“DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products”
DEA Chronicles 08/21/14 By Shannon F. O'Boye
In 45 days, hydrocodone combination products (“HCPs”) will be Schedule II controlled substances. This means that by early October, manufacturers, wholesalers, pharmacies, prescribers, and everyone in the drugs’ supply chains will have to be in compliance with the more restrictive regulatory requirements applicable to Schedule II drugs.
HCPs are drugs that contain hydrocodone, which by itself is a Schedule II, and another substance, such as acetaminophen or aspirin. They are used to treat moderate to severe pain and to relieve cough. Brand names include Vicodin, Lorcet, Norco, and Tussionex. Last year, more than 137 million HCP prescriptions were dispensed.
Currently, HCPs were Schedule III controlled substances under federal law and in every state except New York, which moved them to Schedule II in February 2013. Schedule II is reserved for drugs with the highest potential for harm and abuse, including psychological and physical dependence.
DEA is expected to publish its Final Rule in the Federal Register on this topic tomorrow, August 22, 2014, but a preview was made available today.
Some of the impacts of moving the drugs to Schedule II include:
- Prescribers will not be allowed to authorize refills for HCPs, though they will be allowed to issue multiple prescriptions for up to a 90-day supply.
- Note: DEA will permit pharmacies to dispense HCP refills after the effective date of the rescheduling if the prescription was issued before the effective date and the dispensing occurs before April 8, 2015.
- Prescribers will not be able to fax or phone in prescriptions for HCPs, though verbal prescriptions will be allowed in emergency situations.
- Mid-level practitioners in some states will lose the ability to prescribe HCPs or have their prescriptive authority limited, pursuant to state law.
- In some states, pharmacists will have to count the prescriptions themselves because pharmacy technicians are not allowed to do so.
- Registrants will have to use official DEA Forms 222 to transfer HCPs, rather than simple invoices or packing slips.
- Manufacturers and wholesale distributors will have to store HCPs in vaults, rather than cages.
- Labeling and Packaging
- Manufacturers will be required to label every commercial container of HCPs, including all bottles, with a “C-II” designation.
- DEA noted that the packaging and labeling requirements for manufacturers and distributors do not apply to dispensers. Thus, dispensers with HCPs in commercial containers labeled as Schedule III can continue to dispense them after the rescheduling takes effect.
Despite all of these changes, DEA rejected calls to delay the implementation of the new rules for two years, one year, or even six months, noting that scheduling actions are normally effective 30 days after publication of the Final Rule. DEA acknowledged that HCPs are the most prescribed drug in the United States and that the supply chain “will need to plan and coordinate efforts, and may even need to temporarily modify existing ordering and inventory management practices.” But it concluded that it could not delay implementing the new rule beyond 45 days due to “the risk of diversion and risk to public health and safety of U.S. residents.”