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PrimeRx and InfiniTrak Help Pharmacies Prepare for DSCSA Compliance

Pharmacists should mark November 27, 2023, on their calendars as an important date, as key provisions of the Drug Supply Chain Security Act (DSCSA) - also known as the "track-and-trace" law - are set to take effect on that day. PrimeRx has partnered with InfiniTrak, a leading solutions provider for DSCSA requirements, to enhance its compliance efforts.

The FDA implemented the DSCSA to safeguard the US pharmaceutical drug supply chain from dangerous or counterfeit drugs. Its objective is to improve the FDA's ability to protect consumers from drugs that may be fake, contaminated, stolen, or otherwise harmful.

Pharmacies must comply with the following requirements for DSCSA:

- Verify the licensure of ALL drug suppliers.

- Receive and store all transaction data for six years.

- Reconcile transaction information with the actual product received.

- Develop Standard Operating Procedures (SOP) for investigating, identifying, and reporting suspect or illegitimate products.

- Verify that ALL products have a product identifier (2D barcode).

- Provide ALL data in question within 48 hours to satisfy the auditor in case of an audit or inspection.

- Provide complete and accurate transaction data if selling or lending products to other pharmacies.

Pharmacies must comply with the following requirements on November 27, 2023:

- Continue to comply with the first phase of the law.

- Electronic Product Code Information Services (EPCIS) format will officially replace EDI from drug suppliers; pharmacies will be required

        to receive and store electronic data only.

- Have Global Location Numbers (GLN) as required by ALL pharmacies.

- Conduct product verification for ALL suspected products.

- Trace products within 24 hours of a request.

PrimeRx acknowledges the necessity for a comprehensive DSCSA compliance solution and is collaborating with InfiniTrak to offer an integrated solution that streamlines the processes that pharmacies must observe.

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