Ga. Comp. R. & Regs. R. 480-11-.08 - Records and Reports

(1) Any procedures or other records required to be maintained in compliance with this chapter shall be retained for the same period of time as required in chapter 480-10 of the Board Rules for the retention of prescription files.

(2) All records required to be retained under this chapter or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection.

(3) Records required under this chapter may be retained either as the original records or as true copies, such as photocopies, microfilm, microfiche, electronic files or other accurate reproductions of the original records. All records or reports must be producible immediately if requested by the Board or an agent of the GDNA or within forty-eight (48) hours if maintained in a central database.

(4) In addition to standard record and reporting requirements, the following records and reports must be maintained for sterile pharmaceuticals:

(a) A policy and procedure manual, including policies and procedures for cytotoxic and/or infectious waste, if applicable; and

(b) Lot numbers and expiration dates of all the components used in compounding sterile prescription drug orders.

(c) This record-keeping requirement does not apply when FDA approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.

Notes

Ga. Comp. R. & Regs. R. 480-11-.08

O.C.G.A. §§ 26-4-5, 26-4-27, 26-4-28, 26-4-86.

Original Rule entitled "Records and Reports" adopted. F. Apr. 19, 2004; eff. May 9, 2004. Amended: F. Nov. 26, 2014; eff. Dec. 16, 2014.