What is Title II of the Drug Supply Chain Security Act and how are pharmacies affected?

Title II of the Drug Supply Chain Security Act (Act) established a national system for the tracking of pharmaceutical drugs. It was created to address, as well as prohibit, threats to the security of the drug supply chain.

It was designed to prevent:

• Counterfeit products
• Product theft
• Gray market transactions

When passed, the Act took the place of any separate state requirements and extended regulations into all categories of the supply chain including:

• Dispensers -i.e. retail pharmacies.
• Hospital pharmacies.
• Groups of chain pharmacies under common ownership.
• Any other professionals who dispense or administer prescription drugs, as authorized by law.

What types of documentation is required for pharmacies under Title II?

As a product moves through the supply chain, certain documentation is required, and pharmacies are required to keep records of this movement.

Types of documents required:

• Transaction History
  • A statement (paper or electronic) including the transaction information for each prior transaction going back to the manufacturer.
• Transaction Information
  • The proprietary or established name(s) of the product; strength and dosage form; National Drug Code Number; container size; number of containers; lot number of the product; date of the transaction; date of the shipment (if more than 24hrs after transaction); and the business name and address of the destination.
• Transaction Statement
  • A statement (paper or electronic) that transfer of ownership is authorized and the person or entity performing the transaction:
    • Received the product from an authorized person.
    • Received proper transaction information from the previous owner.
    • Did not knowingly ship a suspect or illegitimate product.
    • Had compliance and process systems in place.
    • Did not knowingly provide false transaction information or alter the history.

What documentation do pharmacists need in order to take ownership of a product?

Prior to taking ownership of a product, the previous owner must provide the transaction history, transaction information, and a transaction statement. In addition, any transfer of ownership that is not through dispensing to a patient or making a return must be accompanied by the same document.

            Exceptions:

• Sales from one dispenser to another to fulfill a specific patient need.

Dispensers are also required to capture transaction information and history, as it may be pertinent to investigate suspicious product. This information is required to be kept for six years.

• Dispensers may engage with Third Parties to maintain transaction information, history, and statements on their behalf.
• A written copy of such an agreement is required to be kept on file, and the dispenser remains responsible for the obligations related to the documents.

What should pharmacies do in the event of a recall, or when investigating a suspicious product?

Pharmacies must comply with the appropriate state and federal officials by providing the Transaction History, Transaction Information and Transaction Statements which were received by the previous owner.

• These documents must be submitted within two days of the receipt of the request, or as otherwise specified.
• The initial lot number, transaction date and shipment date from the manufacturer are not required, unless they were included in the documents the dispenser received from the manufacturer or wholesaler.

What do Pharmacies need to know about “Product Identifiers?”

Beginning in 2020 stricter regulations will take effect. A dispenser is prohibited from engaging in transactions involving non-coded or non-identified products coming from authorized trading partners with appropriate state and federal licensure.

• A “Product Identifier” is a graphic containing both human and machine readable data including an expiration date and a set of uniquely identifiable data for tracking and fraud prevention purposes.

What should a pharmacy do if they believe a product in their possession is illegitimate?

,Beginning in 2020, dispensers are required to have systems in place that enable them to determine if a product is suspect upon receipt, quarantine the product and promptly conduct an investigation.

• The investigation must include a verification of the lot number, standardized numerical identifier, and product identifier.
• At least three packages must be checked, or ten percent – whichever is greater.
• If there are fewer than three packages, the transaction history and transaction information must be validated.
• Any irregularities discovered throughout this process must be reported to the authorities and the dispensers’ trading partners within twenty-four hours to begin an investigation.
  • Records of this process must be kept for six years.
• Proper protocol must be used when disposing of irregular products, and a sample must be retained for investigative purposes.

Are there any other rules or regulations that pharmacies should be aware of?

It should be noted that the FDA issues regular guidance and rules regarding drug compounding and drug security. It is important to be aware of the FDAs process and their implementation of the Act.