Beginning April 1, 2015, Georgia law will require that non-resident pharmacies be licensed by the Georgia Board of Pharmacy ("Board") before delivering prescriptions to Georgia patients.1 Originally, the non-resident licensure requirement was scheduled to take effect on January 1, 2015. In its December meeting, however, the Board voted to delay enforcement of the rule, pushing the effective date back to April 1, 2015.2
Once this requirement takes effect, Pennsylvania will be the only state that does not require licensure or registration for non-resident pharmacies. Soon, however, Pennsylvania may also require licensure, as the Pennsylvania General Assembly is currently considering legislation that would require the registration of non-resident pharmacies.3 Massachusetts is another state to recently require licensure. In 2014, the Massachusetts Legislature passed a law requiring the licensure of non-resident pharmacies, but the Massachusetts Board of Pharmacy has not yet written rules to implement this requirement.4
Requirements for Georgia Licensure as a Non-Resident Pharmacy
The Georgia non-resident pharmacy license application is available on the Board's website. The fee is $1,000 and the license is issued for a period of two years. The requirements for licensure as a non-resident pharmacy in Georgia are similar to what is required for non-resident licensure in other states.
The Board is currently recommending applicants allow 25 days for application processing; thus, in order to ensure timely licensure, non-resident pharmacies delivering prescriptions to Georgia patients should submit their licensure application to the Board no later than March 1, 2015. After April 1, 2015 it will be unlawful for a non-resident pharmacy to ship, mail, or deliver drug orders into Georgia or to advertise its services in Georgia without a non-resident pharmacy license issued by the Board.
In order to obtain Georgia licensure, along with an application, a non-resident pharmacy must submit the following:
- Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in the pharmacy's home state;
- The name and license number of the pharmacist-in-charge and evidence that the pharmacist is licensed and in good standing in the pharmacy's home state; and
- Information necessary to comply with O.C.G.A. Title 50, Chapter 36, which requires that applicants for Georgia licensure verify their lawful presence in the United States.
A non-resident pharmacy is not required to have a Georgia-licensed pharmacist designated as the pharmacist-in-charge. Additionally, non-resident pharmacies are not required to submit an inspection report unless the pharmacy engages in sterile or non-sterile compounding. If the pharmacy does engage in sterile or non-sterile compounding, the pharmacy will have to submit an inspection report that is not older than six months old and demonstrates compliance with both USP-NF standards for compounding pharmacies and the Board's rules.
Additional Compliance Requirements for Georgia-Licensed Non-Resident Pharmacies
Georgia licensure will impose additional compliance requirements for non-resident pharmacies. For example, a licensed non-resident pharmacy must:
- Notify the Board within 72 hours of a change in the pharmacy's pharmacist-in-charge;
- Maintain a toll-free telephone number operational during the pharmacy's regular hours of operation, but not less than six days per week for a minimum of 60 hours per week, in order to provide patient counseling; and
- Notify the Board within five business days of the receipt of any final order or decision by any other licensing board or federal agency of the imposition of disciplinary action or restriction.
Change of Ownership and other Status Change Requirements for Georgia Non-Resident Pharmacies
Georgia requires that change of ownership and change of location applications be submitted pre-close/pre-relocation. A new non-resident pharmacy application is required for both events. These applications must be "made and approved" before the change. Georgia non-resident licenses become "null and void upon the sale, transfer or change of mode of operation or location of the business." Therefore, pharmacies should inquire from the Board of Pharmacy about the current processing time to determine how far in advance to submit the application because a failure to timely submit a new application may result in a gap in licensure.
By creating this new licensure requirement, Georgia joins the majority of states which require licensure or registration of non-resident pharmacies. Non-Georgia pharmacies dispensing into the state should monitor developments in the licensure requirements and regulations regarding the same. Failure to comply with the Georgia licensure requirements could result in the suspension or revocation of a non-resident pharmacy's Georgia license. Any revocation or suspension of a state or federal license or permit will result in immediate suspension of the Georgia non-resident license.
GA. COMP. R. & REGS. 480-6-.02; GA. CODE ANN. § 26-4-114.1.
Board Meeting Minutes for Dec. 17, 2015, GA. BD. OF PHARMACY (Jan. 26, 2015), https://gbp.georgia.gov/sites/gbp.georgia.gov/files/related_files/site_page/December%2017%202014%20Minutes.pdf
H.B. 75, 2015 Sess. (Pa. 2015) (requiring the biennial registration of non-resident pharmacies with the Pennsylvania Board of Pharmacy).
MASS. GEN. LAWS ch. 112, § 39J.