1. (a) Any wholesale drug company or drug manufacturer doing business in Arkansas pursuant to Acts 1969, No. 173, as amended by Acts 1979, No. 75, and Acts 1981, No. 257 shall not distribute any controlled substance or legend drug or both in the State of Arkansas if:

   1. (1) That product requires approval by the Food and Drug Administration for marketing and distribution; and
   2. (2) The product in fact has not been approved for marketing and distribution by the Food and Drug Administration.
2. (b) Violation of this rule shall be grounds for suspension or revocation of the license of the wholesale drug or drug manufacturer’s license to do business in the State of Arkansas.

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