Description
This compliance policy guide describes policies regarding how FDA will handle the illegal interstate commercial shipment of dentures.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2denture
The primary product subject to the interstate shipment restrictions.
prosthetic dental appliance
Regulated product under the Federal Denture Act.
Stakeholders
1person licensed to practice dentistry
Authorized individual required for making impressions or prescriptions.
Regulatory Context
Regulatory Activities
1criminal prosecution
Legal action recommended to DOJ for violations of the FD&C Act.
Document Types
1prescription
Requirement for compounding under Section 503A
See Also (8)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates
- CPG Sec. 345.200 Diaphragms - Rx Devices
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))
- CPG Sec. 320.100 Ear Piercing Devices
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System
- CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects