Vaccines, Blood & Biologics

Laws & Regulations about Advertising & Promotional Labeling

Select Laws and Regulations for:

Prescription Drugs and Biologics
Biologic Devices
Tissues

 

Prescription Drugs and Biologics

Definitions: 

- Biologic products  42 USC 262(i)

- Drugs  21 USC 321(g)

- Advertisement  21 CFR 202.1(l)(1)

- Promotional labeling  21 CFR 202.1(l)(2) and 21 USC 321(m)

Required submission of advertising and promotional labeling

- Biologics 21 CFR 601.12(f)(4)

- Drugs 21 CFR 314.81(b)(3)(i)

- Accelerated approval biologics  21 CFR 601.45 

- Accelerated approval drugs  21 CFR 314.550

- Changes to an approved application biologics:  21 CFR 601.12(a)(4)

- Changes to an approved application drugs:  21 CFR 314.70(a)(4)

Content of Advertisements and Promotional Labeling

- Information to be included in advertisements:  21 CFR 202.1(e)(1) through (5)

- Advertisements that are false, lacking in fair balance, or otherwise misleading:  21 CFR 202.1(e)(6), 21 USC 321(n), and 21 USC 352

- Advertisements that may be false, lacking in fair balance, or otherwise misleading:  21 CFR 202.1(e)(7)

- Promotion of an investigational new drug/biologic:  21 CFR 312.6(b) and 21 CFR 312.7(a)

- Ingredients and proprietary names in advertisements:  21 CFR 202.1(a) through (d)

- “Intended uses”: 21 CFR 201.128, and 201.100(c)(1) and 21 USC 502 (f)(1)

- Reminder advertisements:  21 CFR 202.1(e)(2)(i) and 21 CFR 200.200

- Reminder labeling:  21 CFR 201.100(f) and 21 CFR 200.200

- Misleading statements:  21 CFR 201.6

- Proprietary names: 

     - Size and location 21 CFR 202.1(b)

     - Fanciful:  21 CFR 201.10(c)(3), and 202.1(a)(3) and 21 USC 321(n)

     - Similarity in spelling or pronunciation:  21 CFR 201.10(c)(5) and 202.1(a)(3)

Prohibited Acts, Injunction Proceedings, and Penalties:  21 USC 331, 332, and 333

Established names: 21 CFR 299.4, FFDCA Sec. 502(e)

 

Devices:

Definitions:

- Device:  21 USC 321(h)

- Restricted device:  21 USC 360j(e)(1)

- “Intended uses”  21 CFR 801.4

Misleading statements:  21 CFR 801.6, 21 USC 321(n), and 21 USC 352

Misbranding by reference to premarket notification:  21 CFR 807.97

Promotion of an investigational device:  21 CFR 812.7(a)

Reminder labeling:  21 CFR 801.109(d)

Prohibited Acts and Penalties:  21 USC 331, 332, 333, and 334

  •  
  • Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Definition:  21 CFR 1270.3(j)

Regulation of HCT/Ps:  21 CFR 1271.10

 

 

Key Resources

Contact FDA

Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1093 New Hampshire Avenue

WO Building 71

Silver Spring, MD 20993

Page Last Updated: 05/20/2015
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