Drug product tracing: the effect of section 585 of the FD&C Act : questions and answers
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Prescription Drugs -- standards Prescription Drugs -- supply & distribution United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- The Food and Drug Administration (FDA) is issuing these questions and answers to assist industry and State and local governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee4), added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on drug product tracing. Title II, which is also referred to as the Drug Supply Chain Security Act (DSCSA), establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain and requires trading partners to pass, receive, and maintain certain product and distribution information. Section 585 requires there be a uniform national policy, preempting States from establishing or continuing in effect certain standards and requirements. FDA is issuing this guidance to: (1) help industry and States understand the law as it is currently in effect; and (2) clarify the effect of section 585(a) on any regulation of drug product tracing by States. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (3 pages)).
- NLM Unique ID:
- 9918451285906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918451285906676