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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

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

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
 
PART 208MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
 

Subpart A - General Provisions
   § 208.1 - Scope and purpose.
   § 208.3 - Definitions.

Subpart B - General Requirements for a Medication Guide
   § 208.20 - Content and format of a Medication Guide.
   § 208.24 - Distributing and dispensing a Medication Guide.
   § 208.26 - Exemptions and deferrals.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 360, 371, 374; 42 U.S.C. 262.
Source: 63 FR 66396, Dec. 1, 1998, unless otherwise noted.

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