Glossary for DSCSA

  • ASN – Advance Shipping Notice.  Required to be sent to the pharmacies prior to or when the product ships.  It includes information on the products and quantities being shipped. In the US there are roughly 67,000 pharmacies and 20mm ASNs per year. 
  • Direct Purchase – products purchased by a wholesale distributor directly from a manufacturer may not contain a lot number, previous transaction date or previous ship date.  A wholesale distributor that purchases “direct” is buying from a manufacturer, a repackager that purchased direct, or an exclusive distributor. 
  • Distributor – an entity or person (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider (3PL) or repackager) engaged in wholesale distribution (as defined in the DSCSA and FD&C Act) 
  • DQSA – the Drug Quality and Security Act.  Composed of two sections, Title I and Title II.  The first section, Title I, focuses primarily on pharmaceutical compounding while the second section is concerned with supply chain safety of manufactured pharmaceuticals.  The legislation can be found here: https://www.gpo.gov/fdsys/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf  
  • DSCSA – Title II of the Drug Supply Chain Security Act of 2013, sometimes referenced as “Track and Trace” is legislation passed November 27, 2013 designed to identify and quarantine potentially illegitimate or counterfeit drug products.  The goal is complete tracking of pharmaceuticals throughout the US supply chain. 
  • Electronic Interoperability – a term used within the DSCSA that describes the ability of supply chain partners to exchange drug product information and ownership history within an interoperable database or process.  Scheduled to be implemented for compliance by the entire pharmaceutical supply chain by November 27, 2023. 
  • Dispenser – has final ownership of drug product in the pharmaceutical supply chain.  Dispensers are generally pharmacies, but can be hospitals, clinics, or other facilities that “dispense” the medications directly to patients.  
  • Exempted Products – ownership of some products is not required by DSCSA to be traced for some drug products.  These include: 
    • Blood or blood components 
    • Compounded drugs under 503A or 503B 
    • Homeopathic drugs 
    • Imaging drugs including imaging intravenous products 
    • Medical Gases 
    • non-prescription drugs 
  • FDA – the Food and Drug Administration is the federal agency with oversight of implementation, regulation, and enforcement of the DSCSA legislation.  FDA provides “guidance” through publication of guidance documents for interpretation of legislation and has published several guidance documents for DSCSA since passage of this legislation.  More guidance is expected through 2023 for DSCSA and can be found here: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa 
  • FDA Form 3911 – Drug Notification form for submission of suspect product data to FDA upon determination that a drug product is illegitimate.  This form must be filled out online.  Directions, information, and a link to the webform may be found here: https://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm  
  • Manufacturer – as used within the DSCSA to refer to those supply chain partners where ownership of drug product originates. 
  • Repackager – a supply chain participant that does not manufacture pharmaceuticals, but repackages them for themselves or other supply chain participants. 
  • Serial Numbers – pharmaceutical products manufactured after November 27, 2017 must be serialized.  This is generally done by placing serial numbers, in human readable form and embedded in 2D barcodes on the smallest saleable unit of pharmaceutical containers.  Investigation by FDA or other authorities may require collection of serial numbers for submission and documentation of prior ownership. 
  • Product Identifier – DSCSA requires drug manufacturers and repackagers (as defined in sections 581(10) and 581(16) of the FD&C Act, respectively) to affix or imprint a product identifier on packages for certain prescription drugs for human use. Under section 581(14) of the FD&C Act, a “product identifier” is a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier, the “standardized numerical identifier,” lot number, and expiration date of the product. 
  • Standardized Numerical Identifier – a component of the product identifier, is comprised of the NDC and a serial number. 
  • Prohibited Act – Failure to comply with a DSCSA requirement is a prohibited act under the FD&C Act. Commission of a prohibited act subjects a party to: 
    • Civil and criminal fines and penalties. This may include jail. 
    • Injunction of unlawful activity 
    • Seizure of goods 
    • States may also impose separate or additional penalties. 
  • Lot Numbers – Dispensers, when responding to FDA requests, do not need to provide the lot number as part of transaction history if not originally included in your transaction data report. 
  • OTC (over-the-counter) – over the counter drugs are those that do not require a prescription for sale to patients.  OTC drugs are exempt from DSCSA tracking requirements.  Some controlled substances are in DEA Schedule 5 and are also classified as OTC.  These are exempt from DSCSA tracking requirements. 
  • T3 Data – Refers to the three pieces of data that are to accompany drug products; Transaction Information, Transaction History, and Transaction Statement.  This data is required to be made available electronically by November 27, 2017 and it must be stored for at least six (6) years.  Wholesalers are permitted to hold this data for dispensers, but a written agreement is required by law to have been in place by November 27, 2017. 
  • Transaction history (TH) – An electronic statement that includes the transaction information for each prior transaction for a product back to the manufacturer. 
  • Transaction Information (TI) – information about the drug product required to be included with transfer of ownership of a drug product between supply chain partners and includes the following information: 
    • Proprietary or established name or names of the product; 
    • Strength and dosage form of the product; 
    • Container size; 
    • Number of containers; 
    • Date of the transaction; 
    • Date of the shipment, if more than 24 hours after the date of the transaction; 
    • Business name and address of the person from whom ownership is being transferred;  
    • Business name and address of the person to whom ownership is being transferred; 
    • National Drug Code number of the product; 
    • Lot number of the product; 

November 27, 2023 the following two elements must be added to the Transaction Information:  Serial Number (new) & Expiry (new)

  • Transaction statement (TS) – Paper or electronic attestation by the entity transferring ownership of the product that it: 
    • Received the product from an authorized party 
    • Received the TI and TS from the previous owner of the product 
    • Did not knowingly ship suspect or illegitimate product 
    • Selling entity has systems and processes in place to perform verification 
    • Selling entity did not knowingly provide false transaction information and did not alter the transaction history 
  • Wholesaler – pharmaceutical supply partners that purchase, house, and warehouse drug products for final purchase typically by dispensers.  Wholesalers do not distribute to patients.