What must be true for manufacturers to ship dialysate without being licensed as a pharmacy?

Manufacturers involved in shipping dialysate without the need to obtain a pharmacy license must be licensed as wholesalers. This requirement ensures that they comply with regulations pertaining to the distribution of pharmaceutical products. By being licensed as a wholesaler, they demonstrate that they meet the necessary standards for storage, handling, and distribution, which are critical for maintaining the integrity and safety of the dialysate products they are shipping.

In many jurisdictions, including South Dakota, the classification of a wholesaler allows manufacturers to operate within the legal framework established for distributing medical products. This contrasts with the other options, which do not reflect the legal requirements governing the distribution of dialysate. For example, storing the product for a certain period, providing free samples, or having a contract with a pharmacy do not fulfill the necessary legal criteria for bypassing pharmacy licensing. Therefore, having a wholesaler license is essential for manufacturers to operate legally in the distribution of dialysate without being classified as a pharmacy.