Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
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, August 2023
Language(s):
English
Format:
Text
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.
Genre(s):
Guideline
Technical Report
Abstract:
On October 23, 2020, FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product - Compliance Policies guidance (the 2020 Compliance Policies). This guidance revises and extends the 2020 Compliance Policies for an additional year, from November 27, 2023, to November 27, 2024. Previously, on September 24, 2019, FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product - Compliance Policy guidance (the 2019 Compliance Policy), where FDA announced a 1-year delay in enforcement of the requirement for wholesale distributors to verify saleable returned product4 as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee1(c)(4)(D)). The 2019 Compliance Policy explained that the Agency intended to delay enforcement of this requirement until November 27, 2020. Subsequently, the 2020 Compliance Policies announced FDA’s extension of the enforcement policy embodied in the 2019 Compliance Policy with respect to this requirement for an additional three years, until November 27, 2023. This guidance, like the 2019 and 2020 Compliance Policies, addresses the readiness of wholesale distributors to comply with the requirement under section 582(c)(4)(D) of the FD&C Act to verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute. The requirement under section 582(c)(4)(D) of the FD&C Act for wholesale distributors to verify saleable returned products prior to redistribution went into effect on November 27, 2019.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (7 pages))
NLM Unique ID:
9918716789006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918716789006676