FDA Signals Issuance of Its Recommendation To DEA To Move Hydrocodone Combo Products to Schedule II

October 24, 2013

By Delia A. Stubbs

While typically not made public, today, FDA issued a statement that it intends to forward a recommendation to DEA by December to move hydrocodone combination products from their current placement in Schedule III to Schedule II.  That change would mean, among other things, stricter security controls on those drugs as well as a restriction on the amount of medication – 90 days worth – that a patient can be prescribed at one time.   

FDA’s recommendation comes as no surprise, given its advisory committee’s recommendation earlier this year that it reach this result (see our previous post here).  CDER Director, Janet Woodcock, projected that the regulations re-scheduling hydrocodone “could take effect as early as next year.” 

The development is interesting given pending legislation that would accomplish the same result, but would afford a grace period to certain DEA registrants, namely manufacturers and distributors and other “non-practitioners,” to comply with the new storage and security requirements (see our previous post here).