by Oxana Lypska, PharmD Candidate 2021
Dan van Oss, PharmD Candidate 2024
Eric Raine, PharmD Candidate 2024
As the opioid crisis continues, there are an increasing number of prescriptions being written for buprenorphine. As such, it is important to understand the many laws surrounding this medication so that we can do our part as pharmacists during this difficult time. There are numerous statutes and regulations that govern the use of medication-assisted treatment (MAT) for opioid addiction, which often includes the use of buprenorphine. Among these regulating bodies is the Substance Abuse and Mental Health Services Administration (SAMHSA) Division of Pharmacologic Therapies, which oversees the standards of accreditation, as well as certification processes for opioid treatment programs (OTP). This division also works with the Drug Enforcement Agency (DEA) and state governments to regulate medications that could be used in OTPs. In addition to these entities, some medications used in MAT are regulated by Title 21 Chapter 13 Subchapter I of the Controlled Substances Act, which has policies overseeing the manufacturing, importation, possession, use, and distribution of controlled substances. Recently, many of the laws surrounding buprenorphine have changed, and staying current on these changes is vital to effective and lawful pharmacy practice.
Buprenorphine is a schedule III-controlled substance drug under the Controlled Substances Acts of both New York State and our federal government. The medication works as a partial opioid agonist that was developed to treat patients struggling with opioid addiction; buprenorphine can be used for detoxification as well as regular maintenance treatment of opioid addiction. The drug acts by minimizing the cravings and withdrawal associated with stopping opioid use, and it has the added benefit of inhibiting the feeling of euphoria from using other opioids. Buprenorphine comes in many different forms - including sublingual, implantable, and injection, allowing patients and physicians multiple treatment options. See table 1 (below) for common forms of buprenorphine. More information on buprenorphine for opioid addiction treatment may be found here.
Physicians who prescribe buprenorphine for the treatment of narcotic addiction must register for a waiver upon the completion of specified training with the DEA prior to prescribing for the medication, as per the Rules and Regulations of Controlled Substances. The Drug Addiction and Treatment Act (DATA) of 2000 waived requirements for physicians to obtain a separate DEA number as a Narcotic Treatment Program (NTP). As a result, physicians registered with the DEA who apply and have the qualifications pursuant to DATA 2000 are issued a waiver authorizing them to treat patients for maintenance and detoxification of narcotic addiction with schedule III, IV, and V medications outside of treatment program clinics. These physicians with a waiver are issued an additional DEA number that begins with an “X”. This X-DEA number must be included on all prescriptions for drugs that contain buprenorphine when used for opioid dependence. Authorized prescribers may not exceed the limit set by DATA 2000 on the number of patients that they may treat with buprenorphine. When prescriptions are phoned in, pharmacists must have this number on the prescription record. Hospital and mid-level prescribers do not qualify for participation in this program under the DATA 2000, but newer regulations have changed this; see below. Although an OTP must be certified by SAMHSA and licensed by the state, they are neither required to obtain a DATA 2000 waiver, nor subject to the same patient limits as registered physicians.
There have been some changes to the DATA 2000 over time. This law initially allowed physicians to apply for a waiver to prescribe buprenorphine to treat opioid addiction outside of an opioid treatment program. In order to do so, prescribers must meet the following requirements: they have to have a current state medical license, a valid DEA registration, and a certification in addiction from an approved medical organization, such as the American Society of Addiction Medicine. None of the bodies governing these medications have any rules against the use of buprenorphine to maintain or detoxify a patient as an adjunct to medical or surgical conditions other than opioid dependency. This means that if a patient is admitted to the hospital for a condition other than opioid dependency, buprenorphine may be administered (but not prescribed) to avoid an opioid withdrawal that could further complicate the primary problem. In such a case, a DATA waiver is not required for the physician, but a consultation with the addiction treatment provider is recommended to obtain treatment history. Such an exception is also possible in instances where the prescriber administers (but does not prescribe) buprenorphine to relieve acute withdrawal symptoms, while arranging for a referral for follow-up treatment. This exception is known as the “Three Day Rule”, found in Part 1306 in the Title 21 Code of Federal Regulations, and must adhere to the following conditions:
● No more than a single day’s medication may be administered to the patient at a time
● Treatment may not be continued for more than 72 hours
● The 72-hour period may not be renewed or extended in any way
The purpose of Part 1306.07 is to give providers some level of flexibility in cases of emergency, where he or she may be confronted with an individual experiencing withdrawal, and obtaining a waiver may not be practicable.
DATA 2000 allows for a prescriber to treat up to 30 patients. If the prescriber maintains this for a year, they may apply for up to 100 patients. As of 2016, the Comprehensive Addiction Recovery Act (CARA) allows licensed Physician Assistants and Nurse Practitioners to also obtain waivers to prescribe buprenorphine. CARA also expanded the ability of qualifying practitioners to treat up to 100 patients in their first year of having the DATA waiver, on account of meeting one of the following conditions:
● Currently hold a board certification in addiction medicine or addiction psychiatry by the American Board of Preventive Medicine or American Board of Psychiatry and Neurology
● Provide MAT within a qualified practice setting
Following enactment of CARA, a rule was published in the Federal Register, titled, “Medication Assisted Treatment for Opioid Use Disorders” stating that eligible prescribers who have maintained their waiver for a full year may apply to increase the number of patients they may treat from 100 patients to up to 275 patients.
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act of 2018 expanded the definition of “qualifying prescribers” to more than physicians, which now includes Clinical Nurse Specialists, Certified Registered Nurse Anesthetists, Certified Nurse Midwives (CNSs, CRNAs, and CNMs), Nurse Practitioners, and Physician Assistants until October 1st, 2023. Compared to the eight hours of training required for physicians, these qualifying prescribers are required to have 24 hours.
Buprenorphine products are now available in pharmacies throughout the United States. Pharmacists and pharmacies do not need a waiver to dispense buprenorphine. However, pharmacists still have to follow the appropriate laws relating to controlled substances, as buprenorphine is a schedule III drug. Pharmacists must verify that prescriptions written for buprenorphine have the authorized physician’s unique DEA number on the face of the prescription, which contains the letter “X” in the beginning, as previously mentioned. If a prescription has this unique X-DEA number and the prescriber is authorized to prescribe buprenorphine for the treatment of narcotic addiction, then the pharmacist may dispense the drug. Prescriptions of buprenorphine are restricted to no more than five refills in a six-month period. The pharmacist must also verify that the prescriber’s DATA waiver is active, which can be done using the Buprenorphine Pharmacy Lookup Tool. These regulations may be found in NY Title 10 Volume A-1a Subchapter K - Part 80 Rules and Regulations of Controlled Substances Section 80.84 “Practitioners and pharmacies; prescribing, administering and dispensing for the treatment of narcotic addiction” and Section 80.69 “Schedule III, IV and V substances”.
Additional Helpful Resources:
● Buprenorphine Practitioner Locator for patients can be found here.
● Erie County 24-hour Addiction Hotline: 716-831-7007
o Get immediate help, education, information, referrals and assistance
o Hotline Flyers – Please consider posting this flyer to help inform others.
● New York State HOPELine flyers
● New York MATTERS is a network of health care systems and community-based programs for improvement of prescription practices and access to treatment of substance use.
1. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. (Treatment Improvement Protocol (TIP) Series, No. 40.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK64245/
2. “Opiate Epidemic Task Force: Erie County, NY Department of Health.” Opiate Epidemic Task Force | Erie County, NY Department of Health, http://www2.erie.gov/health/index.php?q=opiate-epidemic-task-force
3. “MAT Statutes, Regulations, and Guidelines.” SAMHSA, 9 Sept. 2019, https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#DATA-2000
4. “Medication-Assisted Treatment (MAT).” SAMHSA, 27 Mar. 2020, https://www.samhsa.gov/medication-assisted-treatment
5. “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.” 115th U.S. Congress, 24 Oct. 2018,
6. “Comprehensive Addiction Recovery Act of 2016.” 114th U.S. Congress, 22 Jul. 2016, https://www.congress.gov/bill/114th-congress/senate-bill/524/text
The Compassionate Care Act, signed into law on July 5, 2014, will enable patients with a “serious condition” to receive medical cannabis if the qualified certifying physician believes the patient will receive “therapeutic or palliative benefit”. Unlike other states, New York will only permit refined dosage forms, specifically eliminating the crude delivery method of smoking. The Department of Health (“DoH”) published regulations further clarifying specific details necessary for safe, secure, and responsible implementation of this new therapy. It is important to realize that virtually all of New York’s practicing pharmacists will be involved in the care of patients receiving medical cannabis.
As of December 2018, unvaccinated healthcare workers in New York State must now wear masks when working with patients due to the current rise of influenza around the state. The updated news release can be found here.
This rule first went into effect in 2014, when the commissioner required the use of surgical/procedural masks during times of high influenza prevalence. Exceptions to this rule may be found in Title 10 section 2.59 of the public health law. The reinstated regulation will serve to protect at-risk patients in New York State, and the NYS Department of Health encourages any patients older than 6 months old to receive the flu vaccine during this time.
Additionally, NYSDOH has also launched the NYS Flu Tracker to help the public stay informed about rates of influenza in their counties. It is regularly updated every day at 5 p.m., and will help keep the public aware of local influenza activity.
Federal law prohibits buying controlled substances such as narcotic pain relievers, sedatives , stimulants (and anabolic steroids without a valid prescription from your doctor. This means there must be a real doctor-patient relationship, which by most state laws requires a physical examination. Prescriptions written by "cyber doctors" relying on online questionnaires are not legitimate under the law.
Buying controlled substances online without a valid prescription may be punishable by imprisonment under Federal law.
Public access to dextromethorphan has become increasingly more restricted, with recent concerns over its abuse. Current restrictions hold that any establishment selling products with dextromethorphan as an active ingredient must require a prescription for sales to anyone under the age of 18, as well as legal proof of age for purchasers over 18. Proof of legal age is not required for consumers who looks at least 25 years of age; however, this will not serve as a defense for an unlawful sale to an individual under the age of 18. Violations of these provisions will result in fines of $250 per violation. For further information, see Article 26 of the General Business Law, Section 391-S.