Ga. Comp. R. & Regs. R. 480-10-.20 - Required Notifications to the Board

(1) For purposes of this rule, the following terms shall means as follow:
(a) "Board" shall mean the Georgia Board of Pharmacy;
(b) "Immediate notification" shall mean written notification sent within twenty-four hours of the event;
(c) "Significant adverse drug reaction" shall mean any reaction which requires any medical treatment beyond a consultation between Pharmacist/patient, Pharmacist/Prescriber, patient/prescriber or Pharmacist/patient/Prescriber; and
(d) "Written notification" shall mean in writing and sent by statutory overnight delivery or by email.
(2) The following occurrences require immediate notification to the Board at its address of record, unless otherwise provided:
(a) Permanent closing of a licensed pharmacy. Notification shall include the name and contact information for the person responsible for maintaining the pharmacy records after the pharmacy has closed and location of the records.
(b) Change of ownership or location of a licensed pharmacy. Since a pharmacy license cannot be transferable, unless such change has been previously approved by the Board following the submission of the appropriate applications, the existing pharmacy license is void and there is no continuing authority to operate as a pharmacy.
(c) Change in management of a licensed pharmacy.
(d) Change of the pharmacist in charge of a licensed pharmacy. When the Board receives notice that a pharmacy no longer has a pharmacist in charge and no replacement pharmacist in charge is named, the pharmacy's license is suspended pending further action by the Board.
(e) Any theft or loss of drugs or devices of a licensed pharmacy. This notification must also be made to the Georgia Drugs and Narcotics Agency, and if involving controlled substances, the pharmacy must comply with Rule 480-16-.06.
(f) Any known conviction of any employee of a licensed pharmacy of any state or federal drug laws, not previously reported.
(g) Disasters or accidents involving the licensed pharmacy.
(h) Thefts or break-ins at the licensed pharmacy.
(i) Theft, destruction, or loss of records of a licensed pharmacy required to be maintained by state or federal law.
(j) Occurrence at a licensed pharmacy of a significant adverse drug reaction by a customer or person receiving medication dispensed or compounded by the licensed pharmacy.

Notes

Ga. Comp. R. & Regs. R. 480-10-.20
O.C.G.A. ยงยง 26-4-27, 26-4-28, and 26-4-112.
Original Rule entitled "Required Notifications to the Board" adopted. F. Dec. 19, 2013; eff. Jan. 8, 2014.

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