When will the federal final rule rescheduling hydrocodone combination products (HCP) from Schedule III to Schedule II become effective?
October 6, 2014.
Where may I access the federal final rule rescheduling hydrocodone combination products?
https://www.federalregister.gov/articles/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule
May prescriptions issued prior to October 6, 2014 for hydrocodone combination products (HCPs) be refilled after October 6, 2014?
Yes. According to the final rule, “Any prescriptions for HCPs that are issued before October 6, 2014, and authorized for refilling, may be dispensed in accordance with 21 CFR 1306.22-1306.23, 1306.25, and 1306.27, if such dispensing occurs before April 8, 2015.”
Should prescriptions issued on or after October 6, 2014 for hydrocodone combination products (HCPs) include refills?
No. According to the final rule, “No prescription for HCPs issued on or after October 6, 2014 shall authorize any refills.
When will I have to start using DEA Form 222 or DEA's Controlled Substance Ordering System (CSOS) to order hydrocodone combination products?
October 6, 2014.
Can I use a manufacturer’s stock bottle for a hydrocodone combination product (HCPs) after October 6, 2014 if it is still labeled “C III”?
Yes. While manufacturers must begin on October 6, 2014 using labels indicating Schedule II, the final rule indicates, “Dispensers with HCPs in commercial containers labeled as schedule III may continue to dispense these HCPs after the implementation of this rule.
When will pharmacists be required to perform monthly perpetual inventories of hydrocodone combination product as indicated in Board of Pharmacy Regulation 18VAC110-20-240?
While pharmacists practicing in a pharmacy that maintains a DEA registration must comply with all federal requirements regarding the rescheduling of HCPs from Schedule III to Schedule II, these pharmacists are not legally required to perform monthly perpetual inventories of HCPs until the drug is rescheduled as a Schedule II in state law. State drug scheduling actions have historically been performed by the General Assembly, as warranted, and become effective July 1.
What are the requirements related to inventorying hydrocodone combination products?
Per requirements in the federal Controlled Substances Act, a pharmacy must conduct an inventory of all hydrocodone-containing products prior to the opening of business on October 6, 2014. Pharmacies must maintain that inventory with all other controlled substance inventory records.