Dextropropoxyphene

Under United States federal law, bulk dextropropoxyphene in non-dosage form is listed in Schedule II, while dextropropoxyphene dosage forms are listed in Schedule IV, under 21 C.F.R. §§ 1308.12(c)(5) and 1308.14(b)(2). Possession is unlawful unless obtained by valid prescription or otherwise authorized; unauthorized manufacture, distribution, dispensing, and possession with intent to carry out those activities are also unlawful. The FDA withdrew approval of identified propoxyphene drug applications, but that action did not remove dextropropoxyphene from the federal controlled-substance schedules.

Dextropropoxyphene is expressly listed within the phenalkoxams class in Schedule I, item 7(3) of the Controlled Drugs and Substances Act; item 7 also covers the class's salts, derivatives, and salts of derivatives. The Act prohibits unauthorized possession, trafficking, possession for trafficking, import, export, and production of Schedule I substances. Health Canada's Drug Product Database records branded, generic, and combination dextropropoxyphene products as Cancelled Post Market and identifies them as NARCOTICS (CDSA I). SOR/2025-243 will restate the same Schedule I subitem on October 1, 2026, when the Controlled Substances Regulations, SOR/2025-242, will also place the substance in Schedule 1 (Narcotics); neither pending instrument changes the current Schedule I classification.