FDA to recommend tougher restrictions for hydrocodone combos

By early December, FDA said it plans to formally recommend to HHS that hydrocodone combination products be raised to the class II schedule from the lower-risk class III schedule. In U.S. Drug Enforcement Agency (DEA) scheduling, class I indicates the highest potential for abuse and class V the lowest; hydrocodone-only products are already class II. The change would place greater restrictions on hydrocodone combination products, including requiring written prescriptions that cannot be refilled and limiting prescriptions to a 90-day supply. Schedule III drugs can be refilled five times over a six-month period. ...