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DEA PRACTITIONERS MANUAL ABRIDGED

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section1.htm

 

SECTION I- INTRODUCTION

This manual summarizes the requirements under Controlled Substances Act (CSA), 21 USC 801-890, and the DEA regulations, Title 21, Code of Federal Regulations(CFR), Parts 1300 to 1316.   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.

SECTION II- GENERAL REQUIREMENTS

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.

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.

A duplicate Certificate of Registration may be requested online. It appears on DEA’s website, www.DEAdiversion.usdoj.gov,

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.

The registration renewal application may be completed online at www.DEAdiversion.usdoj.gov

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 online 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. 1.Materially falsified any application filed
  2. 2.Been convicted of a felony relating to a controlled substance or a List I chemical
  3. 3.Had their state license or registration suspended, revoked, or denied
  4. 4.Committed an act which would render the DEA registration inconsistent with the public interest
  5. 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. 1.The recommendation of the appropriate state licensing board or professional disciplinary authority
  2. 2.The applicant’s experience in dispensing or conducting research with respect to controlled substances
  3. 3.The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances
  4. 4.Compliance with applicable state, federal, or local laws relating to controlled substances
  5. 5.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 oremployees 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. 1.The dispensing, administering, or prescribing is in the usual course of professional practice
  2. 2.Practitioners are authorized to do so by the state in which they practice
  3. 3.The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state
  4. 4.The practitioner acts only within the scope of employment in the hospital or institution
  5. 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):

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. 

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 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.

 

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

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

Safeguards for Prescribers

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

  1. 1.Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.
  2. 2.Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order.
  3. 3.Use prescription blanks only for writing a prescription order and not for notes.
  4. 4.Never sign prescription blanks in advance.
  5. 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. 6.Contact the nearest DEA field office (see Appendix E) to obtain or to furnish information regarding suspicious prescription activities.
  7. 7.Use tamper-resistant prescription pads.

 

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. 1.Whether the inventory was taken at the beginning or close of business
  2. 2.Names of controlled substances
  3. 3.Each finished form of the substances (e.g., 100 milligram tablet)
  4. 4.The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle)
  5. 5.The number of commercial containers of each finished form (e.g., four 100 tablet bottles)
  6. 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.

 

SECTION V – VALID PRESCRIPTION REQUIREMENTS

Prescription Requirements

Aprescription is an order for medication which is dispensed to or for an ultimate user. A prescriptionis 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. 1.drug name
  2. 2.strength
  3. 3.dosage form
  4. 4.quantity prescribed
  5. 5.directions for use
  6. 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. 1.Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice
  2. 2.Registered with DEA or exempted from registration (that is, Public Health Service, Federal Bureau of Prisons, or military practitioners)
  3. 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.

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 professionalpractice. 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 controlledsubstances 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. 1.Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
  2. 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. 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. 4.The issuance of multiple prescriptions is permissible under applicable state laws.
  5. 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.

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. 1.
  2. 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. 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.

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.

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 online.

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 .

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

 

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

Locked Cabinet or Other Secure Storage

Locked Cabinet or Other Secure Storage

Theft or Significant Loss

Report and complete DEA Form 106

Report and complete DEA Form 106

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.