What Is the DSCSA and Why Should I Care About It?
The Drug Quality and Security Act of 2013
Passed into law in 2013, the Drug Quality and Security Act has 2 sections. The first, The Compounding Quality Act, Went into effect in 2013 and gave the FDA more authority to regulate compounded medications. The second, The Drug Supply Chain Security Act (DSCSA) aims to overhaul the security of medications in the US. Designed to protect Americans from counterfeit and misbranded medications. The goal is total visibility and accountability for medications from manufacturer to patient, ensuring there is no place for illegitimate medications in the United States.
For the last 9 years the DSCSA has been shaping pharmaceutical manufacturing and distribution networks. This year it will change the dispensing of pharmaceuticals.
By November 27, 2023, every dispenser of prescription medications must have a secure electronic database with EPCIS data level supported EDI connections to every manufacturer and wholesaler they purchase from in order to both validate and store pedigree information on every medication they receive for a minimum of 6 years.
November 2013
Introduced by Rep. Fred Upton from Michigan, The bill was signed into law on November 27, 2013.
The bill was written in response to the fungal meningitis outbreak that occurred at the New England Compounding Center that killed 64 people and sickened over 750 people others.
The Law has two Acts- The Compounding Quality Act and the Drug Supply Chain Security Act.
The Compounding Quality Act requires compounding pharmacies to register with the FDA and prohibits certain compounding procedures. The Drug Supply Chain Security Act has a 10 year implementation schedule discussed below.
November 2015
Starting November 2015, all medications were required to have lot-level traceability. The Law required the creation of the new GTIN identifier. The DSCSA required manufacturers and wholesalers to begin including Transaction Information (TI), Transaction Statement (TS) and Transaction History (TH) data (T3 Data) information with all medications sold. These data allow purchasing pharmacies to verify where their medications came from.
November 2017
Starting November 2017, Manufacturers of medications were required to begin affixing serial numbers to all products and including that information on their T3 data transmissions. Additionally, manufacturers were required to begin including 2D barcodes on all products. The barcodes contain the GTIN, Serialization Data, Lot Number, and Expiration date.
November 2018
Starting November 2018, Repackagers of medications were required to begin affixing serial numbers to all products they repackaged and including that information on their T3 data transmissions.
November 2019
Starting in November 2019, Wholesalers of medications were required to only accept serialized products from manufacturers. They were also required to begin validating the serial numbers of any products they purchased from other wholesalers.
The FDA announced in October 2020 that they would not enforce this requirement before the November 2023 requirements go into effect. You can read the policy statement here.
November 2020
Starting in November 2020, Resellers of medications, including pharmacies, required to verify the serial number of at least 3 packages or 10 percent of all packages, if there are fewer than 3, in response to a notification of illegitimate product from FDA or a trading partner. Dispensers must only buy and sell serialized products and must comply with other suspect and illegitimate verification requirements, including quarantining such products, conducting investigations, and dispositioning illegitimate products.
The FDA announced in October 2020 that they would not enforce this requirement before the November 2023 requirements go into effect. You can read the policy statement here.
November 2023
November 27, 2023 marks the date the FDA will fully implement all the provisions of the DSCSA, including those that had been unenforced previously. It requires every manufacturer, wholesaler and dispenser of medications to operate a secure, interconnected electronic database that can validate serial numbers, receive and pass T3 data, and report illegitimate products.
So What Does That Mean?
Manufacturer Requirements
As of November 27, 2023 manufacturers are required to include serialization data and package level detail on every medication they produce. They are also required to create T3 data and transmit it to purchasers. Additionally, they are required to validate serialization data requests they receive from wholesalers and dispensers.
Wholesaler Requirements
As of November 27, 2023 wholesalers are required to only accept products with serialization data and package level detail on every medication. They are also required to receive T3 data and transmit it to purchasers. All data must be stored for a minimum of 6 years in a secure electronic database. Additionally, they are required to validate serialization data with the manufacturers and validate serialization requests they receive from dispensers.
A big change that will affect many pharmacies is that now the FDA views any pharmacy that sells, trades or furnishes a medication to another dispenser is recognized as acting as a wholesaler by the FDA. Even if you are just trading with another pharmacy, that transaction will require you to act as a wholesaler and comply with wholesaler provisions of the DSCSA.
Pharmacy Requirements
As of November 27, 2023 dispensers are required to only accept products with serialization data and package level detail on every medication. They are also required to receive and store T3 data according to EPCIS standards for 6 years electronically in a secure database that can both receive data from the wholesalers and manufacturers and send requests for information electronically to them as well. Additionally, dispensers are required to validate serialization data with the manufacturers and wholesalers and validate serialization requests they receive from wholesalers as well.
All of this means each pharmacy will need to have a secure, electronic database that is connected with both wholesalers and manufacturers and is able to electronically verify serial numbers through secure data interchange.
