View Source

42 C.F.R. § 447.506

Authorized generic drugs.

§ 447.506 Authorized generic drugs.

(a) Definitions. For the purpose of this section, the following definitions apply:

Primary manufacturer means a manufacturer that holds the NDA of the authorized generic drug.

Secondary manufacturer of an authorized generic drug means a manufacturer that is authorized by the primary manufacturer to sell the drug.

This document is only available to subscribers. Please log in or purchase access.
Purchase Login

About SCCE

The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

952.933.4977

About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

952.988.0141

Facebook X LinkedIn
Copyright © 2024 by Society of Corporate Compliance and Ethics (SCCE) & Health Care Compliance Association (HCCA). No claim to original US Government works. All rights reserved. All information provided through this site, including without limitation all information such as the “look and feel” of the site, data files, graphics, text, photographs, drawings, logos, images, sounds, music, video or audio files on this site, is owned and/or licensed by SCCE & HCCA or its suppliers and is subject to United States and international copyright, trademark and other intellectual property laws. Any third party logos and/or content provided herein is owned by such third parties and is used by permission herein. Your use of this site to is subject to our Terms Of Use and Privacy Statement.
Cookie settings