### Question
How does DRUGS AND DEVICES define authorized distributors of record” means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products, and


(B) the term “wholesale distribution?


### Answer
Under *21 U.S.C. § 353*, **authorized distributors of record” means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products, and


(B) the term “wholesale distribution** is defined as:

> distribution of drugs subject to subsection (b) of this section to other than the consumer or patient but does not include intracompany sales and does not include distributions of drugs described in subsection (c)(3)(B) of this section

#### Citation:
  - *21 U.S.C. § 353*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

