"Until 1970, Paregoric could be purchased at a pharmacy without a medical prescription, in accordance with federal law. Federal law dictated that no more than 2 ounces of paregoric be dispensed by any pharmacy to the same purchaser within a 48-hour period. Purchasers were also required to sign a register or logbook, and pharmacies were technically required to request identification from any purchaser not personally known to the pharmacist. Some states further limited the sale of paregoric, or banned over-the-counter sales entirely. For example, Michigan law allowed over-the-counter (non-prescription) sale of paregoric until April 1964, but still allowed OTC sales of certain Exempt cough medication preparations that contain 60 mg. of codeine per fluid ounce.” Even where legally permissible by law, OTC sale of paregoric was subject to the discretion of individual pharmacists.
In 1970, Paregoric was classified as a Schedule III drug under the Controlled Substances Act (DEA #9809); however, drugs that contained a mixture of kaolin, pectin, and paregoric (i.e., Donnagel-PG, Parepectolin, and their generic equivalents) were classified as Schedule V drugs. They were available over-the-counter without a prescription in many states until the early 1990’s, at which time the FDA banned the sale of anti-diarrheal drugs containing kaolin and pectin. Paregoric is currently list in the United States Pharmacopeia. Manufacture of the drug was discontinued for several months beginning in late 2011; however, production and distribution resumed in 2012, so the drug is still available in the United States by prescription. Thus, it is unclear as to whether the lapse in manufacture actually resulted in a shortage of the drug at any time, since prescription drugs are often still available for many months after manufacture has been discontinued. In France, paregoric was available without prescription until 1986; nowadays, it is used to wean infants born from opiate-addicted women.”