§814 Removal of Exemption of Certain Drugs

Summary

The Attorney General must remove a drug or group of drugs from its special exemption if they find people are taking the drug to get a listed chemical used to make illegal drugs. In deciding to remove an exemption, the Attorney General will look at how big, how long, and how important the diversion is; whether the drug’s form makes it hard to use for making illegal drugs; and whether the listed chemical can be easily recovered from the drug. Any removal must be as narrow as the evidence allows, unless there is proof the problem will spread to other drugs. A drug maker can ask the Attorney General to put a product back under the exemption if the maker shows it is made and sold in a way that stops diversion. The Attorney General will consider package size and packaging, how it is sold and advertised, any evidence of diversion, actions the maker took to stop diversion, and other health and safety factors. If a maker files a real application within 60 days after the exemption is removed, sales during the application review are not treated as regulated. If the application is denied, that safe period lasts 60 more days unless the Attorney General has evidence of diversion and tells the maker. The Attorney General can change or remove a reinstated exemption later if diversion is found or the facts change.