Drug Supply Chain Security Act (DSCSA) Resources for Dispensers.
What is The DSCSA?
The DSCSA, enacted in 2013, preempts a 50-state patchwork of pedigree requirements to create one federal traceability framework for prescription medicines. The DSCSA sets out a 10-year timeline to build an electronic, interoperable system for the exchange of transaction documentation [transaction information (TI), transaction history (TH) and transaction statements (TS)] to enable the tracing of prescription medicines, serialized at both the case and the smallest unit of sale, throughout the pharmaceutical supply chain. At the end of August, 2023, FDA announced a one-year stabilization period. This period extends enforcement flexibility until November 27, 2024 in order to give supply chain partners the time they need to stabilize data exchange, systems and processes developed to meet the final implementation requirements of DSCSA The FDA has stated that it intends for trading partners to keep working diligently but also recognized supply chain readiness gaps and wanted to ensure that products continue to move through the supply chain.
DSCSA defines a dispenser as:
- A retail pharmacy;
- A hospital pharmacy;
- A group of chain pharmacies under common ownership and control that do not act as a wholesale distributor; or
- Any other person authorized by law to dispense or administer prescription drugs and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor
Overview of DSCSA Milestones
Manufacturers and wholesale distributors must provide lot TI, TH and TS.
Product identifiers by manufacturers
Manufacturers must affix product identifiers to each package and homogenous case.
Product identifiers by repackagers
Repackagers must affix product identifiers to each package and homogenous case.
Verification by distributors
Wholesale distributors must only accept serialized product. They must also verify product identifiers with the manufacturer before redistributing returns. However, FDA has announced, by way of a “compliance policy” that it will not enforce this saleable returns verification requirement until November 27, 2023. The compliance policy is limited to the requirements that wholesale distributors verify saleable returned products prior to further distribution and have verification systems in place to comply with the requirements of section 582(c)(4)(D) of the FD&C Act; it does not extend to the other requirements in section 582 of the FD&C Act.
Verification by dispensers
FDA has announced in this compliance policy that it will not enforce until November 27, 2023, two dispenser verification requirements that went into effect on November 27, 2020. Without this enforcement discretion, beginning November 27, 2020, dispensers would have been required to verify the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all packages, if there are fewer than 3. Dispensers would also have had to verify product in this manner (3 packages/10 percent) in response to a notification of illegitimate product from FDA or a trading partner. Dispensers now do not have to verify suspect and illegitimate product in this manner until November 27, 2023. Other requirements, however, are still in effect. Dispensers must still only transact product encoded with a product identifier (unless the product is grandfathered or subject to an applicable waiver, exemption or exception) and must comply with other suspect and illegitimate verification requirements, including quarantining such products, conducting investigations, and dispositioning illegitimate products.
Manufacturers, distributors and dispensers must provide and receive TI (including product identifier) and TS in a secure, electronic and interoperable manner. Note this requirement is subject to the stabilization period described below.
In August 2023, FDA announced a 1-year “stabilization period” for the industry to accommodate additional time for trading partners to adhere to DSCSA requirements.
Enhanced Drug Distribution Security Requirements
Manufacturers, distributors and dispensers must provide and receive TI (including product identifier) and TS in a secure, electronic and interoperable manner.