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The Iowa Board of Pharmacy recently amended rule 657 IAC 10.40 to classify all butalbital containing products as schedule III controlled substances, effective June 26, 2019.
Currently, products that contain butalbital/aspirin/caffeine are classified as schedule III controlled substances; butalbital products listed on the DEA’s list of Exempted Prescription Products, including butalbital/acetaminophen/caffeine products, are unscheduled. This rule change eliminates the disparity of scheduling for butalbital containing products and places all products containing butalbital, including Fioricet, into schedule III.
This change will have the following impacts on prescribing community:
- Butalbital prescriptions issued on or before December 26, 2018 will need to be reauthorized before a pharmacy may dispense the prescription (657 IAC 10.24).
- Butalbital prescriptions may only be refilled up to five times within six months after the date on which the prescription was issued. Any prescriptions that have already been refilled five or more times will need to be reauthorized before a pharmacy may dispense the prescription (657 IAC 10.24).
- Any prescriber with a stock supply of previously unscheduled butalbital containing products must take an inventory of stock on hand on June 26, 2019 (657 IAC 10.19(6)).
- If a prescriber dispenses any butalbital containing products, the dispensing must be reported to the PMP with one business day (657 IAC 37.12(2)).
Pharmacies will generally initiate communication with prescribers to request reauthorization of prescriptions that are more than six months old or that have already been refilled five or more times in order to meet the needs of patients.
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