17 CAR § 160-2102 – Drug products must have a new drug application or an abbreviated new drug application

(a)
1. (1) In order to provide for the protection of the public health and safety, drug products that are offered for sale by or stored at the premises of any manufacturer, distributor, wholesaler, or pharmacy located in Arkansas must have an approved new drug application (NDA) or abbreviated new drug application (ANDA) designation by the Food and Drug Administration pursuant to 21 U.S.C. § 355 unless they are exempt from the requirements for such a designation.
2. (2) In order to protect the public health and safety, drug products offered for sale by or stored at the premises of a manufacturer, wholesaler, distributor, or pharmacy location in Arkansas, which do not have the required NDA or ANDA designation or exemption therefrom referenced in the above paragraph, are hereby declared to be contraband and subject to surrender to and destruction by the Department of Health.
(b)
1. (1) Whenever it is made to appear to the Arkansas State Board of Pharmacy that any licensee of the board is in possession of a stock of drugs that are contraband as defined above, a representative of the board shall confirm with the Food and Drug Administration by telephone that the particular drug or drugs involved do not have the requirement.
2. (2) Upon receipt of this confirmation, the board shall inform the owner or person in charge of the contraband status of the drugs in question.
(c)
1. (1) Retention, dispensing, promotion, or advertisement of drug products by a licensee of the board, either at its business premises or at any separate storage facility after notification of their contraband status:
  1. (A) Shall constitute a direct and immediate danger to the public health and safety; and
  2. (B) Will be good and sufficient cause for the suspension or revocation of any license issued by the board for knowingly retaining, dispensing, promoting, or advertising any drug products that are contraband under this rule.
2. (2) This suspension or revocation would occur only after proper hearings are held by the board.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(10/14/81, Amended 6/20/91 and 5/10/2022)"