Following are items of note from the November 2022 State of Ohio Board of Pharmacy (SOBP) E-News:
Amoxicillin Shortage and Pharmacy Compounding
The Food and Drug Administration (FDA) recently added amoxicillin to its list of drugs that are experiencing shortages. Amoxicillin, specifically the “Amoxicillin Oral Powder for Suspension,” was added to the FDA Drug Shortages list on October 28.
As a result, this drug may be compounded under section 503A of the Federal Food, Drug, and Cosmetic Act provided that all conditions of 503A are met, including a patient-specific prescription. Additionally, Ohio laws and rules require compliance with USP standards (as set forth in Ohio Revised Code (OAC) 4729:7-2).
Due to amoxicillin being added to the FDA Drug Shortages list, the FDA does not consider the drug product to be commercially available. For more information regarding FDA guidance on essential copies visit the FDA website.
In addition to pharmacy compounding, amoxicillin that is in shortage may also be produced by registered outsourcing facilities. Learn more about outsourcing facilities.
As a reminder, the SOBP has several COVID-19 related compounding waivers in effect. For more information on those waivers, visit the SOBP website.
Required OARRS Review for Gabapentin Prescriptions – Effective November 15, 2022
Effective November 15, OAC 4729:5-5-08 will be amended to require pharmacists to check a patient’s OARRS report prior to dispensing medications containing gabapentin. This rule is intended to address an increase in the overutilization of gabapentin as reported by the Ohio Automated Rx Reporting System (OARRS) and SOBP staff. For example, 24.9% (159,163) of Ohio patients in 2020 received gabapentin from multiple prescribers. View the amendments to the rule.
Mandatory Electronic Prescribing of Schedule II Controlled Substances: Safe Harbor Provision
Under current law, prescribers are required to issue an electronic prescription when prescribing a Schedule II controlled substance. The law does include several exceptions which still allow prescribers to issue a written prescription in specified circumstances.
Please note that this law includes a “safe harbor” provision that does not require a pharmacist to verify any exceptions prior to dispensing a written Schedule II controlled substance prescription.
For additional information, the SOBP has published a guidance document on the electronic prescribing of schedule II controlled substances.