A DSCSA guide for dispensers who are too busy for DSCSA

The Drug Supply Chain Security Act is putting in place new requirements for all trading partners in the prescription drug supply chain. These measures, which go into full enforcement on November 27, 2023, make pharmaceutical products fully traceable to prevent illegitimate, damaged, or harmful drugs from reaching patients.

After the deadline, trading partners who haven't carried out the requirements for their business type will effectively be unable to receive or sell pharmaceutical products. They'll face audits by the FDA and other bodies, and potentially even penalties from their trading partners (some of whom have already set their own compliance deadlines, months in advance of the final one).

It's a transformation of how business is done in the pharmaceutical supply chain, requiring serialized packaging, the creation of interoperable connections between trading partners, a data exchange before or during any product transaction, and more.

Read on for a quick look at the requirements for dispensers: pharmacies, hospitals, supermarkets, and other businesses that dispense prescription drugs to patients.

Authorized Trading Partners

DSCSA defines and provides licensure requirements for pharmaceutical trading partners to do business as Authorized Trading Partners. This doesn't include veterinarians or other businesses that only dispense products for animals. To be considered an Authorized Trading Partner, a dispenser must:

• Accept or transfer direct ownership or possession of a product from or to another pharmaceutical trading partner, including manufacturers, repackagers, wholesale distributors, and other dispensers.
• Hold a valid license under state law.

As well, they must meet one of the following criteria:

• Operate a retail pharmacy; operate a hospital pharmacy; or operate a group of chain pharmacies, under common ownership and control, that do not act as a wholesale distributor.
• Be authorized by law to dispense or administer prescription drugs.
• Operate affiliated warehouses or distribution centers of a dispenser, under common ownership and control, that does not act as a wholesale distributor.

There are also measures for management of trading partners. Dispensers must:

• Implement protocols to verify any applicable state laws for licensure and registration for all new trading partners.
• Implement protocols for regular audits to verify the status of its trading partners.

Interoperability

DSCSA requires trading partners to form interoperable point-to-point connections to conduct transactions, using systems that can import and process one another’s data. After this requirement goes into effect, dispensers can only receive shipments with serialized and properly aggregated data. The industry has largely adopted GS1’s EPCIS standard for interoperable data.

The EPCIS onboarding process must be completed between each pair of trading partners; each implementation can take a few weeks, so it's a good idea to start on this with several months to spare before the DSCSA deadline.

Under this requirement, dispensers must exchange serial data in a secure, interoperable, electronic manner. As well, they must implement systems and process that can:

• Verify serialized products.  
• Respond to FDA requests.
• Accept saleable returns.

Serialization, Verification, and Enhanced Security

Dispensers can only buy or sell prescription drug products that are encoded with serial numbers in the 2D data matrix barcode and the human-readable text format, with exceptions for certain grandfathered products.

You'll need systems and processes in place to handle suspect or illegitimate products.

• Verify suspect products using serialized data.
• Quarantine suspect products until they can be either cleared to be dispensed or removed from the supply chain.
• Conduct investigations to determine illegitimacy.
• Resolve discrepancies in transaction information within three business days. (This is an element of exceptions management, which is a must for all pharma trading partners!)
• Report findings to the FDA, including notifying the agency of illegitimate product within 24 hours (via FDA Form 3911).
• Report findings to trading partners, including notifying immediate trading partners of illegitimate product within 24 hours.

You can satisfy DSCSA’s verification requirements by developing a secure electronic database, or using a secure electronic database developed by a third party.

Product Tracing

Product tracing relies on electronically delivered 3Ts data: Transaction History, Transaction Information, and Transaction Statement. (Note that Phase II of DSCSA eliminates the requirement for Transaction History.)

Dispensers must:

• Receive or send transaction data for each product before or at the time of a given transaction.
• Capture transaction data as necessary to investigate a suspect product.
• Maintain this information for at least six years after a transaction.

Requests For Information

Dispensers must respond to any request for information from the FDA, or any other state or federal agencies, relating to a recall or suspect product investigation.

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While DSCSA is complex and transformative, a pharmacy can complete its DSCSA compliance journey months in advance of the November deadline. LSPedia offers the industry's leading tools and its most affordable price. Further, it employs serialization data for expiration management and store transfer to cut dead stock costs.

LSPedia's OneScan Pharmacy Pro is the most accessible path to audit-proof compliance:

• Easy-to-use interface
• 1-3 day implementation time
• API integration
• ATP database
• FDA 3911 reporting
• Multi-level user assignment
• LSPedia Compliance Guarantee

Waiting too long into 2023 will have serious costs and risks; don't put your business in danger of non-compliance when help is easily within reach. Contact us today or write to DSCSA@lspedia.com to get on the path to a stress-free 2024.