Description
Issued: 1/1/73Revised: 7/1/80, 9/4/87Revoked: 08/19/2005 (Obsolete - Superseded by 21 CFR 310.502(a)(14) )
Scope & Applicability
Product Classes
1Controlled Release Dosage Form Drugs
Subject of the Compliance Policy Guide regarding rate of release of active ingredients
Stakeholders
1Dockets Management
Entity responsible for receiving written comments regarding the guidance
Regulatory Context
Attributes
1Rate of Release
The specific characteristic of active ingredients addressed in the CPG
Related CFR Sections (1)
- 21CFR310.502§ 310.502 Certain drugs accorded new drug status through rulemaking procedures.
(a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of thRead full regulation →