Georgia's New Nonresident Pharmacy Permit - Proposed Rules Hearing Dec. 11, 2013

This is the second in a series of client updates regarding a new Georgia law enacted April 24, 2013, House Bill 209. A previous update on this law can be found here.

As you may know, on April 24, 2013, Georgia’s legislature enacted a new law requiring the Georgia Board of Pharmacy to issue licenses to and regulate pharmacies located outside of Georgia. The Board recently proposed Rule 480-6.02 regulating nonresident pharmacies. A copy is available here. The Board will consider the proposed rule at a December 11, 2013 hearing. (There are other pending rules generally applicable to pharmacies within Georgia that will also be considered at that time.) The application for a nonresident pharmacy permit is not yet available.

Requirements to Obtain a Permit

The Board’s proposed rule may change when finalized, but it provides a preview of the likely requirements. In addition to the usual name and phone number requirements for the pharmacy, the proposed rule indicates the following information would also be required:

1. Address, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs;
2. Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in compliance with the laws and rules of each state in which the applicant receives and dispenses prescription drug orders;
3. The names and license numbers of each pharmacist and pharmacy technician involved in dispensing drugs to residents of Georgia and evidence that the pharmacists and pharmacy technicians are licensed and in good standing in the state where they are located; and
4. Information necessary to determine compliance with O.C.G.A. T.50 Ch.36 (lawful presence).

A nonresident pharmacy will be considered “registered” after filing the application with the Board, paying the $1,000 registration fee, and receiving certification from the Georgia Drugs and Narcotics Agency that the permit qualifications are met. The nonresident pharmacy permits issue for two years, expiring on June 30th of each odd numbered year. If renewal applications and fees are not received by September 1st of the odd numbered year, the permit will lapse, and an application for a new permit will need to be filed.

The proposed rule also establishes reasons the Board can deny nonresident pharmacy permits. Specifically, permits may be denied for failure to comply with Board rules, failure to meet the minimum qualifications for a permit, conviction by an owner or pharmacist of a felony involving the practice of pharmacy or distribution of drugs, false representations on an application, or any other good cause related to misfeasance or malfeasance by the applicant. Permits may also become void upon the sale, transfer, or change of mode of operation or location of the business if the sale, transfer, or change is not approved by the Board.

Additional Requirements Applicable To Nonresident Pharmacies

Similar to many other states, the proposed rule imposes operational compliance obligations on permitted nonresident pharmacies. These obligations include:

• For all prescriptions shipped, mailed, or delivered into Georgia, compliance with Georgia requirements regarding recordkeeping; minimum labeling; delivery of prescriptions by mail; compounding; and patient counseling requirements, including a requirement to maintain a toll-free number for counseling; and
• Compliance with all applicable USP and FDA requirements for storage, packaging, and shipping of prescription drugs and devices.

Nonresident pharmacy permit holders must also maintain records and provide them to the Board upon request, including: normal delivery protocols and times; procedures to be followed if a prescription is not available at the pharmacy or if delivery will be delayed; procedures to be followed if a prescription for an acute illness is received; and procedures to be followed regarding interim dosages when a permit holder is advised that a patient’s medication has not been received on time, and the patient is out of medication.

The proposed rule also imposes certain notification requirements on nonresident pharmacies, including notification of final orders imposing disciplinary action or restrictions by other state pharmacy boards. The nonresident pharmacy must also cooperate with Board investigations and respond to Board communications within 10 calendar days.

Updates will follow when the Georgia Board of Pharmacy provides additional information about this new rule, and when the nonresident pharmacy permit application is made available.

For more information, contact Roger Morris at (602) 229-5269 / roger.morris@quarles.com, Rachel Bryers at (414) 277-5829 / rachel.bryers@quarles.com, or your Quarles & Brady attorney.