[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.1]

[Page 86-87]
 
                        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 A_General Provisions
 
Sec. 203.1  Scope.




                      Subpart A_General Provisions

Sec.
203.1 Scope.
203.2 Purpose.
203.3 Definitions.

                         Subpart B_Reimportation

203.10 Restrictions on reimportation.
203.11 Applications for reimportation to provide emergency medical care.
203.12 An appeal from an adverse decision by the district office.

                      Subpart C_Sales Restrictions

203.20 Sales restrictions.
203.22 Exclusions.
203.23 Returns.

                            Subpart D_Samples

203.30 Sample distribution by mail or common carrier.

[[Page 87]]

203.31 Sample distribution by means other than mail or common carrier 
          (direct delivery by a representative or detailer).
203.32 Drug sample storage and handling requirements.
203.33 Drug sample forms.
203.34 Policies and procedures; administrative systems.
203.35 Standing requests.
203.36 Fulfillment houses, shipping and mailing services, comarketing 
          agreements, and third-party recordkeeping.
203.37 Investigation and notification requirements.
203.38 Sample lot or control numbers; labeling of sample units.
203.39 Donation of drug samples to charitable institutions.

                    Subpart E_Wholesale Distribution

203.50 Requirements for wholesale distribution of prescription drugs.

        Subpart F_Request and Receipt Forms, Reports, and Records

203.60 Request and receipt forms, reports, and records.

                            Subpart G_Rewards

203.70 Application for a reward.

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

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



    This part sets forth procedures and requirements pertaining to the 
reimportation and wholesale distribution of prescription drugs, 
including both bulk drug substances and finished dosage forms; the sale, 
purchase, or trade of (or the offer to sell, purchase, or trade) 
prescription drugs, including bulk drug substances, that were purchased 
by hospitals or health care entities, or donated to charitable 
organizations; and the distribution of prescription drug samples. Blood 
and blood components intended for transfusion are excluded from the 
restrictions in and the requirements of the Prescription Drug Marketing 
Act of 1987 and the Prescription Drug Amendments of 1992.