[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.50]
[Page 110]
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.
[[Page 111]]
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