On January 1, 2018, new rules recently approved by the Iowa Board of Pharmacy (Board) will become enforceable, affecting nonresident pharmacies that are licensed, or seeking to become licensed, with the state. In particular, the State will now require that every nonresident pharmacy seeking to deliver, dispense, or distribute prescription drugs or devices to an ultimate user in Iowa, must ensure that its Pharmacist-in-Charge (PIC) is registered with the state.
A pharmacy’s PIC is ultimately responsible for establishing and implementing policies and procedures for all operations of the pharmacy and for ensuring the pharmacy operations and practices comply with all requirements of federal and state pharmacy and drug laws, rules, and regulations. The registration of the PIC will be a part of the Board’s nonresident pharmacy license application, which is required to be submitted and approved for each nonresident pharmacy seeking to operate in the state. The registration will be a one-year registration that will begin on January 1st of the calendar year and expire on December 31st of the same year. In the event that a pharmacy’s PIC changes, the pharmacy will be required to notify the Board within ten (10) days of the change, and must subsequently complete a new license application with a new permanent PIC’s registration within ninety (90) days of the change.
As a general matter, a pharmacy’s PIC is responsible for establishing and implementing policies and procedures for all operations of the pharmacy and for ensuring the pharmacy operations and practices comply with all requirements of federal and state pharmacy and drug laws, rules, and regulations. In furtherance of the PIC’s obligations, the Board has further required that, upon registration, the PIC complete an educational training module regarding Iowa rules.
It should be clear that the Board’s new rules do not require the PIC to become licensed in the State, but only that he/she become registered. Pharmacies hoping to deliver, dispense, or distribute into the state of Iowa should be aware of the changes and prepare to comply with the new requirements by the start of the new year. Failure to comply could result in disciplinary action by the state as well as audits by Pharmacy Benefit Managers (PBMs) that could result in recoupments from the pharmacy.
Pharmacies seeking to expand their practice into a state outside of its home state should be cognizant of similar rules in many states, including some, that require that a PIC actually be licensed in the state prior to the pharmacy being granted a nonresident pharmacy license. Contact Frier Levitt today for help ensuring your pharmacy is in compliance with state licensing requirements.