### Question
Can you define what 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 means?


### Answer
**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 the following in *21 U.S.C. § 353*:

> 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 8-NARCOTIC FARMS > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

