Government Regulations on Prescribing Controlled Substances

Government Regulations on Prescribing Controlled Substances


This guide provides:

  • A synopsis of the main Federal regulations on prescribing opioids
  • Information on how Federal and state regulations interact
  • Access to the complete Federal regulations and State regulations on prescribing opioids
  • Case examples

Substantial changes in these regulations have occurred in recent years and so clinicians should review both state and federal policies to fully understand their responsibilities (Chou et al, 2009).

This guide adapted by Clinical Tools with permission from: Heit, HA. Regulatory update: What every physician must know. Presented in New Orleans, LA on April 30, 2009.
Last Updated by Clinical Tools, Inc. in November 2010


Federal Regulations Introduction

Federal Regulations Introduction

Did you know?: Only 0.1% of active patient care physicians had criminal and/or administrative charges and sanctions against them related to prescribing opioid analgesics between 1998 and 2006 (Goldenbaum, et al, 2008).

Federal laws concerning the possession, use, and prescription of controlled substances are defined by the Controlled Substances Act (CSA) and Federal Food, Drug, and Cosmetic Act (FDCA). Five schedules or levels of drugs and chemical are based upon the substance's medical use, potential for abuse, and safety or dependence liability. The Act also provides a mechanism for substances to be controlled, or added to a schedule; decontrolled, or removed from control; and rescheduled or transferred from one schedule to another. The procedure for these actions is found in Section 201 of the Act (21 U.S.C. 811).

Examples of opioid scheduling are the following:

  • Example of schedule I: Heroin (no accepted medicinal purpose)
  • Example of schedule II: Oxycodone
  • Example of schedule III: Combinations of codeine with aspirin or acetaminophen

States may place a substance in another schedule, for example tramadol is unscheduled by the DEA but is schedule IV in some states. The lowest schedule on either the federal or state list applies.

View ReferencesHide References
Goldenbaum DM, Christopher M. Gallagher RM, Physicians charged with opioid-analgesic prescribing offenses. Pain Med. 2008; 9(6): 737-747.
Regulations.gov. Answers to frequently asked questions (FAQs). Regulations.gov. 2010. Accessed on: 2010-07-12.
U.S. Government Printing Office. Code of Federal regulations: About. U.S. Government Printing Office. 2010. Available at: http://www.gpo.gov/help/index.html Accessed on: 2014-04-28.


Description: 
This website provides access to the official version of the U.S. federal regulations on prescribing and dispensing controlled substances.
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U.S. Govt. Printing Office
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Prescription Requirements

Prescription Requirements

21 CFR 1306.11

  • Prescriptions for Schedule II controlled substances must be written. Facsimile of a schedule II prescription may serve as the original written prescription in the following circumstances:
  • Patient is a resident of a long-term care facility
    • Prescription faxed to dispensing pharmacy
  • Patient enrolled in a hospice program certified/paid for by Medicare under Title XVIII or licensed by the state
    • Prescription faxed to dispensing pharmacy
    • Note on script: i.e. Hospice patient
  • For compounding for "direct administration" by parenteral, I.V., I.M., SQ, or intraspinal infusion

21 CFR 1306.21

  • Prescriptions for schedule III-V controlled substances may be written, faxed, or orally transmitted

21 CFR 1306.05

Prescriptions for controlled substances must:

  • be dated as of, and signed on, the day when issued and
    never be post dated
  • include full name and address of patient, drug name, dosage form, strength, quantity, and directions for use
  • include the name, address, and registration number of practitioner
  • be written with ink, indelible pencil, or typewriter and manually signed by the practitioner


Description: 
A list of questions answered by the Drug Enforcement Administration concerning controlled substances and their prescriptions.
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Tenets of Lawful Prescriptions

Tenets of Lawful Prescriptions

21 CFR 1306.04

  • Each separate prescription for a controlled substance must be issued:
    • For a legitimate medical purpose
    • By an individual practitioner acting in the usual course of professional practice

21 CFR 1306.04(b)

  • A prescription may not be issued for an individual practitioner in order to obtain controlled substances for the purpose of general dispensing to patients
  • All prescriptions must be written for a specific patient


Changes a Pharmacist Can and Cannot Make

Changes a Pharmacist Can and Cannot Make

Changes a pharmacist can make to a prescription for schedule II-V controlled substances

  • May add or change patient’s address upon verification
  • May add or change dosage form, drug strength, quantity, directions for use, or issue date:
    • Only after consultation with and agreement of the prescribing practitioner
    • Such changes are noted on the prescription and medical records
    • In compliance with state/local laws, regulations, or policies

Changes a pharmacist cannot make to a prescription for schedules II-V controlled substances

  • May never change the patient's name
  • May never change the controlled substance prescribed
  • May never change the prescriber's signature

A pharmacist cannot make changes to a prescription for a schedule II controlled substance

  • DEA stated that “the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)...may not be modified orally” (DEA, 2009).
View ReferencesHide References
Drug Enforcement Administration (DEA). Questions and answers. Office of Diversion Control, DEA, U.S. Dept of Justice. DEADiversion.usdoj.gov. 2009. Available at: http://www.deadiversion.usdoj.gov/faq/general.htm Accessed on: 2010-07-12.


Description: 
A list of questions answered by the Drug Enforcement Administration concerning controlled substances and their prescriptions.
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Partial Prescription Filling

Partial Prescription Filling

21 CFR 1306.13

  • A pharmacist can partially fill a prescription for a schedule II controlled substance if:
    • Unable to supply the full quantity of a written or emergency oral prescription
    • Notates the quantity supplied on the prescription face
    • Fills remaining portion of the prescription within 72 hours
      • A new prescription is needed if the time goes beyond 72 hours
    • Pharmacist must notify the prescribing practitioner if unable to supply the remaining portion of the prescription
  • A patient with a terminal illness or in a long term care facility (LTCF) may have a prescription filled in partial quantities
    • Pharmacist must record on the prescription whether the patient is terminally ill or a LTCF patient
    • The prescription is valid for a period not to exceed 60 days from the date of issuance unless sooner terminated by the discontinuation of the medicine


Sequential Prescriptions (Do Not Fill Until...)

Sequential Prescriptions (Do Not Fill Until...)

21 CFR 1306.12

  • Sequential prescriptions up to a 90-day supply of a Schedule II controlled substance are permitted
    • Example:  Writing 3 prescriptions to be dispensed every 30 days by the pharmacist (all prescriptions have the same date of issuance)
      • Write one prescription for one-third of the total quantity of controlled substance to be prescribed
      • Write a second prescription for one-third of the total quantity of controlled substance to be prescribed
        • Write DO NOT FILL UNTIL ____/___/_____on the second prescription, with the date 30 days after the first prescription date of issue
      • Write a third prescription for one-third of the total quantity of controlled substance to be prescribed
        • Write DO NOT FILL UNTIL ____/___/_____on the third prescription, with the date 60 days after the first prescription date of issue

Interpretation of CFR 1306.12

  • Issuance of multiple prescriptions for schedule II controlled substances
    • DEA's regulations allow practitioners to provide individual patients with multiple prescriptions for a specific schedule II controlled substance, written on the same date, to be filled sequentially
    • This combined effect of such sequential multiple prescriptions is that it allows a patient to receive, over time, up to a 90-day supply of that controlled substance

21 CFR 1306.14(e)

  • A pharmacist cannot fill a prescription issued as one in a series of multiple prescriptions prior to the date written by the prescribing physician


Emergency Situations

Emergency Situations

Some Federal regulations regarding controlled substances address unique scenarios a physician may encounter while others are only applicable in certain situations. Examples of such regulations are discussed here and on the following pages.

21 CFR 1306.11

  • A pharmacist may dispense a schedule II controlled substance after receiving an oral authorization if:
    • Quantity is limited to the emergency period only!
    • Prescription shall be reduced to writing with all the required information except the signature of the practitioner
    • The pharmacist makes a reasonable attempt to make sure the oral authorization came from a registered practitioner
  • A pharmacist MUST receive the written prescription within 7 days from an oral authorization
    • The prescription should include:
      • A notation: “Authorization for Emergency Dispensing”
      • Date of oral authorization
  • If the information is not received within 7 days, the pharmacist is required to report this missing information to the DEA

21 CFR 290.10

  • The definition of an emergency situation includes:
    • Immediate administration of the controlled substance is necessary for proper treatment
    • No appropriate alternatives are available, including drugs in lower schedules or non-controlled drugs
    • Not reasonably possible for practitioner to provide a written prescription before dispensing


Narcotic-Dependent Patients

Narcotic-Dependent Patients

This section discusses the laws and required physician certifications concerning the treatment of pain for currently or previously narcotic-addicted patients.

21 CFR 1306.07

  • To administer or dispense directly (but not prescribe) narcotic drugs to a narcotic-dependent person for "detoxification" or "maintenance treatment," a physician MUST have a separate registration with the DEA as an opioid treatment program (OTP)
  • Can administer (not prescribe) a narcotic drug to relieve acute withdrawal symptoms while arranging for a referral to an OTP
    • In or out patient
      • One day's medication at a time
      • Can be done for 3 days
      • Cannot be renewed or extended
  • DEA does not impose any limitations on a physician or authorized hospital staff to administer or dispense (but not prescribe) narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction
  • May treat acute/chronic pain with a schedule II controlled substance in a recovering narcotic-addicted patient
    • Federal law or regulations do not prohibit the prescribing, dispensing, or administering of a narcotic medication to a narcotic-addicted patient for the purpose of alleviating pain if such prescribing is medically appropriate within standards set by the medical community
      • One must keep good records to document the physician is treating a pain syndrome and not the disease of narcotic addiction
  • May administer, prescribe, or dispense a schedule II controlled substance to a person with intractable pain in which no relief or cure is possible or none has been found after a reasonable effort
    • This language has served as the basis to define "intractable pain" in state law


Office Based Opioid Treatment

Office Based Opioid Treatment

Drug Addiction Treatment Act of 2000 (DATA 2000)

  • Permits Office-Based Opioid Treatment (OBOT)
    • Uses sublingual buprenorphine with or without naloxone
  • Prescribed by certified and specially trained physicians
    • Has received a waiver from the requirement to register as an NTP from the Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA)

The Office of National Drug Control Policy Reauthorization Act of 2006 (P.L. 109-469, ONDCPRA)

  • Modified restriction on the number of patients (30) a physician authorized under the Drug Addiction Treatment Act of 2000 (DATA 2000) can treat with buprenorphine with or without naloxone
  • Under, ONDCPRA, physicians who meet the following criteria may notify the Secretary of Health and Human Services (HHS) of their need and intent to treat up to 100 patients at any one time:
    • Must currently be qualified under DATA 2000
    • At least one year must have elapsed since the physician submitted the initial notification for authorization
    • Must certify his/her capacity to refer patients for appropriate counseling and other ancillary services
    • Must certify that the total number of patients at any one time will not exceed the applicable number

Buprenorphine for Pain

  • A formulation of buprenorphine that is specifically for the treatment of pain has been approved. A waver, required to treat opioid addiction with buprenorphine, is not required to treat pain with buprenorphine.


Description: 
Frequently asked questions by patients, physicians, and pharmacists about buprenorphine and its general information.
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SAMHSA
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Federal and State Policy Examples

Federal and State Policy Examples

Length of time a Schedule II controlled substance prescription is valid

  • Federal regulations
    • No limit
    • The Controlled Substances Act and Drug Enforcement Administration regulations contain no specific limits on the number of days worth of a Schedule II controlled substance that a physician may authorize per prescription
  • State specific
    • Virginia
      • Six-month limitation
    • Hawaii
      • Three-day limitation

Amount or duration of a Schedule II controlled substance that can be prescribed at one time

  • Federal regulations
    • No limit
  • State specific
    • Virginia
      • No limit
    • Hawaii
      • 34-day supply/100 dosage units

 



Reporting a Crime and Privileged Information

Reporting a Crime and Privileged Information

Information communicated to a physician in an effort to procure unlawfully a prescription drug or the administration of a prescription drug is not privileged communication

  • The physician no longer is bound by the physician-patient relationship
  • However, the physician is not obligated to report the criminal behavior

Health Insurance Portability and Accountability Act (HIPAA)

  • There is an exception for reporting crimes against a provider
    • The exception is limited to the information needed to report the necessary facts; it does not authorize turning over the patient's entire chart, including unrelated materials, to the police
    • It does permit a full report, sufficient to enable identification of the perpetrator and prove all elements of the crime


Electronic Prescriptions for Controlled Substances

New Electronic Prescription Regulations from the DEA

The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.

State Regulations

State Regulations

State Policies for the Use of Controlled Substances in Pain Treatment

Healthcare professionals must comply with both federal and state lawas and regulations that govern prescribing scheduled controlled substances (Federation of Medical Boards, 2004).

States attempt to maintain a balance with Federal regulations in order to prevent abuse and diversion of controlled substances and to ensure their accessibility for genuine medical purposes. Both Federal and State governments should establish a system of controls to prevent abuse, trafficking, and diversion of controlled substances and at the same time ensure medical availability (Joranson, 1990).

States have the ability to schedule or reschedule a drug depending on its use within a particular state. Usually, an unscheduled substance is placed on a schedule for that state or a scheduled substance is placed on a higher schedule. In an attempt to increase control over the use of certain controlled substances, some states have limited dosage size or required the use of government-issued prescribing forms in specific situations.

  • States with pain treatment policy: 47
  • States with no pain treatment policy: 4 (AK, DE, IL, IN)

(Pain & Policy Studies Group, March 2008)

  • See the related resource below to review your state's treatment policy
View ReferencesHide References
Angarola RT. Joranson DE, State controlled substances laws and pain control. Aust Prosthodont Soc Bull. 1992; 2(3): 10-11, 15.
Federation of State Medical Boards of the United States. Model policy for the use of controlled substances for the treatment of pain. Federation of State Medical Boards of the United States, Inc. 2004. Available at: http://library.fsmb.org/pdf/2004_grpol_Controlled_Substances.pdf Accessed on: 2010-05-13.


Case Studies

Case Studies

Case 1

(adapted from Goldenbaum, et al, 2008)

  • 70 yr old physician in a small solo practice
  • Most patients are elderly and experience pain ranging from minor to severe.
  • Physician begins prescribing high-dosage, sustained-release opioid analgesics.
  • One patient nearly dies from an overdose and the family reports the incident to the state medical board.
  • Investigators deemed many of the prescriptions unnecessary.
  • Why is the physician fined, the practice put on probation, and the DEA controlled substance registration suspended?

    • The physician has violated federal regulation 21 CFR 1306.04, which states that each controlled substance prescription must be issued for a legitimate medical purpose.

Case 2

  • 40 yr old general practitioner in a small community
  • The physician is 7 patients behind the daily schedule, and the waiting room is full.
  • A chronic pain patient comes in for an appointment for ongoing monitoring and needs a prescription for the schedule II opioid that he is prescribed regularly.
  • The physician hurries through the appointment and tells the patient that the prescription for a schedule II opioid will be faxed to the pharmacy later in the day. He asks a nurse to take care of it and moves on to the next patient.
  • Does this follow federal guidelines?

    • According to federal regulation 21 CFR 1306.11, all schedule II controlled substances must be written by the physician. A facsimile of the prescription may be sent to the pharmacist to expedite the filling of the prescription, however, the pharmacist must receive a hard written copy before dispensing the medication.

Case 3

  • A patient arrives at a pharmacy requesting a refill for a schedule III opioid prescription.
  • The pharmacist notices that this is the fifth refill on the prescription, and it has been 5 months since the prescription was written (the patient skipped a couple of months due to lack of pain).
  • The pharmacist calls the prescribing physician to inquire if the prescription can be filled.
  • If the physician OK's the refill and the pharmacist fills the prescription, is this acceptable within the federal regulations for prescribing controlled substances?

    • The prescription can be filled according to federal regulations. Federal law 21 CFR 1306.22 authorizes a schedule III or IV medication to be dispensed up to 6 months after the date of issuance (maximum of 5 refills). State limits may vary.

Case 4

  • A physician in Hawaii wrote a prescription for a schedule II opioid.
  • The patient's arthritis-related pain decreased immediately after the appointment so she did not try to fill the prescription until her pain flared up 2 weeks later.
  • Will the pharmacist be able to fill this prescription?

    • No. Although US federal regulations provide no time limits on dispensing schedule II drugs after the prescription is issued in these circumstances, the state of Hawaii has a 7 day time limit.

      Healthcare professionals must comply with both federal and state laws and regulations that govern prescribing scheduled controlled substances. When federal laws or regulations differ from state laws or regulations, the more stringent rule applies. (Fed. State Med. Boards, 2004).

View ReferencesHide References


Description: 
This series of five clinical vignettes focuses on common concerns of clinicians and illustrates the relationship between the Drug Enforcement Administration (DEA) and health professionals, noting that the DEA can help explain federal regulations on legally prescribing controlled substances to patients. Authors: Heit HA, Covington E, Good PM.
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Pain Medicine
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Federal and State Overlap

Federal and State Overlap

The primary objective of Federal and state regulations may be identical, but frequently, the laws contradict one another. However, a physician should acknowledge this fact and understand which law he or she is obliged to follow. The ensuing pages offer examples of such circumstances and how a physician should respond.

Dual Obligation of Governments

  • Establish system of controls to prevent abuse, trafficking, and diversion of controlled substances
  • Ensure medical availability

Federal vs. State Regulations: Which to comply to?

  • Healthcare professionals must act in accordance with both federal and state laws and regulations that govern prescribing scheduled controlled substances
  • When federal laws or regulations differ from state laws or regulations, the more stringent rule applies


Prescription Refills and Date Limitations

Prescription Refills and Date Limitations

21 CFR 1306.12

  • Prescriptions for schedule II controlled substances cannot be refilled

21 CFR 1306.13

  • Prescriptions for schedule II have no specific time limitations on dispensing after the prescription is issued other than 60 days if the patient is in a long term care facility or has a medical diagnosis documenting a terminal
    illness.

    State specific limitations vary on dispensing time from date of issuance for schedule II: e.g., Virginia's is 6 months and Hawaii's is 7 days.

21 CFR 1306.22

  • Prescriptions for Schedule III and IV controlled substances cannot be dispensed after 6 months from date of issue or refilled more than 5 times
  • Rules for refilling Schedule V controlled substances are not established by federal law, and the authorized number of refills depends on the professional judgment of the prescriber and the pharmacist


Family and Self Prescription

Family and Self Prescription

No specific state or federal regulations for prescribing of drugs for family or self

  • State guidelines do not have the force of a law or regulation

Drug Control Act of Virginia

  • State-specific; therefore, check your state's guidelines
    • Prescriber must have a bona fide physician-patient relationship with any person for whom he or she prescribes controlled substances

Virginia guidelines for treatment of self

  • Self-prescribing
    • A physician cannot have a bona fide physician-patient relationship with himself or herself
    • Only in an emergency should a physician prescribe himself or herself a nonscheduled medication
    • Prescribing a Schedule II, III, IV, or V controlled substance to himself or herself is prohibited

Virginia guidelines for treatment of immediate family members

  • Treatment of immediate family should be reserved only for minor illnesses or emergency situations
  • Appropriate consultation should be obtained for managing major or extended periods of illness
  • No Schedule II, III, or IV controlled substances should be dispensed or prescribed except in emergency situations
  • Records should be maintained of all written prescriptions and the dispensing or administration of any drugs


Regulations on Crimes

Regulations on Crimes

No specific state or federal regulations for criminal behavior

  • State-specific; therefore, check your state's guidelines

Wisconsin's Pharmacy Act [s450.11(7)]

  • No person may obtain or attempt to obtain a prescription drug, or procure or attempt to procure the administration of a prescription drug by:
    • Fraud
    • Deceit
    • Willful concealment or by forgery or alteration of a prescription order
    • Willful concealment of a material fact or by use of a false name or address


Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies

The FDA is considering requiring Risk Evaluation and Mitigation Strategy (REMS) for certain opioids in order to decrease rates of misuse, abuse, overdose and death (FDA, 2010a). A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required for long-acting and extended release opioids if FDA finds that it is necessary to ensure that the benefits of the drugs or biological products outweigh the risks of the products. Some drug and biological products that were previously approved/licensed with risk minimization action plans may now be required to have a REMS.

News:

July 2010: The FDA proposal released in July 2010 for opioid risk evaluation and mitigation strategy (REMS) did not require physician and patient training; however, this plan was highly criticized by an advisory panel and the agency is working to review recommendations.The FDA says it will closely monitor the proposed REMS and responses to it, and reserves the right to make further restrictions, including mandatory prescriber education and patient registration, if the more limited REMS fails to curb serious adverse outcomes (FDA, 2010b). The FDA plans on releasing final guidelines in 2011.

View ReferencesHide References
US Food and Drug Administration (FDA). FDA Opioid REMS Proposal Contains No Mandatory Physician Training. FDAnews. 2010b; 7 (128).
US Food and Drug Administration (FDA). Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting. US Food and Drug Administration. 2010a.


Summary

Summary

  • Federal regulations concerning the prescription of controlled substances are updated annually and have the force of law.
  • State regulations attempt to complement Federal regulations to prevent substance misuse and enhance medical accessibility.
  • Federal and state regulations regarding controlled substances have similar objectives, but if they differ in a certain circumstance, the more strict rule always applies.


Description: 
This website provides access to the official version of the U.S. federal regulations on prescribing and dispensing controlled substances.
Source: 
U.S. Govt. Printing Office
field_vote: 
Chronic Opioid Therapy: 
Tags: