FDA’s DSCSA deadline is approaching quickly.
Drug manufacturers, distributors, repackers, and third-party logistics (3PL) providers are struggling to meet the requirements.
The Drug Quality and Security Act (DQSA) was enacted on the 27th of November 2013 by Congress.
The DSCSA i.e. Drug Supply Chain Security Act put forward new requirements and definitions for ensuring high security of drug distribution in the US pharmaceutical industry.
An interoperable system is developed by the body to trace the prescribed drugs from manufacturers to dispensers.
This system is capable of tracing drugs at individual as well as lot package levels.
An amendment to the law was made in the same year that required the companies to take specific steps for improving the traceability and safety of the prescription drug supply.
- Manufacturers must affix a product identifier on each package that they ship
- Repackagers must track any product changes
- Distributors must verify the pedigree of the received products
- Dispensers must report to FDA if any suspect product is identified
The Food and Drug Administration will do a thorough analysis along with combat drug counterfeiting.
The DSCSA was the response of government to the growing problems in the US Pharmaceutical supply chain such as,
- Counterfeit drugs
- Adultered drugs
- Mislabeled drugs
These drugs were identified by the FDA and were restricted from entering the drug supply chain.
This act aimed to build a traceability system that can identify potentially dangerous drugs and prevent them from reaching patients.
The act applies to all the distributed and dispensed medicines in the US.
The only excepted drugs are
- Over-the-counter (OTC)
The companies need to keep records of all the transactional information related to the drugs included in the act.
The deadline to meet the DSCSA compliance is on the 27th of November, 2023.
This deadline applies to:
- Wholesale distributors
- Third-party logistics providers
Interoperable electronic tracing is one of the key components of the DSCSA 2023 requirements.
2023 DSCSA requirements are composed of three specific yet highly interrelated components.
1. Interoperable Exchange
All trading partners will be required to exchange transaction information and statements.
The information should be transferred in an electronic, interoperable, and secure manner.
The package-level product identifier must be included in the information.
2. Interoperable Verification
All trading partners will be required to verify packages and sealed homogenous cases with the help of a product identifier.
3. Interoperable Tracing
All trading partners will have to provide transactional information and statements with secure, electronic, interoperable systems and processes.
The request should be responded quickly in order to facilitate information gathering for each transaction going back to the manufacturer.
Phase I requirements end on the given deadline by the FDA DSCSA including the full transaction history of the product to the manufacturer.
DSCSA is a “one up and one back” model where each trading partner has a record of the entity they are connected to.
FDA believes interoperable tracing systems and processes should be capable of providing information equivalent to unit-level transaction history.
The members of the pharmaceutical distribution supply chain are required to report their
- State license
- Contact information
- Disciplinary actions (by federal or state government)
- Translation statement
The reporting of transaction statements is the final phase which goes into effect on November 27, 2023.
Trading partners need to exchange transaction information and statements for each transfer or sale of products subjected to DSCSA.
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