Article Summary
[Delayed until 2023] Information regarding two new DSCSA medication serialization requirements that will take effect for Dispensers on November 27, 2020.
Please review our Previous Article on DSCSA Regulations for additional background information on what DSCSA is and how it impacts drug supply-chain and dispensing.
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10/23/2020 UPDATE: FDA Releases Guidance that Wholesaler and Provider Verification Requirements will be delayed until November 27, 2023.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser
- Below information no longer applies to providers, but will be left in place to educate providers on requirements that will be required in the future.
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DSCSA Background
The Drug Supply Chain and Security Act (Title II, Drug Quality and
Security Act, 2013) addresses risks in the pharmaceutical distribution
supply chain by establishing a national system that allows stakeholders
and regulators to trace each package of product. The serialization and
traceability requirements will be phased in over 10 years (2013-2023).
The law requires all sectors in the supply chain, manufacturers,
repackagers, wholesale distributors, and dispensers to participate.
Two New Requirements for Dispensers that become effective on November 27, 2020 2023
1. Accept only serialized products: Dispensers may engage in transactions only of products encoded with a unique product identifier (PIs), which will be used to verify a drug's legitimacy and enable product tracing in the event of a recall or identification of a suspect product.
- A
PI is a standardized graphic with three elements: the product's
standardized numerical identifier (SNI), which comprises the National
Drug Code (NDC) plus a unique alphanumeric serial number; a lot number; and
an expiration date. PIs must be in human- and machine-readable formats.
- The FDA issued guidance that clarified that any product packaged by the manufacturer before November 27, 2018 is considered grandfathered or exempt from being serialized and may be sold until expiration date.
2. Verify unique product identifier of suspect products at package level: Dispensers must verify the product identifier, which includes the standardized numerical identifier, or SNI, for products they suspect are potentially counterfeit, diverted, or otherwise unsafe at the package level for at least three packages or 10 percent of suspect products, whichever is greater.
- The
FDA defines a package as the smallest unit placed into interstate
commerce by the manufacturer or the repackager that is intended by that
manufacturer or repackager, as applicable, for individual sale to the
pharmacy or other dispenser of the drug product.
- Since 2015, all DSCSA trading partners, including Dispensers, have been required to have policies and procedures to detect and investigate suspect products. As a part of that suspect product investigation, beginning November 27, 2020, Dispensers are expected to add the verification of product identifiers, including serial number, to the process.
FAQ
- Do dispensers have to scan barcodes to prove they are receiving only in serialized product? No. The DSCSA does not require dispensers to scan product barcodes upon receipt. Some dispensers may see a benefit to scanning barcodes to capture serial numbers at the time of dispense. Others see simply documenting a process to visually check for the 2D barcode prior to accepting product as compliant.
- Does receiving serialized product require dispensers to receive and/or store serialized data in 2020? No, serial numbers are not required to be incorporated into dispensing transaction information (TI) until November 27, 2023. MDScripts already supports capturing and storing serial numbers at the time of dispense by scanning the serialized barcodes. You can enable Serial Number field in the Cart under Home -> My Site -> Input Fields if you would like to begin monitoring serial numbers of bottles you are scanning and dispensing.
- Do dispensers need to have processes in place to authenticate and verify all the medicines they receive? No. Dispensers are not required verify all the medicines they buy prior to dispense. Dispensers are only required to verify the product identifier exists and only verify specific serial numbers when investigating suspect product.
Additional Information:
DSCSA Law Link: https://www.govinfo.gov/conten...
FDA Grandfathering Policy for Packages and Homogeneous Cases of Product Without a Product Identifier,Guidance Link: https://www.fda.gov/media/1095...
This information is being provided for informational purposes and is not intended to be construed as legal advise. Please consult your legal or regulatory counsel if you have specific questions relating to how DSCSA requirements may impact your practice. If you have specific questions about how the medications you purchase and dispense may be impacted, please contact your medication supplier.