§814 Removal of Exemption of Certain Drugs

Summary

The Attorney General must make rules to remove a drug or group of drugs from a special exemption when they find people are using those drugs to get a listed chemical for making illegal drugs. In deciding to remove an exemption, the Attorney General will look at three things: how big, long, and important the diversion is; whether the drug is made so it can't easily be used for making illegal drugs; and whether the listed chemical can be easily taken out. The removal should target only the specific type of drug showing diversion unless there is evidence the problem will spread to others. A manufacturer can ask the Attorney General to put the exemption back for a particular product if the company shows it stops diversion. The Attorney General will consider package size and packaging, how the product is sold and advertised, any evidence of diversion, steps the manufacturer took to prevent diversion, and other health and safety factors. If the manufacturer files a real application within 60 days after the removal rule, sales of that product while the application is pending (and for 60 days after a denial) are not treated as regulated, unless the Attorney General finds diversion and tells the applicant. The Attorney General can later change or cancel a reinstated exemption if diversion starts again or key data change.