The DEA’s Reschedule of Hydrocodone Combination Products and How It Affects Your Dental Practice

In an attempt to curb the growing misuse of prescription medications, a new reschedule of hydrocodone combination products (“HCPs”) went into effect on October 6, 2014 that rescheduled HCPs from Schedule III to Schedule II of the Controlled Substances Act. Pursuant to this reschedule, HCPs, or any drugs that contain a mixture of hydrocodone and another substance, are now classified as having the highest potential for abuse of any drugs with accepted medical use. According to the Federal Register, HCPs are the most frequently prescribed drugs in the United States, with nearly 137 million prescriptions dispensed in 2013 alone. Under this reschedule, brand name HCPs commonly prescribed for pain management, such as Vicodin, Norco, Lorcet, and Lortab, are now considered Schedule II drugs and will be subject to stricter rules and regulations associated with Schedule II substances. In addition, cough syrups containing hydrocodone, such as Tussionex and Novasus now fall under the Schedule II category as well.

What Does This Mean for Your Dental Practice? 

  • A reschedule of HCPs from Schedule III to Schedule II means stricter regulatory controls on those who handle and prescribe HCPs.
  • Pursuant to these new regulations, prescriptions for HCPs issued on or after October 6, 2014 will not be authorized for refills. Authorized HCP prescriptions issued before October 6, 2014, however, may be dispensed only if they are refilled before April 8, 2015. After April 8, 2015, refills on HCP prescriptions issued prior to October 6, 2014 will no longer be authorized.
  • According to the DEA, pharmacies will not be able to issue new Schedule II prescriptions, even if those prescriptions are tied back to original prescriptions issued before the new reschedule went into effect.
  • Pursuant to these new regulations, dentists and other prescribers will have to physically write all prescriptions for HCPs. Pharmacies will no longer be able to accept prescriptions that are submitted by telephone of fax. Any electronic submission of HCP prescriptions will be pursuant to varying state law.
  • Dentist and other prescribers will, however, be permitted to call-in HCP prescriptions under emergency circumstances.
  •  The recent reschedule will also reduce the number of pills that can be prescribed at one time. Multiple prescriptions may be issued at one time, however, to ensure patients receive up to a 90-day supply.

  • Pursuant to state law, some nurse practitioners, physicians assistants, and clinical nurse specialists may lose their ability to prescribe Schedule II substances, or have their current abilities limited.

  • Dentists and other prescribers of Schedule II substances are encouraged to take an exact inventory account of all HCPs. According to the Ohio State Pharmacy Board, these inventories should have been taken before the reschedule went into effect.

  • Effective January 1, 2015, all HCP prescribers in Ohio will also be required to conduct annual drug inventories of Schedule II controlled substances. More information regarding these inventories can be found at pharmacy.ohio.gov/inventory.

In sum, it is important for dentists and other HCP prescribers to be aware of these new, stricter regulations and the effects they may have on your practice. Since many laws regarding Schedule II substances vary across state lines, the best approach is checking the specific laws of your state to see how these changes will affect both your practice and its patients, and to ensure that you are able to maintain the quality of both your dental practice and its patient care.

About the Author

Brooke Mangiarelli is one of our paralegals here at Nardone Limited. She is a graduate of The Ohio State University, where she obtained her Bachelor’s in International Relations & Diplomacy.