Title 21

PART 201 SUBPART A

Subpart A - General Labeling Provisions

21:4.0.1.1.2.1.1.1SECTION 201.1
   201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
21:4.0.1.1.2.1.1.2SECTION 201.2
   201.2 Drugs and devices; National Drug Code numbers.
21:4.0.1.1.2.1.1.3SECTION 201.5
   201.5 Drugs; adequate directions for use.
21:4.0.1.1.2.1.1.4SECTION 201.6
   201.6 Drugs; misleading statements.
21:4.0.1.1.2.1.1.5SECTION 201.10
   201.10 Drugs; statement of ingredients.
21:4.0.1.1.2.1.1.6SECTION 201.15
   201.15 Drugs; prominence of required label statements.
21:4.0.1.1.2.1.1.7SECTION 201.16
   201.16 Drugs; Spanish-language version of certain required statements.
21:4.0.1.1.2.1.1.8SECTION 201.17
   201.17 Drugs; location of expiration date.
21:4.0.1.1.2.1.1.9SECTION 201.18
   201.18 Drugs; significance of control numbers.
21:4.0.1.1.2.1.1.10SECTION 201.19
   201.19 Drugs; use of term “infant”.
21:4.0.1.1.2.1.1.11SECTION 201.20
   201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
21:4.0.1.1.2.1.1.12SECTION 201.21
   201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
21:4.0.1.1.2.1.1.13SECTION 201.22
   201.22 Prescription drugs containing sulfites; required warning statements.
21:4.0.1.1.2.1.1.14SECTION 201.23
   201.23 Required pediatric studies.
21:4.0.1.1.2.1.1.15SECTION 201.24
   201.24 Labeling for systemic antibacterial drug products.
21:4.0.1.1.2.1.1.16SECTION 201.25
   201.25 Bar code label requirements.
21:4.0.1.1.2.1.1.17SECTION 201.26
   201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.