Category:Schedule III controlled substances: Difference between revisions

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The medicines presently classified as Schedule III are dominated by three groups: certain opioid-containing combination products, the [[wikipedia:Buprenorphine|buprenorphine]] products used for opioid use disorder and for chronic pain, and the [[wikipedia:Anabolic steroid|anabolic-androgenic steroids]]. The combination opioid products in Schedule III include the older codeine-acetaminophen combinations ([[wikipedia:Tylenol with codeine|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). [[wikipedia:Fiorinal|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 [[wikipedia:Suboxone|Suboxone]] (Reckitt Benckiser, 2002) and the buprenorphine-only Subutex established a clinical infrastructure of ~~medication~~-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.<ref name="data2000">U.S. Congress. Drug Addiction Treatment Act of 2000. ''Public Law 106-310'', Title XXXV. October 17, 2000.</ref> 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 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 [[wikipedia:Suboxone|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.<ref name="data2000">U.S. Congress. Drug Addiction Treatment Act of 2000. ''Public Law 106-310'', Title XXXV. October 17, 2000.</ref> 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. [[wikipedia:Ketamine|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|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.

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