US PHARMA REGULATION

Regulatory Agency

U.S. Department of Health and Human Services (HHS), Food and Drug Administration (U.S. FDA)

Regulation Name

The Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), and which amended the Food, Drug and Cosmetics Act (FD&C) of the U.S. Code of Federal Regulations (CFR)

DSCSA Requirements and Timeline

• January 1, 2015
o Lot traceability: All pharmaceutical manufacturers are required to print lot numbers on packaging for all prescription drugs.
o For: manufacturers, repackagers, distributors, dispensers
• November 27, 2018
o Serialization: All pharmaceutical manufacturers and repackagers are required to include unique serial numbers and expiration dates on prescription drug packaging.
o For: manufacturers, repackagers
• November 27, 2019
o Serial verification: All pharmaceutical wholesale distributors must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute.
o For: distributors
• November 27, 2020
o Serial verification: All pharmaceutical dispensers are required to authenticate and verify all the medicines they buy before selling them to consumers.
o For: dispensers
• November 27, 2023
o Interoperability: The entire supply chain must comply with the DSCSA. Complete unit-level traceability, including aggregation, will be mandatory.
o For: manufacturers, repackagers, distributors, dispensers
WHICH PRODUCTS ARE COVERED AND NOT COVERED IN THE DSCSA?
• Covered: prescription drugs in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution, etc.)
• NOT covered: blood or blood components intended for transfusion (such as radioactive drugs or biologics, imaging drugs, certain IV products, medical gas, homeopathic drugs, lawfully compounded drugs, etc.)

WHAT ARE THE EXEMPTIONS IN THE DSCSA?

– Intracompany distributions
– Distribution among hospitals under common control
– Public health emergencies
– Dispensed pursuant to a prescription
– Product sample distribution
– Blood and blood components for transfusion
– Minimal quantities by a licensed pharmacy to a licensed practitioner
– Certain activities by charitable organizations
– Distribution pursuant to a merger or sale
– Certain combination products
– Certain medical kits
– Certain IV products
– Medical gas distribution
– Approved animal drugs

WHAT ARE THE ADVANTAGES OF DSCSA COMPLIANCE?

The new requirements make it extremely easy to rework packages, meaning that all necessary and important information about the medications will be accessible when scanning the parent. This saves an enormous amount of time, as it will no longer be necessary to open each container to scan each individual child. Since all the data is easily accessible, tracking products throughout the supply chain becomes much easier, and the entire distribution system becomes more efficient, secure and trustworthy.

WHAT ARE THE PENALTIES OF NOT COMPLYING WITH DSCSA REGULATIONS?

Not complying with the DSCSA can lead to fines, suspension or revocation of license, and even civil penalties or imprisonment.