RULE 480-19-.04 - Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine

RULE 480-19-.04. Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine

(a) A record created this rule must be maintained in the pharmacy at which the transaction occurred, except that records may be kept either at a single, central location for the pharmacy or by a third party information technology company on behalf of the pharmacy only if the pharmacy has notified the GDNA of its intention to do so and received GDNA approval.

(1) Written notification must be submitted by registered or certified mail, return receipt requested, to the Director, Georgia Drugs and Narcotics Agency, 40 Pryor Street, SW, Suite 2000, Atlanta, Georgia 30303.

(2) This notification must include telephone and address contact information as well as a telephone number and email address for a point of contact person who is responsible for providing requested record for either the pharmacy's central record keeping location or any third party information technology company.

(3) The Director of the Georgia Drugs and Narcotics Agency shall issue written approval of any central record keeping location or third party information technology company prior to records being maintained in such a manner.

(b) The records required to be kept under this rule must be readily retrievable and available for inspection and copying by GDNA or other law enforcement officers as requested as provided for under the provisions of 21 U.S.C. 880, and the U.S. Combat Methamphetamine Epidemic Act of 2005.

(1) A record developed and maintained to comply with federal law may be used to meet the requirements of this rule if the record includes the information specified by this rule.

(2) Readily retrievable shall mean records must be produced by the pharmacy or the harmacy's third party information technology company in less than 6 hours for all electronically maintained records or 24 hours for any handwritten records.

(c) If a pharmacy fails to produce records or produce records in the required time is considered a violation of O.C.G.A. Sections 16-13-37, 16-13-39, and 16-13-42.

(Original Rule entitled "Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine" adopted. F. Nov. 11, 2011; eff. Dec. 18, 2011.)

O.C.G.A. ยงยง . 16-13-22, 16-13-29, 16-13-29.2,16-13-34, 16-13-35, 26-4-27, 26-4-28, 26-4-60.

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