Category:Schedule III controlled substances

A Schedule III controlled substance is a medicine that the United States Drug Enforcement Administration has placed in the third schedule of its Controlled Substances Act of 1970. Schedule III substances have an accepted medical use, a potential for abuse less than the Schedule II medicines but greater than the Schedule IV ones, and an abuse pattern that may lead to moderate or low physical dependence or to high psychological dependence. The prescribing restrictions are correspondingly intermediate.

The clinical operating difference between a Schedule III and a Schedule II prescription is substantial in everyday practice. A Schedule III prescription may be telephoned in to the pharmacy or transmitted electronically, may be refilled up to five times within six months of the date of the original prescription, and may be faxed under conditions broader than the narrow Schedule II exceptions. State prescription drug monitoring program reporting is required for Schedule III in most states. Pharmacy security requirements and dispensing documentation are intermediate between the Schedule II and Schedule IV tiers.

The medicines presently classified as Schedule III are dominated by three groups: certain opioid-containing combination products, the buprenorphine products used for opioid use disorder and for chronic pain, and the anabolic-androgenic steroids. The combination opioid products in Schedule III include the older codeine-acetaminophen combinations (Tylenol with Codeine in the standard doses of codeine, classified Schedule III rather than Schedule II by virtue of the small codeine quantity per dosage unit), the codeine-containing antitussive preparations, the dihydrocodeine-acetaminophen combinations, and the now-rare paregoric (camphorated tincture of opium). Fiorinal (butalbital with aspirin and caffeine) and the closely related Fiorinal with Codeine are Schedule III when they contain codeine and Schedule III (without codeine) on the basis of butalbital, a barbiturate. The dronabinol oral capsule (synthetic delta-9-tetrahydrocannabinol) is Schedule III; the standard cannabis-derived medicines remain Schedule I federally, despite extensive state-level rescheduling for medical use.

The decisive Schedule III addition of the 2000s was buprenorphine. Buprenorphine, a partial agonist at the mu opioid receptor with high receptor affinity but a ceiling on its analgesic and respiratory-depressant effect, had been used in Europe as an analgesic for thirty years. The U.S. Drug Addiction Treatment Act (DATA) of 2000 permitted physicians to prescribe buprenorphine for opioid use disorder from an office-based outpatient setting (in contrast to the federally licensed opioid treatment programmes through which methadone for opioid use disorder must be dispensed); the buprenorphine-naloxone combination Suboxone (Reckitt Benckiser, 2002) and the buprenorphine-only Subutex established a clinical infrastructure of medicine-assisted treatment for opioid use disorder, dispensed in primary care, with a Schedule III prescribing convenience that would not have been possible in Schedule II.^[1] The X-waiver requirement, which had restricted buprenorphine prescribing to clinicians who completed an eight-hour training course and registered with the DEA, was eliminated in the Consolidated Appropriations Act of 2023; any practitioner with a current DEA registration may now prescribe buprenorphine for opioid use disorder.

The anabolic-androgenic steroids were added to Schedule III by the Anabolic Steroid Control Act of 1990, which extended the CSA to include all synthetic testosterone derivatives and several non-steroidal selective androgen-receptor modulators. The clinical use of testosterone replacement in hypogonadism and the supraphysiologic-dose use in athletic performance enhancement are both subject to the Schedule III restrictions, although the regulatory environment for clinical replacement therapy is well-defined and routine. Ketamine was rescheduled from unscheduled to Schedule III in 1999 in response to its growing recreational use; the medicine retains substantial clinical utility in anaesthesia, in subanaesthetic intravenous infusions for treatment-resistant depression and chronic pain, and in the (S)-enantiomer formulation esketamine nasal spray for treatment-resistant depression and for major depressive disorder with active suicidal ideation. Esketamine is Schedule III in the United States, accessed only through a REMS programme.

Not exhaustive; the DEA publishes a comprehensive list at DEA Schedule III in the USLegal: namespace.

• Opioid combination products at restricted codeine doses: Tylenol with Codeine (acetaminophen + codeine, usually 30 mg or less per tablet); dihydrocodeine combinations; the historical paregoric (camphorated tincture of opium)
• Buprenorphine and buprenorphine-naloxone combinations (for opioid use disorder and chronic pain): Suboxone (sublingual film and tablet), Subutex (sublingual buprenorphine alone), Zubsolv, Sublocade (monthly extended-release buprenorphine subcutaneous injection)
• Barbiturates at the Schedule III tier (those whose abuse potential is less than the Schedule II barbiturates, often by virtue of formulation or co-formulation): butalbital combinations including Fiorinal (butalbital + aspirin + caffeine), Fioricet (butalbital + acetaminophen + caffeine, Schedule III only when combined with a Schedule III-tier substance)
• Anabolic-androgenic steroids: testosterone esters (cypionate, enanthate, undecanoate); nandrolone; oxandrolone; stanozolol (the medical use that brought oxandrolone to widespread attention was the treatment of Turner syndrome and HIV-associated wasting); methyltestosterone; the synthetic non-steroidal selective androgen-receptor modulators in the same Schedule III tier
• Ketamine and esketamine: ketamine (anaesthesia, subanaesthetic depression/pain), esketamine nasal spray
• Synthetic cannabinoids in clinical use: dronabinol (synthetic THC, oral capsule for chemotherapy-induced nausea and AIDS-related anorexia)

The boundary of this category is "medicine or substance placed in Schedule III of the U.S. Controlled Substances Act." The U.S. Schedule III designation is, like the other CSA schedules, a federal classification; state-level scheduling may move medicines between tiers, although typically in the more restrictive direction. The international counterparts (the 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances, the Canadian CDSA, the UK Misuse of Drugs Act and Misuse of Drugs Regulations) classify these medicines by different criteria and the cross-walk is not always one-to-one. The [[USLegal:|USLegal:]] namespace on this wiki carries the comprehensive Schedule-by-Schedule reference pages.

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.