Wednesday, November 5, 2014

FAQ About Rescheduling All Hydrocodone Combination Products from Federal Schedule III to Federal Schedule II

We have received questions from physicians and pharmacies about the new DEA rules for hydrocodone combination products (HCPs).  Effective October 6, 2014, the DEA rescheduled HCPs from federal Schedule III to federal Schedule II.  This change impacts how hydrocodone combination products are prescribed and dispensed in California. Federal requirements for prescribing and dispensing Schedule II controlled substances will apply to all hydrocodone combination products. This means, among other thing, a very limited ability to orally prescribe HCPs (see below) and ability to authorize refills.
This “up scheduling” is a major change for California. According to CURES, over 1 billion dosage units of HCPs were dispensed last fiscal year in California. HCPs are the most frequently prescribed opioid in the United States: nearly 137 million prescriptions for HCPs were dispensed in 2013.
Here are frequently asked questions and answers: 
Question 1: Does this mean California law has also reclassified ALL hydrocodone combination products as Schedule II controlled substances?
Answer 1: This is a technical question where federal law governs. Technically, there has been no equivalent change to California law, or to the controlled substance schedules in California. But for many intents and purposes, the practical effect will be the same: that all prescribers and practitioners in California will be required to treat HCPs as Schedule II controlled substances.
Question 2: Are prescriptions written for HCPs before October 6, 2014 that are presented to the pharmacy for dispensing on or after October 6, 2014 to be dispensed as a Schedule II or Schedule III controlled substance? 
Answer 2: If the prescription is first presented on or after October 6, it must follow federal Schedule II requirements. For example, this means no HCP prescription issued on or after this date may authorize any refills. It also means that as of October 6 oral, telephone or fax-transmitted prescriptions for HCPs are no longer possible. 
Question 3:  Can the remaining refills for HCP prescriptions written and filled before October 6 as a Schedule III, be dispensed after October 6?   
Answer 4:  Yes. The DEA has stated that it will allow refills on HCPs written and initially filled before October 6 (under Schedule III requirements and limitations), to be dispensed up to six months from October 6, 2014 (until April 8, 2015). This extends the Schedule III treatment of prescriptions for HCPs written and initially dispensed prior to October 6, 2014 to the maximum allowable period for Schedule III refills. Of course, the original date on the prescription cannot exceed 180 days, or the maximum allowable period for Schedule III refills. 
If there are any questions for prescribing physicians or dispensing pharmacists, err on the safe side and seek consultation so that you comply with the federal laws and regulations. Patients may be frustrated by the change in the law but do not let them pressure you into prescribing or dispensing unless you are fully compliant. 
Posted by Tracy Green, Esq.


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