Rules

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  1. (a) The Arkansas State Board of Pharmacy shall adopt rules for the wholesale distribution of prescription drugs which promote the public health and welfare and which comply with the minimum standards, terms, and conditions of the Prescription Drug Marketing Act and federal regulations, including without limitations 21 C.F.R. § 205, for licensing by state authorities of persons who engage in the wholesale distribution in interstate commerce of prescription drugs. The rules shall include without limitation:

    1. (1) Minimum information from each wholesale distributor required for licensing and renewal of licenses;

    2. (2) Minimum qualifications of persons who engage in the wholesale distribution of prescription drugs;

    3. (3) Appropriate education or experience, or both, of persons employed in wholesale distribution of prescription drugs who assume responsibility for positions related to compliance with state licensing requirements;

    4. (4) Minimum requirements for the storage and handling of prescription drugs; and

    5. (5) Minimum requirements for the establishment and maintenance of prescription drug distribution records.

  2. (b) In the event that this subchapter or rules promulgated under this subchapter conflict with the federal Prescription Drug Marketing Act or federal regulations, the federal Prescription Drug Marketing Act or federal regulations shall control.

  3. (c) The board shall appoint an advisory committee composed of seven (7) members, one (1) of whom shall be a representative of a pharmacy but who shall not be a member of the board, three (3) of whom shall be representatives of wholesale drug distributors, and three (3) of whom shall be representatives of drug manufacturers. The committee shall review and make recommendations to the board on the merit of all rules dealing with pharmacy distributors, wholesale drug distributors, and drug manufacturers which are proposed by the board.


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