Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, the guidance covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as “trading partners”) after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns. The guidance finalizes the revised draft guidance “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” issued on March 10, 2022.
Scope & Applicability
Product Classes
6Human prescription drugs including biological products
products intended for further distribution after return
Products covered by the DSCSA verification requirements.
Product for which there is a reason to believe it is potentially illegitimate
Product determined to be counterfeit, diverted, or otherwise unfit for distribution
Suspect product determined after investigation not to be illegitimate
Stakeholders
7Entity responsible for submitting NDINs
Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to verify product identifiers with manufacturers; must maintain systems for disposition; must first verify that the product identifier imprinted upon or affixed to the package
Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner such as a pharmacy required to verify at least 3 packages or 10 percent of suspect product; must identify and quarantine illegitimate product; may return product, saleable and non-saleable, to the trading partner
Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute
Considered trading partners but verification provisions do not impose direct requirements
Appropriate person to terminate quarantine for a manufacturer; authorized to release product from quarantine
authorized to terminate quarantine for a dispenser
Regulatory Context
Attributes
3Property of a device that may be changed via established protocols
verify the product identifier for each sealed homogeneous case
criteria for notifying FDA and trading partners
Identified Hazards
Hazards
3Product that may be counterfeit, diverted, stolen, or intentionally adulterated.
Product determined to be counterfeit, diverted, stolen, or unfit for distribution.
associated with illegitimate product
Related CFR Sections (2)
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR207.33§ 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
(a) What is the NDC for a drug and what products must have unique NDCs ? The NDC for a drug is a numeric code. Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type.Read full regulation →
See Also (8)
- Nonproprietary Naming of Biological Products Guidance for Industry (Status: Final)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (Status: Draft)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Nonproprietary Naming of Biological Products: Update Guidance for Industry (Status: Draft)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry (Status: Draft)