relating to the appropriate dispensing and prescribing practices of physicians. Th ese regulations, however detailed, need to be understood and followed in order to avoid engaging in conduct that may be construed as a violation of law.

In addition, pain practitioners should be mindful of the general legal standard as to what constitutes a lawful prescription and drug distribution. Under current federal law, in order for the distribution of a controlled substance by a medical practitioner, either by prescription or in the offi ce, to be lawful, it must be authorized “for a legitimate medical purpose” by a practitioner “acting in the usual course” of his or

her “professional practice” (21 Code of Federal Regulations, Section 1306.04.). Th is applies to the dispensing of drugs by a medical practitioner in his or her offi ce, in a hospital setting, as well as to the writing and calling-in of prescriptions or having someone else do so at your direction. If you are the authorizing medical practitioner, you are responsible for that distribution, and you will be held accountable for meeting the legal standard that such distribution was made “for a legitimate medical purpose” by a practitioner “acting in the usual course” of his or her “professional practice.” If a medical professional’s distribution of drugs does not meet this legal standard, then the distribution may

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well be regarded as unlawful. Title 21, United States Code, Section 841(a)(l) provides that anyone who knowingly, intentionally and unlawfully distributes, aids and abets, or causes the distribution of a controlled substance is guilty of a felony. Th e penalty for this off ense includes a period of imprisonment of up to 20 years, a $1 million fi ne and a period of supervised release to follow imprisonment of up to three years.

Recent cases report multiple instances where federal agents or private individuals hired by the agents have posed as patients and entered the doctor’s offi ce equipped with a hidden listening device in order to record the actions of medical practitioners. Th ey also include instances where existing patients have elected to cooperate with law enforcement and recorded their interactions with a treating physician. Th ese investigative practices are wholly lawful and, however invasive they may seem, are often relied upon by law enforcement in its quest to gain admissible evidence of a crime.

I am reviewing the law and reported convictions not to frighten, but to educate. It is extremely important that physicians remain abreast of the law and legal developments relating to their practice area. Reported events occur everyday relating to health care professionals being prosecuted for health care fraud, for procedures not being performed or for improper coding and billing practices. In addition, there has been rigorous enforcement of anti-kickback statutes in the medical provider area, and close examination of the fi nancial relationships between doctors, hospitals, drug companies and medical suppliers. Physicians and medical facilities are also experiencing increased regulation and legal exposure in regard to disclosure of patient health information, where reckless or improper disclosure of such information, or security breaches regarding that information, can lead to hefty civil and criminal penalties under the federal HIPAA and HITECH Acts and recent implementing federal regulations.

We live in an era where drug samples are frowned upon and accepting any benefi t from a drug company in return for recommending or prescribing its drugs is deemed a violation of law, where too many prescriptions of one drug or another can lead to a federal criminal investigation, and where statements made by an addicted patient to authorities as to the relative ease of acquiring pain medications from a physician can lead to a broad and time-consuming criminal investigation of one’s practice.

4. Ten Recommendations

Given the prevailing winds, one is well advised to act diligently and with care. In this regard, the following ten recommendations are made:

a. As a practitioner, it is always wise to assume (however odd this may seem) that all of your interactions with your patients are being recorded and that someday these recordings will be made available to legal authorities for their review. Never say anything to a patient or perform any actions on behalf of a patient that you would not feel comfortable being reviewed by your peers. Never write a prescription for a patient or advocate a course of treatment for a patient that you would not feel comfortable being reviewed by your peers.

b. Be familiar with the standard of care and prescriptive practices of trained physicians in your area and fi eld of practice. If you need additional Continuing Medical Education so that you can render better and more informed judgments, then acquire that education.

c. Read and make sure that you are fully familiar with the federal regulations set forth in Title 21, United States Code, and that all appropriate and required records are kept. Failure to do so may constitute a violation of law and have dire consequences to your ability to practice. Consult with trained legal counsel, the DEA or other medical professionals if you have questions concerning the applicability or meaning of such regulations. Consider having an independent professional review your records and procedures annually to ensure and maintain proper record compliance.

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d. Make especially sure that you adequately document all of your patient interactions and reasons for acting, especially where you are prescribing controlled substances to patients over a period of time. All of your actions must be medically and legally defensible and within the standard of care. Detailed records will go a long way to justifying your decisions, especially when they are being questioned many months after the fact. As previously explained, all drugs dispensed must be dispensed “for a legitimate medical purpose” by a practitioner “acting in the usual course” of his or her “professional practice.”

e. Only dispense medications to those with whom you have a truly constituted doctor-patient relationship and as part of a legitimate course of treatment. Always perform an adequate physical examination and use appropriate diagnostic tests and procedures prior to prescribing a controlled substance. Sometimes it will be necessary to turn down a patient’s request for narcotics. Sometimes it will be appropriate to refer the patient to an addiction specialist who can wean the patient from certain addictive drugs.

f. If you have your patients sign an agreement not to dispense their drugs, and you become aware of conduct indicating that such distribution or diverting is taking place, you should end your relationship with the patient. Indeed, any violation of a physician-patient contract suggesting unlawful conduct by the patient must be taken seriously. Not enforcing such written patient agreements is wrought with peril.

g. If you maintain supplies of narcotics at your practice, keep them under appropriate lock and key and in conformity with DEA regulations requiring licensed practitioners to follow anti-diversion measures and have an anti-diversion compliance program in eff ect. Your failure to do so can result in civil fi nes and loss of one’s DEA registration. Consider having an independent professional review your practice and assist you in having a written anti-diversion protocol suffi cient to withstand regulatory scrutiny.

h. You are also well-advised to consider whether you have compliance procedures in place at your practice which meet the standards set forth in HIPAA, HITECH, and implementing federal regulations regarding the proper disclosure of patient health information, and safeguards you have implemented to avoid improper or reckless disclosure. Further, there are specifi c legal requirements that must be followed in the event of even innocent and unintentional security breaches and disclosures.

i. If, within your practice, you develop your own substance abuse issues, it is highly recommended that you seek immediate treatment for chemical dependency as well as legal counsel to protect your interests. Chemical dependency by physicians results from a variety of factors, including stress and unique access and ability to obtain such products. Th at doctors face an increased risk of addiction due to such factors should be a surprise to no one. One should regard such chemical dependency as a hazard of the job that can happen to anyone and not as a basis for self-imposed embarrassment, career destruction or denial. Many states, including Washington, have excellent treatment programs (Washington Physicians Health Program) designed specifi cally for impaired medical professionals. Such treatment programs protect the confi dences of the physician and are an invaluable resource to the impaired medical practitioner enabling that professional to recover and maintain their license and medical practice. Feeding that addiction through criminal means by diverting drugs to which you have preferred access as a physician is a huge mistake.

j. If you become aware that you are the target of a criminal or regulatory investigation or wish to consult with counsel prior to entering any discussions with regulatory authorities, please remember that it is your right to do so and that any statements you do make to authorities, unless formally protected, may be used against you. Even though the DEA may have the right to audit your practice or obtain an administrative inspection warrant, you always maintain the right to be silent, the right to have counsel present to interact with regulatory authorities on your behalf and the right to have counsel present for any audit or inspection. While the aim is not to antagonize those seeking legitimate regulation, the aim is to ensure fairness and that your rights and your patients’ rights are respected.

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5. Conclusion

Medical professionals, especially those involved in pain management, face a great many challenges in their practice. While the law should not be allowed to have a “chilling eff ect” on the doctor-patient relationship, such as to deprive patients of needed medications or make doctors afraid to act due to fear of being second-guessed and prosecuted or civilly fi ned, the diligent physician needs to be armed with an adequate understanding of the law and regulations in this area. Th e challenge, of course, is to continue to practice good medicine and to help those in need, notwithstanding what may be an increased governmental presence in this area. Th at is each doctor’s noble privilege and responsibility. It is earnestly hoped that this article may assist each physician in having a greater understanding and success in the fulfi llment of that noble and necessary mission.

Ronald J. Friedman is a shareholder at Lane Powell, a Pacifi c Northwest law fi rm. He focuses his practice on health care issues, including investigations of health care providers and business entities, and criminal defense. Prior to joining Lane Powell, he served as an Assistant United States Attorney in the Western District of..Washington and handled numerous investigations of health care professionals and pharmaceutical suppliers. Ron is a graduate of Harvard Law School. He can be reached at [email protected] or 206.223.7032.

Note: Th e statements expressed in this article are personal statements by the author, not intended to be legally binding or incur legal reliance, or constitute a lawyer-client relationship with any reader.

Copyright © 2010 Lane Powell PC

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DEA Audits: An Editorial H B Edwards, MD

Consider:

• All physicians who obtained special DEA numbers for prescribing buprenorphine for addiction and withdrawal under DATA 2000 agreed to allow audit of their records. Any physician who wishes to avoid the audit may do so by surrendering his special DEA number and desisting from prescribing buprenorphine. We should all strive to keep adequate records in compliance with the law.

• Physicians may have experience with administrative audits from JCAHO or

similar organizations. Physicians often do not have sufficient knowledge of their rights to assert themselves when audited by law enforcement agents.

• DEA agents are law enforcement officers trained to investigate crimes and arrest

criminal suspects. They may or may not be accustomed to conducting audits of physician offices possessed of no evidence of wrong doing. The are reports of poor judgment in at least one case; by speaking to one another in another language in front of patients. Physicians report feeling intimidated by threat of obtaining administrative order or search warrant. They may have exceeded their authority by interrogating a physician in domains not related to the buprenorphine record audit.

• DEA can avoid disruption of physician practices by allowing physicians to

schedule audits. Since physicians already know to expect the audits, by refusing to schedule them DEA obtains no benefit of surprise. However, it effectively prevents physicians from having an attorney present during the audit and puts physicians in the position of having to decide whether to delay patient contact because of a threat of unknown consequences in the form of an administrative order or search warrant. This policy also wastes agents’ time and taxpayer money.

What I want from my professional associations:

• ASAM, AAAP, and APA should demand that DEA allow physicians to schedule their audits, and attempt to enlist ONDCPA, and CSAT in pressuring DEA to do so as well as warning these agencies of the chilling effect these audits will have on provision of this treatment.

• ASAM, AAAP, and APA should make it clear to DEA that misconduct on the

part of agents, particularly if it interferes with patient care, will be aggressively pursued or prosecuted and offer to assist DEA with training agents in how to conduct themselves in a physician’s office.

• ASAM, AAAP, and APA should assist members of their respective organizations

as follows:

DEA Audits: An Editorial H B Edwards, MD

• Inform members that audits are conducted, not by administrative personnel, but by law enforcement agents who are reported to have demonstrated a lack of respect for physician, patient, and the operation of the physician practice.

• Obtain legal opinion to educate members how best to respond to questioning not

related directly to buprenorphine prescribing or dispensing and how to best respond to perceived misconduct on the part of agents.

• Obtain legal opinion to educate members as to what will likely happen if a

physician refuses to sign Form 82.

• Advise all members to inform all their patients that audits are imminent and what to expect.

• Advise members how to file complaints for misconduct on the part of DEA

agents.

• Candidly advise members of the disruption and risks attendant to providing OBOT and associated with audits.

Strategies for forcing DEA to schedule audits and for minimizing risk to physicians:

• Consider advising all members to send certified letters, return receipt requested, to their local DEA field office requesting that their audit be scheduled and advising DEA what to expect when they arrive at their office and how the physician will expect the agents to conduct themselves. It is important understand that agents are in the physician’s office only with permission of the physician, and that if their conduct is unacceptable physicians may ask them to leave. If they do not leave, they may be charged with criminal trespass. (This should likely be confirmed with an attorney, and of course ejection of the agents might lead to administrative order or search warrant which might or might not be preferable.)

Additional resources: www.behavenet.com. http://bup-webboard.samhsa.gov

Sec. 802. Definitions

-STATUTE-

As used in this subchapter: (1) The term ''addict'' means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.

(2) The term ''administer'' refers to the direct application of a controlled substance to the body of a patient or research subject by -

(A) a practitioner (or, in his presence, by his authorized agent), or

(B) the patient or research subject at the direction and in the presence of the practitioner, whether such application be by injection, inhalation, ingestion, or any other means.

(3) The term ''agent'' means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.

(4) The term ''Drug Enforcement Administration'' means the Drug Enforcement Administration in the Department of Justice.

(5) The term ''control'' means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.

(6) The term ''controlled substance'' means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

(7) The term ''counterfeit substance'' means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.

(8) The terms ''deliver'' or ''delivery'' mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.

(9) The term ''depressant or stimulant substance'' means -

(A) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or

(B) a drug which contains any quantity of (i) amphetamine or any of its optical isomers; (ii) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or

(C) lysergic acid diethylamide; or

(D) any drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.

(10) The term ''dispense'' means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term ''dispenser'' means a practitioner who so delivers a controlled substance to an ultimate user or research subject.

(11) The term ''distribute'' means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term ''distributor'' means a person who so delivers a controlled substance or a listed chemical.

Page 1 of 3DEA, Title 21, Section 802

2/25/2010http://www.justice.gov/dea/pubs/csa/802.htm

(12) The term ''drug'' has the meaning given that term by section 321(g)(1) of this title.

(13) The term ''felony'' means any Federal or State offense classified by applicable Federal or State law as a felony.

(14) The term ''isomer'' means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term ''isomer'' means any optical, positional, or geometric isomer. As used in schedule II(a)(4), the term ''isomer'' means any optical or geometric isomer.

(15) The term ''manufacture'' means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term ''manufacturer'' means a person who manufactures a drug or other substance.

(16) The term ''marihuana'' means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

(17) The term ''narcotic drug'' means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.

(B) Poppy straw and concentrate of poppy straw.

(C) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.

(D) Cocaine, its salts, optical and geometric isomers, and salts of isomers.

(E) Ecgonine, its derivatives, their salts, isomers, and salts of isomers.

(F) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).

(18) The term ''opiate'' means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

(19) The term ''opium poppy'' means the plant of the species Papaver somniferum L., except the seed thereof.

(20) The term ''poppy straw'' means all parts, except the seeds, of the opium poppy, after mowing.

(21) The term ''practitioner'' means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

(22) The term ''production'' includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.

(23) The term ''immediate precursor'' means a substance -

(A) which the Attorney General has found to be and by regulation designated as being the principal



compound used, or produced primarily for use, in the manufacture of a controlled substance;

(B) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and

(C) the control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance.

(24) The term ''Secretary'', unless the context otherwise indicates, means the Secretary of Health and Human Services.

(25) The term ''serious bodily injury'' means bodily injury which involves -

(A) a substantial risk of death;

(B) protracted and obvious disfigurement; or

(C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty.

(26) The term ''State'' means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.

(27) The term ''ultimate user'' means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.

(28) The term ''United States'', when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States.

(29) The term ''maintenance treatment'' means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.

(30) The term ''detoxification treatment'' means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.



Cases Against Doctors

This is a listing of investigations of physician registrants in which DEA was involved that resulted in the arrest and prosecution of the registrant.

Last Updated: January 14, 2010

Name: ABBEY, Julian A., MD

City, State: Saugus, MA

Date of Arrest: 10/28/2005

Date of Conviction: 04/30/2008

Judicial Status: Pled Guilty

Conviction: Possession with intent to distribute

DEA Registration: Revoked 03/09/2007

Remarks:

Julian A. Abbey, MD, age 47, of Saugus, MA, pled guilty to possession with intent to distribute controlled substances.

Abbey was sentenced to five years probation.

x

Name: ADAMS, Lawrence, MD

City, State: Phillipsburg, PA



Judicial Status: Jury Conviction

Conviction: Prescribing outside accepted medical treatment principles; Criminal conspiracy to obtain possession of a controlled substance by misrepresentation or fraud; Dispensing/prescribing to a drug dependent person; Refusal or failure to keep required records; Willful dispensing of a controlled substance without proper labeling; Delivery of or possession with the intent to deliver a controlled substance; Criminal use of communication facility; and Criminal conspiracy to commit delivery of or possession with the intent to deliver a controlled substance

DEA Registration: Retired 07/09/2009

Remarks:

Lawrence Adams, MD, age 48, of Phillipsburg, PA, was found guilty in the Court of Common Pleas of Center County, Pennsylvania of 11 counts Prescribing Outside Accepted Medical Treatment Principles; four counts Criminal Conspiracy to Obtain Possession of a Controlled Substance by Misrepresentation or Fraud; 10 counts Dispensing/Prescribing to a Drug Dependent Person; four counts Refusal or Failure to Keep Required Records, three counts Willful Dispensing of a Controlled Substance without Proper Labeling; six counts Delivery of or Possession with the Intent to Deliver a Controlled Substance; one count Criminal Use of Communication Facility; and one count Criminal Conspiracy to Commit Delivery of or Possession with the Intent to Deliver a Controlled Substance.

According to court documents, Adams continually prescribed controlled substances to drug dependent individuals.

Adams was sentenced to seven to 14 years incarceration, with a credit of 59 days time served, followed by 20 years probation. In addition, Adams was ordered to pay a $30,000 fine.

x

Name: AHLES, Peter, MD

City, State: Anaheim, CA




Conviction: Dispensing a controlled substance outside the scope of professional practice


Remarks:

Peter Ahles, MD, age 67, of Anaheim, CA, pled guilty in United States District Court to one count of dispensing hydrocodone, a controlled substance,outside the scope of professional practice with no legitimate medical purpose. According to court documents, Ahles dispensed 500 units of hydrocodone to confidential informants in exchange for $500.

Ahles was placed on home detention for a period of six months and sentenced to three years probation.

Name: ALEXANDER, Bruce, MD

City, State: Frisco, TX




Conviction: Conspiracy to possess morphine, a schedule ii controlled substance, with intent to distribute

DEA Registration: Surrender 2/22/2006

Remarks:

Bruce Alexander, MD, age 40, of Frisco, TX, pled guilty to conspiracy to possess morphine, a Schedule II controlled substance, with intent to distribute.

According to the court documents, Alexander knowingly conspired with others to possess with the intent to distribute morphine, a Schedule II controlled substance. Alexander mailed numerous packages containing various controlled substances (including morphine, alprazolam, and hydrocodone) to an accomplice in Indiana.

Alexander was sentenced to 6 months home confinement and 3 years probation. He was also fined $2,000.00.

Name: ALEXANDERIAN, Harry, MD

City, State: West Pittston, PA




Conviction: Dispensing controlled substances with no legitimate medical purpose

DEA Registration: Surrendered 3/30/2004

Remarks:

Harry Alexanderian, MD, age 80, of West Pittston, PA, pled guilty in state court to dispensing controlled substances outside of the scope of professional practice with no legitimate medical purpose. He also pled guilty to Medicaid fraud and unlicensed treatment of drug addiction.

Alexanderian was sentenced to six months house arrest to be followed by two years probation.

Name: ALLARA, Robert, MD

City, State: Charleston, WV




Conviction: Obtaining a controlled substance by fraud


Remarks:

Robert Allara, MD, age 52, of Charleston, WV, pled guilty in U.S. District Court, Southern District of West Virginia, to Obtaining a Controlled Substance by Fraud.

According to court documents, Allara knowingly and intentionally aided and abetted another person in acquiring and obtaining possession of a quantity of hydrocodone by deception.

Allara was sentenced to 5 months incarceration followed by 1 year supervised release (five months of the supervised release will be completed on home confinement) and ordered to pay a fine of $10,000.

Name: ARMASHI, A. Hussam, MD

City, State: Spring Hill, FL


Date of Conviction:

Judicial Status: Outstanding arrest warrant for sexual battery on person incapacitated; battery

Conviction:


Remarks:

Hussam Armashi, MD, age 60, was charged with intentionally administering a narcotic, anesthetic, or intoxicating substance to a female patient who was under his care that resulted in the patient’s mental or physical incapacitation, and then attempting to engage the patient in sexual activity without her consent and causing her injury.

There continues to be an active, outstanding arrest warrant for Armashi in Hernando County, FL. Anyone who has information pertaining to Dr. Armashi’s whereabouts is encouraged to contact the nearest Drug Enforcement Administration office or the Hernando County (Florida) Police Department.

Name: ASTIN, Phil III, MD

City, State: Carrollton, GA




Conviction: Unlawful drug distribution


Remarks:

Phil Astin III, MD, age 54, of Carrollton, GA, pled guilty in U.S. District Court for the Northern District of Georgia to 175 counts of illegal distribution of controlled substances.

According to the indictment, Astin distributed and dispensed a quantity of controlled substances for other than a legitimate medical purpose and not in the usual course of professional practice. The controlled substances included Schedule II pharmaceuticals Percocet and Adderall; Schedule III pharmaceuticals Vicoprofen and Lorcet; and the Schedule IV pharmaceutical Xanax. In the plea agreement, Astin admitted that he knowingly violated federal law by illegally writing prescriptions for 19 patients.

Astin was sentenced to 10 years imprisonment, followed by 3 years supervised release and 250 hours community service. He was ordered to pay a special assessment of $17,500.

Name: AUZINE, Donald, MD

City, State: Prairieville, LA




Conviction: Unlawful distribution of adderall, oxycodone, hydrocodone and benzphetamine


Remarks:

Donald Auzine, MD, age 38, of Prairieville, LA, pled guilty in U.S. District Court, Middle District of Louisiana, to one count unlawful distribution of adderall, oxycodone, hydrocodone and benzphetamine

According to court documents, Auzine prescribed and dispensed controlled substances without a legitimate medical purpose and not in the usual course of medical practice.

Auzine was sentenced to 37 months incarceration, followed by three years probation. He was also ordered to pay a fine of $10,000.00.

Name: BAJWA, Jatinder, MD

City, State: Springdale, PA




Conviction: Obtaining a Schedule II controlled substance by fraud; Insurance fraud


Remarks:

Jatinder Bajwa, MD, age 57, of Springdale, PA, pled guilty in state court to obtaining OxyContin, a Schedule II controlled substance, by fraud and insurance fraud.

Bajwa was sentenced to two years probation and ordered to pay restitution to insurance providers in the amount of $6,502.02.

Name: BAMDAD, Masoud, MD

City, State: San Fernando, CA




Conviction: Distribution and dispensing of a controlled substance; Distribution and dispensing of a controlled substance to persons under twenty-one years of age


Remarks:

Masoud Bamdad, MD, age 55, of San Fernando, CA, was found guilty by a federal jury in the Central District of California on ten counts of distribution and dispensing of a controlled substance; and three counts distribution and dispensing of a controlled substance to persons under twenty-one years of age.

According to court documents, Bamdad, while acting and intending to act outside the usual course of professional practice and without legitimate medical purpose, knowingly and intentionally distributed and dispensed a number of pills containing a detectable amount of Oxycodone, a Schedule II controlled substance to several patients, some of whom were under twenty-one years of age.

Bamdad is currently awaiting sentencing.

Name: BARANWAL, Akhil, MD

City, State: Douglas, GA




Conviction: Distribution of controlled substances


Remarks:

Akhil Baranwal, MD, age 35, of Douglas, GA, was found guilty by a federal jury in the Middle District of Florida (Orlando Division) on two counts of distribution of Schedule IV controlled substances and one count of distribution of Schedule III controlled substances.

According to court documents, Baranwal knowingly and intentionally distributed and dispensed Adipex-P and phentermine, Schedule IV controlled substances, and Phendimetrazine, a Schedule III controlled substance, other than for a legitimate medical purpose and not in the usual course of professional practice.

As a doctor recruited by Jive Network, an organization that used the Internet to unlawfully distribute and dispense prescription drugs to customers, Baranwal reviewed health questionnaire answers provided by customers over the Internet or telephone and approved customer orders for controlled pharmaceuticals solely on the basis of those answers.

Baranwal was sentenced to 27 months in federal prison followed by 3 years supervised release and ordered to pay a special assessment of $300 and a fine of $25,000.

Name: BARNETT, Randy, MD

City, State: Philadelphia, PA

Date of Arrest: 01/12/2005 (formal arrest processing delayed until sentencing date)



Conviction: Illegal sale of prescription drug samples

DEA Registration: Active

Remarks:

Randy Barnett, MD, age 42, of Philadelphia, PA, pled guilty to one count of illegal sale of prescription drug samples.

According to court records, Barnett delivered thousands of non-controlled prescription drug samples to a pharmacist who, in turn, placed the drug samples into inventory and sold them to patients. The patient’s insurers reimbursed the pharmacist for the drug samples. Barnett was paid approximately $10,000 by the pharmacist for the drug samples.

Barnett was sentenced to in federal court in the Eastern District of Pennsylvania to 24 months probation and ordered to pay a $10,000 fine.

Name: BARON, David M., MD

City, State: Pueblo, CO




Conviction: Conspiracy to distribute pharmaceutical controlled substances


Remarks:

David M. Baron, MD, age 61, of Pueblo, CO, pled guilty in U.S. District Court, Southern District of Florida, to conspiracy to distribute pharmaceutical controlled substances.

According to court documents, Baron was involved with the illegal distribution of Schedule III and Schedule IV controlled pharmaceuticals via the Internet. Baron was paid to review online customer questionnaires and authorize the filling of customer orders for controlled substances. There was no contact between the physician and the customer and therefore no established physician/patient relationship which is required for a valid prescription.

Baron was sentenced to 25 months in federal prison followed by supervised release for a term of three (3) years, and ordered to pay an assessment of $100. An appeal has been filed and further judicial action is pending.

Name: BARRERA, Carlos Manuel, MD

City, State: Miami, FL




Conviction: Conspiracy to distribute controlled substances; Conspiracy to launder money


Remarks:

Carlos M. Barrera, MD, age 57, of Miami, FL, pled guilty in federal court to one count of conspiracy to distribute Schedule III and Schedule IV controlled substances, and one count of conspiracy to launder money.

According to court documents, between August and October of 2003 in the Northern District of Iowa, Barrera unlawfully dispensed thousands of dosage units of controlled substances by means of electronic prescriptions outside the usual course of medical practice and without legitimate medical purpose.

Barrera was sentenced to probation for a term of three (3) years with the first six months in home detention and ordered to pay a fine of $10,000 and a special assessment of $200.00. Barrera also forfeited $10,897.50.

Name: BASS, Harriston, MD

City, State: Las Vegas, NV



Judicial Status: Convicted

Conviction:Murder in the second degree; Sale of Schedule II controlled substances; and Unlawful possession with intent to sell Schedule II controlled substances


Remarks:

Harriston Bass, MD, age 54, of Las Vegas, NV, was found guilty in the District Court of Clark County, Nevada, of one count murder in the second degree; 49 counts of sale of a controlled substance; and six counts of possession of a controlled substance for purpose of sale.

According to court documents, Bass prescribed controlled substances to young adults and juveniles without a medical indication at their homes and hotels/casinos in Las Vegas. Several young adults overdosed and/or died as a result of Bass’ prescribing and dispensing patterns.

Bass was sentenced to ten years to life incarceration, with a credit of 57 days time served. Bass filed an appeal on December 22, 2008.

Name: BATES, Jeffrey Kent, MD

City, State: South Charleston, WV




Conviction: Obtaining controlled substance by fraud


Remarks:

Jeffrey Kent Bates, MD, age 42, of South Charleston, WV, pled guilty in federal court to one count of obtaining controlled substance by fraud.

According to court documents, from August 2005 and continuing until April 2006, Dr. Bates, knowingly and intentionally acquired and obtained possession of hydrocodone, a schedule III controlled substance, by deception and subterfuge.

Bates was sentenced to three months in prison; one year supervised release, and fined $5000.00.

Name: BATTLE, Frederick, MD

City, State: Michigan City, IN




Conviction: Unlawful dispensing of a Schedule II controlled substance


Remarks:

Frederick Battle, MD, age 72, of Michigan City, IN, pled guilty in U.S. District Court to one count of unlawful dispensing of a Schedule II controlled substance.

According to court documents, Battle prescribed OxyContin, a Schedule II controlled substance, outside the scope of professional practice to an individual working with law enforcement.

Battle was sentenced to one year probation and ordered to pay an assessment of $100.

Name: BEK, Jong H., MD

City, State: Gary, IN




Conviction: Illegal distribution; Conspiracy to distribute; Aiding and abetting


Remarks:

Jong H. Bek, MD, of Gary, IN, was convicted on 26 of 27 counts for Illegal distribution, conspiracy to distribute controlled substances, and aiding and abetting.

Bek was sentenced to 41 months in prison followed by 2 years supervised release.

Name: BETHENCOURT, Megaly S., MD

City, State: Miami, FL




Conviction: Conspiracy to distribute Schedule III and IV controlled substances


Remarks:

Megaly S. Bethencourt, MD, age 56, of Miami, FL, pled guilty in federal court to one count of conspiracy to distribute Schedule III and IV controlled substance.

According to court documents, between October 2003 and November 2003, Bethencourt authorized at least 6,060 dosage units of Schedule III and IV controlled substances via the internet. Said prescriptions were not issued for a legitimate medical purpose and not in the usual course of a practitioner’s professional practice.

Bethencourt was sentenced to two years probation, six months home detention, and ordered to forfeit $7,710.00.

Name: BILYEU, Stuart W., DO

City, State: Southfield, MI




Conviction: Unlawful distribution of a controlled substance

DEA Registration: Expired 07/31/2006

Remarks:

Stuart W. Bilyeu, DO, age 46, of Southfield, MI, pled guilty to the unlawful distribution of hydrocodone, a Schedule III controlled substance.

According to court documents, the defendant admitted that he prescribed without medical necessity or justification quantities of controlled substances to patients. For example, in October, 2004, the defendant wrote a prescription for #120 Vicodin to an individual, without any good faith attempt to determine the legitimate medical needs of the patient. From January 2003 until May 10, 2005, Bilyeu prescribed without medical necessity or justification 100 dosage units of oxycodone 80mg; 100 dosage units of Dilaudid, 20,000 Schedule III drugs, and 40, 000 Schedule IV drugs.

Bilyeu was sentenced to five years imprisonment, followed by three years of supervised release.

Name: BISCHOFF, James, MD

City, State: Ennis, MT




Conviction: Negligent homicide; fraudulently obtaining dangerous drugs; robbery with a weapon


Remarks:

James Bischoff, MD, age 48, of Ennis, Montana, pled guilty in state court to negligent homicide and to two counts of fraudulently obtaining dangerous drugs.

Bischoff was sentenced to ten years imprisonment with five years suspended on the first count and was sentenced to six years imprisonment on theadditional counts, to be served concurrently.

Name: BORKSON, Joseph, MD




Judicial Status: Plead Guilty

Conviction: Conspiracy to Distribute Controlled Substances; Distribution of Controlled Substances and Aiding and Abetting


Remarks:

Joseph Borkson, MD of Philadelphia, PA, plead guilty in U.S. District Court, District of Pennsylvania, to one count Conspiracy to Distribute Controlled Substances; and four counts Distribution of Controlled Substances and Aiding and Abetting.

According to court documents, from around 2001 through February 2007, Borkson operated a prescription “pill mill”, at which customers paid Borkson

for prescriptions for drugs, without there being any medical necessity for these prescriptions.

Borkson was sentenced to 60 months incarceration, followed by three years supervised release. He was also ordered to forfeit $600,000.

Name: BRADLEY, Thomas, MD

City, State: Dubois, PA




Conviction: Procure drug for self/other by fraud


Remarks:

Thomas Bradley, MD, age 57, of Dubois, PA, pled guilty to seven counts procuring drug for self/other by fraud.

According to court documents, during 2007, Bradley obtained for his own personal use controlled substances, such as hydrocodone/acetaminophen, that had been prescribed by Bradley to another person.

Bradley was sentenced to five years probation and ordered to pay $2,100 in fines.

Name: BRAUN, Robert Z, MD

City, State: West Hills, CA




Conviction: Conspiracy to unlawfully distribute controlled substances


Remarks:

Robert Z. Braun, MD, age 56, of West Hills, CA, pled guilty in federal court to one count of conspiracy to unlawfully distribute controlled substances.

According to court documents, Braun’s license to practice medicine and prescribe controlled substances was revoked by the Medical Board of California in March 2005. Subsequent to that date and up to August 2005, Braun conspired with others to unlawfully distribute and dispense oxycodone, methadone, morphine, and hydromorphone, all Schedule II controlled substances, hydrocodone, a Schedule III controlled substance, and lorazepam, a Schedule IV controlled substance.

Braun was sentenced to seventy (70) months in federal prison followed by probation for a term of three (3) years and ordered to pay a fine of $17,500 and an assessment of $100.00.

Name: BREGAR, Frank, MD

City, State: Pittsburgh, PA




Conviction: Insurance fraud; Felony Drug Act violation


Remarks:

Frank Bregar, MD, age 52, of Pittsburgh, Pennsylvania, pled guilty in state court to one count of insurance fraud and a felony Drug Act violation.

Bregar was sentenced to 23 months intermediate punishment with the first three months on house arrest, followed by 20 months probation. He was also ordered to perform 100 hours of community service and pay a $5,000 fine.

Name: BROADNAX, Walter, MD

City, State: Cincinnati, OH



Judicial Status: Plead Guilty

Conviction:Conspiring to unlawfully distribute and possess with intent to distribute certain controlled substances; Willfully failing to pay over certain employment taxes


Remarks:

Walter Broadnax, MD, age 50, of Cincinnati, OH, plead guilty to one count conspiring to unlawfully distribute and possess with intent to distribute certain controlled substances and one count willfully failing to pay over certain employment taxes.

According to court documents, Broadnax operated a sole proprietorship known as “The Pain Management Group”. He participated in the conspiracy by writing prescriptions, at the direction of his co-conspirators, for OxyContin and Percocet to persons that were not patients of Dr. Broadnax, who had not been medically examined, and who were not in need of the medication. In addition, Broadnax failed to file the quarterly employment tax returns and to pay over the collected employment taxes to the Internal Revenue Service.

Broadnax was sentenced to five years probation and ordered to pay $145,691.00 in restitution.

Name: BROWN, Michael R., MD

City, State: Mashpee, MA




Conviction: Distribution of a controlled substance; Medicaid fraud; possession; larceny


Remarks:

Michael R. Brown, MD, age 52, of Mashpee, MA, was found guilty in Barnstable Superior Court, Commonwealth of Massachusetts, on seventeen counts of distribution of a controlled substance; ten counts of Medicaid fraud; one count of possession of a controlled substance; and one count of larceny.

Brown was sentenced to 2 ½ to 3 years in state prison followed by five years probation.

Name: BUSH, Irving, MD

City, State: Elgin, IL




Conviction: Unlawful Delivery of a Controlled Substance


Remarks:

Irving Bush, MD, age 74, of Elgin, IL, pled guilty to Unlawful Delivery of a Controlled Substance.

According to court documents, Bush knowingly delivered a substance containing alprazolam, a controlled substance without a legitimate medical purpose.

Bush was sentenced to 30 months probation and order to pay a $1000 fine.

Name: CASTELLANOS, Agustin M., MD

City, State: Palm Beach Garden, FL




Conviction: Conspiracy to commit health care fraud


Remarks:

Agustin M. Castellanos, MD, age 51, of Palm Beach Gardens, FL, pled guilty in federal court to one count of conspiracy to commit health care fraud.

According to court documents, Castellanos knowingly allowed a licensed pharmacist to use his name in submitting false and fraudulent prescription drug claims for Ketamine HCL and other prescription medications to private health insurance companies. In exchange for allowing the pharmacist to use his name, Castellanos received prescription drugs, including hydrocodone.

Castellanos was sentenced to thirty-six months imprisonment and three years supervised release.

Name: CAVINESS, Paul H., MD

City, State: Middleton, PA




Conviction: Possession with Intent to Deliver and Criminal Conspiracy to Engage in Delivery


Remarks:

Paul Caviness, MD, age 49, of Middleton, PA, pled guilty to two charges: Possession with Intent to Deliver and Delivery of Controlled Substances; and Criminal Conspiracy to Possess with Intent to Deliver and Delivery of Controlled Substances.

According to court documents, from January 2006 to June 2007, Caviness ordered large sums of various Controlled Substances, rarely used in dermatology, Caviness’ medical specialty. Caviness admitted he ordered the drugs to sell them for money.

Caviness was sentenced to a period of 9 to 23 months incarceration, followed by 3 years of probation.

Name: CHAIT, Michael, MD

City, State: Sag Harbor, NY




Conviction: Conspiracy in the second degree; Grand larceny; and criminal possess of a controlled substance


Remarks:

Michael Chait, MD, age 49, of Sag Harbor, NY, pled guilty in the Suffolk County Court one count Conspiracy in the Second Degree; one count GrandLarceny; and one count Criminal Possession of a Controlled Substance.

According to court documents, Chait prescribed hundreds of prescriptions for controlled substances, particularly OxyContin and Dilaudid, to new “patients” for conditions he made no attempt to verify, without making bona fide inquiries into whether the patients had previous experience with these drugs or other opiates, and without determining whether the dosages prescribed would be safe to take alone or in combination with other substances the patient might be ingesting.

Chait was sentenced to 3 years in prison, followed by 5 years supervised parole.

Name: CHAUDHRY, Aziz, MD





Conviction: Conspiracy to distribute and distribution of controlled substancesFraud against the Social Security Administration


Remarks:

Aziz Chaudhry, MD, age 59, of Philadelphia, PA, pled guilty in U.S. District Court, Eastern District of Pennsylvania, to one count of conspiracy to distribute controlled substances; two counts of distribution of controlled substances; and one count of fraud against the Social Security Administration.

According to court documents, Chaudhry operated the Family Medical Center (“FMC”) in Philadelphia, PA. Although it purported to be a medical clinic, FMC was in actuality a “pill mill” at which so-called patients (“customers”) could, for a fee, obtain medical prescriptions for Schedule III, IV, and V controlled substances without there being any medical necessity for these prescriptions. Chaudhry allowed customers to obtain prescriptions under multiple false names as long as the customer initially provided some sort of identification in each false name so that FMC could establish a “patient file.” Chaudhry would also sometimes write prescriptions for customers, and then direct those customers to fill the prescriptions at local pharmacies and bring the pills back to FMC where Chaudhry would sell the pills.

Chaudhry also pled guilty to concealing and failing to report an event that he knew affected his initial and continued right to obtain payment under Title II of the Social Security Act, that is, his return to employment, in order to fraudulently secure payment when no payment was authorized.

Chaudhry was sentenced to prison for a term of 15 months followed by supervised release for two years, and ordered to pay a special assessment of $400, a fine of $7,500, and restitution in the amount of $59,684 to the Social Security Administration. Chaudhry was also ordered to forfeit over $1 million in cash and properties that were the proceeds of his sales of fraudulent prescriptions.

Name: CHENG, PAUL P., MD

City, State: Enid, OK




Conviction: Knowingly and intentionally distributed a Schedule IV controlled substance


Remarks:

Paul P. Cheng, MD, age 49, of Enid, OK, pled guilty in federal court to one count of knowingly and intentionally distributing a Schedule IV controlled substance.

According to court documents, Cheng was an anesthesiologist licensed to practice in the State of Oklahoma. In February 2006, Cheng provided a prescription for alprazolam, a Schedule IV controlled substance, to an individual who was not one of his patients and with whom he did not have a doctor-patient relationship.

Cheng was sentenced to probation for a term of two (2) years, 104 hours of community service, and ordered to pay a fine of $17,500 and an assessment of $100.

Name: CHUA, Noel N., MD

City, State: Kingsland, GA




Conviction: Felony Murder


Remarks:

Noel N. Chua, MD, age 46, of Kingsland, GA, was found guilty by a jury in the Superior Court of Camden County, State of Georgia, of violating the Georgia Controlled Substances Act, the result of which was the death of an individual.

According to court documents, Chua prescribed or ordered multiple controlled substances for the victim, said prescriptions not being for legitimate medical purpose and said act not being in the usual course of Chua’s professional practice.

Chua was sentenced to life in prison.

Name: CHUBE, Charles Randall, MD





Conviction: Distribution of a controlled substance outside the scope of professional practice


Remarks:

Charles Chube was found guilty by a federal jury of one count of distribution of a controlled substance outside the scope of professional practice and not for a legitimate medical purpose. He was sentenced to be imprisoned for a term of 60 months followed by 2 years supervised release.

Name: CHUBE, David, MD





Conviction: Distribution of a controlled substance outside the scope of professional practice; Healthcare fraud


Remarks:

David Chube was found guilty by a federal jury of four counts of distribution of a controlled substance outside the scope of professional practice and not for a legitimate medical purpose; and two counts of healthcare fraud. He was sentenced to be imprisoned for a term of 188 months followed by 3 years supervised release.

Name: CLARK, Cordell, MD

City, State: Dallas, TX




Conviction: Fraudulent use of a controlled substance registration


Remarks:

Cordell Clark, MD, pled guilty in State Criminal Court in Texas to fraudulently using a DEA controlled substance registration that had previously been suspended to prescribe dihydrocodeine.

Clark was sentenced to 10 years community supervision and ordered to pay a fine of $5,000.

Name: CONNOLLY, Christine Ann, MD

City, State: Littleton, CO




Conviction: Possession of a Controlled Substance – Schedule II

DEA Registration: Suspended 3/12/2008

Remarks:

Christine Ann Connolly, MD, age 45, of Littleton, CO, pled guilty in First Judicial District of Colorado to one count of possession of a controlled substance.

According to the court documents, Connolly prescribed a controlled substance, specifically oxycodone, to a known drug dependent patient, outside the usual course of medical practice and not for legitimate medical purposes.

Connolly was sentenced to one year probation.

Name: CRAKE, Robert J, DO

City, State: Wheeling, WV




Conviction: Unlawful possession of a controlled substance


Remarks:

Robert J. Crake, DO, age 40, of Wheeling, WV, pled guilty in U.S. District Court, Southern District of West Virginia, to one count of unlawfully, knowingly, and intentionally possessing controlled substances, namely phentermine, a Schedule IV controlled substance, which was not obtained directly or pursuant to a valid prescription or order from a practitioner while acting in the course of the practitioner’s professional practice or as otherwise authorized.

Crake was sentenced to probation for a term of 36 months and ordered to pay a special assessment of $25 and a fine of $1,000.

Name: CROUTHAMEL, Matthew R., MD

City, State: Seattle, WA



Judicial Status: Guilty Plea

Conviction: Aiding and abetting unlawful acquisition of a controlled substance


Remarks:

Matthew R. Crouthamel, MD, age 29, of Seattle, WA, pled guilty in federal court to one count of aiding and abetting unlawful acquisition of a controlled substance.

According to court documents, Crouthamel provided blank prescription scripts to others, knowing that the scripts would be forged and used to unlawfully acquire oxycodone, a Schedule II controlled substance.

Crouthamel was sentenced to three years probation and ordered to pay an assessment of $100.

Name: CULLINS, Suzette, MD

City, State: New Orleans, LA




Conviction: Illegal dispensing of controlled substances

United States Department of Justice Drug Enforcement Administration Office of Diversion Control

Practitioner’s Manual

An Informational Outline of the Controlled Substances Act

2006 Edition

Drug Enforcement Administration Practitioner’s Manual

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2006 Edition ii

Joseph T. Rannazzisi Deputy Assistant Administrator Office of Diversion Control Mark W. Caverly Chief, Liaison and Policy Section This manual has been prepared by the Drug Enforcement Administration, Office of Diversion Control, to assist practitioners (physicians, dentists, veterinarians, and other registrants authorized to prescribe, dispense, and administer controlled substances) in their understanding of the Federal Controlled Substances Act and its implementing regulations as they pertain to the practitioner’s profession.


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2006 Edition iii

Table of Contents Section I - Introduction Disclaimer………………………………………………………………………….. 1 Authorization for Public Dissemination…………………………………………… 2 Message from the Administrator………………………………………………….. 3 Preface……………………………………………………………………………… 4 Section II – General Requirements Schedules of Controlled Substances……………………………………………….. 5

Schedule I Substances ……………………………………………………… 5 Schedule II Substances……………………………………………………... 5 Schedule III Substances……………………………………………………. 6 Schedule IV Substances…………………………………………………… 6 Schedule V Substances…………………………………………………….. 6 Registration Requirements………………………………………………………… 7 Application for Registration……………………………………………… 7 Certificate of Registration………………………………………………… 8 Registration Renewals…………………………………………………… 9 Change of Business Address……………………………………………………….. 11 Termination of Registration……………………………………………………… 11 Denial, Suspension or Revocation of Registration………………………………… 11 Practitioner’s Use of a Hospital’s DEA Registration Number……………………. 12 Inappropriate Use of the DEA Registration Number……………………………… 12 Exemption of Federal Government Practitioners from Registration………………. 13 Section III – Security Requirements Required Controls………………………………………………………………….. 14 Safeguards for Prescribers…………………………………………………………. 15 Section IV – Recordkeeping Requirements Recordkeeping Requirements……………………………………………………... 16 Inventory…………………………………………………………………… 16 Disposal of Controlled Substances………………………………………… 17


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2006 Edition iv

Table of Contents (continued)

Section V – Valid Prescription Requirements Prescription Requirements…………………………………………………………. 18

Who May Issue…………………………………………………………….. 18 Purpose of Issue……………………………………………………………. 19

Schedule II Substances…………………………………………………………….. 19 Refills……………………………………………………………………… 19 Issuance of Multiple Prescriptions for Schedule II Substances……………. 19 Facsimile Prescriptions for Schedule II Substances……………………….. 20 Exceptions for Schedule II Facsimile Prescriptions……………………….. 21 Schedule III-V Substances………………………………………………………… 21

Refills……………………………………………………………………… 21 Facsimile Prescriptions for Schedule III-V Substances…………………… 22 Telephone Authorization for Schedule III-V Prescriptions……………….. 22 Delivery of a Controlled Substance to Persons Outside the U.S………………….. 22 Section VI – Opioid (Narcotic) Addiction Treatment Programs Opioid (Narcotic) Addiction Treatment Programs………………………………….23

Appendices Appendix A CSA and CFR Definitions…………………………………………. 26 Appendix B Questions and Answers……………………………………………. 28 Appendix C Summary of Controlled Substances Act Requirements……………. 32 Appendix D Internet Resources………………………………………………….. 33 Appendix E DEA Diversion Field Office Locations……………………………..34 Appendix F Small Business and Agriculture Regulatory Enforcement Ombudsman……………………………………………………….. 40 Appendix G Additional Assistance and Plain Language Statements……………. 41 Appendix H DEA Forms………………………………………………………… 42 DEA Form 41 - Registrants Inventory of Drugs Surrendered…………….. 43 DEA Form 106 – Report of Theft or Loss of Controlled Substances……… 45 DEA Form 222 - U.S. Official Order Form for Controlled Substances…… 47 DEA Form 224 – Application for Registration…………………………….. 48 DEA Form 224a - Renewal Application for Registration…………………. 52 DEA Form 363 - Application for Registration Under the Narcotic

Addict Treatment Act of 1974............................................ 56 DEA Form 363a – Renewal for Registration Under the Narcotic

Addict Treatment Act of 1974......................................... 60


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2006 Edition Page 1

SECTION I - INTRODUCTION This practitioner’s manual is intended to summarize and explain the basic requirements for prescribing, administering, and dispensing controlled substances under the Controlled Substances Act (CSA), 21 USC 801-890, and the DEA regulations, Title 21, Code of Federal Regulations (CFR), Parts 1300 to 1316. Pertinent citations to the law and regulations are included in this manual. Printed copies of the CFR and the complete regulations implementing the CSA may be obtained from:

Superintendent of Documents U.S. Government Printing Office Washington, D.C. 20402

Both the CFR and the Federal Register (which includes proposed and final regulations implementing the CSA) are available on the Internet through the U.S. Government Printing Office (GPO) website. This website, which provides information by section, citation and keywords, can be accessed at:

www.gpoaccess.gov/cfr/index.html Unofficial copies of pertinent CFR citations may be found at: www.DEAdiversion.usdoj.gov This practitioner’s manual may also be found on the Internet at DEA’s Web Site (under “publications”): www.DEAdiversion.usdoj.gov Should any pertinent provisions of the law or regulations be modified in the future, DEA will issue a revised electronic version of this document, which will be published on the DEA Diversion Website. If you encounter errors in this document, please notify: Editor, DEA Practitioner’s Manual c/o DEA, Office of Diversion Control Liaison and Policy Section Washington, D.C. 20537 Inquiries regarding topics within this document may be addressed to your local DEA field office (listed in Appendix E) or the address above.


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2006 Edition Page 2

This Document is Authorized for Public Dissemination All material in this publication is in the public domain and may be reproduced without the express permission of the Drug Enforcement Administration.


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2006 Edition Page 3

Message from the Administrator The Drug Enforcement Administration is pleased to provide this updated edition of the 1990 Practitioner’s Manual to assist you in understanding your responsibilities under the Controlled Substances Act (CSA) and its implementing regulations. This manual will help answer questions that you may encounter in your practice and provide guidance in complying with federal requirements. DEA remains committed to the 2001 Balanced Policy of promoting pain relief and preventing abuse of pain medications. In enforcing the CSA, it is DEA’s responsibility to ensure drugs are not diverted for illicit purposes. Unfortunately, this country is now experiencing an alarming prescription drug abuse problem:

• Today, more than 6 million Americans are abusing prescription drugs—that is more than the number of Americans abusing cocaine, heroin, hallucinogens, and inhalants, combined.

• Researchers from the Centers for Disease Control and Prevention report that opioid

prescription painkillers now cause more drug overdose deaths than cocaine and heroin combined.

• Today more new drug users have begun abusing pain relievers (2.4 million) than

marijuana (2.1 million) or cocaine (1.0 million). It is more important now than ever to be vigilant in preventing the diversion and abuse of controlled substances. This manual will help you do that by listing some safeguards you can take to prevent such diversion. It also explains registration, recordkeeping, and valid prescription requirements. As a practitioner, your role in the proper prescribing, administering, and dispensing of controlled substances is critical to patients’ health and to safeguarding society against the diversion of controlled substances. DEA is committed to working jointly with the medical community to ensure that those in need are cared for and that legitimate controlled substances are not being diverted for illegal use. Karen P. Tandy Administrator September 2006


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2006 Edition Page 4

Preface The Drug Enforcement Administration (DEA) was established in 1973 to serve as the primary federal agency responsible for the enforcement of the Controlled Substances Act (CSA). The CSA sets forth the federal law regarding both illicit and licit (pharmaceutical) controlled substances. With respect to pharmaceutical controlled substances, DEA’s statutory responsibility is twofold: to prevent diversion and abuse of these drugs while ensuring an adequate and uninterrupted supply is available to meet the country’s legitimate medical, scientific, and research needs. In carrying out this mission, DEA works in close cooperation with state and local authorities and other federal agencies. Under the framework of the CSA, the DEA is responsible for ensuring that all controlled substance transactions take place within the “closed system” of distribution established by Congress. Under this “closed system,” all legitimate handlers of controlled substances – manufacturers, distributors, physicians, pharmacies, and researchers – must be registered with DEA and maintain strict accounting for all distributions. To carry out DEA’s mission effectively, this 2006 Practitioner’s Manual seeks to aid DEA registrants in complying with the CSA and its implementing regulations. The DEA understands that it can best serve the public interest by working with practitioners to prevent diversion of legal pharmaceutical controlled substances into the illicit market. The federal controlled substances laws are designed to work in tandem with state controlled substance laws. Toward this same goal, DEA works in close cooperation with state professional licensing boards and state and local law enforcement officials to ensure that pharmaceutical controlled substances are prescribed, administered, and dispensed for legitimate medical purposes in accordance with federal and state laws. Within this cooperative framework, the majority of investigations into possible violations of the controlled substances laws are carried out by state authorities. However, DEA also conducts investigations into possible violations of federal law as circumstances warrant. In the event a state board revokes the license of a practitioner, the DEA will take action and request a voluntary surrender of the practitioner’s DEA registration. If the practitioner refuses to voluntarily surrender the registration, the DEA will pursue administrative action to revoke the DEA registration. The DEA may also pursue judicial action if there is sufficient evidence of illegal distribution or significant recordkeeping violations. All such actions are intended to deny the practitioner the means to continue to divert or abuse controlled substances as well as to protect the health and safety of the public and the practitioner. The DEA is authorized under federal law to pursue legal action in order to prevent the diversion of controlled substances and protect the public safety. A lack of compliance may result in a need for corrective action, such as administrative action (that is, Letter of Admonition, an informal hearing or “order to show cause”), or in extreme cases, civil, or criminal action.


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SECTION II – GENERAL REQUIREMENTS

Schedules of Controlled Substances The drugs and other substances that are considered controlled substances under the CSA are divided into five schedules. A complete list of the schedules is published annually on an updated basis in the DEA regulations, Title 21 of the Code of Federal Regulations, Sections 1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States and their relative abuse potential and likelihood of causing dependence when abused. Some examples of the drugs in each schedule are outlined below. IMPORTANT NOTE: All drugs listed in Schedule I have no currently accepted medical use in treatment in the United States and therefore may not be prescribed, administered, or dispensed for medical use. In contrast, drugs listed in Schedules II through V all have some accepted medical use and therefore may be prescribed, administered, or dispensed for medical use.

Schedule I Substances

Substances in this schedule have no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Some examples of substances listed in Schedule I are: heroin; lysergic acid diethylamide (LSD); marijuana (cannabis); peyote; methaqualone; and methylene-dimethoxy-methamphetamine (“ecstasy”).

The CSA allows for bona fide research with controlled substances in Schedule I, provided that the FDA has determined the researcher to be qualified and competent, and provided further that the FDA has determined the research protocol to be meritorious. Researchers who meet these criteria must obtain a separate registration to conduct research with a Schedule I controlled substance.

Schedule II Substances

Substances in this schedule have a high potential for abuse with severe psychological or physical dependence.

Examples of single entity Schedule II narcotics include morphine, codeine, and opium. Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®), and fentanyl (Sublimaze® or Duragesic®).


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2006 Edition Page 6

Examples of Schedule II stimulants include amphetamine (Dexedrine® or Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other Schedule II substances include: cocaine, amobarbital, glutethimide, and pentobarbital.

Schedule III Substances

Substances in this schedule have a potential for abuse less than substances in Schedules I or II.

Examples of Schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone per dosage unit (i.e., Vicodin®) and products containing not more than 90 milligrams of codeine per dosage unit (i.e., Tylenol with codeine®).

Examples of Schedule III non-narcotics include benzphetamine (Didrex®), phendimetrazine, dronabinol (Marinol®), ketamine, and anabolic steroids such as oxandrolone (Oxandrin®).

Schedule IV Substances

Substances in this schedule have a lower potential for abuse relative to substances in Schedule III. Examples of a Schedule IV narcotics include propoxyphene (Darvon® and Darvocet-N 100®). Other Schedule IV substances include alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®). Schedule V Substances

Substances in this schedule have a lower potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs. These are generally used for antitussive, antidiarrheal and analgesic purposes.

Examples include cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, and Phenergan with Codeine®).


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2006 Edition Page 7

Registration Requirements Under the CSA, the term “practitioner” is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration. The DEA registration grants practitioners federal authority to handle controlled substances. However, the DEA registered practitioner may only engage in those activities that are authorized under state law for the jurisdiction in which the practice is located. When federal law or regulations differ from state law or regulations, the practitioner is required to abide by the more stringent aspects of both the federal and state requirements. In many cases, state law is more stringent than federal law, and must be complied with in addition to federal law. Practitioners should be certain they understand their state as well as DEA controlled substance regulations.

Application for Registration To obtain a DEA registration, a practitioner must apply using a DEA Form 224. Applicants may submit the form by hard copy or on-line. Complete instructions accompany the form. To obtain the application, DEA may be contacted at:

• www.DEAdiversion.usdoj.gov (DEA Diversion Internet Web Site) • any DEA field office (see listing in Appendix E of this manual) • DEA Headquarters’ Registration Section in Washington, D.C. at 1-800-882-9539

(Registration Call Center) The DEA Form-224 may be completed on-line or in hard copy and mailed to:

Drug Enforcement Administration Registration Unit Central Station P.O. Box 28083 Washington, D.C. 20038-8083

A sample DEA Form 224 – New Application for Registration, is located at Appendix H, DEA Forms.


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2006 Edition Page 8

Certificate of Registration

The DEA Certificate of Registration (DEA Form 223) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection.

The CSA requires that a separate registration be obtained for each principal place of business or professional practice where controlled substances are manufactured, distributed, or dispensed. DEA has historically provided an exception that a practitioner who is registered at one location, but also practices at other locations, is not required to register separately for any other location at which controlled substances are only prescribed. If the practitioner maintains supplies of controlled substances, administers, or directly dispenses controlled substances at the separate location the practitioner must obtain a separate DEA registration for that location. The exception applies only to a secondary location within the same state in which the practitioner maintains his/her registration. DEA individual practitioner registrations are based on state authority to dispense or conduct research with respect to controlled substances. Since a DEA registration is based on a state license, it cannot authorize controlled substance dispensing outside that state. Hence, the separate registration exception applies only to locations within the same state in which practitioners have their DEA registrations.


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A duplicate Certificate of Registration may be requested on-line. It appears on DEA’s website, www.DEAdiversion.usdoj.gov, as follows:

Registration Renewals

Practitioner registrations must be renewed every three years. Renewal registrations use DEA Form 224a, Renewal Application for DEA Registration (see example at Appendix H, DEA Forms). The cost of the registration is indicated on the application form.

A renewal application is sent to the registrant approximately 45 days before the registration expiration date. The renewal application is sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the practitioner should contact the DEA registration office for their state, or DEA Headquarters at 1-800-882-9539, and request a renewal registration form.


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2006 Edition Page 10

The registration renewal application may be completed on-line at www.DEAdiversion.usdoj.gov, or in hard copy and mailed to:

Drug Enforcement Administration Registration Unit Central Station P.O. Box 28083 Washington, D.C. 20038-8083


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Change of Business Address A practitioner who moves to a new physical location must request a modification of registration. A modification of registration can be requested on-line at www.DEAdiversion.usdoj.gov or in writing to the DEA field office responsible for that state. If the change in address involves a change in state, the proper state issued license and controlled substances registration must be obtained prior to the approval of modification of the federal registration. If the modification is approved, DEA will issue a new certificate of registration and, if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-224a) will only be sent to the registered address on file with DEA. It will not be forwarded.

Termination of Registration Any practitioner desiring to discontinue business activities with respect to controlled substances must notify the nearest DEA field office (see Appendix E ) in writing. Along with the notification of termination of registration, the practitioner should send the DEA Certificate of Registration and any unused Official Order Forms (DEA Form-222) to the nearest DEA field office. Denial, Suspension or Revocation of Registration Under the CSA, DEA has the authority to deny, suspend, or revoke a DEA registration upon a finding that the registrant has:

1. Materially falsified any application filed 2. Been convicted of a felony relating to a controlled substance or a List I chemical 3. Had their state license or registration suspended, revoked, or denied 4. Committed an act which would render the DEA registration inconsistent with the public interest

5. Been excluded from participation in a Medicaid or Medicare program In determining the public interest, the CSA states the following factors are to be considered:

1. The recommendation of the appropriate state licensing board or professional disciplinary authority

2. The applicant’s experience in dispensing or conducting research with respect to controlled substances

3. The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances

4. Compliance with applicable state, federal, or local laws relating to controlled substances

5. Such other conduct which may threaten the public health and safety


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Practitioner’s Use of a Hospital’s DEA Registration Number Practitioners (e.g., intern, resident, staff physician, mid-level practitioner) who are agents or employees of a hospital or other institution may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in which they are employed, provided that:

1. The dispensing, administering, or prescribing is in the usual course of professional practice

2. Practitioners are authorized to do so by the state in which they practice 3. The hospital or institution has verified that the practitioner is permitted to

dispense, administer or prescribe controlled substances within the state 4. The practitioner acts only within the scope of employment in the hospital or

institution 5. The hospital or institution authorizes the practitioner to dispense or prescribe

under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below):

HospitalDEA Registration

Number

Physician’sHospital Code

Number

AB1234567-012

A current list of internal codes and the corresponding individual practitioners is to be maintained by the hospital or other institution. This list is to be made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. Inappropriate Use of the DEA Registration Number DEA strongly opposes the use of a DEA registration number for any purpose other than the one for which it was intended, to provide certification of DEA registration in transactions involving controlled substances. The use of DEA registration numbers as an identification number is not an appropriate use and could lead to a weakening of the registration system. The Centers for Medicare and Medicaid Services has developed a National Provider Identification (NPI) number unique to each healthcare provider. The Final Rule for establishment of the NPI system was published in the Federal Register (FR 3434, Vol. 69, No. 15) by the Department of Health and Human Services on January 23, 2004. The effective date of this Final Rule was May 23, 2005; all covered entities must begin using the NPI in standard transactions by May 23, 2007.


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Exemption of Federal Government Practitioners from Registration The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase controlled substances in the course of his/her official duties. Such officials shall follow procedures set forth in Title 21, CFR § 1306 regarding prescriptions, but shall state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his/her Social Security identification number. If a Federal Government practitioners wish to maintain a DEA registration for a private practice, which would include prescribing for private patients, they must be fully licensed to handle controlled substances by the state in which they are located. Under these circumstances, the Federal Government practitioner will not be eligible for the fee exemption and must pay a fee for the registration.


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SECTION III – SECURITY REQUIREMENTS Required Controls Title 21, CFR Section 1301.71(a), requires that all registrants provide effective controls and procedures to guard against theft and diversion of controlled substances. A list of factors is used to determine the adequacy of these security controls. Factors affecting practitioners include:

1. The location of the premises and the relationship such location bears on security needs

2. The type of building and office construction 3. The type and quantity of controlled substances stored on the premises 4. The type of storage medium (safe, vault, or steel cabinet) 5. The control of public access to the facility 6. The adequacy of registrant’s monitoring system (alarms and detection systems) 7. The availability of local police protection

Practitioners are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially constructed cabinet. Practitioners authorized to possess carfentanil, etorphine hydrochloride and/or diprenorphine, must store these controlled substances in a safe or steel cabinet equivalent to a U.S. Government Class V security container. Registrants should not employ as an agent or employee who has access to controlled substances:

1. Any person who has been convicted of a felony offense related to controlled substances 2. Any person who has been denied a DEA registration 3. Any person who has had a DEA registration revoked 4. Any person who has surrendered a DEA registration for cause

Lastly, practitioners should notify the DEA, upon discovery, of any thefts or significant losses of controlled substances and complete a DEA Form 106 regarding such theft or loss.


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Safeguards for Prescribers In addition to the required security controls, practitioners can utilize additional measures to ensure security. These include:

1. Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.

2. Write out the actual amount prescribed in addition to giving a number to

discourage alterations of the prescription order. 3. Use prescription blanks only for writing a prescription order and not for notes. 4. Never sign prescription blanks in advance. 5. Assist the pharmacist when they telephone to verify information about a prescription order; a corresponding responsibility rests with the pharmacist who dispenses the prescription order to ensure the accuracy of the prescription. 6. Contact the nearest DEA field office (see Appendix E) to obtain or to furnish information regarding suspicious prescription activities. 7. Use tamper-resistant prescription pads.


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SECTION IV – RECORDKEEPING REQUIREMENTS

Recordkeeping Requirements Each practitioner must maintain inventories and records of controlled substances listed in Schedules I and II separately from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in Schedules III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years. A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment. A registered practitioner is not required to keep records of controlled substances that are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. A registered practitioner is also required to keep records of controlled substances administered in the course of maintenance or detoxification treatment of an individual.

Inventory

Each registrant who maintains an inventory of controlled substances must maintain a complete and accurate record of the controlled substances on hand and the date that the inventory was conducted. This record must be in written, typewritten, or printed form and be maintained at the registered location for at least two years from the date that the inventory was conducted. After an initial inventory is taken, the registrant shall take a new inventory of all controlled substances on hand at least every two years. Each inventory must contain the following information:

1. Whether the inventory was taken at the beginning or close of business 2. Names of controlled substances 3. Each finished form of the substances (e.g., 100 milligram tablet) 4. The number of dosage units of each finished form in the commercial container

(e.g., 100 tablet bottle) 5. The number of commercial containers of each finished form (e.g., four 100

tablet bottles)


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6. Disposition of the controlled substances

It is important to note that inventory requirements extend to controlled substance samples provided to practitioners by pharmaceutical companies. Disposal of Controlled Substances

A practitioner may dispose of out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. These registrants are referred to as “Reverse Distributors.” The practitioner should contact the local DEA field office (See Appendix E) for a list of authorized Reverse Distributors. Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III–V compounds may be transferred via invoice. The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.


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SECTION V – VALID PRESCRIPTION REQUIREMENTS

Prescription Requirements

A prescription is an order for medication which is dispensed to or for an ultimate user. A prescription is not an order for medication which is dispensed for immediate administration to the ultimate user (for example, an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription). A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number. The prescription must also include:

1. drug name 2. strength 3. dosage form 4. quantity prescribed 5. directions for use 6. number of refills (if any) authorized

A prescription for a controlled substance must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (secretary or nurse) may be designated by the practitioner to prepare prescriptions for the practitioner’s signature. The practitioner is responsible for ensuring that the prescription conforms to all requirements of the law and regulations, both federal and state.

Who May Issue

A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid-level practitioner, or other registered practitioner who is:

1. Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice 2. Registered with DEA or exempted from registration (that is, Public Health Service, Federal Bureau of Prisons, or military practitioners) 3. An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered provided that additional requirements as set forth in the CFR are met.


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Purpose of Issue

To be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances. In addition, a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription within the meaning and intent of the Controlled Substances Act 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.

A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

Schedule II Substances

Schedule II controlled substances require a written prescription which must be signed by the practitioner. There is no federal time limit within which a Schedule II prescription must be filled after being signed by the practitioner. While some states and many insurance carriers limit the quantity of controlled substance dispensed to a 30-day supply, there are no specific federal limits to quantities of drugs dispensed via a prescription. For Schedule II controlled substances, an oral order is only permitted in an emergency situation.

Refills

The refilling of a prescription for a controlled substance listed in Schedule II is prohibited (Title 21 U.S. Code § 829(a)).

Issuance of Multiple Prescriptions for Schedule II Substances

DEA has revised its regulations regarding the issuance of multiple prescriptions for schedule II controlled substances. Under the new regulation, which became effective December 19, 2007, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:

1. Each separate prescription is issued for a legitimate medical purpose by an

individual practitioner acting in the usual course of professional practice.


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2. The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.

3. The individual practitioner concludes that providing the patient with multiple

prescriptions in this manner does not create an undue risk of diversion or abuse.

4. The issuance of multiple prescriptions is permissible under applicable state

laws. 5. The individual practitioner complies fully with all other applicable

requirements under the Controlled Substances Act and Code of Federal Regulations, as well as any additional requirements under state law.

It should be noted that the implementation of this change in the regulation should not be construed as encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. Facsimile Prescriptions for Schedule II Controlled Substances

In order to expedite the filling of a prescription, a prescriber may transmit a Schedule II prescription to the pharmacy by facsimile. The original Schedule II prescription must be presented to the pharmacist for review prior to the actual dispensing of the controlled substance.

In an emergency, a practitioner may call-in a prescription for a Schedule II controlled substance by telephone to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a written and signed prescription to the pharmacist within seven days. Further, the pharmacist must notify DEA if the prescription is not received.


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Exceptions for Schedule II Facsimile Prescriptions

DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. The facsimile of a Schedule II prescription may serve as the original prescription as follows:

1. A practitioner prescribing Schedule II narcotic controlled substances to be

compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. The pharmacy will consider the facsimile prescription a “written prescription” and no further prescription verification is required. All normal requirements of a legal prescription must be followed.

2. Practitioners prescribing Schedule II controlled substances for residents of

Long Term Care Facilities (LTCF) may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy.

3. A practitioner prescribing a Schedule II narcotic controlled substance for a

patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or the practitioner’s agent may transmit the prescription to the pharmacy. The practitioner or agent will note on the prescription that it is for a hospice patient. The facsimile serves as the original written prescription.

Schedule III-V Substances A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.

Refills

Schedule III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date on which the prescription was issued. After five refills or after six months, whichever occurs first, a new prescription is required.


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Facsimile Prescriptions for Schedule III-V Substances

Prescriptions for Schedules III-V controlled substances may be transmitted by facsimile from the practitioner or an employee or agent of the individual practitioner to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription.

Telephone Authorization for Schedule III-V Prescriptions

A pharmacist may dispense a controlled substance listed in Schedule III, IV, or V pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required for a valid prescription, except for the signature of the practitioner.

Delivery of a Controlled Substance to Persons Outside the U.S.

Controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in another country. Any such delivery or shipment is a prohibited export under the CSA.


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SECTION VI – OPIOID (NARCOTIC) ADDICTION TREATMENT PROGRAMS The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction Treatment Act of 2000 amended the CSA with respect to the use of controlled substances in the medical treatment of addiction. These laws established the procedures for approval and licensing of practitioners involved in the treatment of opioid addiction as well as improving the quality and delivery of that treatment to the segment of society in need. Practitioners wishing to administer and dispense approved Schedule II controlled substances (that is, methadone) for maintenance and detoxification treatment must obtain a separate DEA registration as a Narcotic Treatment Program. Application for registration as a Narcotic Treatment Program is made using DEA Form 363. In addition to obtaining this separate DEA registration, this type of activity also requires the approval and registration of the Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS), as well as the applicable state methadone authority. If a practitioner wishes to prescribe, administer, or dispense Schedule III, IV, or V controlled substances approved for addiction treatment (i.e., buprenorphine drug products), the practitioner must request a waiver (Form SMA-167) and fulfill the requirements of CSAT. CSAT will then notify DEA of all waiver requests. DEA will review each request. If DEA approves this waiver, the practitioner will receive a Unique Identification Number. If a practitioner chooses to dispense controlled substances, the practitioner must maintain, separate from all other records, for a period of at least two years, all required records of receipt, storage, and distribution. If a practitioner chooses to prescribe these controlled substances, the practitioner must utilize their Unique Identification Number on the prescription in addition to his/her regular DEA registration number. The practitioner must also maintain a record of each such prescription for a period of at least two years. Practitioners should be aware that there may be limits on how many patients they may treat for opioid addiction at any given time and should check with SAMHSA to determine these limits. Note that not all treatment programs utilize controlled substances, that is, some are drug free. Accordingly, these activities do not require DEA registration or approval. Practitioners can find additional information regarding addiction treatment by visiting DEA’s Office of Diversion Control website at www.DEAdiversion.usdoj.gov. Click on “Publications,” then “Narcotic Treatment Programs: Best Practices Guidelines.” The DEA application Form 363 may be completed on-line.

To learn more about CSAT’s requirements, practitioners may visit one or more of the following websites: www.samhsa.gov/centers/csat2002/csat_frame.html, www.csat.samhsa.gov, or www.buprenorphine.samhsa.gov.


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If the practitioner has a patient who is in need of addiction treatment, but does not wish to treat the individual, the practitioner can refer the patient to an existing facility through the following website: www.findtreatment.samhsa.gov.


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APPENDICES


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APPENDIX A

CSA & CFR Definitions

Administer The direct application of a controlled substance to the body of a patient or research subject by 1) a practitioner or (in his presence) by his authorized agent, or 2) the patient or research subject at the direction and in the presence of the practitioner, whether such application is by injection, inhalation, ingestion, or any other means.

Dispense To deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery.

Dispenser An individual practitioner, institutional practitioner, pharmacy or, pharmacist who dispenses a controlled substance.

Individual Practitioner A physician, dentist, veterinarian, or other individual licensed, registered or otherwise permitted, by the United States or the jurisdiction in which they practice, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

Institutional Practitioner A hospital or other person (other than an individual) licensed, registered or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

Inventory All factory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise acquired by a registrant, whether in bulk, commercial containers, or contained in pharmaceutical preparations in the possession of the registrant (including stocks held by the registrant under separate registration as a manufacturer, importer, exporter, or distributor).


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Long Term Care Facility A nursing home, retirement care, mental care, or other facility or institution which provides extended health care to resident patients.

Mid-level Practitioner An individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, and physician assistants who are authorized to dispense controlled substances by the state in which they practice.

Pharmacist Any pharmacist licensed by a state to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by such state.

Prescription An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).

Readily Retrievable Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.


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APPENDIX B

Questions and Answers The following questions are those that are frequently encountered by DEA’s Office of Diversion Control and its field units. These questions and their accompanying answers are provided in context of the CSA and its federal regulations.

Q Are separate registrations required for separate locations?

A separate registration is required for each principal place of business or professional practice where controlled substances are stored or dispensed by a person.

Q Does a practitioner need a separate registration to treat patients at remote health care facilities?

A Separate registration is not required in an office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

Q Do all practitioners in a group practice need to be registered?

A An individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself.

Q Do medical residents assigned to hospitals need to register?

A An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered provided that additional requirements as set forth in the CFR are met.

A


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Q Are military personnel exempted from registration?

A Registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, or Coast Guard who is authorized to prescribe, dispense, or administer, but not procure or purchase, controlled substances in the course of his/her official duties. Such officials must follow procedures set forth in 21 CFR Part 1306 regarding prescriptions. Branch of service or agency and the service identification number of the issuing official is required on the prescription form in lieu of the DEA registration number. If any exempted official engages as a private individual in any activity or group of activities for which registration is required, that individual must obtain a registration for those private activities. Further, practitioners serving in the U.S. Military are exempt from registering with DEA, but are not authorized to procure or purchase controlled substances in the course of their official duties. A number of states also require military practitioners to acquire a separate state license if they issue prescriptions that are filled outside the military facility where they practice.

Q Are contract practitioners working at U.S. Military Installations also exempt from registration?

A They are not exempt. A contract practitioner who is not an official of the military on active duty, but is engaged in medical practice at a military installation, must possess a current DEA registration. The individual must also possess a valid state license for the same state in which he/she is registered with DEA.

Q What should a practitioner do if he/she discovers a theft or loss?

A Registrants must notify the DEA field office in their area of the theft or significant loss of any controlled substances upon discovery. The registrant must also complete DEA Form 106 documenting the loss or theft.


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Q What is meant by “acceptable medical practice?”

A The legal standard that a controlled substance may only be prescribed, administered, or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice has been construed to mean that the prescription must be “in accordance with a standard of medical practice generally recognized and accepted in the United States.”

Federal courts have long recognized that it is not possible to expand on the phrase “legitimate medical purpose in the usual course of professional practice” in a way that will provide definitive guidelines to address all the varied situations physicians may encounter.

While there are no criteria to address every conceivable instance of prescribing, there are recurring patterns that may be indicative of inappropriate prescribing: • An inordinately large quantity of controlled substances prescribed or large

numbers of prescriptions issued compared to other physicians in an area; • No physical examination was given; • Warnings to the patient to fill prescriptions at different drug stores; • Issuing prescriptions knowing that the patient was delivering the drugs to

others; • Issuing prescriptions in exchange for sexual favors or for money; • Prescribing of controlled drugs at intervals inconsistent with legitimate

medical treatment; • The use of street slang rather than medical terminology for the drugs

prescribed; or • Νo logical relationship between the drugs prescribed and treatment of the

condition allegedly existing.

Each case must be evaluated based on its own merits in view of the totality of circumstances particular to the physician and patient.

For example, what constitutes “an inordinately large quantity of controlled substances,” can vary greatly from patient to patient. A particular quantity of a powerful Schedule II opioid might be blatantly excessive for the treatment of a particular patient's mild temporary pain, yet insufficient to treat the severe unremitting pain of a cancer patient.

Q What information is required to be provided on a written prescription?

A All written prescriptions for controlled substances must be dated as of, and signed on, the date when issued. Each prescription must indicate the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed,


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directions for use and the name, address, and DEA number of the practitioner. Further, prescriptions must be written in ink, indelible pencil, or by typewriter, and must be manually signed by the practitioner.

Q What is meant by “date of issuance?”

A The date a prescription is issued is the same date that the prescribing practitioner actually writes and signs the prescription.

Q Is there a time limit for filling Schedule II prescriptions?

A There is no federal time limit for filling Schedule II prescriptions. However, some state laws do set time limits.


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APPENDIX C

Summary of Controlled Substances Act Requirements

Schedule II

Schedule III & IV

Schedule V

Registration

Required

Required

Required

Receiving Records

Order Forms (DEA Form-222)

Invoices, Readily Retrievable

Invoices, Readily Retrievable

Prescriptions

Written Prescription (See exceptions*)

Written, Oral, or Fax

Written, Oral, Fax, or Over The Counter**

Refills

No

No more than 5 within 6 months

As authorized when prescription is issued

Distribution Between Registrants

Order Forms (DEA Form-222)

Invoices

Invoices

Security

Locked Cabinet or Other Secure Storage



Theft or Significant Loss

Report and complete DEA Form 106



Note: All records must be maintained for 2 years, unless a state requires a longer period. * Emergency prescriptions require a signed follow-up prescription.

Exceptions: A facsimile prescription serves as the original prescription when issued to residents of Long Term Care Facilities, Hospice patients, or compounded IV narcotic medications.

** Where authorized by state controlled substances authority.


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APPENDIX D

Internet Resources

DEA’s Diversion Control Program Website www.DEAdiversion.usdoj.gov DEA Homepage www.dea.gov U.S. Government Printing Office www.gpoaccess.gov/cfr/index.html

Provides access to the Code of Federal Regulations (21 CFR, Parts 1300 to end), primary source for the Practitioner’s Manual, and the Federal Register which contains proposed and finalized amendments to the CFR.

Office of National Drug Control Policy (ONDCP) www.whitehousedrugpolicy.gov Food and Drug Administration www.FDA.gov HHS & SAMHSA’s National Clearinghouse for Alcohol and Drug Information www.health.org SAMHSA/CSAT www.csat.samhsa.gov Federation of State Medical Boards

www.FSMB.org National Association of Boards of Pharmacy www.nabp.net National Association of State Controlled Substances Authorities www.nascsa.org


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APPENDIX E

Drug Enforcement Administration Diversion Field Office Locations

For address and telephone number updates, please see the DEA website: www.deadiversion.usdoj.gov NORTHERN ALABAMA

DEA Birmingham Resident Office 920 Eighteenth Street, North Birmingham, Alabama 35203 (205) 321-1300

SOUTHERN ALABAMA

DEA Mobile Resident Office 900 Western America Circle Suite 501 Mobile, Alabama 36609 (334) 441-5831

ALASKA DEA Seattle Field Division 400 2nd Avenue West Seattle, Washington 98119 (206) 553-5443 NORTHERN & CENTRAL

ARIZONA DEA Phoenix Field Division 3010 N. 2nd Street, Suite 301 Phoenix, Arizona 85012 (602) 664-5600 SOUTHERN ARIZONA DEA Tucson District Office 3285 E. Hemisphere Loop Tucson, Arizona 85706 (520) 573-5500 ARKANSAS DEA Little Rock Resident Office 10825 Financial Center Pkwy, Suite 200 Little Rock, Arkansas 72211 (501) 312-8602

CENTRAL & COASTAL CALIFORNIA

DEA San Francisco Field Division 450 Golden Gate Avenue, 14th Floor San Francisco, California 94102 (415) 436-7900 DEA San Jose Resident Office One North First Street, Suite 405 San Jose, California 95113 (408) 291-7235 CENTRAL CALIFORNIA DEA Fresno Resident Office 2444 Main Street, Suite 240 Fresno, California 93721 (559)487-5402 NORTHERN CALIFORNIA DEA Oakland Resident Office 1301 Clay Street, Suite 460N PO Box 70301 Oakland, California 94612 (510) 637-5600 DEA Sacramento District Office 4328 Watt Avenue Sacramento, California 95821 (916) 566-7401 SOUTH CENTRAL CALIFORNIA DEA Los Angeles Field Division 255 East Temple Street, 20th Floor Los Angeles, California 90012 (213) 621-6700 DEA Riverside District Office 4470 Olivewood Avenue Riverside, California 92501- 4155 (909) 328-6000


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SOUTHERN CALIFORNIA DEA San Diego Field Division 4560 Viewridge Avenue San Diego, California 92123 (858) 616-4100 COLORADO DEA Denver Field Division 115 Inverness Drive, East Englewood, Colorado 80112 (303) 705-7300 SOUTHERN COLORADO DEA Colorado Springs Resident Office Plaza of the Rockies 111 S Tejon, Suite 306 Colorado Springs, Colorado 80903 (719) 866-6100 CONNECTICUT DEA Hartford Resident Office 450 Main Street, Room 628 Hartford, Connecticut 06103 (860) 240-3700 DELAWARE DEA Philadelphia Field Division William J. Green Federal Building 600 Arch Street, Room 10224 Philadelphia, Pennsylvania 19106 (215) 597-9540 DISTRICT OF COLUMBIA DEA Washington Field Division TechWorld Plaza 801 I Street, NW, Suite 500 Washington, DC 20001 (202) 305-8500 NORTHERN FLORIDA DEA Tallahassee Resident Office 3384 Capital Circle, NE Tallahassee, Florida 32308 (850) 942-8417 CENTRAL FLORIDA DEA Orlando Resident Office Heathrow Business Center 300 International Pkwy, Suite 424 Heathrow, Florida 32746 (407) 333-7046

WEST CENTRAL FLORIDA DEA Tampa District Office 4950 W. Kennedy Boulevard, Suite 400 Tampa, Florida 33609 (813) 287-5165 SOUTHEASTERN FLORIDA DEA Miami Field Division 8400 NW 53rd Street Miami, Florida 33166 (305) 994-4870 GEORGIA DEA Atlanta Field Division 75 Spring Street, SW, Suite 800 Atlanta, Georgia 30303 (404) 893-7000 EASTERN GEORGIA DEA Savannah Resident Office 56 Park of Commerce Boulevard Savannah, Georgia 31405 (912) 447-1035 HAWAII DEA Honolulu District Office 300 Ala Moana Boulevard, Room 3-147 Honolulu, Hawaii 96850 (808) 541-1930 NORTHERN IDAHO DEA Seattle Field Division 400 2nd Avenue West Seattle, Washington 98119 (206) 553-5443 SOUTHERN IDAHO DEA Boise Resident Office 607 North 8th Street, Suite 400 Boise, Idaho 83702-5518 (208) 334-1620 NORTHERN & CENTRAL

ILLINOIS DEA Chicago Field Division Klyuczynski Federal Building 230 South Dearborn Street, Suite 1200 Chicago, Illinois 60604 (312) 353-7875


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CENTRAL ILLINOIS DEA Springfield Resident Office 2875 Via Verde Street Springfield, Illinois 62703 (217) 585-2750 SOUTHERN ILLINOIS DEA St. Louis Field Division 317 South 16th Street St. Louis, Missouri 63103 (314) 538-4600 INDIANA DEA Indianapolis District Office 575 N Pennsylvania Street, Room 408 Indianapolis, Indiana 46204 (317) 226-7977 NORTHERN INDIANA DEA Merrillville Resident Office 1571 East 85th Avenue, Suite 200 Merrillville, Indiana 46410 (219) 681-7000 IOWA DEA Des Moines Resident Office 210 Walnut Street, Room 937 Des Moines, Iowa 50309 (515) 284-4709 KANSAS DEA Kansas City Resident Office 8600 Farley, Suite 200 Overland Park, Kansas 66212 (913) 825-4116 KENTUCKY DEA Louisville Resident Office 600 Dr. Martin Luther King Jr. Place Suite 1006 Louisville, Kentucky 40202 (502) 582-5908 SOUTHEASTERN KENTUCKY DEA London Resident Office PO Box 5065 London, Kentucky 40745 (606) 862-4500

LOUISIANA DEA New Orleans Field Division 3838 N Causeway Boulevard, Suite 1800 Lakeway III Metairie, Louisiana 70002 (504) 840-1100 MAINE DEA Boston Field Division JFK Federal Building 15 New Sudbury Street, Room E-400 Boston, Massachusetts 02203-0402 (617) 557-2100 MARYLAND DEA Baltimore District Office 200 St. Paul Place, Suite 2222 Baltimore, Maryland 21202-2004 (410) 244-3500 MASSACHUSETTS DEA Boston Field Division JFK Federal Building 15 New Sudbury Street, Room E-400 Boston, Massachusetts 02203-0131 (617) 557-2100 MICHIGAN DEA Detroit Field Division 431 Howard Street Detroit, Michigan 48226 (313) 234-4000 MINNESOTA

DEA Minneapolis/St Paul Resident Office

330 Second Avenue S, Suite 450 Minneapolis, Minnesota 55401 (612) 725-3280 MISSISSIPPI DEA Jackson District Office 100 W. Capitol Street, Suite 1213 Jackson, Mississippi 39269 (601) 965-4400 EASTERN MISSOURI DEA St Louis Field Division 317 South 16th Street St. Louis, Missouri 63103 (314) 538-4600


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WESTERN MISSOURI DEA Kansas City Resident Office 8600 Farley, Suite 200 Overland Park, Kansas 66212 (913) 825-4118 MONTANA DEA Denver Field Division 115 Inverness Drive, East Englewood, Colorado 80112 (303) 705-7300 NEBRASKA DEA Des Moines Resident Office 210 Walnut Street, Room 509 Des Moines, Iowa 50309 (515) 284-4709 NEVADA DEA Las Vegas District Office 550 South Main, Suite A Las Vegas, Nevada 89101 (702) 759-8016 NEW HAMPSHIRE DEA Boston Field Division JFK Federal Building 15 New Sudbury Street, Room E-400 Boston, Massachusetts 02203-0402 (617) 557-2100 NORTHERN & CENTRAL NEW JERSEY DEA Newark Field Division 80 Mulberry Street, 2nd Floor Newark, New Jersey 07102 (973) 776-1100 SOUTHERN NEW JERSEY DEA Camden Resident Office 211 Boulevard Avenue Maple Shade, New Jersey 08052 (856) 321-2439 NEW MEXICO DEA Albuquerque District Office 301 Martin Luther King Ave, NE Albuquerque, New Mexico 87102 (505) 346-7419

NEW YORK DEA New York Field Division 99 Tenth Avenue New York, New York 10011 (212) 337-3900 CENTRAL & WESTERN NEW YORK DEA Buffalo Resident Office 28 Church Street, Suite 300 Buffalo, New York 14202 (716) 551-3391 LONG ISLAND NEW YORK DEA Long Island District Office 175 Pinelawn Road, Suite 205 Melville, New York 11747 (631) 420-4500 NORTH CAROLINA DEA Greensboro Resident Office 1801 Stanley Road, Suite 201 Greensboro, North Carolina 27407 (336) 547-4219 NORTH DAKOTA

DEA Minneapolis/St Paul Resident Office

330 Second Avenue S, Suite 450 Minneapolis, Minnesota 55401 (612) 725-3280 NORTHERN OHIO DEA Cleveland Resident Office Courthouse Square 310 Lakeside Avenue, Suite 395 Cleveland, Ohio 44113 (216) 552-3705 SOUTHERN & CENTRAL OHIO DEA Columbus Resident Office 500 S Front Street, Suite 612 Columbus, Ohio 43215 (614) 255-4145 SOUTHERN OHIO DEA Cincinnati Resident Office 36 East 7th Street, Suite 1900 Cincinnati, Ohio 45202 (513) 684-3671


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NORTHEASTERN OKLAHOMA DEA Tulsa Resident Office Three Memorial Place 7615 E 63rd Place, Suite 250 Tulsa, Oklahoma 74133 (918) 459-9600 OKLAHOMA DEA Oklahoma City District Office 9900 Broadway Extension Oklahoma City, Oklahoma 73114 (405) 475-7500 OREGON DEA Portland District Office 1220 SW 3rd Avenue, Suite 1525 Portland, Oregon 97204 (503) 326-5739 EASTERN PENNSYLVANIA DEA Philadelphia Field Division William J. Green Federal Building 600 Arch Street, Room 10224 Philadelphia, Pennsylvania 19106 (215) 861-3474 WESTERN PENNSYLVANIA DEA Pittsburgh Resident Office Federal Building 1000 Liberty Avenue, Room 1328 Pittsburg, Pennsylvania 15222 (412) 395-4502 PUERTO RICO DEA Caribbean Field Division Metro Office Park, #17, calle 2 San Juan, Puerto Rico 00968-1706 (787) 775-1815 RHODE ISLAND DEA Boston Field Division JFK Federal Building 15 New Sudbury Street, Room E-400 Boston, Massachusetts 02203-0402 (617) 557-2100 SOUTH CAROLINA DEA Columbia District Office 1835 Assembly Street, Suite 1229 Columbia, South Carolina 29201 (803) 253-3441

SOUTH DAKOTA DEA Des Moines Resident Office 210 Walnut Street, Room 509 Des Moines, Iowa 50309 (515) 284-4793 TENNESSEE DEA Nashville District Office 801 Broadway, Suite 500 Nashville, Tennessee 37203 (615) 736-2559 NORTHERN TEXAS DEA Dallas Field Division 10160 Technology Boulevard Dallas, Texas 75220 (214) 366-6900 TEXAS DEA Fort Worth Resident Office 819 Taylor Street, Room 13A33 Ft Worth, Texas 76102 (817) 978-3455 EASTERN & SOUTHERN TEXAS DEA Houston Field Division 1433 west Loop S, Suite 600 Houston, Texas 77027-9506 (713) 693-3000 CENTRAL & WESTERN TEXAS DEA San Antonio District Office 10127 Morocco, Suite 200 San Antonio, Texas 78216 (210) 442-5634 CENTRAL TEXAS DEA Waco Post of Duty 6801 Sanger Avenue, Suite 2000 Waco, Texas 76710 (254) 741-1920 WESTERN TEXAS DEA El Paso Field Division El Paso Federal Justice Center 660 S Mesa Hills Drive, Suite 2000 El Paso, Texas 79912 (915) 832-6000


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UTAH DEA Salt Lake City Resident Office 348 East South Temple Salt Lake City, Utah 84111 (801) 524-4156 VERMONT DEA Hartford Resident Office 450 Main Street, Room 628 Hartford, Connecticut 06103 (860) 240-3700 VIRGIN ISLANDS DEA Caribbean Field Division Metro Office Park, #17, calle 2 San Juan, Puerto Rico 00968-1706 (787) 775-1815 VIRGINIA DEA Richmond Resident Office 111 Greencourt Road Richmond, Virginia 23228 (804) 627-6307 WASHINGTON STATE DEA Seattle Field Division 400 2nd Avenue, West Seattle, Washington 98119 (206) 553-1147

WEST VIRGINIA DEA Charleston Resident Office 2 Monongalia Street, Suite 202 Charleston, West Virginia 25302 (304) 347-5209 WISCONSIN DEA Milwaukee District Office 1000 N. Water Street, Suite 1010 Milwaukee, Wisconsin 53202 (414) 297-3395 WYOMING DEA Salt Lake City Resident Office 348 East South Temple Salt Lake City, Utah 84111 (801) 524-4156 HEADQUARTERS Office of Diversion Control Registration Unit / ODRR Washington, DC 20537 (202) 307-7250 (800) 882-9539 NOTE: The address in Atlanta, Georgia is listed on the application and renewal application for mailing applications ONLY. It is a Financial Institution and not the physical address of the DEA. All inquiries relating to DEA registrations must be directed to the following: Telephone inquiries: 1-800-882-9539 or Written inquiries: Drug Enforcement Administration Registration Unit – ODRR Washington, DC 20537


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APPENDIX F

Small Business and Agriculture Regulatory Enforcement Ombudsman

The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency’s responsiveness to small business. If you wish to comment on DEA enforcement actions, you may contact the Ombudsman at 1-888-REG-FAIR (1-888-734-3247).


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APPENDIX G Additional Assistance This publication is intended to provide guidance and information on the requirements of the Controlled Substances Act and its implementing regulations. If you require additional clarification or assistance, or wish to comment on any matter regarding the DEA’s requirements or regulatory activities, please contact your local DEA Diversion field office (see Appendix E). Every effort will be made to respond promptly to your inquiry. Plain Language The Drug Enforcement Administration has made every effort to write this manual in clear, plain language. If you have suggestions as to how to improve the clarity of this manual, please contact us at:

Drug Enforcement Administration Office of Diversion Control Liaison and Policy Section Washington, D.C. 20537 Telephone: (202) 307-7297


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APPENDIX H – DEA FORMS The following pages provide samples of several forms frequently encountered by DEA registrants. Included are: DEA Form 41 Registrants Inventory of Drugs Surrendered DEA Form 106 Report of Theft or Loss of Controlled Substances DEA Form 222 U.S. Official Order Form for Controlled Substances DEA Form 224 Application for Registration DEA Form 224a Renewal Application for DEA Registration DEA Form 363 Application for Registration as a Narcotic Treatment Program DEA Form 363a Renewal Application for DEA Registration as a Narcotic Treatment Program


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See Reverse of PURCHASER’SCopy of Instructions

No order form may be issued for Schedule I and II substances unless acompleted application form has been received, (21 CFR 1305.04).

OMB APPROVALNo. 1117-0010

TO: (Name of Supplier) STREET ADDRESS

CITY and STATE DATE TO BE FILLED IN BY SUPPLIERSUPPLIERS DEA REGISTRATION No.

TO BE FILLED IN BY PURCHASERLINE

No.

No. ofPackages

Size ofPackage Name of Item National Drug Code Packages

ShippedDate

Shipped

1

2

3

4

5

6

7

8

9

10

LAST LINECOMPLETED (MUST BE 10 OR LESS)

SIGNATURE OR PURCHASEROR ATTORNEY OR AGENT

Date Issued DEA Registration No.

Schedules

Registered as a No. of this Order Form

Name and Address of Registrant

DEA Form-222(Oct. 1992)

U.S. OFFICIAL ORDER FORMS - SCHEDULES I & IIDRUG ENFORCEMENT ADMINISTRATION

SUPPLIER’S Copy 1

DEPICTION of PAGE 1 of DEA FORM-222U.S. OFFICIAL ORDER FORM - SCHEDULES I & II

Note: The graphic illustrated above is not intended to be used as an actual order form.


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