(AGENPARL) - Roma, 17 Marzo 2023

(AGENPARL) – SILVER SPRING ven 17 marzo 2023

Date Published Type Title Additional Information 3/16/2023 Final Guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry Notice of Availability 9/23/2022 Final Guidance Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry Notice of Availability 7/06/2022 Draft Guidance Identifying Trading Partners Under the Drug Supply Chain Security Act Notice of Availability 7/06/2022 Draft Guidance DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry Notice of Availability 3/10/2022 Draft Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Notice of Availability 2/4/2022 Proposed Rule National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers

Notice of Availability

Announcement

Webinar

Extension of Comment Period

2/4/2022 Proposed Rule Certain Requirements Regarding Prescription Drug Marketing

Notice of Availability

Announcement

2/4/2022 Proposed Rule; Withdrawal Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Withdrawal

Notice of Availability

Announcement

2/4/2022 Final Guidance Guidance: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers

Notice of Availability

Announcement

6/3/21 Final guidance Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability Notice of Availability
FDA in Brief 6/3/21 Final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Notice of Availability
FDA in Brief 6/3/21 Draft guidance Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry Notice of Availability
FDA in Brief 6/3/21 Draft guidance Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Notice of Availability
Notice of Availability
FDA in Brief 10/22/2020 Final Guidance Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies Notice of Availability 4/30/2020 Final Guidance Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency   9/23/2019 Final Guidance Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry Notice of Availability 7/3/2019 Notice Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information   10/24/2018 Draft Guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Notice of Availability 9/19/2018 Final Guidance Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (PDF – 254 KB)

Notice of Availability

FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain

9/19/2018 Final Guidance Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF – 319 KB)

Notice of Availability

FDA in Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain

9/19/2018 Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers (PDF – 363 KB) Notice of Availability 5/8/2018 Draft Guidance Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF – 117 KB) Notice of Availability 2/28/2018 Draft Guidance Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (PDF – 170 KB)   Notice of Availability 8/18/2017 Draft Guidance Identifying Trading Partners Under the Drug Supply Chain Security Act, Guidance for Industry Notice of Availability 7/20/2017 Notice Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments   4/28/2017
  Notice

Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information

  2/16/2017 Final Guidance Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act–Compliance Policy Guidance for Industry Notice of Availability 1/9/2017 Draft Guidance Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers: Guidance for Industry Notice of Availability 12/8/2016 Guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry Notice of Availability

Webinar

10/28/2015 Final Guidance DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy Guidance for Industry (Revised) Notice of Availability 12/23/2014 Final Guidance DSCSA Implementation: Product Tracing Requirements — Compliance Policy Guidance for Industry  Notice of Availability 12/8/2014  Draft Guidance  Drug Supply Chain Security Act Implementation–Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Notice of Availability

Webinar

11/26/2014 Draft Guidance DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information

Notice of Availability

Public Workshop

10/7/2014 Draft Guidance The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers Notice of Availability

Fonte/Source: http://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies