The quandary of opioid misuse and prescription negligence has long been recognized by the government, and federal regulation has evolved over the past century. Despite widespread claims (especially in the 1990s) that dependence and addiction are exceedingly rare sequelae of opioid therapy, it has been evident to elected leadership that from a public health perspective at least, opioid addiction is a significant societal burden closely intertwined with the medical profession. While early legislation focused more on consumer safety, the issues of psycho-/behavioral effects of mind-altering substances including opium and dependence/addiction have been more than implicit in local, state, and federal governmental policy for over a century. Virtually, all legislation for the past 50 years having to do with opioids has been written to address abuse liability and frank addiction management.

The first major legislative effort by Congress to control opioid distribution was the Harrison Narcotics Tax Act of 1914, which dealt primarily with commercial registration and taxation issues pertaining to “opium or coca leaves, their salts, derivatives, or preparations” but also introduced legal requirement for recordkeeping of prescriptions for these substances. Five years later, in Webb vs. United States, the US Supreme Court ruled that physicians could not prescribe opioids solely for maintenance of addiction.

In 1924, the Heroin Act rendered manufacture or importation and possession of heroin illegal for all purposes. In 1932, the Uniform State Narcotic Act called for states to pass legislation in line with federal legislation (the Narcotic Drug Import and Export Act). The Food, Drug, and Cosmetic Act in 1938 brought the determination of safety of these substances under the control of the Food and Drug Administration (FDA), mandating new drug approval by that agency prior to marketing, and also required safe use instruction labeling. The Durham-Humphrey Amendment of 1951 further established the classification of certain drugs, especially those that are “habit-forming” as prescription only.

The Controlled Substance Act (CSA) of 1970 reorganized and consolidated several previous laws regulating drugs and substances with high abuse potential. Five “Schedules” were created, based primarily upon abuse and addiction potential, with Schedule I containing drugs with no recognized legitimate medical use (e.g., heroin, LSD, marijuana) and Schedules II through V containing drugs such as opioids, sedatives, stimulants, and others in tiers of decreasing risk.

The Narcotic Addict Treatment Act of 1974 amended the CSA to provide for the federally supervised treatment of opioid dependence by either maintenance of dependence using prescription opioids for longer than 21 days or detoxification using a weaning schedule of 21 days or less. This provided the legal basis for methadone maintenance therapy.

The Drug Addiction Treatment Act of 2000 (DATA 2000) established office-based treatment (OBT) of opioid dependence using FDA-approved Schedule III–V opioids (the only one currently approved is buprenorphine). Physicians must obtain a special DEA number (“waiver” or “X-number ”) in order to prescribe buprenorphine for OBT; requirements for waiver include:

Subsequent amendments in 2005, 2006, and 2016 have sequentially increased the limit or “cap” on how many patients may be treated with OBT per qualifying physician.

The Comprehensive Addiction and Recovery Act of 2016 (CARA 2016) represents the first major piece of legislation attempting to comprehensively address the opioid epidemic, with components including prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. Among other initiatives, an interagency group (comprising HHS, VA, DEA, CDC, other federal agencies, addiction treatment organizations, and other stakeholder communities) have been tasked with the development of best practices for opioid prescription. Mandatory prescriber education recommendations have been assigned to the Secretary of Health and Human Services (HHS) . Among the vast scope and provisions of CARA 2016, one of the more striking decisions is the amendment of the CSA to allow mid-level practitioners to become eligible to prescribe buprenorphine for the treatment of opioid use disorder.

The CSA and Title 21 of the Code of Federal Regulations 1300–1316 (the “DEA Regulations”) allow, inform, and direct legal prescription of opioids, including:

Regulatory and enforcement authority is delegated primarily to the FDA and the DEA. The FDA’s “scope of practice” pertinent to prescription opioids is to ensure public safety by determining the safety of the drug, recommending scheduling within the five CSA schedules, and recommending indications for use. The DEA is ultimately responsible for the scheduling of controlled substances and is also tasked with enforcing the CSA.

The CSA and DEA regulations are summarized for providers within the DEA’s Practitioner’s Manual , available online at https://​www.​deadiversion.​usdoj.​gov/​pubs/​manuals/​pract/​index.​html; a cursory review of highlights follows below.

Opioids (with the exception of heroin, which is classified as Schedule I, i.e., no medical use) fall within Schedules II through V as shown in Table 8.2, with the majority classified as Schedule II, the most stringently controlled category. Considerable differences in prescriptive regulation exist between Schedule II and lower categories and are highlighted in Table 8.2. All controlled substances, however, by law must be prescribed only for “legitimate medical purpose by a practitioner acting in the usual course of professional practice” [1].

Federal law restricts opioid prescription privileges to practitioners who are registered with the DEA to prescribe controlled substances within Schedules II through V and then assigned a registration number (“DEA number”). Practitioners in training, or who work solely as employees of a hospital may use the hospital’s DEA registration, and federal government practitioners (e.g., armed services or US Public Health Services or Prison Bureau practitioners) receive a waiver of this requirement.

Strict legal requirements concerning the security and accounting of stored and administered or dispensed controlled substances do not apply to most practitioners. Security of prescriptions however are the responsibility of all prescribers and tamper-resistant prescription pads or paper are advised by the DEA (and mandated by several states). In addition, by federal law, controlled prescriptions require notation of the patient’s address as well as name and date of birth. The drug name, dosage form, strength, quantity, and directions for use, and of course the name, address, and registration number of the prescriber must also be on the prescription. Until recently, when electronic prescription of Schedules II through V substances was allowed, Schedule II substances required hard copy/paper prescription with a manual signature (no stamps).

Recordkeeping of controlled substances prescribed (not administered/dispensed) is not mandatory unless said prescriptions are for maintenance or detoxification purposes.

In 1970, after the CSA was enacted, the states commissioned a Uniform Controlled Substances Act (UCSA) as a model for individual states to consider when updating and revising their own drug laws, with the intent of promoting uniformity and a means of achieving consistent and more effective control of the possession, use, sale, distribution, and manufacture of controlled substances. The most recent revision took place in 1994 and may be accessed at (http://​www.​uniformlaws.​org/​shared/​docs/​controlled%20​substances/​UCSA_​final%20​_​94%20​with%20​95amends.​pdf).

The diversity of state-specific statutes concerning controlled substances is complex to the point that a comprehensive presentation of these laws state-by-state is prohibitive. Every prescriber should be aware of their own state’s legislation concerning the prescription of controlled substances, and the internet has rendered that task a relatively simple one. For those interested in an overview of state regulations, the National Criminal Justice Association created a Guide to State Controlled Substances Acts in 1988 that presents a thorough albeit currently dated compilation of state-specific regulations [5]. At present, the National Association of State Controlled Substances Authorities provides an easily navigable website (http://​www.​nascsa.​org/​stateprofiles.​htm) with links to each state’s statutes and rules pertinent to controlled substances, current authorities, and other pertinent deviations from federal regulations/scheduling.

Despite recent confusion (and frank violation of national law) surrounding the marijuana controversy in several states, the states may not enact controlled substance schedules less stringent than the national schedule determined by the DEA. Some states have historically classified some controlled substances more restrictively than the national schedule; for example, codeine cough syrups are assigned a category more restricted than Schedule V in several states, and many states controlled tramadol prior to federal categorization as a controlled substance in 2014. The state of Massachusetts recently passed legislation restricting initial opioid prescriptions for adults (and all opioid prescriptions for minors) to a seven-day prescription; this is to date the most stringent limitation on prescription duration in this nation.

At the time of this writing, 22 states, the District of Columbia, Puerto Rico, and Guam also require a state (or territory)-specific controlled substance prescription registration as well. While most states currently allow mid-level practitioners (e.g., physician assistants and nurse practitioners) to prescribe most controlled substances, there are several that restrict Schedule II drugs to the order of a physician only, and some states do not allow controlled substance prescribing at all by mid-levels. The question of whether or not opioids should be prescribed by physicians or mid-level practitioners who have not been adequately trained to do so is a “hot-bed issue” enjoying discussion in many circles and at various levels of governance. There is no easy answer to this question, and in many cases there are no providers available who have undergone formal residency or fellowship-level training in opioid prescription. This will always remain impractical for many communities, and regarding these situations where nonspecialists are responsible for the pain management component of the health and well-being of their communities, the question should not be so much “should they be prescribing?” but rather “how can we best educate them and provide guidance?” This book is one such attempt to answer that question, and a significant amount of continuing medical education has become available over the past several years in order to assist with this endeavor as well. In many states, it is now becoming mandatory for prescribers to undergo opioid-related continuing medical education (CME) , in some cases once in a lifetime and in others on an ongoing basis. At the time of this writing:

Several other states require pain management CME on a regular basis without specifying a requirement for controlled substances/opioid education.

State Prescription Drug Monitoring Programs/Databases (PDMPs) have become a ubiquitous tool in the monitoring of controlled substance prescriptions and serve a valuable role in diversion prevention. At the time of this writing, all but one state (Missouri) have adopted legislation requiring creation of a PDMP, and many states have been using them for several years now. At the time of this writing, 16 states require checking the State Prescription Drug Monitoring Program prior to issuing controlled substance prescriptions [6]. (Interestingly only 11 states, not all of which are represented in the 16 mentioned above require registering with the PDMP.) These requirements are summarized in Table 8.3.