Proposal to Reschedule Hydrocodone Combination Products

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Background

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.

Where does ASCP stand?

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.

What does this mean?

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.

What has ASCP done on this issue to date?

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 signed on to a joint pharmacy industry letter (PDF) opposing the October 24, 2013 announcement by the FDA that they would move to recommend the rescheduling of hydrocodone combination products.
  • ASCP attended a vital public meeting hosted by the FDA on January 24 and 25, 2013, regarding the proposal to reschedule hydrocodone combination products under the Controlled Substances Act (CSA).
  • ASCP submitted comments in response to the proposal discussed at the January 2013 public meeting.
  • ASCP signed on to a joint pharmacy industry letter in response the proposal discussed at the January 2013 public meeting.
  • ASCP met with Sen. Joe Manchin (D-WV) to explain the Society’s opposition to the proposal.
  • ASCP met with staff from Rep. Vern Buchanan’s (R-FL) office to explain the Society’s opposition to the proposal.
  • ASCP continues to coordinate with key, pharmacy and LTC stakeholders on responding to the proposed rescheduling.


What will ASCP do next?

ASCP will remain a candid voice in opposing the rescheduling of hydrocodone combination drugs.

  • ASCP will submit a response to DEA during the comment period.
  • ASCP will solicit feedback from its members during the review and comment phase.
  • ASCP will work with LTC stakeholders concerning the impact of DEA’s proposed rule on the LTC community and the actions that need to be taken, should this rule be finalized.
  • ASCP will continue to seek an open dialogue with a variety of policymakers in order to mitigate the impact of this policy proposal on LTC residents.


How can I get involved?

ASCP understands and appreciates your desire to participate in this critical mission. There are many ways that you, as a member, can become involved:

News Archive

February 2014

October 2013

March 2013

February 2013

December 2012

DEA releases draft rule to reschedule hydrocodone combination drugs

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.

FDA Announces Move to Recommend Reclassification of Hydrocodone Combination Drugs

On Thursday, October 24, 2013, the Food and Drug Administration (FDA) announced its intent to submit a formal recommendation to the Department of Health and Human Services (HHS), in which they would propose moving hydrocodone combination products to Schedule II of the Controlled Substances Act (CSA). As it is currently a Schedule III drug, the move would dramatically increase the restrictions on prescribing practices for hydrocodone combination drugs.

The FDA’s rationale for the move is to combat prescription drug abuse. The Administration says opioid pain relievers, specifically hydrocodone combination products, remain some of the most abused prescription drugs on the market.

While ASCP commends the FDA’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. However, it is likely that the increased controls will delay access to these crucial medications.

Click here to write a letter to your representatives about your opposition to this recommendation and the corresponding house and senate bills.

Visit our Advocacy Center for more information.

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