Rule 480-7-.01 - Manufacturer's Permit(1) Applications for registration for a manufacturer's permit must be filed with the Office of the Georgia State Board of Pharmacy ("Board") with the required fee.(2) Registration of a manufacturer will be considered on the basis of the application filed, fee paid, and a report from the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the applicant possesses the necessary qualifications for a permit.(3) Application fees shall NOT be refundable.(4) No license issued under this Rule shall be transferred or assigned by a licensee. However, the Board may reassign a license to a licensee or successor entity by request upon application to the Board.(5) Prior to any change in name, ownership, mode of operation or location of a pharmacy, licensees shall apply for approval of such change by submitting a Board-approved application to the Board and paying a fee. To comply with the requirements of this Rule, applications must be made and approved prior to the change.(a) A change of ownership is deemed to have occurred upon the closure of any transaction which results in a change to any of the ownership information submitted to the Board as part of the licensee's initial application for licensure or renewal of licensure.(6) Licensees shall notify the Board in writing of the occurrence of any change to any of the information submitted to the Board as part of the licensee's initial application for licensure or application for renewal of licensure. This shall not apply to any event the occurrence of which these rules require immediate notification to the Board, in which event such immediate notification shall be made.(7) Licenses are renewed for two years and expire on June 30th of each odd numbered year and may be renewed upon the payment of the required fee and the filing of an application for renewal. If the application for renewal is not made and the fee paid before September 1st of the odd numbered year, the license shall lapse and shall not be renewed, and an application for reinstatement shall be required. Reinstatement is at the sole discretion of the Board.(8) Upon request by the Board or its designee, any manufacturer holding a permit issued by the Board that causes a dangerous drug or controlled substance product to be marketed or distributed in this state shall provide, at no cost to this state, a quantity of one gram or more of the pure compound of each such product to the Georgia Drugs and Narcotics Agency. Such quantities of pure compound will only be used for testing and analysis purposes. (a) All quantities of a pure compound provided to the Georgia Drugs and Narcotics Agency will be accounted for using a perpetual inventory system, and a copy of each product inventory will be available for review by the manufacturer providing the compound upon written request to the Board.(b) As the manufacturer is required by this subsection to submit the dangerous drug or controlled substance for analysis, the results of any chemical analysis shall be considered a trade secret within the meaning of Code Section 50-18-72(b)(1).Ga. Comp. R. & Regs. R. 480-7-.01
O.C.G.A. §§ 16-13-35, 16-13-45, 16-13-72, 26-4-20, 26-4-27 to 26-4-29, 26-4-60, 26-4-111, 26-4-113, 26-4-115, 26-4-120, 26-4-131, 43-1-19, 50-18-72.
Original Rule entitled "Rules and Regulations Concerning the Chief Drug Inspectors Office" was filed and effective on June 30, 1965.Amended: Rule repealed and a new Rule entitled "Manufacturer's Permit" adopted. Filed October 6, 1970; effective October 26, 1970.Amended: Filed August 2, 1974; effective August 22, 1974.Amended: Filed March 3, 1977; effective March 23, 1977.Amended: Filed March 26, 1982; effective April 15, 1982.Amended: Filed October 18, 1983; effective November 7, 1983.Repealed: New Rule, same title, adopted. F. Aug. 6, 2001; eff. Aug. 26, 2001.Repealed: New Rule of same title adopted. F. Feb. 22, 2007; eff. Mar. 4, 2007.Amended: F. Dec. 18, 2014; eff. Jan. 7, 2015.Amended: F. June 29, 2015; eff. July 19, 2015.Amended: F. July 24, 2024; eff. Aug. 13, 2024.