Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry | Guideline Explorer

Description

Additional copies are available from:Office of Training and CommunicationsDivision of Drug Information, WO51, Room 220110903 New Hampshire Ave.Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714druginfo@fda.hhs.govGuidances (Drugs)

Scope & Applicability

Product Classes

5

Prescription Drug Packages

subject of the standardized numerical identification guidance

HCT/Ps

Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271

Biological Products

Requires analytical comparability per ICH Q5E

Biological Product

Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition

Prescription Drug

Early-phase randomized, double-blind, parallel assignment clinical study

Stakeholders

6

retailers

Entities subject to the regulations

distributors

entities involved in the distribution of devices

manufacturers

manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws

Repackager

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

Manufacturer

Entity responsible for submitting NDINs

Secretary of Health and Human Services

Published report on health care regulation reform

Regulatory Context

Attributes

2

Lot Number

Question of whether SNI includes lot or batch number; Not part of the recommended SNI but required on labels

Expiration Date

Property of a device that may be changed via established protocols

Related CFR Sections (2)

21CFR211.130§ 211.130 Packaging and labeling operations.
There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features:Read full regulation →
21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →

Related Warning Letters (10)

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CGMP/Finished Pharmaceutical/Adulterated
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CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
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Failure to Register and List
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Failure to Register and List
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2024-04-23