[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.50]

[Page 92]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 203--PRESCRIPTION DRUG MARKETING--Table of Contents
 
                    Subpart E--Wholesale Distribution
 
Sec. 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 Sec. 203.60 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.

    Effective Date Note: At 64 FR 67756, Dec. 3, 1999, Sec. 203.50 was 
added, effective Dec. 4, 2000. At 65 FR 25639, May 3, 2000, the 
effective date for Sec. 203.50 was delayed until Oct. 1, 2001. At 66 FR 
12851, Mar. 1, 2001, Sec. 203.50 was further delayed until Apr. 1, 2002. 
At 67 FR 6646, Feb. 13, 2002, the effective date was further delayed 
until April 1, 2003. At 68 FR 4912, Jan. 31, 2003, the effective date 
was further delayed until Apr. 1, 2004.

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