Editing Laudanum (section)

== Modern status ==

===United Kingdom===
Opium tincture remains in the [[British Pharmacopoeia]], where it is referred to as Tincture of Opium, B.P., Laudanum, Thebaic Tincture or Tinctura Thebaica, and "adjusted to contain 1% w/v of anhydrous morphine."<ref>''The Extra Pharmacopeia Martindale''. Vol. 1, 24th edition. London: The Pharmaceutical Press, 1958, page 924.</ref> It is a [[Drugs controlled by the UK Misuse of Drugs Act|Class A]] substance under the Misuse of Drugs Act of 1971. At least one manufacturer ([[Macfarlan Smith]]) still produces opium tincture in the UK {{as of|2011|lc=yes}}.<ref name="Opium Tincture">{{cite web
|url = http://www.macsmith.com/index.php?page=product-list
|title = Macfarlan Smith Product List of Controlled Drugs
|access-date = 2011-02-14
|publisher = Johnson Matthey Website
|archive-date = 2011-07-14
|archive-url = https://web.archive.org/web/20110714013157/http://www.macsmith.com/index.php?page=product-list
|url-status = dead
}}</ref>
"Gee's Linctus" is also available from most UK pharmacies, especially independent stores. This contains "Opium Tincture", at 0.083&nbsp;mL, per 5&nbsp;mL.{{Citation needed|date=December 2022}}

===United States===
Tincture of Opium is available by [[Medical prescription|prescription]] in the United States. It is regulated as a [[List of Schedule II drugs|Schedule II]] drug (No. 9639) under the [[Controlled Substances Act]].

In the United States, opium tincture is marketed and distributed by several pharmaceutical firms, each producing a single formulation of the drug, which is deodorized. Each mL contains 10&nbsp;mg of anhydrous morphine (the equivalent of 100&nbsp;mg of [[List of Schedule II drugs|powdered opium]]), other opium alkaloids (except [[noscapine]]), and ethanol, 19%. It is available packaged in bottles of {{Convert|4|USoz|mL|spell=in|0}} and {{Convert|16|USoz|USpt mL|0}}.<ref>{{Cite journal | vauthors = Kelly K, Vaida AJ |date= June 2003 | journal = Pharacy Times | volume = 69 | issue = 6 | pages = 58–63 |title=Recurring Confusion Between Opium Tincture and Paregoric |url=https://www.pharmacytimes.com/view/2003-06-7241 }}</ref>

Tincture of Opium is known as one of many "unapproved drugs" regulated by the U.S. [[Food and Drug Administration]] (FDA); the marketing and distribution of opium tincture prevails only because opium tincture was sold prior to the Federal Food, Drug & Cosmetic Act of 1938.<ref name="Unapproved Drugs">{{cite web|url = http://www.ijpc.com/RxTriad/pdf/RxTriad_V09_N02_Sample.pdf|title = Unapproved Drugs, What's the Big Deal?|access-date = 2009-01-03|publisher = International Journal of Pharmaceutical Compounding, Winter 2006|archive-url = https://web.archive.org/web/20100705075733/http://www.ijpc.com/rxtriad/pdf/RxTriad_V09_N02_Sample.pdf|archive-date = 2010-07-05|url-status = dead}}</ref> Its "grandfathered" status protects opium tincture from being required to undergo strict FDA drug reviews and subsequent approval processes. However, the FDA closely monitors the labeling of opium tincture. Bottles of opium tincture are required by the FDA to bear a bright red "[[poison|POISON]]" label given the potency of the drug and the potential for overdose (see discussion about confusion with Paregoric below). Additionally, in a warning letter to a manufacturer of opium tincture in late 2009, the FDA noted that "we found that your firm is manufacturing and distributing the prescription drug Opium Tincture USP (Deodorized – 10&nbsp;mg/mL). Based on our information, there are no FDA-approved applications on file for this drug product."<ref>{{cite web |title = Warning Letter to Ohm Laboratories | work = Inspections, Compliance, Enforcement, and Criminal Invesitations | url =  https://www.fdanews.com/ext/resources/files/archives/o/Ohm-Laboratories-WL.pdf | date = December 21, 2009 | publisher = U.S. Food and Drug Administration }}</ref>