Title 21

PART 203

Part 203 - Prescription Drug Marketing

PART 203 - PRESCRIPTION DRUG MARKETING Authority:21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 381. Source:64 FR 67756, Dec. 3, 1999, unless otherwise noted.

21:4.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:4.0.1.1.4.1.1.1SECTION 203.1
   203.1 Scope.
21:4.0.1.1.4.1.1.2SECTION 203.2
   203.2 Purpose.
21:4.0.1.1.4.1.1.3SECTION 203.3
   203.3 Definitions.
21:4.0.1.1.4.2SUBPART B
Subpart B - Reimportation
21:4.0.1.1.4.2.1.1SECTION 203.10
   203.10 Restrictions on reimportation.
21:4.0.1.1.4.2.1.2SECTION 203.11
   203.11 Applications for reimportation to provide emergency medical care.
21:4.0.1.1.4.2.1.3SECTION 203.12
   203.12 An appeal from an adverse decision by the district office.
21:4.0.1.1.4.3SUBPART C
Subpart C - Sales Restrictions
21:4.0.1.1.4.3.1.1SECTION 203.20
   203.20 Sales restrictions.
21:4.0.1.1.4.3.1.2SECTION 203.22
   203.22 Exclusions.
21:4.0.1.1.4.3.1.3SECTION 203.23
   203.23 Returns.
21:4.0.1.1.4.4SUBPART D
Subpart D - Samples
21:4.0.1.1.4.4.1.1SECTION 203.30
   203.30 Sample distribution by mail or common carrier.
21:4.0.1.1.4.4.1.2SECTION 203.31
   203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).
21:4.0.1.1.4.4.1.3SECTION 203.32
   203.32 Drug sample storage and handling requirements.
21:4.0.1.1.4.4.1.4SECTION 203.33
   203.33 Drug sample forms.
21:4.0.1.1.4.4.1.5SECTION 203.34
   203.34 Policies and procedures; administrative systems.
21:4.0.1.1.4.4.1.6SECTION 203.35
   203.35 Standing requests.
21:4.0.1.1.4.4.1.7SECTION 203.36
   203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.
21:4.0.1.1.4.4.1.8SECTION 203.37
   203.37 Investigation and notification requirements.
21:4.0.1.1.4.4.1.9SECTION 203.38
   203.38 Sample lot or control numbers; labeling of sample units.
21:4.0.1.1.4.4.1.10SECTION 203.39
   203.39 Donation of drug samples to charitable institutions.
21:4.0.1.1.4.5SUBPART E
Subpart E - Wholesale Distribution
21:4.0.1.1.4.5.1.1SECTION 203.50
   203.50 Requirements for wholesale distribution of prescription drugs.
21:4.0.1.1.4.6SUBPART F
Subpart F - Request and Receipt Forms, Reports, and Records
21:4.0.1.1.4.6.1.1SECTION 203.60
   203.60 Request and receipt forms, reports, and records.
21:4.0.1.1.4.7SUBPART G
Subpart G - Rewards
21:4.0.1.1.4.7.1.1SECTION 203.70
   203.70 Application for a reward.