On Thursday, February 27, 2014, the Drug Enforcement Administration (DEA) published a proposed rule in the Federal Register to reschedule hydrocodone combination products to Schedule II of the Controlled Substances Act (CSA) As these drugs are currently in Schedule III, this would dramatically increase the restrictions on prescribing and dispensing practices for hydrocodone combination products.
The DEA’s rationale for the move is to combat prescription drug abuse. The proposed rule follows the recommendation of a Food and Drug Administration (FDA) Public Advisory Committee meeting held January 24-25, 2013, where the committee voted 19 to 10 in favor upscheduling hydrocodone combination products. The Administration also cited its duty to protect the health and safety of the public as a motivating factor. In the proposed rule, they laid out an eight-factor analysis of the substances’ potential for abuse.
While ASCP commends the DEA’s efforts to combat prescription drug abuse, we believe that the increased controls imposed on these products will have an adverse effect in LTC settings. Because many residents of LTC facilities are patients living with chronic pain, it is imperative that they receive relief in a timely manner. It is likely that the increased controls will delay access to these crucial medications.
Therefore, ASCP opposes rescheduling hydrocodone combination products from Schedule III to Schedule II.
It is important to note this does not mean that hydrocodone combination products are now moved to Schedule II effectively immediately. As this is a proposed rule, it is subject to an official comment period in which stakeholders can submit comments to DEA. ASCP will submit a response to the proposal by the April 28, 2014 deadline. After reviewing all public comments, DEA will determine whether or not they will move forward with the rescheduling by issuing a final rule.
ASCP has been closely tracking this matter and has been an active and resolute voice on the issue of reclassifying hydrocodone combination drugs.
ASCP’s Action Steps:
ASCP will remain a candid voice in opposing the rescheduling of hydrocodone combination drugs.
ASCP understands and appreciates your desire to participate in this critical mission. There are many ways that you, as a member, can become involved:
Join ASCP’s Grassroots Network to get regular updates on the status of this issue.
On February 27, 2014, the Drug Enforcement Administration (DEA) released its proposal to reschedule hydrocodone combination products to a Scheduled II controlled substance. Citing its duty to protect public health and safety, DEA presented an eight-factor analysis of the substances’ potential for abuse as justification for its decision. ASCP will submit comments on the proposed regulation by the regulatory deadline.