New Legislation Would Schedule Any Substance Containing Hydrocodone in Schedule II; Leaves Hydrocodone Combination Product Storage Requirements for Non-Practitioners Consistent with Schedule III

March 21, 2013

By Karla L. Palmer

Senators Joe Manchin (D-W.Va.) and Mark Kirk (R-IL), along with Representatives Vern Buchanan (R-FL) and Edward Markey (D-MA) introduced on March 20, 2012 bipartisan, bicameral legislation to combat prescription drug abuse by attempting to tighten restrictions on what they characterize as some of the most powerful, addictive narcotics on the market.  Titled the “Safe Prescribing Act of 2013,” the legislation will reschedule hydrocodone combination product painkillers, such as Vicodin and Lortab, from Schedule III to Schedule II controlled substances.  The press release, listing all 44 co-sponsors of the bill (29 Republicans, 15 Democrats), claims that this rescheduling will accurately reflect the drugs’ high potential for addiction and abuse. Quoting Dr. Andrew Kolodny, President of Physicians for Responsible Opioid Prescribing, the press release further states, “[t]his legislation will correct an error made over 40 years ago when the Controlled Substances Act (“CSA”) incorrectly classified hydrocodone combination products. There is clear and convincing medical evidence that hydrocodone has the same abuse liability as the Schedule II opioids.”

Although there have been grumblings of potential rescheduling since as long ago as 1999, rescheduling hydrocodone products has gained momentum in the past year or so on several fronts due to increased reports of abuse and diversion, FDASIA’s requirement of a public hearing on the issue, and FDA’s 363-page briefing memorandum setting forth its scientific and medical evaluation of hydrocodone products, which report was requested by DEA.  The latest legislative push also comes on the heels of Senator Manchin’s bi-partisan letter to FDA’s Commissioner Margaret Hamburg urging the Agency immediately to reschedule hydrocodone products to Schedule II.  At the end January of this year, the FDA also held a Drug Safety and Risk Management (“DSaRM”) Advisory Committee meeting where, after two days of discussion and deliberation, the Committee voted 19-10 in favor of rescheduling combination hydrocodone products from their current placement in Schedule III to Schedule II.  (See our prior posts addressing these subjects here, here, and here.)  As stated in these prior blogposts, rescheduling hydrocodone products from Schedule III to Schedule II would affect popular hydrocodone combination products such as Vicodin, Lortab, Lorcet, Norco, Hycodan and Vicoprofen.  (However, bulk and single entity hydrocodone products have been classified in schedule II since the passage of the CSA in 1970).
Rescheduling hydrocodone products would also impact every legitimate controlled substance handler including patients who rely on the products for pain relief.  Rescheduling would subject manufacturers, distributors, dispensers such as pharmacies and physicians, importers and exporters to more stringent regulatory requirements.  For example, among other restrictions, Schedule II substances can only be transferred between registrants via a triplicate, sequentially-numbered DEA Form 222 Official Order Form or its electronic equivalent while registrants need only document transfers of schedule III-V drugs with invoices, packing slips or other records.  Prescriptions for Schedule II substances, with limited exceptions, must be written, and pharmacies must have the original prescriptions in-hand before dispensing.  Prescriptions for Schedule III-V may be in a written, oral or faxed format.  Pharmacists cannot refill Schedule II prescriptions; but they can, if authorized to do so, refill Schedule III-V prescriptions up to five times within a six month period.  Manufacturers and distributors must secure Schedule II substances in a safe, steel cabinet or vault while schedule III-V substances may be stored in a less secure controlled substance cage or other enclosure.

As to controlled substance manufacturers and distributors of hydrocodone products,  unlike the prior Manchin bill introduced in April 2012, the proposed legislation calls for the amendment of 21 C.F.R § 1301.72 (relating to the physical security controls for non-practitioners, narcotic treatment programs and compounders for narcotic treatment programs, and storage areas for controlled substances), to allow, for a three-year period following enactment, manufacturers and distributors to store hydrocodone combination products in accordance with the physical security requirements for schedule III, IV and V controlled substances.  The proposed legislation is silent on whether other controlled substance handlers (such as pharmacies) would have to comply with more restrictive handling, storage and security requirements if hydrocodone is rescheduled to schedule II. 

The proposed legislation also requires that, within eighteen months after enactment the Comptroller General shall submit to Congress a GAO report addressing the reclassification of hydrocodone products under the Act.  The report must include an assessment of the degree to which the reclassification  of hydrocodone products “impacts the ability of patients with legitimate medical needs, particularly those in rural areas and nursing home facilities, to access adequate pain management;” and recommendations necessary to address issues, if any relating to patient access to adequate pain management.” 

Notably, legislative scheduling hydrocodone is typically a less cumbersome and quicker process than DEA’s rescheduling via the administrative rulemaking procedures set forth in 21 U.S.C. §§  811, 812.  That administrative process requires a notice and comment period and requires DEA to engage in an eight factor analysis in making a determination on whether to control or reschedule a drug.  These factors include:  (1) the drug’s actual or relative potential for abuse; (2) scientific evidence of its pharmacological effect, if known; (3) the state of current scientific knowledge regarding the drug or other substance; (4) its history or current pattern of abuse; (5) the scope, duration, and significance of abuse; (6) what, if any, risk there is to the public health; (7) its psychic or physiological dependence liability; and (8) whether the substance is an immediate precursor of a substance already controlled under this title.  21 U.S.C. § 811.