Category:Schedule II controlled substances

A Schedule II controlled substance is a medicine, a precursor chemical, or a substance of abuse that the United States Drug Enforcement Administration has placed in the second schedule of its Controlled Substances Act (CSA), the 1970 legislation that consolidated and replaced the previous Harrison Narcotics Act of 1914. Schedule II substances are those that have an accepted medical use but also a high potential for abuse, with abuse liability that may lead to severe psychological or physical dependence; they are subject to the most restrictive prescribing requirements of any clinically used medicine class in the United States, and their movement and dispensing are tracked by the DEA at every step from manufacturer to pharmacy.

The federal regulatory framework that this category reflects was assembled in three stages. The Pure Food and Drug Act of 1906 required accurate labelling of patent medicines but did not restrict their sale; cocaine, morphine, and heroin were sold freely in soda fountains, pharmacies, and mail-order catalogues. The Harrison Narcotics Tax Act of 1914, framed nominally as a revenue measure (the Act required registration and tax stamps for the importation, manufacture, and distribution of "opium and coca leaves and their salts, derivatives, and preparations"), was used by the Bureau of Internal Revenue and its successor enforcement agencies to prosecute physicians who maintained opioid-dependent patients on opioid medicines and to construct, in effect, a federal prohibition of opioid use outside the strict bounds of acute therapeutic treatment.^[1] The Controlled Substances Act of 1970 superseded the Harrison framework, established the five-schedule classification that remains in use, and created the DEA (then the Bureau of Narcotics and Dangerous Drugs) as the federal enforcement authority.^[2]

The Schedule II tier carries restrictions distinct from any other prescription medicine class. A Schedule II medicine cannot be refilled; each prescription requires a new written order or, since the federal regulations were updated in 2010, an electronic prescription transmitted through an EPCS (Electronic Prescriptions for Controlled Substances)-certified system. A faxed Schedule II prescription is accepted only in limited specified circumstances (long-term-care facilities, hospice patients, parenteral home-infusion). State-level requirements often add additional restrictions: a maximum thirty-day supply on a single prescription, mandatory consultation of the state's prescription drug monitoring program (PDMP) before prescribing, and (in several states) a maximum days-supply limit on the initial opioid prescription for an acute pain indication. The pharmacy that fills the prescription is required to verify identity, log the dispensing transaction in the state PDMP, and maintain physical security of the unfilled and filled Schedule II inventory.

The medicines presently classified as Schedule II are dominated by the opioid analgesics and the medical psychostimulants. Most of the full mu-receptor opioid agonists are Schedule II: morphine, oxycodone and its combination products (Percocet is oxycodone plus paracetamol; Percodan is oxycodone plus aspirin), hydrocodone (moved from Schedule III to Schedule II in October 2014, including Vicodin which had been Schedule III since 1970), hydromorphone, oxymorphone, fentanyl and its medical congeners sufentanil and alfentanil and remifentanil, methadone (Schedule II for analgesic use; the medication-assisted-treatment use of methadone is regulated separately through DEA-licensed opioid treatment programmes), and meperidine. Cocaine, used now medically only as a topical anaesthetic in ear-nose-and-throat procedures, remains Schedule II. The medical psychostimulants used for ADHD are Schedule II: methylphenidate, the amphetamines (mixed amphetamine salts marketed as Adderall, dextroamphetamine, lisdexamfetamine), and the very-short-half-life dextromethamphetamine (rarely prescribed for ADHD but Schedule II when it is). Phencyclidine (now used in research and rarely in veterinary medicine) is also Schedule II.

Several Schedule II medicines exist principally as scheduling artefacts of compounding regulations. Pentobarbital and secobarbital (Schedule II barbiturates) and amobarbital (Schedule II as the parent; in combination with other ingredients drops to Schedule III) remain in occasional use for refractory status epilepticus, for medically assisted dying in the jurisdictions where the practice is legal, and (in Mexico and the United Kingdom) for veterinary euthanasia. Several precursor chemicals (anhydrous hydrogen iodide and red phosphorus, key precursors of methamphetamine synthesis) are also Schedule II, although these are regulated under separate sections of the CSA that affect manufacturers and chemists rather than prescribers.

The clinical implications of the Schedule II classification go well beyond the additional paperwork. The 1996 introduction and aggressive marketing of controlled-release oxycodone (OxyContin) was followed by a two-decade rise in opioid prescribing, dependence, and overdose mortality that has been the subject of substantial legal action against the manufacturer (Purdue Pharma) and its owners. The contemporary regulatory environment of Schedule II prescribing reflects that history: state PDMP consultation is now mandatory in 49 states for opioid prescriptions; CMS audit and the corresponding fear of regulatory consequence have measurably reduced opioid prescribing in primary care; and the "OUD" (opioid use disorder) and "MAT" (the older term for medicine-assisted treatment, now usually styled "MOUD" for medicines for opioid use disorder) infrastructure of buprenorphine (Schedule III), methadone (Schedule II via opioid-treatment programmes), and extended-release naltrexone has developed in parallel. The Schedule II classification is, in clinical practice, a marker that prescribing carries regulatory consequence in addition to clinical responsibility.

Not exhaustive; the DEA publishes a comprehensive list at the DEA Schedule II reference page in the USLegal: namespace of this wiki.

• Opioid analgesics: morphine, oxycodone, hydrocodone, hydromorphone, oxymorphone, fentanyl, sufentanil, alfentanil, remifentanil, meperidine, methadone, tapentadol (note: distinct from non-Schedule II tramadol, which is Schedule IV); the high-potency carfentanil is Schedule II (in veterinary use)
• Combination opioid products: Percocet (oxycodone + paracetamol), Percodan (oxycodone + aspirin), Vicodin (hydrocodone + paracetamol, all hydrocodone combinations moved to Schedule II in 2014)
• Psychostimulants: methylphenidate (Ritalin, Concerta), dextroamphetamine, mixed amphetamine salts (Adderall), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn, rarely prescribed)
• Barbiturates (Schedule II tier): pentobarbital, secobarbital, amobarbital (parent)
• Other: cocaine (medical topical anaesthetic), phencyclidine (research, veterinary), nabilone (synthetic cannabinoid, antiemetic for chemotherapy)

The boundary of this category is "medicine or substance placed in Schedule II of the U.S. Controlled Substances Act." The Schedule designation is United States federal; other jurisdictions have analogous but not identical classifications (the Canadian Controlled Drugs and Substances Act schedules I-VIII; the United Kingdom Misuse of Drugs Act Class A/B/C and the Misuse of Drugs Regulations Schedules 1-5; the international schedules established by the 1961 Single Convention and the 1971 Convention on Psychotropic Substances). Cross-references to these other jurisdictions are made on individual medicine pages where the international scheduling differs notably from the U.S. designation. The [[USLegal:|USLegal:]] namespace on this wiki contains a comprehensive set of pages for each of the U.S. legal status categories (Prescription only, Over-the-counter, DEA Schedule I through DEA Schedule V) and serves as the authoritative reference for the regulatory framework.

This category page is an encyclopedia article about its subject. The actual index of medicines belonging to the category is generated automatically by the wiki engine, from category-membership declarations on the individual medicine pages, and appears at the foot of the page below the references.