Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR
Rule 480-7A-.10 - Returned, Damaged, and Outdated Listed Chemicals

Universal Citation: GA Rules and Regs r 480-7A-.10

Current through Rules and Regulations filed through March 20, 2024

(1) Any drug or device that is outdated, damaged, deteriorated, misbranded, adulterated, or otherwise deemed unfit for human consumption shall be quarantined and physically separated from other listed chemicals until they are returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.

(a) When listed chemicals are adulterated, or misbranded, notice of the adulteration, or misbranding shall be provided to the Board and manufacturer or wholesale distributor from which it was acquired within three (3) business days.

(b) Any listed chemical returned to a manufacturer or wholesale distributor shall be kept under proper conditions for storage, handling, and shipping, transporting, and documentation showing that proper conditions were maintained is provided to the manufacturer or wholesale distributor to which the drugs are returned.

(2) Any listed chemical whose immediate or sealed outer or secondary containers or labeling are adulterated or misbranded shall be quarantined and physically separated from other listed chemicals until they are returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.

(a) When the immediate or sealed outer or secondary containers or Labeling of any listed chemical are adulterated or misbranded notice of the adulteration or misbranding shall be provided to the Board and manufacturer or wholesale distributor from which it was acquired within three (3) business days.

(3) Any listed chemical that has been opened, outdated, or used, shall be identified as such, and shall be quarantined and physically separated from other drugs or devices until they are returned to the manufacturer or wholesale Distributor from which acquired or destroyed via distribution to a reverse distributor.

(4) The record-keeping requirements in 480-7A-.06 of this rule shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated listed chemicals, as provided by law, and such action shall be consistent with relating the drugs.

O.C.G.A. Secs. 16-13-30.3, 16-13-30.4, 26-3-7 to 26-3-9, 26-3-16, 26-4-27, 26-4-28.

Disclaimer: These regulations may not be the most recent version. Georgia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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