Rescheduling Hydrocodone Combination Products

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Background

On Friday, August 22, 2014, the Drug Enforcement Administration (DEA) published the final rule (PDF) in the Federal Register to rescheduling hydrocodone combination products to Schedule II of the Controlled Substances Act (CSA). 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.

As these drugs are currently in Schedule III, this will dramatically increase the restrictions on prescribing and dispensing practices for hydrocodone combination products.

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?

This rule goes into effect October 6, 2014 at which time hydrocodone combination products will be regulated as Schedule II drugs under the CSA.  ASCP members should begin the process of identifying patients with chronic pain being treated with hydrocodone combination products in anticipation of meeting new CSA compliance requirements. 

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 issued a news release August 22, 2014 in reaction to the publication of the final rule.
  • ASCP submitted comments (PDF) to the DEA docket April 28, 2014 opposing the rescheduling of hydrocodone combination products in response to a proposed rule published February 27, 2014.
  • ASCP signed on to a joint PAC/LTC industry letter (PDF) opposing the rescheduling of hydrocodone combination products in response to the proposed rule published February 27, 2014.
  • ASCP signed on to a joint pharmacy industry letter (PDF) opposing the rescheduling of hydrocodone combination products in response to the proposed rule published February 27, 2014.
  • 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’s leadership is in the process of evaluating the finer details of the final rule before determining the Society’s next steps. ASCP will continue to express opposition to rescheduling hydrocodone combination products and seek relief for post-acute and long-term care patients who encounter delays in access to pain care due to burdensome regulatory restrictions.  Throughout this process and going forward:

  • ASCP will continue to solicit feedback from its members to evaluate the impact of the final rule on their patients and pharmacy operations.
  • ASCP will work with post-acute and long-term care stakeholders concerning the impact of DEA’s final rule on the community.
  • ASCP will continue to seek an open dialogue with a variety of policymakers in order to mitigate the impact of this regulation on post-acute and long-term care facility residents.
  • ASCP will consider the Society’s options for proposing new policies that would substantially reduce or eliminate current and anticipated growth in pain medication access barriers in the post-acute and long-term care settings.

How can I get involved?

ASCP understands and appreciates your desire to stay informed and to get directly involved in ASCP’s next steps. To receive regular updates and to receive instructions on how to get involved, join ASCP’s Grassroots Network (members only).

News Archive

August 2014

April 2014

February 2014

October 2013

March 2013

February 2013

December 2012

DEA Issues Final Rule on Hydrocodone Combination Products

The Drug Enforcement Administration (DEA) released on August 22, 2014 its long-anticipated final rule (PDF) rescheduling hydrocodone combination products to Schedule II of the Controlled Substances Act (CSA). The new regulation will go into effect October 6, 2014, 45 days after its publication in the Federal Register. ASCP submitted comments to the DEA docket in April 2014 opposing the proposed regulation, citing increased pain medication access barriers for patients residing in post-acute and long-term care facilities.  ASCP’s leadership is currently evaluating the details of the regulation outlined in the Federal Register notice to determine next steps. ASCP members who want to stay informed on this issue should subscribe to ASCP’s Grassroots Network.

ASCP Submits Comments to DEA Regarding Rescheduling of Hydrocodone Combination Products

On April 28th ASCP submitted comments (PDF) to the Drug Enforcement Administration’s (DEA) public docket regarding the administration’s proposed rescheduling of hydrocodone combination products (HCPs). This proposed rule would move HCPs from Schedule III to Schedule II of the Controlled Substances Act (CSA), which could exacerbate existing pain medication access barriers for patients in LTC settings. DEA cites the ever-growing prescription drug abuse and diversion epidemic in the country as a rationale for this proposal. While ASCP agrees the U.S. prescription drug abuse epidemic must be a priority for DEA, we believe that this proposal will profoundly and negatively impact the quality of care for LTC residents. ASCP’s comments explained the access issues that we currently face in LTC settings, the new problems that will arise because of HCP rescheduling, and possible solutions to these challenges.

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.

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