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

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

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, October 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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 product as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(c)(4)(D)). The 2019 Compliance Policy explained that the Agency intended to delay enforcement of this requirement until November 27, 2020. This guidance announces FDA’s extension of such delay in enforcement. It also sets forth the Agency’s enforcement policy with respect to section 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the FD&C Act (21 U.S.C. 360eee-1(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)), which generally provide that, beginning November 27, 2020, a dispenser5 must verify the product identifier of suspect or illegitimate product in the dispenser’s possession or control. This guidance addresses the readiness of wholesale distributors to comply with the requirement to verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute under section 582(c)(4)(D) of the FD&C Act. 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. FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the FD&C Act. This represents an additional 3-year delay from the delay set forth in the 2019 Compliance Policy in enforcement of the requirement for wholesale distributors to verify the product identifier prior to further distributing that returned product.
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:
9918231190606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918231190606676