---
kind: "section"
citation: "21 C.F.R. § 203.50"
title: "21"
number: "203.50"
heading: "Requirements for wholesale distribution of prescription drugs."
url: "https://uscodex.org/cfr/21/203.50"
---

# §203.50. Requirements for wholesale distribution of prescription drugs.

- (a) **Identifying statement for sales by unauthorized distributors.** Before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller shall provide to the purchaser a statement identifying each prior sale, purchase, or trade of such drug. This identifying statement shall include:
  - (1) The proprietary and established name of the drug;
  - (2) Dosage;
  - (3) Container size;
  - (4) Number of containers;
  - (5) The drug's lot or control number(s);
  - (6) The business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer; and
  - (7) **The date of each previous transaction.**
- (b) The drug origin statement is subject to the record retention requirements of [§ 203.60](/cfr/21/203.60.md) and must be retained by all wholesale distributors involved in the distribution of the drug product, whether authorized or unauthorized, for 3 years.
- (c) **Identifying statement not required when additional manufacturing processes are completed.** A manufacturer that subjects a drug to any additional manufacturing processes to produce a different drug is not required to provide to a purchaser a statement identifying the previous sales of the component drug or drugs.
- (d) **List of authorized distributors of record.** Each manufacturer shall maintain at the corporate offices a current written list of all authorized distributors of record.
  - (1) Each manufacturer's list of authorized distributors of record shall specify whether each distributor listed thereon is authorized to distribute the manufacturer's full product line or only particular, specified products.
  - (2) Each manufacturer shall update its list of authorized distributors of record on a continuing basis.
  - (3) Each manufacturer shall make its list of authorized distributors of record available on request to the public for inspection or copying. A manufacturer may impose reasonable copying charges for such requests from members of the public.

## Notes

### Authority

Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 381.

### Source

Source: 64 FR 67756, Dec. 3, 1999, unless otherwise noted.