Shipping Drugs to Georgia? Better Get a License
This is the first in a series of client updates regarding a new Georgia law enacted on April 24, 2013, House Bill 209.
Georgia recently enacted House Bill 209, relating to pharmacists and pharmacies. Among other things, the bill revises certain pharmacy definitions, the requirements for license transfers for pharmacists licensed in another jurisdiction, provisions relating to dispensing drugs, and the requirements for the use of security paper for hard copy prescriptions.
The Bill also adds a new section to the Georgia Code, section 26-4-114.1. This section enables Georgia to issue nonresident pharmacy permits. Beginning July 1, 2013, Georgia will require a nonresident pharmacy permit for "any person, pharmacy, or facility" located outside of Georgia that wants to "ship, mail, or deliver dispensed drugs, including but not limited to dangerous drugs and controlled substances, into this state." Although this law takes effect on July 1, the Georgia Board of Pharmacy has not yet established the effective enforcement date for nonresident pharmacy permits. This means Georgia will provide a limited grace period for nonresident pharmacies to obtain a Georgia nonresident pharmacy permit. After the effective enforcement date is set by the Georgia Board, it will be unlawful for any person, pharmacy, or facility to ship, mail, or deliver prescription drug orders to Georgia residents. It will also be unlawful for any person to advertise in Georgia the services of a person, pharmacy, or facility that is not properly licensed as a nonresident pharmacy.
The application for a nonresident pharmacy permit is not yet available. However, section 26-4-114.1 details some of the application requirements. The nonresident pharmacy application will require:
- proof of a valid pharmacy license in the resident state;
- the addresses, names, and titles of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of Georgia; and
- a statement that affirms the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state in which the applicant is licensed.
If a nonresident pharmacy is conducting sterile or nonsterile compounding for practitioners to use in patient care in the practitioner's office, the pharmacy must also submit a copy of the most recent and current inspection report conducted by the licensing agency of the jurisdiction in which the facility is located. Such inspection report is considered current if the inspection was conducted no more than six months prior to submitting the application with the Georgia Board, or no more than two years prior to the date of submission for renewal of registration with the Board. If the date of the inspection does not satisfy one of these criteria, the Board may accept an inspection report or other documentation from another entity that is deemed satisfactory by the Board. An inspection report is not required if the compounding within the facility is done pursuant to a prescription.
The new law also sets forth requirements for nonresident pharmacy permit maintenance. For example, the law requires nonresident pharmacy permit holders to provide written notification to the Board within 10 days of any change of a permit holder's principal corporate officers or pharmacist in charge of dispensing drugs to Georgia residents. A nonresident pharmacy permit holder must respond within 10 calendar days to all communications from the Georgia Board. The nonresident pharmacy must provide written notification to the Board of each location at which the permit holder maintains its records for all prescription drug orders dispensed to Georgia patients, and the records must be readily retrievable. And the nonresident pharmacy must maintain a toll-free telephone number that is operational during the permit holder's regular hours of operation, but not less than six days per week for a minimum of 60 hours per week, to facilitate patient counseling. The toll-free number must be disclosed on the label affixed to each container of drugs provided to Georgia patients.
An official copy of House Bill 209 is available here. Updates will follow when the Georgia Board of Pharmacy provides additional information about this new law, adopts rules regarding nonresident pharmacies, and when the nonresident pharmacy permit application is made available. Stay tuned!
For more information on House Bill 209, please contact Roger Morris at (602) 229-5269 / roger.morris@quarles.com, or your Quarles & Brady attorney.