The National Alliance of Advocates
for Buprenorphine Treatment

Buprenorphine (Suboxone®, Subutex®3, Zubsolv™4, Bunavail™5) is an opioid medication used to treat opioid addiction in the privacy of a physician's office.1 Buprenorphine can be dispensed for take-home use, by prescription.1 This, in addition to the pharmacological and safety profile of buprenorphine, makes it an attractive treatment for patients addicted to opioids.2

Laws

Learn about the laws concerning opioids from the 1800s until today.

A History of Opiate Laws in the United States

Prior to 1890, laws concerning opiates were strictly imposed on a local city or state-by-state basis. One of the first was in San Francisco in 1875 where it became illegal to smoke opium only in opium dens. It did not ban the sale, import or use otherwise. In the next 25 years different states enacted opium laws ranging from outlawing opium dens altogether to making possession of opium, morphine and heroin without a physician’s prescription illegal.

The first Congressional Act took place in 1890 that levied taxes on morphine and opium. From that time on the Federal Government has had a series of laws and acts directly aimed at opiate use, abuse and control. These are outlined below:

1906 – Pure Food and Drug Act
Preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes. Punishment included fines and prison time.

1909   – Smoking Opium Exclusion Act
Banned the importation, possession and use of "smoking opium". Did not regulate opium-based "medications". First Federal law banning the non-medical use of a substance.

1914  – The Harrison Act
In summary, The Harrison Act of 1914 was written more to have all parties involved in importing, exporting, manufacturing and distributing opium or cocaine to register with the Federal Government and have taxes levied upon them. Exempt from the law were physicians operating “in the course of his professional practice”

1919 – Supreme Court ratified the Harrison Anti-Narcotic Act in Webb et al., v. United States and United States v. Doremus, then again in Jin Fuey Moy v. United States, in 1920, holding that doctors may not prescribe maintenance supplies of narcotics to people addicted to narcotics. However, it does not prohibit doctors from prescribing narcotics to wean a patient off of the drug. It was also the opinion of the court that prescribing narcotics to habitual users was not considered “professional practice” hence it then was considered illegal for doctors to prescribe opioids for the purposes of maintaining an addiction. It can be argued that today’s addiction medications are not intended to maintain an addiction but to facilitate addiction remission. In which case, this opinion of the court should not preclude practitioners from prescribing buprenorphine or methadone to patients suffering from an addictive disorder.

1924  – Heroin Act
Prohibited manufacture, importation and possession of heroin illegal – even for medicinal use.

1922 -- Narcotic Drug Import and Export Act
Enacted to assure proper control of importation, sale, possession, production and consumption of narcotics.

1927  -- Bureau of Prohibition
The Bureau of Prohibition was responsible for tracking bootleggers and organized crime leaders. They focused primarily on interstate and international cases and those cases where local law enforcement official would not or could not act.

1932 -- Uniform State Narcotic Act
Encouraged states to pass uniform state laws matching the federal Narcotic Drug Import and Export Act. Suggested prohibiting cannabis use at the state level.

1938 -- Food, Drug, and Cosmetic Act
The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold

1951 -- Boggs Act
Imposed maximum criminal penalties for violations of the import/export and internal revenue laws related to drugs and also established mandatory minimum prison sentences.

1956 -- Narcotics Control Act
Increased Boggs Act penalties and mandatory prison sentence minimums for violations of existing drug laws.

1965 -- Drug Abuse Control Amendment
Enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens. Restricted research into psychoactive drugs such as LSD by requiring FDA approval.

1970 -- Controlled Substance Act | Controlled Substances Import and Export Act
These laws are a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. The CSA places all substances that are regulated under existing federal law into one of five schedules. This placement is based upon the substance's medicinal value, harmfulness, and potential for abuse or addiction. Schedule I is reserved for the most dangerous drugs that have no recognized medical use, while Schedule V is the classification used for the least dangerous drugs. The act also provides a mechanism for substances to be controlled, added to a schedule, decontrolled, removed from control, rescheduled, or transferred from one schedule to another.

1973 – Drug Enforcement Agency
By Executive Order, the DEA was formed to take place of the Bureau of Narcotics and Dangerous Drugs.

1974 –Narcotic Addict Treatment Act of  1974  - Public Law 93-281
Amends the Controlled Substance Act of 1970 to provide for the registration of practitioners conducting narcotic treatment programs. [methadone clinics] It also provides legal definitions for the phrases “maintenance treatment” and “detoxification treatment”.

1986 -- Anti-Drug Abuse Act of 1986
Strengthened Federal efforts to encourage foreign cooperation in eradicating illicit drug crops and in halting international drug traffic, to improve enforcement of Federal drug laws and enhance interdiction of illicit drug shipments, to provide strong Federal leadership in establishing effective drug abuse prevention and education programs, to expand Federal support for drug abuse treatment and rehabilitation efforts, and for other purposes. It also re-imposed mandatory sentencing minimums depending on which drug and how much was involved.

1988 -- Anti-Drug Abuse Act of 1988
Established the Office of National Drug Control Policy (ONDCP) in the Executive Office of the President; authorized funds for Federal, state and local drug enforcement activities, school-based drug prevention efforts, and drug abuse treatment with special emphasis on injecting drug abusers at high risk for AIDS.

2000 -- Federal – The Drug Addiction Treatment Act of 2000 (DATA 2000)
It enables qualified physicians to prescribe and/or dispense narcotics for the purpose of treating opioid dependency. For the first time, physicians are able to treat this disease from their private offices or other clinical settings. This presents a very desirable treatment option for those who are unwilling or unable to seek help in drug treatment clinics. Patients can now be treated in the privacy of their doctor’s office, as are other people being treated for any other type of medical condition. One medicine doctors may now prescribe is Buprenorphine. The major downfall of this Act is the limitation of 30 patients per practice – which means that large facilities, no matter how many physicians are there, can only treat 30 patients at a time.

2002-- DEA reschedules buprenorphine from a schedule V drug to a schedule III drug, on October 7, 2002 - the day before the FDA approval of Suboxone and Subutex despite overwhelming objection by the medical community.

2004: June 2004 THE CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE
PATIENT RECORDS REGULATION AND THE HIPAA PRIVACY RULE:

Confidentiality of Alcohol and Drug Dependence Patient Records (summary) Code of Federal Regulations Title 42 Part 2 (42 CFR Part 2)

The confidentiality of alcohol and drug dependence patient records maintained by this practice/program is protected by federal law and regulations. Generally, the practice/program may not say to a person outside the practice/program that a patient attends the practice/program, or disclose any information identifying a patient as being alcohol or drug dependent unless:

  • The patient consents in writing;
  • The disclosure is allowed by a court order, or
  • The disclosure is made to medical personnel in a medical emergency or to qualified personnel for research,  audit, or practice/program evaluation.

Violation of the federal law and regulations by a practice/program is a crime. Suspected violations may be reported to appropriate authorities in accordance with federal regulations. Federal law and regulations do not protect any information about a crime committed by a patient either at the practice/program or against any person who works for the practice/program or about any threat to commit such a crime. Federal laws and regulations do not protect any information about suspected child abuse or neglect from being reported under state law to appropriate state or local authorities.

sample consent form (MS-WORD)

2005: 08-02-2005 Public law 109-56, Amends the Controlled Substances Act to eliminate the 30-patient limit for medical group practices allowed to dispense narcotic drugs in schedules III, IV, or V for maintenance or detoxification treatment (retains the 30-patient limit for an individual physician). This amendment removes the 30-patient limit on group medical practices that treat opioid dependence with buprenorphine. The restriction was part of the original Drug Addiction Treatment Act of 2000 (DATA) that allowed treatment of opioid dependence in a doctor's office. With this change, every certified doctor may now prescribe buprenorphine up to his or her individual physician limit of 30 patients.

2006: On 12/29/2006 President Bush signed Bill H.R.6344 into law. This allows physicians who have been certified to prescribe certain drugs for the treatment of opioid dependence under DATA2000 to treat up to 100 patients (up from 30) by submitting an "intent" notification to the Dept of Health and Human Services. This is a major step forward in both fighting the stigma and allowing access to treatment previously not available to some. For more details see 30/100-PATIENT LIMIT

Sources:

www.archives.gov/research_room/federal_records_guide
www.cga.ct.gov
www.dea.gov
www.druglibrary.org
www.fda.gov/oc/history/historyoffda/section2.html
www.firstgov.gov
www.gpoaccess.gov/databases.html
www.michigan.gov/mdch/0,1607,7-132-2941_4871-30114--,00.html
www.narconon.org/druginfo/heroin_timeline.html
www.nida.nih.gov/about/legislation/Chronology.html
http://thomas.loc.gov
www.whitehousedrugpolicy.gov

This page was last modified on : 10/29/2013

The Purpose of Buprenorphine Treatment:

To suppress the debilitating symptoms of cravings and withdrawal, enabling the patient to engage in therapy, counseling and support, so they can implement positive long-term changes in their lives which develops into the new healthy patterns of behavior necessary to achieve sustained addiction remission. - explain -

The National Alliance of Advocates for Buprenorphine Treatment is a non-profit organization charged with the mission to:

  1. U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
  2. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.
  3. Subutex Discontinued in the US market in late 2011.
  4. Zubsolv (bup/nx sublingual tablet) FDA approved 7/3/2013 see buprenorphine pipeline graphic
  5. Bunavail (bup/nx bucal film) FDA approved 6/6/2014 see buprenorphine pipeline graphic
  6. Probuphine Rejected by FDA 4/30/2013 - may resubmit in late 2015 - Probuphine denied by FDA