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On November 27, 2013 Public Law 113-54 was approved by 113th congress. To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. The law has been implemented in stages:
· 2015- Manufacturers and distributors began the transmission of transaction data TH/TI/TS
· 2017- Manufacturers started product labeling serialization & electronic data transmission TH/TI/TS
· 2019-2020 Distributors & dispenser only make transactions with serialized products.
· 2023 Coming soon the last stage Unit Level traceability
The activity will cover 4 topics:
1) Summary of the DSCSA law "Drug Supply chain Security Act" as approved in 2015.
2) Summary of the first stages of the law that are already implemented. Including Existing Dispenser Requirements – DSCSA
3) 2023 Enhanced Drug Distribution Security within the law.
4) Pharmacy "Dispenser" Requirements effective November 2023
The content will also include the different guides published by the FDA from 2014 to 2023 to facilitate the implementation of the law, the forums where the industry standard was discussed and agreed upon. In addition, the exceptions to the law and the expected results after implementation will be discussed.
We will also address the guidelines provided by the FDA to create an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
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Date: Jun 2, 2023 08:00 AM - 11:00 AM
CE Hours
3.00
CE Units
0.300
Registration closes on Jun 02, 2026 11:55 PM
Activity Type
- Knowledge
Target Audience(s)
- Pharmacists
- PHARMACY TECHNICIANS
Accreditation(s)
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The Colegio de Farmacéuticos de Puerto Rico is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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Objectives
- Identify the different sections or stage of the law and how it applies to them.
- Outline Policy and Procedures within their pharmacy for the identification of Suspect Products and Notification processes.
- Explain the Interoperable Data Exchange approved by the FDA
- Describe the Dispenser Requirements that will be effective November 2023
Speaker(s)/Author(s)
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Shirley J. Danner Rph |
Activity Number
0151-0000-23-011-L03-P/T
Date:
06/02/23
Time:
08:00 AM - 11:00 AM
CE Hours
3.00