What You Need to Know about the Rescheduling of Hydrocodone Combination Products

Thursday, October 2, 2014
By Lenis L. Archer, J.D., M.P.H., The Health Law Firm

Physicians and pharmacists: mark your calendars.

The Drug Enforcement Administration (DEA) is reclassifying "hydrocodone combination products" from Schedule III to the more-restrictive Schedule II under the Controlled Substances Act. The final regulation will take effect on October 6, 2014.

Upon the effective date, this change will have a widespread impact on healthcare professionals, particularly physicians and pharmacists. This regulation was approved in response to the nationwide abuse of prescription painkillers.

What the Reclassifications Means for Physicians.

Under the Schedule II category of controlled substances, physicians will have a harder time refilling patients' prescriptions. Refills will not be dispensed with faxed prescriptions or prescriptions called in by telephone. Only written prescriptions from a doctor will be acceptable. A physician will be allowed to call in a prescription only in an emergency situation.

It is important to note that any prescription refills involving hydrocodone are already prohibited. However, a doctor can, at his or her discretion, issue multiple prescriptions that would provide up to a 90-day supply of a hydrocodone combination products.

Also of note: due to the Schedule change, physician assistants (PAs) and nurse practitioners are no longer legally allowed to prescribe hydrocodone combination products. Only physicians can prescribe Schedule II substances.

What Pharmacists Can Expect from Reclassification.

Pharmacists will also need to be extremely diligent in their dispensing practice. Existing supplies of hydrocodone combination products must be relabeled as Schedule II drugs before they can be sold. Beginning on the effective date, pharmacies won't be able to sell their existing stock of the products unless they are relabeled.

Don't count on patients to know or understand this new regulation. Many will be confused and unhappy when they try to refill their prescriptions written before the regulation takes effect. Patients may not know that in order to obtain a valid prescription, they must make another appointment with their doctor and subsequently pay for that visit.

Take this opportunity to explain the change to patients and to physicians who routinely prescribe these drugs. Do not assume that any practitioner is aware of the Schedule change.

The Bottom Line.

You can be certain that beginning on October 6, 2014, there will be much greater scrutiny on the purchasing, prescribing, retailing and use of hydrocodone combination products. The DEA does not grant grace periods when it comes to the implementation of new regulations, so be prepared, and inform everyone in your office or pharmacy of these changes immediately. Prosecution and administrative actions can be expected for those slow to comply.


As a healthcare professional, how will the rescheduling of hydrocodone combination products affect you? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys.
The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


Andrews, Michelle. "DEA: Vicodin, Some Other Pain Meds Will Be Harder to Get." Kaiser Health News. (September 26, 2014). From: http://bit.ly/1ryiRkM

DEA Public Affairs. "DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products." DEA. (August 21, 2014). From: http://www.justice.gov/dea/divisions/hq/2014/hq082114.shtml

About the Author: Lenis L. Archer is as attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

Tag Words:
Drug Enforcement Administration, DEA, Controlled Substance Act, hydrocodone, hydrocodone combination products, schedule II, schedule III, physician, doctor, pharmacist, opioid painkiller, physician defense, doctor defense, pharmacist defense, health law, defense attorney, defense lawyer, health law firm, The Health Law Firm

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.
Lenis L. Archer 10/2/2014


Response to: What You Need to Know about the Rescheduling of Hydrocodone Combination Products
Friday, October 17, 2014
Seth Solomon says:

With all the restrictions on pain medication and doctors and pharmacists going to jail is there anyone trying to help those who are really in pain and cant get a primary care doctor or a pain management doctor to effectively handle their pain.

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