What Pharmacies Need to Know about the Drug Supply Chain Security Act (DSCSA)
Pharmacies need to prepare for DSCSA. Here’s what to be thinking about now.
While most Americans were getting ready for Thanksgiving on November 27, 2013, and retailers were preparing for the busy holiday season, the Drug Quality and Security Act (DQSA) was being signed into law. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Some provisions took effect immediately — like the pre-emption of all state pedigree laws and traceability requirements — with other provisions scheduled to take effect in 2015.
Provided below is basic information about why DSCSA was passed, what it is, some of the key terms, a timeline, and what pharmacy owners should be thinking about now.
Why DSCSA Was Passed
The DSCSA was enacted to improve the security of the U.S. drug supply chain, increase visibility into the supply chain, and provide more specific information about all aspects of the supply chain. In addition, this legislation provides a consistent set of national laws and regulations, replacing a patchwork of often differing state-level rules. This enables consistent traceability of drugs on a national scale, throughout the supply chain.
What DSCSA Is
The Drug Supply Chain Security Act is new federal legislation that creates national requirements for tracing pharmaceutical products throughout the entire supply chain. This new legislation includes provisions for:
- Product identification
- Tracing and verification
- Detection and response
- Wholesaler licensing
- Third-party logistics provider licensing
Full implementation of DSCSA within the next 10 years will result in standardized, unit-level traceability throughout the entire drug supply chain — from the manufacturer to the pharmacy (or provider).
Key Terms and Ideas
Three of DSCSA’s most important terms and ideas are:
- Traceability. Beginning with the drug manufacturer, all human prescription products must be tracked through the supply chain down to dispensers.
- Chain of ownership. Prescription products must be tracked through the entire supply chain, with detail provided at the point of change of ownership. The DSCSA tracks ownership and not the custody of products.
- Transaction records. Transaction records include three components:
- Transaction History (TH), which identifies who has owned the product
- Transaction Information (TI), which describes the product (NDC, description, etc.)
- Transaction Statement (TS), where the seller attests that the transaction is correct and that the TI is accurate
Here are key dates and milestones related to DSCSA, and what they mean for independent pharmacies.
|Date||Event/Milestone||Implications for Pharmacies|
|November 27, 2013||DSCSA enacted. All state pedigree laws and requirements are pre-empted.||No longer need to comply with state pedigree laws, as requirements are no longer in place. Retention of pedigrees from prior to 11-27-13 should be maintained according to prior state requirements.|
|January 1, 2015||Pharmacy trading partners begin passing traceability data.||McKesson and others begin sharing traceability data (TI, TH, TS) with customers. (Dispensers are exempt from retaining this data until 7-1-15.)Also, all supply chain parties, including pharmacies, must have systems in place for appropriately handling suspect and illegitimate products.|
|July 1, 2015||Retention by pharmacies of traceability data.||Dispensers must begin storing/maintaining traceability data for six years from receipt.|
Additional DSCSA milestones have been established by the Food and Drug Administration. See the FDA Implementation Timeline for DSCSA.
What to Be Thinking about Now
In preparation for implementation of DSCSA, independent pharmacy owners can benefit by thinking about:
- Reviewing your state’s traceability laws. DSCSA establishes national traceability requirements, which pre-empt any state-level requirements. If your pharmacy is currently participating in any traceability practices required by your state, speak with your legal representative to understand how those practices may change under DSCSA.
- Establishing a plan to store and retain transaction data. The DSCSA requirement for dispensers to retain traceability data (TH, TI, TS) begins on July 1, 2015. In anticipation of this requirement, it makes sense for pharmacies to think about how to receive, store and maintain traceability data. Preparing can also include thinking about technology requirements. At a minimum, McKesson customers will need to have access to McKesson ConnectSM to pull in traceability data. Also, pharmacies will want to consider how best to respond in the event of an audit or a request for data.
- Learning about requirements for product investigations and reporting. Beginning January 1, 2015, the DSCSA requires all trading partners — including pharmacies — to have systems in place for appropriately handling suspect and illegitimate products and making notifications to the FDA. Pharmacies should understand what is required under the law and have the appropriate systems in place.
So, while some important parts of the DSCSA don’t take effect until 2015, it is important for pharmacy owners to understand the law and begin planning now.
- General information from the FDA about the Drug Supply Chain Security Act
- FDA Implementation Timeline for DSCSA
- FDA Webinar on the DSCSA
- FDA Draft Guidance on Suspect and Illegitimate Product Investigations
- Healthcare Distribution Management Association State Pedigree Map
- Additional information from Healthcare Distribution Management Association