FDA: Expect Delays Before Hydrocodone Combination Drugs Reclassified

The Food and Drug Administration (FDA) told lawmakers this month that the process of reclassifying hydrocodone combination products, in order to make them more difficult to prescribe, will be long, The Hill reports.

In January, an FDA advisory panel voted to strengthen restrictions on hydrocodone combination drugs, such as Vicodin. The panel recommended that the FDA make the drugs more difficult to prescribe.

The Drug Enforcement Administration (DEA) classifies drugs on a five-stage scale, which takes into account the potential for addiction. Currently, hydrocodone is considered by the DEA to be a Schedule II controlled substance, the second-highest level.

Hydrocodone combinations, such as Vicodin, are Schedule III, and therefore have fewer restrictions on sales. Under the advisory panel recommendation, Vicodin and other hydrocodone combination products would move from Schedule III to Schedule II.

The proposal forbids refills without a new prescription, as well as faxed prescriptions and those called in by phone. Distributors of the drugs would have to store the drugs in special vaults. Nurse practitioners and physician assistants would be banned from prescribing the drugs.

Following the vote, U.S. Representatives Vern Buchanan of Florida and Edward Markey of Massachusetts sent a letter to the FDA, urging the agency to follow the recommendations of the advisory panel.

In response, the FDA wrote a letter to the Congressmen explaining that many regulatory obstacles must be overcome before the drug can be reclassified. The DEA must first publish information in the Federal Register and receive public comment. The FDA also must research the addictiveness of the medication, the article notes.

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    October 20, 2014 at 1:50 AM

    The new DEA guidelines for Hydrocodone; Federal Register /Vol. 79, No. 163 / Friday, August 22, 2014 /Rules and Regulations are an extremely bad move! Their logic is to reduce the abuse of class II drugs, but sadly that will not be the end result. For those people that use Hydrocodone, Vicodin, etc. for severe chronic pain, they will now need to visit their Doctor every time they need a refill. Now a patient must spend more money on Doctor’s visits, travel etc. for a simple refill. Alternatively, they can avoid that cost and buy large quantities of acetaminophen, destroy their liver, run up huge hospital expenses and die in no time, or live with chronic pain and have little ability to work or do much else except suffer.

    If a person is an abuser of Class II drugs, they will simply go to illegal means of acquiring them or move to illegal street drugs. So to make it a little difficult (if that) for a drug abuser to obtain Vicodin, legitimate patients that need pain management pay the price in more than just dollars. This new rule is one of the stupidest since Obamacare (but that is another subject).

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    October 5, 2014 at 3:24 PM

    This is a large and stupid over reaction to a issue that really isnt about vicodin abuse ,but a change in social drug culture.most addicts abandon vicodin for stronger drugs like oxycodone,opana,actiq,methadone and sadly as seen here in saan diego and most cities that have issues with perscription abuse,people who are suddenly without their vicodin and go into withdrawl will suddenly find themselvs with a spoon in one hand and a needle in the otger finding themselvs shooting heroin.i have been thru medical detox to get off of oxycodone and i was shocked by the number of young kids whos lives were ruined by switching to heroin as its often much cheaper than pills,easier to get and offers a much better high.
    This reclass of vicodin will not stop addicts from getting scripts.it will just end up making lines at offices longer,e.r rooms will be flooded with people with small dental issues whos doc cant call in aa script of vicodin over the weekend till they can be seen to get a toothache taken care of.people who need stromger meds after minor surgeries will now find themselvs going to the e.r instead of calling the surgons 24hr service.if u are on the meds and an addict this change dosent do anything except make the pills (legal or illegal) more expensive and harder to get so now people who were on 50-100 tabs of norco or vicodin a week will find themselvs trying stronger more illicit drugs insearch of an easier score.u watch im betting the number of heroin related deaths will triple.when a addict cant get what he wants he will find what works.they cant control oxy abuse and that has the same classification as vicodin will now have.so what makes them think this will change anything.its just going to over tax a system of medicine that was struggling to keep up with the amount of patients.now offices will be filled each month as people who could have been given refills are now subject to idiotic rules and docs will be flodded with patients they didnt really need to be seen each month.now there is no pain med that docs can use to treat moderate to severe pain that is able to be phoned in or faxed in.t3 is the closest thing and is weak in comparison.tylenlol with codiene is now going to be abused as vicodin was

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    March 18, 2013 at 8:50 AM

    It’s my understanding that the AMA will strongly oppose this issue. The doctors do not want to have to re-see patients on a monthly basis. They would rather be able to write a 90 day script, and see the patient every 3 months.

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