CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL

PART 203 PRESCRIPTION DRUG MARKETING

Subpart A - General Provisions
   § 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.
   § 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.