Food and Drug Administration Likely to Tighten Controls on Hydrocodone Combination Drugs

Thursday, January 31, 2013

By Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs from schedule III into the more restrictive schedule II category of controlled substances. According to a number of different sources, on January 25, 2013, the committee presented this recommendation to the FDA. If approved, hydrocodone combination drugs, such as Vicodin, will be harder for physicians to prescribe.

The advisory committee met because the Drug Enforcement Administration (DEA) is requesting the FDA to approve the reclassification of hydrocodone combination products. The DEA wants to help curb the growing number of people across the country addicted to painkillers.

Click here to read an FDA briefing document given to the advisory committee.

It is now up to the FDA to decide whether or not to implement the advisory committee’s decision as to whether hydrocodone combination drugs will stay labeled as schedule III controlled substances or move to schedule II controlled substances. If medications containing hydrocodone are moved to schedule II, they will be in the same category as the widely abused oxycodone.

Prescription Drug Abuse is Deadly.

Currently, hydrocodone products are the most widely prescribed drugs in the U.S., according to an article on MedPage Today. Records show that painkiller abuse kills more people in America than heroin and cocaine combined. The DEA argues that since these drugs are so frequently abused, they should be more tightly controlled.

To read the MedPage Today article, click here.

What This Means for Health Care Professionals.

This change would have wide-spread consequences for health care professionals, especially doctors and pharmacists. Under the schedule II category of controlled substances, physician assistants (PAs) and nurse practitioners would no longer be legally allowed to prescribe hydrocodone combination drugs.

If the recommendation is accepted, it would be more difficult for patients to obtain refills on hydrocodone combination drugs. Refills without a new prescription, faxed prescriptions and prescriptions called in by telephone would all be banned. Only written prescriptions from a doctor would be allowed.

If the recommendation is adopted, much stricter scrutiny on the purchasing, prescribing, retailing and use of these medications can also be expected. Prosecutions and administrative actions can also be expected to follow.

The FDA is also debating the DEA’s request to limit prescriptions of hydrocodone combination pills to a 90-day supply instead of the current regulations which permit five refills within six months.

Patient Advocates Argue Against Recommendation.

According to an article in The New York Times, many opponents spoke against the recommendation. Advocates for nursing home patients argued that weak and elderly residents with chronic pain would have to make a difficult trip to see a doctor just to get a prescription refilled. Click here to read The New York Times article.

Some committee members questioned if there was another option to consider versus changing the scheduling. They questioned whether greater use of e-prescribing and Prescription Drug Monitoring Programs, as well as better education efforts for clinicians and patients would be better solutions for the drug abuse epidemic.

Now it remains to be seen how the FDA will interpret the advisory committee’s recommendation.

Prescription Drug Abuse in Florida.

Florida law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse in Florida.

We have written a number of blogs on the abuse of narcotics in Florida. See our blog on a fake prescription ring busted in Osceola County, and a Central Florida nurse accused of illegally obtaining prescriptions for painkillers, for example. Check our website for similar blogs.

Pharmacists, pharmacies, legal distributors and physicians are often too caught up in the frenzy to stem prescription drug abuse and to eliminate “pill mills.”

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


As a health care professional, do you think hydrocodone products should be labeled as a schedule II controlled substance? What are the positive and negative effects of this decision? Please leave any thoughtful comment below.


Fiore, Kristina. “FDA Panel Votes for Tighter Controls on Vicodin.” MedPage Today. (January 25, 2013). From:

Tavernise, Sabrina. “F.D.A. Likely to Add Limits on Painkillers.” The New York Times. (January 25, 2013). From:

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area.  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Tag Words: Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH), hydrocodone, schedule III controlled substances, schedule II controlled substances, physician assistants (PAs), nurse practitioner, doctors, physicians, pharmacists, defense attorney, defense lawyer, administrative hearings, license defense counsel

"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.
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