Track and Trace
Rachel Balick
Despite APhA’s concerns that compliance with certain Drug Supply Chain Security Act (DSCSA) requirements undermines pandemic response efforts, FDA has confirmed that “dispensers,” including pharmacies, must meet a requirement that went into effect on November 27, 2020. APhA and pharmacy partners had requested that FDA delay enforcement of certain portions of the DSCSA—also known as “track and trace”—mandates. Read APhA’s letter expressing its concerns at apha.us/DSCSA_concerns.
Check for product identifiers
DSCSA, once fully implemented, requires all members of the supply chain—including pharmacies—to use an electronic, interoperable system that traces a drug at the unit level throughout the supply chain until it reaches the pharmacy. Requirements unfold in several phases over a 10-year period, ending in 2023. Certain benchmarks were to be hit in 2020, although APhA and pharmacy partners contend that efforts to fight COVID-19 should take precedence.
FDA didn’t quite see it that way.
Starting November 27, 2020, pharmacies must buy and sell—what the track-and-trace law refers to as “engaging in transactions”—only products with a required “product identifier” on their packages.
Most products packaged by manufacturers after November 27, 2018—although not all—must be affixed or imprinted with a product identifier that features the products’ National Drug Code (NDC) plus a unique serial number, lot number, and an expiration date. By November 27, 2020, dispensers should have processes in place to ensure the product identifier is on the package when they receive products that require it. The product identifier must be a standardized graphic in both human-readable format and on a machine-readable data carrier in a 2D data matrix barcode.
“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA senior vice president of pharmacy
practice and government affairs. “If unsure, check the transaction statement to see if a product identifier should be on the package.”
Dispensers, however, will not yet be required to scan product barcodes upon receipt. “[But], dispensers may opt to scan some percentage of their received product to ensure that the product carries a product identifier,” the Pharmaceutical Distribution Security Alliance (PDSA)—a coalition
of supply chain stakeholders of which APhA is a member—wrote in a Q&A for dispensers. “In the future, scanning will aid dispensers in fulfilling key 2023 obligations under the DSCSA.”
► Key tip:
Pharmacists who encounter products without a product identifier should determine whether the product is grandfathered or otherwise doesn’t require one. Dispensers may accept grandfathered product if the transaction statement says that the product was introduced into the drug supply chain before November 27, 2018. Find more information at https://apha.us/FDA_DSCSA. Read the full scope of the grandfathering exemption in FDA’s final guidance at https://apha.us/Grandfathered.
A granted reprieve
In October 19, 2020, guidance, FDA did grant a pharmacy-community request that the agency delay enforcement of the DSCSA requirement that dispensers verify the product identifiers of suspect or illegitimate products. The agency will not act against dispensers who do not comply with the requirement before November 27, 2023. If FDA had not issued the delay, which gives pharmacies more time to focus on COVID-19 response efforts, dispensers would have been expected to comply by November 27, 2020. Read the guidance at apha.us/DSCSA_guidance.
“For suspect and illegitimate product, dispensers must still quarantine product, conduct investigations, and [arrange for] disposition [of] illegitimate product,” Bernstein said.
According to PDSA, the second requirement—which goes into effect on November 27, 2023—mandates that when dispensers conduct a suspect product investigation, they must
Verify whether the lot number of a suspect product corresponds with the lot number for such product.
Verify the product identifier, including the serial number, of at least three packages or 10% of such suspect product, whichever is greater. Investigations must commence “upon making a determination that a product in the possession or control of the dispenser is a suspect product, or upon receiving a request for verification from FDA that has made a determination that a product within the possession or control of a dispenser is a suspect product.” Electronic verification—dispensers may choose to use phone, fax, or other means—was already not to be enforced until 2023.
► Key tip:
If the dispenser, in coordination with the manufacturer, concludes that a product in the dispensers’ possession or control is illegitimate, the dispenser shall follow specific steps outlined in DSCSA:
- Arrange for disposition of illegitimate product, and assist with trading partner’s disposition.
- Retain a sample of the product for further physical examination or laboratory analysis.
- Notify FDA and all immediate trading partners within 24 hours of making an illegitimate product determination.
- Respond to notification from FDA that product is illegitimate, and identify all illegitimate product subject to the notification.
- Terminate the notification if such a determination is made in consultation with FDA.
- Maintain records of disposition of an illegitimate product for 6 years after disposition.
► Key tip:
Transaction information: A paper or electronic statement that includes product name, strength, dosage form, National Drug Code (a unique, three-segment number that serves as a universal product identifier for drugs), container size, strength and dosage form, number of containers, transaction date, shipment date, name and address of the seller and buyer, and lot number.
Transaction history: A paper or electronic statement that includes the transaction information for each prior transaction of the product back to the manufacturer.
Transaction statement: A paper or electronic confirmation transferring ownership of the product.
Current dispenser requirements
The Pharmaceutical Distribution Security Alliance, a coalition of supply chain stakeholders of which APhA is a member, recently published DSCSA questions and answers for dispensers. They noted that dispensers’ current track-and-trace obligations—those for which dispensers must already have systems and processes in place—are that
- They should accept ownership of a product only if the previous owner provides transaction history, transaction information, and a transaction statement (known as “the 3Ts”).
- They must provide subsequent owners of a product with the 3Ts at the time of or prior to the transaction.
- They must capture and store the 3Ts, including lot level information if provided, for no less than 6 years after the transaction.
- They must reply to FDA or other federal or state agency requests for information within 2 business days.
- They must only engage in transactions with authorized trading partners, and
- They must conduct a suspect-product investigation that includes the capability to quarantine suspect products in their possession or control.
► Key tip:
Dispensers that transfer products to another dispenser without a specific patient need may need to register as a wholesale distributor or refrain from the transaction unless another exemption is satisfied.
On the horizon
The next phase of DSCSA’s full implementation involves enhanced drug distribution security. Its compliance deadline is November 27, 2023.
Why it matters: An electronic system will improve the ability to recall products, detect illegitimate products earlier, and secure the supply chain. Currently, FDA and the drug supply chain—including dispensers—are considering the standards and processes needed to achieve this goal. The systems and processes that pharmacies must implement will change workflow as products are received and returned, among other circumstances.
► Exchange transaction information (e.g., product identifier at the package level) and transaction statements in a secure, interoperable, electronic manner.
► Implement systems or processes for package-level product verification, which may include use of aggregation and inference, as nec-essary.
► Implement systems or processes for verification of product at the package level, including the standardized numerical identifier.
► Implement systems or processes to promptly facilitate gathering the information necessary to produce the transaction information and transaction statement for each transaction going back to the manufacturer, if FDA or an authorized trading partner requests a suspect or illegitimate product investigation.
► If a dispenser enters into a written agreement with a third party—including an authorized wholesale distributor—to confidentially maintain required information and statements, the dispenser must maintain a copy of the written agreement.
Key:
► Complete at least once
► Continuous requirement
► Key tip