Title 21

PART 201 SUBPART B

Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
• 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

21:4.0.1.1.2.2.1.1	SECTION 201.50	201.50 Statement of identity.
21:4.0.1.1.2.2.1.2	SECTION 201.51	201.51 Declaration of net quantity of contents.
21:4.0.1.1.2.2.1.3	SECTION 201.55	201.55 Statement of dosage.
21:4.0.1.1.2.2.1.4	SECTION 201.56	201.56 Requirements on content and format of labeling for human prescription drug and biological products.
21:4.0.1.1.2.2.1.5	SECTION 201.57	201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
21:4.0.1.1.2.2.1.6	SECTION 201.58	201.58 Waiver of labeling requirements.

---