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