DEA Registration Compliance: A Practitioner’s Guide To Retaining Their Livelihood Through Controlled SubstancesMedical Defense
The Drug Enforcement Administration (“DEA”) and the Center for Disease Control (“CDC”) have identified opioid drug abuse in the United States fastest growing health crises in the Nation. In response, the DEA’s Diversion Control Program (“DCP”) has stepped up its efforts to revoke the ability of physicians to dispense controlled substances it considers to be improperly prescribing or diverting pharmaceutical medicines.[i] Since physicians are frequently required to have a valid DEA Certificate of Registration (“COR”) as a prerequisite for employment; membership on hospital medical staffs; enrollment on Medicare and Medicaid and third-party private insurance payors – loss of one’s DEA number can mean the end of most physician’s careers. Consequently, retaining the right lawyer can help the physician reestablish their practice as quickly as possible.
Under the “legitimate medical purpose” legal standard, individual practitioners may dispense controlled substances only if an acting in the usual course of his professional practice.”[ii] The Federal Controlled Substances Act (“CSA”) and its implementing regulations establish federal requirements regarding both illicit and licit controlled substances.”[iii] A “controlled substance” is defined as “a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V.” 21 U.S.C. § 802(6).[iv]
“With respect to pharmaceutical controlled substances, the DEA’s responsibility is two-fold: (1) to prevent diversion and abuse of these substances; (2) while ensuring an adequate and uninterrupted supply is available to meet the country’s legitimate medical, scientific, and research needs.”[v]
“The DEA administers this provision of the CSA by issuing a COR that authorizes a central individual or entity(s) (“Registrants”) to dispense controlled substances in Schedules II thru V of the CSA 21 U.S.C. § 81.”[vi] “In accordance with this mandate, the DEA, requires all businesses that import, export, manufacture, or dispense controlled substances; all health care practitioners entitled to give out, administer, or prescribe controlled pharmaceuticals; and all pharmacies authorized to fill prescriptions, to register with the DEA under 21 U.S.C. § 801 et seq. and 21 C.F.R. pt. 1300 (2014) et seq.”[vii]
According to the most recent tally by the Office of Inspector General (“OIG”) in March 2014, the DEA had 1.5 million active retail and wholesale Registrants.[viii] The DEA actively monitors these Registrants through a system of scheduling, quotas, recordkeeping, reporting, and security requirements.[ix] The Agency also uses criminal and regulatory tools to identify and determine who is most likely involved in the illicit distribution of controlled substances.[x] The DEA initiates criminal investigations on those suspected of criminal violations of the CSA.[xi] Criminal prosecutions are coordinated with an Assistant United States Attorney or state district attorney. Criminal cases vary widely in resource requirements and complexity. [xii]
Clearly, one of the central issues in making practitioners “responsible” for ensuring controlled substances are dispensed for a “legitimate medical purpose” is how much the DEA determines what medications are medically necessary. [xiii]
In United States v. Moore, 423 U.S. 122 (1975), the Supreme Court upheld the conviction of a physician alleged to have “knowingly or intentionally, dispensed or distributed [methadone] by prescription, and who did so other than in good faith in the usual course of a professional practice and in accordance with a standard of medical practice generally recognized and accepted in the United States.’” Id. at 138-39 (emphasis added).
That is, that the physicians “knowingly or intentionally, dispensed or distributed by prescription, other than in good faith in the usual course of a professional practice and in accordance with a standard of medical practice generally recognized and accepted in the United States.’” Moore, 423 at 138-39.
Absent clear compliance with this standard, the DEA’s stated policy is that “the government can investigate merely on suspicion that the law is being violated, or even just because it wants assurance that it is not”[xiv] United States v. Morton Salt Co., 338 U.S. 632, 642–643 (1950).[xv]
Non-compliant practitioners will be asked by DEA Diversion Investigators (“DI”) to surrender their DEA Registration. Usually, these requests come with a fair amount of threats of criminal prosecution and intimidation with everything from losing the practitioner’s professional license to lengthy prison sentences.
Those who refuse to acquiesce to these demands are subjected to Order to Show Cause (“OTSC”) proceedings on why the Registrant’s COR should not be revoked, suspended, or application for one denied. This authority is derived from an amendment to the CSA in 1984, which “gives the United States Attorney General the power to revoke the federal registrations of physicians and pharmacists for the purpose of addressing the severe problem of diversion of drugs of legitimate origin into the illicit market.”
If the DEA deems the violation to be egregious enough to pose an “imminent threat to public health or safety,” the DEA may issue an immediate suspension order that summarily revokes the Registrant’s authorization to prescribe or dispense controlled substances. If 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 give up the registration voluntarily, the DEA will pursue administrative action to revoke the DEA registration. The DEA may also pursue prosecution if there is sufficient evidence of illegal distribution or significant recordkeeping violations. All such actions should deny the practitioner the means to continue to divert or abuse controlled substances and to protect the health and safety of the public and the practitioner.
One quasi-judicial method for stripping the practitioner of his DEA COR are OTSC hearings and immediate suspension orders that are collectively known as “Registrant Actions.” Once the DEA Administrator issues an OTSC, the Registrant may either allow the DEA Administrator to issue a Final Decision and Order modifying or revoking the pharmacy’s COR or request an OTSC due process hearing. If the Registrant wants a hearing, a DEA Administrative Law Judge (“ALJ”) hears evidence presented by DEA Counsel and the Registrant. The ALJ will make ﬁndings on whether a preponderance of the evidence submitted shows the Registrant’s continued registration is “inconsistent with the public interest.”
The ALJ will then issue his or her Findings of Fact, Conclusions of Law and a Recommended Decision to the DEA Administrator. The DEA Administrator may agree or disagree with the recommendation of the ALJ and will render his or her ﬁnal Decision and Order adopting, modifying or rejecting the ALJ’s Findings of Fact, Conclusions of Law and a Recommended Decision.
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:
- Materially falsified any application filed
- Been convicted of a felony relating to a controlled substance or a List I chemical
- Had their state license or registration suspended, revoked, or denied
- Committed an act which would render the DEA registration inconsistent with the public interest
- 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:
- The recommendation of the appropriate state licensing board or professional disciplinary authority
- The applicant’s experience in dispensing or conducting research with respect to controlled substances
- The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances
- Compliance with applicable state, federal, or local laws relating to controlled substances
- Such other conduct which may threaten the public health and safety
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:
- The dispensing, administering, or prescribing is in the usual course of professional practice
- Practitioners may do so by the state in which they practice
- The hospital or institution has verified that the practitioner may dispense, administer or prescribe controlled substances within the state
- The practitioner acts only within the scope of employment in the hospital or institution
- 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 an example of a specific internal code number below):
A list of internal codes and the corresponding individual practitioners is to be maintained by the hospital or other institution. This list is to be provided always to other registrants and law enforcement agencies upon request for verifying the authority of the individual prescribing 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. Using 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 the 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 use the NPI in standard transactions by May 23, 2007.
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 authorized to prescribe, dispense, or administer, but not to procure or purchase controlled substances during his/her official duties. Such officials shall follow procedures 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 Federal Government practitioners wish to maintain a DEA registration for private practice, which would include prescribing for private patients, they must be 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.
Questions and Answers
These questions are those that are frequently encountered by DEA’s Office of Diversion Control and its field units. These questions and their answers are provided in the CSA and its federal regulations.
Q: Are separate registrations required for separate locations?
A: separate registration is needed 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 must 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 ordinary 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 a DEA Registration?
A: An individual practitioner who is an agent or employee 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 registered in lieu of being registered provided that additional requirements in the CFR are met.
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 authorized to prescribe, dispense, or administer, but not procure or purchase, controlled substances while his/her official duties. Such officials must follow procedures 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 may not procure or purchase controlled substances in their official duties.
Several states require military practitioners to acquire a separate state license if they issue prescriptions 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 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.
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 acknowledged that it is impossible to expand on the phrase “legitimate medical purpose in the usual course of professional practice” to provide definitive guidelines to address all the varied situations physicians may encounter.
While there are no criteria to address every conceivable instance of prescribing, recurring patterns may be indicative of inappropriate prescribing:
- An inordinately large quantity of controlled substances prescribed or scores 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;
- Using street slang rather than medical terminology for the drugs prescribed; or
- Do the logical relationship between the drugs prescribed and treatment of the condition is allegedly existing.
Each case must be evaluated based on its own merits because of the totality of circumstances to the physician and patient.
For example, what constitutes “an inordinately large quantity of controlled substances,” can vary widely from patient to patient. An amount of a potent Schedule II opioid might be blatantly excessive to treat a patient’s mild temporary pain, yet insufficient to treat the severe, unremitting pain of a cancer patient.
Q: What information must 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, 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 the same date that the prescribing practitioner writes and signs the prescription.
Q: Is there a time limit for filling Schedule II prescriptions?
A: There is no federal deadline for filling Schedule II prescriptions. However, some state laws set time limits.
[i] DEA’s Diversion Control Program (DCP) is responsible for enforcing the Controlled Substances Act (CSA) and its regulations pertaining to pharmaceutical controlled substances and listed chemicals.
[ii] 21 C.F.R. §1300.01 defines “prescription” as 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).
[iii] Controlled Substances Act. (n.d.). Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf
[iv] Controlled Substances Act – Wikipedia, the free encyclopedia. (n.d.). Retrieved from http://en.wikipedia.org/wiki/Schedule_III_(US)
[v] Controlled Substances Act. (n.d.). Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf
[vi] No prescriptions may be written for Schedule I substances, and they are not readily available for clinical use. Schedule I drugs are those that have a high potential for abuse. The drug or other substance has no currently accepted medical treatment use in the U.S. There is a lack of accepted safety for use of the drug or substance under medical supervision. The Substances listed in DEA Schedule I include:
LSD (Lysergic acid diethylamide)
Marijuana (cannabis, THC)
MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”)
GHB (gamma-hydroxybutyric acid)
Ecstasy (MDMA or 3,4-Methylenedioxymethamphetamine)
Bath Salts (3,4-methylenedioxypyrovalerone or MDPV)
NOTE: Tetrahydrocannabinol (THC, marijuana) is still considered a Schedule 1 drug by the DEA, even though some U.S. states have legalized marijuana for personal, recreational use or for medical use.
[vii] Office of Chief Counsel Diversion and Regulatory Litigation. (n.d.). Retrieved from http://www.deadiversion.usdoj.gov/mtgs/drug_chemical/2012/menendez%20.pdf
[viii] See The Drug Enforcement Administration’s Adjudication of Registrant Actions, Evaluation, and Inspections Report I-2014-003. p. 2.
[ix] U.S. Department of Justice Drug Enforcement Administration FY 2016 Performance Budget Congressional Submission DEA-81.
[xi] Ibid at DEA – 93.
[xiv] Supra fn. 29. (Citing DEA’s November 16, 2004 and September 6, 2006 Policy Statement).
36 https://oig.justice.gov/reports/2014/ e1403-summary.pdf. 37 S. Rep. No. 98-225 at 260, 261-62, 1984 U.S.C. C.A.N. at 343-344) (granting authority to the Attorney General to delegate regulatory authority to the DEA). 38 21 U.S.C. §§ 823 & 824, https://www.oig. justice.gov/reports/2014/e1403.pdf. 39 FY 2014 Annual Performance Report and FY 16 Annual Performance Report available at http://www.justice.gov/sites/default/files/doj/ pages/attachments/2015/02/06/fy14. 40 ARTICLE: DRUG DIVERSION ADMINISTRATIVE REVOCATION AND APPLICATION HEARINGS FOR MEDICAL AND PHARMACY PRACTITIONERS: A PRIMER FOR NAVIGATING MURKY, DRUG-INFESTED WATERS, 78 Alb. L. Rev. 327 (2014). 41 DEA Regulation 21 C.F.R. § 1307.37(c) states: “OTSC shall call upon registrant to appear before the Administrator and contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of the registration and a summary of the matters of fact and law asserted.”
42 21 U.S.C. § 824. 43 SENATE STAFF ANALYSIS AND ECONOMIC IMPACT STATEMENT, available at http://leg.state.ﬂ.us/data/session/2001/ Senate/bills/analysis/pdf/2001s1042.