Laudanum Uniform Controlled Substances Act, which regulated opium tincture (Laudanum) as a Schedule II substance (currently DEA #9630), placing even tighter controls on the drug. By the late 20th century, laudanum's use was almost exclusively confined to treating severe diarrhea. The current prescribing information for laudanum in the US states that opium tincture's sole indication is as an anti-diarrheal, although the drug is occasionally prescribed off-label for treating pain and neonatal withdrawal syndrome. Several historical varieties of laudanum exist, including Paracelsus' laudanum, Sydenham's Laudanum (also known as "tinctura opii crocata"), benzoic laudanum ("tinctura opii benzoica"), and deodorized tincture of opium (the
Botanical drug the substance being developed as a botanical drug has been used in traditional medicine, it may be possible to begin initial, small clinical trials without conducting extensive toxicology testing. However, toxicity testing is required before beginning larger clinical trials and trials that will be used to get approval to sell a botanical drug. The endogenous Chinese pharmaceutical industry is made up mostly of companies that make herbal traditional chinese medicines and sell them over the counter; the US regulatory pathway is similar to that established by the China Food and Drug Administration. The European regulatory pathway is also similar. As