The Drug Supply Chain Security Act (DSCSA) is a federal regulation designed to enhance the security and transparency of the U.S. pharmaceutical supply chain. It establishes requirements for product tracing, verification, and partner authorization to help prevent counterfeit, diverted, or otherwise harmful drugs from entering the market. Compliance with DSCSA ensures safer distribution practices and greater accountability across manufacturers, wholesalers, pharmacies, and other trading partners.
The Drug Supply Chain Security Act, signed into law on Nov. 27, 2013, outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. These requirements will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. Implementation of these requirements will also improve the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
Requirements for record keeping for dispensed products are established by various State Boards of Pharmacy and may differ from one jurisdiction to another. Please check with your State Board of Pharmacy about recording lot numbers in your dispensing records. DSCSA defines transactions which are subject to track and trace and states: “EXEMPTIONS. —The term ‘transaction’ does not include—(iv) the dispensing of a product pursuant to a prescription executed in accordance with section 503(b)(1);” DSCSA HR3204, 2013.
The DSCSA defines a dispenser subject to the requirements of the DSCSA as “(3) DISPENSER.—The term ‘dispenser’— ‘‘(A) means a retail pharmacy, 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;” DSCSA, HR3204, 2014
DSCSA requires product transaction data for changes of ownership but excludes dispensing to a patient from the definition of what is a DSCSA transaction. Refer to DSCSAEdu for more information.
Global Standard 1 (GS1) standard identifiers will be used for product and party/location identification in the interoperable electronic exchange.
Products will be identified by a Global Trade Identification Number (GTIN). Trading partners will be identified by the Global Location Number (GLN).
In-scope DSCSA product will continue to have NDC numbers. The GTIN includes the NDC.
DSCSA requirements do not apply to nonprescription drugs (over-the-counter drugs) or animal drugs (drugs subject to section 512 of the Federal Food, Drug and Cosmetic Act (FD&C Act)). Drugs that fall under the DSCSA requirements are defined by the FD&C Act.
Product tracing, product identifier, authorized trading partner and verification requirements in Section 582 of the FD&C Act apply to product as defined by Section 581(13) of this Act. Product means “a prescription drug in finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets and lyophilized products before reconstitution).”
The section 582 requirements do not apply to:
There are also exclusions, refer to the definition of transaction noted in section 581(24) of the FD&C Act. This list of applicable DSCSA drugs is dynamic and is subject to change
There is a website on DSCSA that is maintained by several trade groups to aid dispensers with compliance. The website contains some sample SOPs. It is Resources – DispenserEDU.
To distinguish between an FDA-granted exception and a case of missing data, you should cross reference the indicator in your ordering portal against data provided in your DSCSA transaction data to determine if the product is subject to DSCSA.
The serial number wouldn’t be on a patient medication bottle, but they likely would never need it. Only direct customers will be able to access the serial data and transaction data.
The DSCSA defines a dispenser subject to the requirements of the DSCSA as “(3) DISPENSER.— The term ‘dispenser’— ‘‘(A) means a retail pharmacy, 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;” DSCSA, HR3204, 2014.
Masters requires serial DSCSA transaction data from suppliers when purchasing DSCSA in-scope products. Masters then supports customers by capturing serialized product identifiers in the order fulfillment process to generate DSCSA transactional data, ensuring compliance and traceability. All customers are provided access to view, search, download and export their DSCSA transaction data, including the option to receive an industry-standard EPCIS file pushed to their chosen solution. To meet DSCSA data retention requirements, historical lot-level transaction information will remain available on customer portals for six years.
The DSCSA in-scope product indicator in Customer Center and Masters is under development and expected to be deployed soon.
Distributors have been required to comply with DSCSA since Aug. 27, 2025. Customers who purchase DSCSA in-scope product from distributors are required to comply with data serialization as it relates to receiving product and initiating saleable returns.
While Masters provides tools and data to support compliance — such as access to serialized product information and transaction records — customers are responsible for interpreting regulatory obligations. Any information in this document regarding a customer’s DSCSA obligations is not and should not be received as legal advice. We strongly recommend consulting your own legal counsel to ensure your organization meets all DSCSA requirements appropriately.
In your ordering portal, refer to the dedicated DSCSA page for the latest information.
For easy reference, all FDA links can be found at the bottom of the DSCSA page in your ordering portal.
For questions regarding DSCSA, reach out to Masters Customer Support or contact us via email.
Masters customers can call their account manager at 800.982.7922 or email info@MastersRX.com.
What do I do if I do not receive a response on an inquiry? Please allow 24 hours for a reply to any inquiry sent to one of the DSCSA mailboxes. If you do not receive a follow-up, please contact Customer Support directly via your tollfree number.
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