Rule 351-7-.07 - Testing Requirements(1) All products intended for dispensing shall be tested in final packaged form.(2) The independent laboratory shall test any part of the product in final packaged form that will be consumed or used internally or externally by a patient.(3) The independent laboratory shall follow the methodologies, ranges, and parameters which are contained in the scope of the accreditation for testing product in final packaged form.(4) An independent laboratory shall develop, implement, and validate test methods for the analyses of samples. If an Association of Official Analytical Collaboration (AOAC) International Standard Method Performance Requirement (SMPR) exists, then the selected testing method shall meet the SMPR.(5) The independent laboratory shall analyze the representative sample of product in final packaged form to determine whether foreign material is present.(6) The independent laboratory shall report the results of each test performed by the independent laboratory on the certificate of analysis.(7) If a sample of product in final packaged form passes the required testing, then an independent laboratory shall certify the batch for dispensing.(8) If a sample of product in final packaged form failed required testing, then the independent laboratory shall: (a) Notify the originating production licensee who submitted the controlled sample for testing; and(b) Report the failure in accordance with the Commission-approved tracking system reporting requirements.(9) For the testing of sample of product in final packaged form from a remediated batch, an independent laboratory shall test such sample in accordance with the rules of the Commission. If such sample passes testing, then the independent laboratory shall conduct a second test within twenty-four (24) hours of the issuance of such certificate of analysis for the first test in order to certify the batch for dispensing.(10) An independent laboratory shall destroy the remains of the samples of product in final packaged form upon completion of the test.Ga. Comp. R. & Regs. R. 351-7-.07
O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-217.
Original Rule entitled "Sample Collection Requirements" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.