How is a compounded mixture of codeine classified if it contains 1,000 mg of codeine in 100 cc of Tylenol with codeine Elixir?

A compounded mixture of codeine that contains 1,000 mg in 100 cc of Tylenol with codeine Elixir is classified as a Schedule III controlled substance. In the context of U.S. Drug Enforcement Administration (DEA) regulations, the scheduling of codeine is determined by its concentration and formulation.

In this case, the specific formulation presents a diluted concentration of codeine, which is why it qualifies for Schedule III. According to the Controlled Substances Act, codeine is classified as a Schedule II substance when it is in its pure form or in a higher concentration, but when it is in a combination product (such as with other non-narcotic ingredients) and adheres to specific concentration thresholds, it can be classified in a lower schedule.

Furthermore, Schedule III substances include combinations containing not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, assuming the product is combined with active non-narcotic ingredients. Given that the compounded mixture falls within these limits, a classification as Schedule III is appropriate.

This scheduling reflects the potential for abuse and the accepted medical uses of such preparations, which aligns with how various controlled substances are regulated in pharmacy