26-3-9. Name and address of manufacturer on label of drugs requiring prescription.

Any drug product designed for human usage which is branded as follows:#

1. “Caution: Federal law prohibits dispensing without prescription”

2. shall bear on the label the name and address of the manufacturer.

For the purposes of this Code section, the term “manufacturer” includes any of the following parties:#

1. (1)

   The person who is responsible for the production of the drug and maintains control over the processing of same;#

2. (2)

   The person to whose specifications the drug is manufactured and who reviews adherence to such specifications through a drug testing program;#

3. (3)

   The person who manufactures the drug product and then packs and ships the said drug products on behalf of the person designated on the label as being responsible for the drug product; or#

4. (4)

   The person who manufactures the drug product and which product is distributed by the person designated on the label as being responsible for the drug without testing to determine adherence to specifications for manufacture.#

Where the drug product is manufactured by an affiliated or subsidiary company of the distributor, the name and address of the distributor only need appear.#