§814 Removal of exemption of certain drugs

Summary

The Attorney General must make rules to take a drug or group of drugs off a special exemption if the drug is being used to get a listed chemical, an ingredient used to make illegal drugs. In deciding, the Attorney General must look at how much and how long the drug is being misused, whether the drug’s form makes it hard to get the chemical, and whether the chemical can be easily recovered. The removal must be aimed at the smallest, clearly identified drug or group unless there is proof the problem is wider. A drug maker can ask the Attorney General to put the exemption back for a specific product. The Attorney General must do so if the product is made and sold in a way that stops misuse. The decision will consider package size and type, how it is sold and advertised, any evidence of misuse, steps the maker took to prevent misuse, and other health and safety factors. If a maker files a real application within 60 days after the exemption is removed, sales during the review (and for 60 days after a denial) are not treated as regulated, unless the Attorney General finds misuse and tells the maker. The reinstated exemption can be changed or removed later if misuse is found or the facts change.