Navigating Pharmaceutical Supply Chain Security

The Drug Supply Chain Security Act (DSCSA), signed into law on November 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 enhance the Food and Drug Administration’s (FDA) ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. Implementing these requirements also improves the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

For eligible trading partners that meet the conditions of the FDA’s Oct. 9, 2024, exemption, these trading partners are exempt from certain DSCSA requirements until the following dates:

• Manufacturers and repackagers were required to comply with applicable DSCSA requirements starting May 27, 2025.
• Wholesale distributors were required to comply with applicable DSCSA requirements starting August 27, 2025.
• Dispensers with 26 or more pharmacists and technicians remain exempt until November 27, 2025.
• Dispensers with 25 or fewer pharmacists and technicians remain exempt until November 27, 2026. Here is the  link to the full FDA exemption announcement for small dispensers.

While eligible large dispensers (26 or more pharmacists/technicians) have an exemption from certain DSCSA serialization requirements until Nov. 27, 2025, and eligible small dispensers (25 or less pharmacists/technicians) have an exemption from certain DSCSA serialization requirements until Nov. 27, 2026, the DSCSA requirements for distributors for saleable returns became effective on Aug. 27, 2025.

GS1 (Global Standard 1) standard identifiers are used for product and party/location identification in the interoperable electronic exchange. Products are identified by Global Trade Identification Number(s) (GTIN). Trading partners are identified by Global Location Number(s) (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 Food Drug & Cosmetic 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:

• Blood or blood components intended for transfusion
• Radioactive drugs or biologic products
• Imaging drugs
• Certain intravenous (IV) products
• Medical gases
• Certain homeopathic drugs
• Lawfully compounded drugs
• There are also exclusions, refer to the definition of transaction noted in section 581(24) of the FD&C Act. This list of in-scope DSCSA drugs is dynamic and is subject to change.

This information is available on the item product page of all McKesson ordering portals.

Prior to the customer’s respective serialization DSCSA effective date, customers should make changes, including but not limited to the following:

• All customers (dispensers, health systems, pharmacies, etc.) should be prepared to respond directly to regulators if asked about tracing information for DSCSA products they have purchased. McKesson cannot respond to regulators on the customer’s behalf.
• All trading partners, including dispensers, are expected to be able to search the repositories where their serial DSCSA transaction information and transaction statements are stored and retrieve the requested information upon request.
• DSCSA transaction data will be accessible through McKesson portals or in the customer’s in-house or third-party system if the customer requested this information to be transferred to such system. A link to this data will be added to the portals once this feature goes live.
• All trading partners will need to check the serialization number before making a return of a DSCSA product to McKesson to ensure that they purchased the serial product identifier on the product in question from McKesson before initiating the return.
• Product returns where McKesson is unable to verify or associate the product cannot be accepted for saleable return under the DSCSA.
• Dispensers should continue to perform suspect product reviews and investigations as they have since 2015. Use of the DSCSA transaction data may be necessary when conducting suspect product investigations.
• McKesson will provide training to support education efforts to help enable implementation of the DSCSA’s requirements.

*Customers should not rely on this information as legal or other professional advice with respect to the customer’s DSCSA obligations.

*The information on this page contains references to dates that have now been updated as of Oct. 9, 2024, when the Food and Drug Administration (FDA) announced new deadlines for DSCSA compliance for eligible manufacturers, distributors and pharmacies (FDA Exemption). New deadlines for DSCSA compliance for eligible manufacturers, distributors and pharmacies (FDA Exemption).