Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Practitioner's Manual - APPENDIX B

APPENDIX B

Questions and Answers

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

Question: Are separate registrations required for separate locations?

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

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

Answer: 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.

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

Answer: 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.

Question: Do medical residents assigned to hospitals need to register?

Answer: 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.

Question: Are military personnel exempted from registration?

Answer: 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 but state branch of service or agency and the service identification number of the issuing official in lieu of the DEA registration number required on the prescription forms.

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 write prescriptions that are filled outside the military facility where they practice.

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

Answer: 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.

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

Answer: 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.

Question: What is meant by "acceptable medical practice?"

Answer: 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
  • No 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.

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

Answer: 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.

Question: What is meant by "date of issuance?"

Answer: The date a prescription is issued is the same date that the prescribing practitioner actually writes and signs the prescription.2

2 On September 6, 2006, the DEA published in the Federal Register a Notice of Proposed Rulemaking, which proposes to permit an individual practitioner to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. If and when this proposed rule becomes final, DEA will update this manual as appropriate.

Question: Is there a time limit for filling Schedule II prescriptions?

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

Appendix A Table of Contents | Appendix C

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