Diphenoxylate - Regulation

Regulation

As noted below, diphenoxylate is listed in national controlled-substances and drugs laws such as pure diphenoxylate being in Annex/Schedule/List II of the Single Convention on Narcotic Drugs of 1961 and also in similarly numbered schedules of laws passed to implement the Convention such as the Canadian Controlled Substances Act and the Betäubungsmittelgesetz in Germany and the Suchtgiftverordnung of Austria. This level of regulation is also implemented in the Misuse of Drugs Act of 1971 (UK), the French opium law of 31 December 1970, and royal decrees and laws passed by practically all other countries in Europe, the Pacific Rim, South Asia and the Middle East.

In many cases, Lomotil type preparations with extra active ingredients are over the counter and/or subject to provincial and/or municipal control or minimal national oversight; the schedule numbers vary by country.

This medication is classified as a Schedule V under the United States' Comprehensive Drug Abuse Control & Prevention Act of 1970 aka Controlled Substances Act (CSA) (21 U.S.C. § 801 et. seq.) by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II; having one or more other active ingredients makes it Schedule V. As such, diphenoxylate/atropine tablets are under state and local control and where allowed by state law, can be obtained by signing a log book and the customer can receive up to 48 units (tablets or capsules) in any 48-hour period, much like the 4 fl. oz. limit on codeine, dihydrocodeine, dionine (ethylmorphine), and opium cough syrups and gastrointestinal drugs.

The other Schedule V narcotics, all of which may be obtained in some states without prescription as noted in this article, are cough syrups containing low amounts of codeine. Very dilute syrups of hydrocodone containing three or more other active ingredients were also Schedule V and often available without prescription until rescheduling to Schedule III circa 1990.

As for the rest of the family, in the United States difenoxin & atropine tablets are Schedule IV and therefore federally controlled and require a prescription, loperamide is unscheduled and not on prescription, and diphenoxylic acid is classified as a form of diphenoxylate. Other Schedule IV narcotics also include butorphanol nasal spray, pentazocine, propoxyphene-based mixtures and others of the same type. Unscheduled narcotics and opioid agonists include loperamide (OTC), nalbuphine (Rx), and tramadol (Rx).

As an example of the degree of regulation at the federal level, the most commonly known Schedule IV drug of any type is Valium as well as nearly all other benzodiazepines, whereas Schedule III contains Vicodin (hydrocodone bitartrate), and Schedule II contains cocaine, secobarbital, methamphetamine, methylphenidate, all forms of morphine and derivatives like Dilaudid (hydromorphone hydrochloride), oxymorphone, and oxycodone. Examples of a legitimate medical drug which are generally illegal (Schedule I) would include the morphine derivatives Vilan (nicomorphine HCl), Paramorfan (dihydromorphine HCl) and the synthetics Ketodur (ketobemidone), Dipidolor (piritramide), and Palfium (dextromoramide).

A Schedule V purchase involves the customer having to sign a dispensary log after presenting proper identification to the pharmacist; the Schedule V ledger lists transactions going back two years and must have pages that are difficult to remove and usually pre-numbered. This schedule devolves control over the drugs therein to state and local governments, so in states where it cannot be bought over the counter it may or may not require the duplicate, triplicate, or quintuplicate narcotic prescription order form defined by state law.

Narcotic preparations for gastrointestinal problems tend to be the more available of the narcotics; other narcotics for pain like the Tylenol With Codeine series, (even No. 1 and other combination products with the same quantity and therefore narcotic content number (7½ or 8 mg, i.e. 1/₈ of a grain of codeine phosphate per tablet) are more restricted and therefore all Schedule III.

Lomotil is a Schedule V drug, but it is only available by prescription in the United States. Donnagel-PG: was available without prescription in some states, but has been discontinued. The stimulant pyrovalerone is another Schedule V prescription-only drug, as is Lyrica.